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Strong, Graham --- "Is patent law effective at protecting Māori medical knowledge in mānuka from commercial exploitation by university technology transfer offices? - a New Zealand University Technology Transfer Office perspective" [2021] UOtaLawTD 24

Last Updated: 14 April 2024

Is patent law effective at protecting Māori medical knowledge in mānuka from commercial exploitation by University Technology Transfer Offices?—a New Zealand University Technology Transfer Office Perspective

Graham Strong

A thesis submitted for the degree of MASTER OF LAWS

at the University of Otago, Dunedin, New Zealand Date: 30 September 2021

Dedication

Mō tātou, ā, mō kā uri ā muri ake nei For us and those who come after us

Acknowledgments

Throughout the writing of this thesis, I have received a great deal of support and assistance. First, I would like to thank Otago Innovation Limited, the Technology Transfer Office of the University of Otago, for funding support, without which this work would not have happened. The support is generous, and I am grateful.

I want to thank my supervisors, Professors Shelley Griffiths and Jacinta Ruru. Their expertise has proven invaluable to guiding and sharpening my thinking throughout this work as I navigate the world of law. Their patience with a scientist has been generous; their calm and reassuring presence has proven invaluable. They kindly agreed to help me.

I would like to acknowledge my colleagues from Otago Innovation Limited, who have embraced Te Ao Māori. I would like to specifically single out David Christensen, our CEO, for advocating and supporting this work with time, funding and expertise: this is very much appreciated.

I would like to thank Wendy for her love, support, sympathetic ear and patience for putting up with me during the past couple of years while I undertake this work. Alongside her—Stelly, Milo, Jazz and Baz for providing the happy distractions that only puppies can provide.

Whakamutunga, ki taku whaea. Ka kite ahau i a koe i ngā whenua wairua.

Capstone Editing provided copyediting and proofreading services, according to the guidelines laid out in the university-endorsed national ‘Guidelines for Editing Research Theses’.

Abstract

The research, science and innovation system (RSI) in New Zealand seems set to undergo significant changes. Those changes seem to seek to embed the Treaty of Waitangi and mātauranga Māori into the day-to-day practice of universities. Impending change is significant for technology transfer offices (TTOs) as the commercialisation arm of universities. The TTOs’ mission is to produce revenue for their university through commercialising ideas. Medical inventions are highly coveted since they have a greater chance of attracting potential investors and are thus more likely to succeed. Numerous such inventions are developed from taonga species and/or traditional knowledge. TTOs strive to patent those ideas and then collaborate with pharmaceutical or nutraceutical firms to commercialise them. Suppose changes to the RSI system are implemented. In that case, TTOs will need to confront the tension between the existing intellectual property regime and mātauranga Māori in their day-to-day commercialisation efforts. As such, this thesis employs the perspective of the university technology transfer office to investigate, scrutinise and evaluate whether patent law effectively protects Māori medical knowledge from commercial exploitation by TTOs. I use mānuka as an exemplar.

To investigate the question thoroughly, I broke the legal question down into several contextual and investigatory chapters. Chapter I introduces the problem and whether Māori may be able to successfully safeguard Māori traditional knowledge against commercial exploitation by university TTOs by relying on patent law. Chapter II discusses the legal measures currently in place to protect mātauranga Māori and whether those measures are likely to dissuade TTOs from leveraging Māori medical knowledge in mānuka commercially. Chapter III examines TTOs’ commercial use of Māori medical knowledge in mānuka. The concepts of inventorship, ownership and benefit- sharing are addressed in relation to the commercialisation of an invention. I describe various extra- legal concepts and techniques that TTOs should be aware of and that Māori may use to safeguard their mānuka medical knowledge from commercial misuse. Chapter IV discusses the final component of my thesis—the effectiveness of patent law, where I apply an “effectiveness test” to determine whether the law does what it is supposed to do. Chapter V amalgamates all the above into a discussion and conclusion.

While the foregoing factors are cumulative when applied to my discoveries via a technology transfer lens, I question whether patent law on its own successfully protects Māori medical

knowledge in mānuka from commercial exploitation by university TTOs. Protection seems more likely to result from legal and non-legal sources. These sources of protection include the deterrent of reputational harm caused by commercialising Indigenous peoples’ knowledge without permission. Patent applications for mānuka also have a high failure rate (83 per cent), as it is difficult to meet the legal tests for patentability. Therefore, mānuka inventions are often unable to be protected or monopolised by TTOs.

These factors contribute to the riskiness of investing in technology associated with Māori medical knowledge in mānuka. Without prior informed consent from Māori and access and benefits agreements, TTOs would require a very strong cause to commercialise such a technology. Once such agreements are in place, it becomes a matter of assessing whether the invention meets the patentability criteria or standards defined by patent law. A convincing case can be made for TTOs to become involved early in the commercialisation of university-derived ideas and discoveries and consider partnering with Māori at the early stage of research ideation.

Contents
List of Abbreviations

List of Figures

Figure 1. The mānuka map: an overlay of domestic intellectual property law, traditional rights and intellectual property law, commercially relevant law and regulations, and key facts against patent applications, publications, trade

marks and granted patents. 93

Figure 2. Publication activity for written works using the words mānuka overall (blue), mānuka honey (orange) and mānuka oil (grey) over time from 1959 to 2019. 134

Figure 3. Total number of patent applications and granted patents for mānuka overall, mānuka honey and mānuka oil over time 137

Figure 4. A comparison of the number of patent applications for mānuka overall, mānuka honey and mānuka oil against the number of granted patents for the same (top), and a comparison of the number of patent applications against the success rate (bottom). The linear analysis (including the formulae) also

shows r2 values. 139

Figure 5. Patent applications and granted patents for inventions for traditional medical applications in mānuka that contain mānuka honey (Mhoney), mānuka oil

(Moil) and other (Mother). 141

Figure 6. Analysis cloud illustrating those companies most active at protecting inventions derived from mānuka. The number is the total number of patent

applications filed by the applicant. 142

Figure 7. Examples of combined work and image trade marks identified in the trade mark search where the word “mānuka” was the key search term. The trade mark number, the application date (App Date), trade mark class and whether the trade mark was active or pending at the time of the analysis is also

presented. 143

Figure 8. Total mānuka trademark applications over time (1963 to 2019). 144

Figure 9. Jurisdictions and trade mark classes where mānuka trade marks have been

filed from 1963 to 2019. 144

List of Tables

Table 1. Total patent applications for traditional Māori medical applications for mānuka for mānuka overall, mānuka honey and mānuka oil groups. Medical

applications are ranked from highest to lowest. 140

Table 2. Patent application filing for the United States, World Intellectual Property Organization (WIPO), Australia and other jurisdictions across mānuka overall, mānuka honey and mānuka oil. Characterisation of mānuka honey

and oil (honey + oil) combined and other is also presented. 142

Table 3. Official Information Request information for Patents, Trade Marks, Geographical Indications and Designs presented to the Patent and Trade

Mark Māori Advisory Committees. 146

Table 4. A summary of codified and non-codified intellectual property, what it protects, its characteristics, references to a Māori Advisory Committee and maximum

duration of the intellectual property in New Zealand. 147

Chapter I Introduction

A Background

The successful translation of basic science findings into innovative medical technologies, diagnostics and medicines is critical to medical progress.¹ Nearly 75 per cent of the world’s most creative ideas come from universities,² many of which are medical technologies. Inventions such as the world’s first surgical procedure under anaesthetic, x-ray machines, ultrasound technology, the contraceptive pill and Magnetic Resonance Imaging were conceived in universities.³ While many of these inventions aim to make our lives easier, healthier and more enjoyable, universities also seek to exploit these discoveries commercially.

Commercial exploitation in universities is done through technology transfer, which is how new medical technologies move from the university laboratory to the marketplace and eventually to the general population.⁴ The role of the academic inventor cannot be underestimated.⁵ Still, it is the responsibility of the university’s TTO to ensure that intellectual property rights for new technologies are appropriately handled and exploited.⁶ The TTOs for New Zealand universities are Otago Innovation Ltd. (University of Otago), Lincoln University (in-house office), University of Canterbury (in-house office), Wellington Univentures (Victoria University of Wellington), Massey Ventures (Massey University of New Zealand), Waikatolink (University of Waikato), Auckland Uniservices Ltd. (University of Auckland) and AUT Ventures (Auckland University of Technology).

¹ Gail A. Van Norman and Roï Eisenkot “Technology Transfer: From the Research Bench to Commercialization. Part 1: Intellectual Property Rights—Basics of Patents and Copyrights” (2017) 2(1) JACC: Basic to Translational Science 85–97 at 85.

² Alyssa Walker “University Researchers Led 40 Percent of All Inventions Since 1950s” (June 2017)

<https://www.phddoctorado.com/news/University-Researchers-Led-40-Percent-of-All-Inventions-Since-1950s- 1762/>.

³ CNBC “College Inventions that Shaped the World” (5 June 2015) Consumer News and Business Channel

<https://www.cnbc.com/2015/06/05/college-inventions-that-shaped-the-world.html>.

⁴ Above n 1.

⁵ Anders Brantnell and Enrico Baraldi “The Roles of Academic Inventors in Medical Innovation Processes: Exploring the Influence of IPR Ownership and IP Nature” (2020) 25(5) International Journal of Innovation Management 1–48 at 4.

⁶ Above n 1; D Siegel and others “Technology Transfer Offices and Commercialization of University Intellectual Property: Performance and Policy Implications” (2007) 23(4) Oxford Review of Economic Policy 640–660 at 640.

Within New Zealand, TTOs span both the academic and business worlds⁷ and are involved in all aspects of the research—commercialisation continuum.⁸ Commercialisation typically involves TTO staff scouting the university campus for new ideas and inventions. TTOs assess those inventions for commercial viability, protect any intellectual property rights (IPR) associated with the invention, and broker deals with third-party licensees or purchasers of the invention⁹ once the invention is “investor-ready”.¹⁰ In New Zealand universities, medical inventions are often the result of a scientific endeavour supported by public grant funding.¹¹ Commercialisation costs are supported by TTO operational budgets, revenue from commercial deals and the New Zealand government’s PreSeed Accelerator Fund.¹²

TTOs are frequently accused of being patent-centric organisations. They appear to embrace a “review and protect or reject approach to technology management in hopes of maximising licensing revenues”.¹³ They do this by using a linear model of commercialisation.¹⁴ If an invention is not patentable, it cannot be protected and is consequently rejected as a commercial opportunity. Of course, not every invention lends itself to be patentable (software in New Zealand, for example),¹⁵ nor requires it. However, patent protection for discoveries made via academic biomedical research does boost the chances that patients will benefit from these medical interventions.¹⁶ Patent-protected ideas are also more likely to be assessed through clinical research studies and then commercialised. Thus, they are assumed to provide more significant commercial returns to the university.¹⁷

⁷ Conor O’Kane and others “University Technology Transfer Offices: The Search for Identity to Build Legitimacy” (2015) 44(2) Research Policy 421–437 at 421.

⁸ Conor O’Kane “Technology Transfer Executives’ Backwards Integration: An Examination of Interactions between University Technology Transfer Executives and Principal Investigators” (2018) 76 Technovation 64–77 at 64.

⁹ Above n 1, at 198.

¹⁰ Investor readiness is difficult to define. There is no agreement among TTOs in New Zealand about what it means. Nevertheless, there is a general understanding that it refers to when the technology is prospectively ready to transfer to a third party, and agreeable commercial terms with that party have been reached.

¹¹ Ministry of Business, Innovation and Employment “Funding Information and Opportunities”

<https://www.mbie.govt.nz/science-and-technology/science-and-innovation/funding-information-and- opportunities/>.

¹² Ministry of Business, Innovation and Employment “PreSeed Accelerator Fund”

<https://www.mbie.govt.nz/science-and-technology/science-and-innovation/funding-information-and- opportunities/investment-funds/preseed-accelerator-fund/>.

¹³ CS Hayter “A Social Responsibility View of the “Patent-Centric Linear Model” of University Technology Transfer” (2016)54 Duq. L. Rev. 7 at 9.

¹⁴ Above n 13.

¹⁵ Patents Act 2013, s 11(3).

¹⁶ Joris J Heus and others “Importance of Intellectual Property Generated by Biomedical Research at Universities and Academic Hospitals” (2017) 3(2) Journal of Clinical and Translational Research 250–259 at 250.

¹⁷ Mathew S Clancy and Gian Carlo Moschini “Incentives for innovation: Patents, Prizes, and Research Contracts” (2013) 35(2) Applied Economic Perspectives and Policy 206–241 at 209.

Biomedical products such as pharmaceutical drugs and nutraceuticals often focus on small molecule drug research.¹⁸ Over the last 25 years, small molecule drug research has shown that 5 per cent of medications are derived from natural products (for example plants), 27 per cent are derivatives of natural products, and natural products inspire one-in-three synthetic drugs.¹⁹ However, approximately a quarter of all plant-based pharmaceuticals contain some component acquired through the appropriation of Indigenous people’s knowledge.²⁰ Evidence suggests that Indigenous people’s knowledge contribution to pharmaceutical products may be as high as 60 per cent for developed nations and up to 85 per cent in developing countries, with some 80 per cent of indigenous medical knowledge appropriation occurring by investigating and screening academic literary databases.²¹

The issue is not one of using natural products or traditional knowledge²² to develop new medicines or drugs, but the denial of the “western dependency” on the contribution of Indigenous peoples’ knowledge to the development of pharmaceutical products²³ and not compensating Indigenous peoples accordingly.

That denial seems facilitated by the lack of recognition of Indigenous peoples’ knowledge as a form of “legitimate knowledge”.²⁴ Such denial is especially prevalent where scientific evidence is seen as systematic, objective, quantitative and “the foundation for “real” knowledge creation or evaluation”.²⁵ In contrast, Indigenous peoples’ knowledge is perhaps viewed as disorganised, imprecise and qualitative. This denial is advantageous as it facilitates an essential facet of intellectual property law—it rewards the labour of the “inventors”, not necessarily the contributors’ labour or knowledge.²⁶

¹⁸ Malin Lemurell AstraZeneca “A Big Future for Small Molecules: Targeting the Undruggable”

<https://www.astrazeneca.com/r-d/next-generation-therapeutics/small-molecule.html>.

¹⁹ Feng Li and others “Are We Seeing a Resurgence in the Use of Natural Products for New Drug Discovery?” (2019) 14(5) Expert Opin Drug Discovery 417–420.

²⁰ C Kavelin “Universities as the Gatekeepers of the Intellectual Property of Indigenous People’s Medical Knowledge” (2008) 37 Australian J of Indigenous Education 34–35 at 37.

²¹ Above n 20.

²² There is no internationally accepted definition of traditional knowledge. From an intellectual property perspective, the World Intellectual Property Organization has defined it as follows: “Traditional knowledge (TK) is knowledge, know-how, skills and practices that are developed, sustained and passed on from generation to generation within a community, often forming part of its cultural or spiritual identity”: WIPO “Traditional Knowledge” <https://www.wipo.int/tk/en/tk/>.

²³ Above n 20, at 35.

²⁴ F Akena “Critical Analysis of the Production of Western Knowledge and Its Implications for Indigenous Knowledge and Decolonization” (2012) 6 Journal of Black Studies 599–619 at 599.

²⁵ George Nicolas “When Scientists “Discover” What Indigenous People have Known for Centuries” Smithsonian Magazine (online ed. 21 February 2018).

²⁶ Above n 20, at 35.

The problem may be characterised as commercialising traditional knowledge through unauthorised patenting of inventions (such as patent-based biopiracy). This phenomenon may also be described as the commercial exploitation of other Indigenous people’s intellectual property (trade marks and copyright) or unauthorised research and development done in public organisations, like universities and private organisations (classified as misappropriation).²⁷ In all, the result is the denial of the rights of Indigenous peoples to maintain, control, protect and develop their sovereign right over cultural heritage, traditional knowledge, genetic resources, medicinal practice and intellectual property.

Indeed, research in Australia showed that “nearly every medicine dependent on [Indigenous medicinal knowledge] for its origins had a university involved in its initial identification and development” and that the university then “formed partnerships with pharmaceutical companies” to exploit that invention commercially.²⁸ University TTOs are likely at the heart of forming those public-private partnerships and brokering any commercial opportunity with those partners.

A New Zealand example of this process occurred in 1981, when Professor Peter Molan, an academic researcher from the University of Waikato, “discovered” that mānuka honey²⁹ had antiseptic qualities that improved wound healing. Professor Molan quantified the biological activity of the honey (which he classified as the Unique Mānuka Factor), for which mānuka honey would become world-famous. That quantification resulted in several patent applications that led to granted patents,³⁰ academic kudos for Professor Molan and commercial revenue for the university. Waikatolink, the University of Waikato TTO, commercialised the technology, licensing the inventions to Comvita (one of New Zealand’s largest producers of mānuka honey and associated products) for between NZD 3.5 and 4.0 million, plus ongoing royalty payments. The deal was for patents associated with the anti-bacterial qualities of mānuka honey and for

²⁷ Daniel F Robinson “Biopiracy and the Innovations of Indigenous People and Local Communities” in Indigenous People’s Innovation: Intellectual Property Pathways to Development (ANU Press, Canberra, 2012) Chapter 4 at 80.

²⁸ Above n 20, at 38.

²⁹ From the European honey bee (introduced into New Zealand in 1839) sourcing nectar and pollen from mānuka plant flowers.

³⁰ Patent applications that included using honey for anti-inflammatory purposes (US 2017/0157214 A1), treating of wounds (WO 2007/030023 A1) and honey-based wound dressings (US RE042755 E; CA 2397614 A1). Some patents have expired (such as US RE042755 E; CA 2397614 A1), some have been discontinued and some are still active: two for the use of honey in medical dressings (WO 2001/041776 B1; WO 2001/041776 A3) and one for a honey-based wound dressing (WO 2001/041776 A2). Some have singular applicants (like Waikatolink), and others have many. For US RE042755 E, the owners were: Apimed Honey Research Limited, New Zealand; Waikatolink Limited New Zealand (a TTO); Apimed Medical Honey Limited, New Zealand; and Derma Sciences, Inc., New Jersey.

exclusive access to future developments “to the processing, extraction and application of mānuka honey’s active compound for use in wound care and skincare fields”.³¹ There was a clear biomedical focus to this commercialisation. However, there is evidence that Māori knowledge on the application of mānuka honey for wound treatment was the source and catalyst for Professor Molan to begin his work on mānuka honey and not some serendipitous scientific discovery.³²

Indeed, my preliminary research showed that 52 per cent of all patent applications targeting New Zealand native plants are for inventions derived from mānuka.³³ While it is currently impossible to say how many of these inventions were created within New Zealand universities, mānuka is perhaps the most commercially significant indigenous plant species in New Zealand. Today, the global mānuka honey industry is worth almost USD 940 million. The market size is predicted to reach USD 2160 million by the end of 2025, growing at a compounding annual growth rate of 12.5 per cent during 2019–2025, with products found in the medical, cosmetic, food and beverage industries.³⁴

Worldwide, Indigenous peoples have raised their concerns about the unauthorised appropriation of their traditional knowledge, much of which has played out in the international arena. This unauthorised appropriation is due to the appropriation of traditional knowledge without prior informed consent from Indigenous people and the commercialisation of such knowledge in the absence of mutually agreed terms between parties.³⁵

IPR based on Anglo-American conceptions of personal ownership and property are diametrically opposed to Māori traditional knowledge (mātauranga Māori), which is based on a holistic, comprehensive and opposing ideological framework. The conflict between mātauranga Māori and Anglo-American regimes appears to be facilitating legal inequality in which mātauranga Māori fails to fit inside the constraints of the Anglo-American-defined

³¹ NZPA “Comvita in Honey Deal with Waikato University” The New Zealand Herald (online ed. Auckland, 6 December 2006).

³² Lynley Hargreaves “Miraculous Mānuka” (15 April 2015) Sciblogs <https://sciblogs.co.nz/infrequently-asked- questions/2015/04/15/miraculous-mānuka/>.

³³ See Appendix II B.

³⁴ 360 Market “Updates Global Mānuka Honey Market Insights, Forecast to 2025” (9 April 2019) 360 Market Updates <https://www.360marketupdates.com/global-manuka-honey-market-13859497>.

³⁵ The Universal Declaration of Human Rights (UDHR), the Universal Declaration of the Rights of Peoples (UNPO), the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP), the International Treaty on Plant Genetic Resources for Food and Agriculture, the Convention on Biological Diversity and its Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits.

intellectual property system. Such misalignment may put Māori traditional knowledge at risk of commercial appropriation:³⁶

simply tweaking the edges of current intellectual property statutes is not going to provide Māori with the tino rangatiratanga³⁷ over this taonga that they are seeking. The current subjugation of Māori traditional knowledge simply because it is not recognised by intellectual property regimes is unjust, and in violation of the Treaty of Waitangi.

Within New Zealand, there has been and continues to be growing tension between IPR and Māori traditional knowledge systems: they are simply incompatible.³⁸ Māori, as kaitiaki (cultural guardians), are responsible for protecting traditional knowledge and indigenous species.³⁹ The Treaty of Waitangi⁴⁰ (“Treaty”) grants the New Zealand government the power to govern.⁴¹ Still, it obligates the Crown to protect iwi and hapū’s tino rangatiratanga over taonga katoa (all their treasures).⁴² The Treaty empowers the Crown to enact intellectual property laws and policies. However, the Treaty also requires the Crown to maintain iwi and hapū authority over their taonga and knowledge to fulfil their kaitiaki responsibilities.

Māori concerns were exemplified in the Waitangi Tribunal (“Tribunal”) Claim no. 262 (“Wai 262”). In 1991, the original statement of claim focused on protecting Māori rights concerning indigenous flora and fauna.⁴³ The claim specifically outlined the Crown’s failure to protect such rights guaranteed under the Treaty. But the claim was widened to encompass Māori traditional knowledge more broadly, as Māori recognised the threat also existed to traditional knowledge beyond that of indigenous flora and fauna.⁴⁴

³⁶ Tania Waikato “He Kaitiaki Matauranga: Building a Protection Regime for Māori Traditional Knowledge” (2005) 8(2) Yearbook of New Zealand Jurisprudence 344–410 at 397.

³⁷ Means complete authority.

³⁸ Yao Dong “The Protection of Mātauranga Māori Associated with Taonga Species” (2019) 10(6) PILJNZ 183– 212.

³⁹ Waitangi Tribunal Ko Aotearoa Tēnei: A Report into Claims Concerning New Zealand Law and Policy Affecting Māori Culture and Identity (Wai 262, 2011) Te Taumata Tuarua Vol 1 at 1.2.2 (1).

⁴⁰ Treaty of Waitangi 1840.

⁴¹ Jack Hood “Ko ngā take ture Māori. Our Significantly Indigenous Administrative Law: The Treaty of Waitangi and Judicial Review” (2013) Auckland Law Review at 53.

⁴² Above n 40, art 2.

⁴³ Waitangi Tribunal Statement of Claim by Haana Murray (Ngati Kuri) and Dell Wihongi (Te Rarawa) and others

(9 October 1991) Wai 262, 1–2.

⁴⁴ See Waitangi Tribunal Fourth Amended Statement of Claim on Behalf of Ngati Kahungunu (21 September 2001) Wai 262, 11; Waitangi Tribunal Second Amended Statement of Claim for Ngati Porou (19 October 2001) Wai 262, 9; Waitangi Tribunal Second Amended Statement of Claim on Behalf of Ngati Koata (October 2001) Wai 262, 9; Waitangi Tribunal Second Amended Statement of Claim on Behalf of Ngati Kuri, Te Rarawa and Ngati Wai (20 October 2001) Wai 262, 10.

The Tribunal report regarding the Wai 262 claim was released in 2011. The report was called “Ko Aotearoa Tēnei: A Report into Claims Concerning New Zealand Law and Policy Affecting Māori Culture and Identity” (Wai 262, 2011; shortened to Ko Aotearoa Tēnei). However, at the time of the Tribunal’s response, patent law⁴⁵ did not appear to recognise or encourage kaitiaki connections, nor appear to safeguard against offensive or disparaging uses of traditional knowledge, including the unsanctioned public and commercial use of that knowledge. Patent law potentially left traditional knowledge vulnerable to unauthorised commercial exploitation by third parties like university TTOs. The only means for Māori to address their concerns over the misappropriation of their traditional knowledge was via the morality clause in the Act.⁴⁶

Ko Aotearoa Tēnei embodied several recommendations to amend the IPR system to account for claimants’ concerns. First, we need new standards of legal protection. Such standards need to accommodate the need to distinguish between traditional knowledge linked to taonga works (a unique kaitiaki relationship)⁴⁷ from taonga-derived works (knowledge that might appear Māori in origin but lacks a kaitiaki relationship).⁴⁸ Different types of knowledge require different levels of protection and mātauranga Māori.⁴⁹ Protection also needs to include mechanisms to prevent the derogatory or offensive use of traditional knowledge. Second, a general Commission is needed to make binding decisions on the inappropriate use of taonga or taonga-derived works, identify the appropriate kaitiaki associated with such works, and hear complaints against improper use of mātauranga Māori.⁵⁰ Third, the implementation of new decision-making principles for guiding kaitiaki in the commercial exploitation of taonga works.⁵¹

When considering taonga species’ genetic and biological resources, the Tribunal focused on several proposed reforms concerning bioprospecting, genetic modification, and intellectual property.⁵² The tribunal recognises the interplay between bioprospecting, genetic modification, and IPR, reflecting the pathway from research discovery and invention to commercialisation.⁵³ I agree they are linked. However, I note that bioprospecting and genetic modification sit

⁴⁵ Patents Act 1953; repealed by the Patents Act 2013.

⁴⁶ Patents Act 1953, s 17(1).

⁴⁷ Above n 39, Te Taumata Tuarua Vol 1 at 1.5.2 (1).

⁴⁸ Above n 47, at 65.

⁴⁹ Above n 45, at 74.

⁵⁰ Above n 45, at 99.

⁵¹ Above n 50.

⁵² Above n 47, at 113.

⁵³ Above n 47, at 140.

predominately within the research discovery space, while IPR protection is the domain of TTOs and my focus in this thesis.

There have been some attempts to ease some of the tension in current patent law. For example, the Patents Act 1953 was repealed and replaced by the Patents Act 2013, establishing the Māori Advisory Committee (MAC). The MAC’s role is to determine if the commercial exploitation of an invention based on traditional knowledge or native plants and animals was contrary to Māori values and whether an invention derived from such is contrary to public order and morality. However, the MAC’s role is advisory: it is not a binding decision-making authority.⁵⁴

Indeed the government did a stocktake of government initiatives undertaken concerning Māori cultural and IPR.⁵⁵ The stocktake found that the reforms outlined by the Tribunal could, for the most part, operate within the framework of the current IPR regime,⁵⁶ with only one exception requiring a law change to the Patents Act 2013—a mandatory disclosure of origin requirement.⁵⁷

However, the Tribunal recommendations do not appear to have been implemented by the government. The tension between the Anglo-American IPR regime and mātauranga Māori persists. Indeed, it is argued that the recommendations made by the Tribunal are inadequate because they are restricted to the existing IPR regime.⁵⁸ Since 2011, successive governments have failed to respond publicly to the Tribunal’s report.⁵⁹ However, the current New Zealand government (Labour-led 2017–2022) is taking a practical approach to the recommendations outlined in Wai 262. The government has implemented a work programme called Te Pae Tawhiti to respond to Wai 262 and the Tribunal’s report.⁶⁰ Recent scholarly work has suggested that Māori should engage with the programme, but with caution, noting: “The Labour-led Government is yet to be properly tested on its Wai 262 response”.⁶¹

⁵⁴ Patents Act 2013, s 227.

⁵⁵ Te Puni Kōkiri “Review of the Crown’s Activities in Relation to Ko Aotearoa Tēnei (WAI 262)” (briefing paper), 20 November 2015 [‘Review’ (Nov 2015)], para. 5.

⁵⁶ Above n 52, at 211.

⁵⁷ Disclosure of origin is discussed in Ko Aotearoa Tēnei (see 2.5.2 (3)). See Chapter II D5 for further discussion.

⁵⁸ Above n 38, at 183.

⁵⁹ Jayden Houghton “The New Zealand Government’s Response to the Wai 262 Report: The First Ten Years” (2021) 25(5) The International Journal of Human Rights 870–893 at 870.

⁶⁰ Te Puni Kōkiri “Te Pae Tawhiti: Wai 262” 30 August 2019 <www.tpk.govt.nz/en/a-matoukaupapa/wai-262- te-pae-tawhiti>.

⁶¹ Above n 59, at 13.

Moreover, the New Zealand research and science sector has not escaped scrutiny and is also under review by the government, becoming the subject of a “green paper” called “Te Ara Paerangi Future Pathways”.⁶² The paper’s goal is to seek feedback on what seems to be a significant shake-up of the sector, including “honouring the Treaty and enabling mātauranga Māori”.⁶³ As key research institutions, universities are part of the New Zealand science system. If change does occur, we may expect to see the Treaty and mātauranga Māori embedded more firmly into the fabric of New Zealand universities and TTOs.

But why is this important to TTOs? As I mentioned earlier, TTOs must generate revenue for their university from the commercial exploitation of inventions. Medical inventions are highly prized due to the increased likelihood of attracting potential investors, thus, likely to be successful. Many such inventions are derived from traditional knowledge and or taonga species. TTOs seek to protect those inventions through the patents regime and then work with pharmaceutical or nutraceutical companies to exploit those inventions commercially. Consequently, it seems that if the changes to the RSI system do occur, TTOs must address the tension between the current IPR regime and mātauranga Māori in their day-to-day commercialisation activities. Embedded fully within the IPR regime, patent-centric organisations such as TTOs may not be adequately equipped to handle such a change and may need to adjust their practice accordingly.

But is that truly the case? While it seems that the current IPR system, including patent law, inadequately protects Māori traditional knowledge from “unauthorised” commercial exploitation, it appears that most of the Tribunal’s recommendations could be implemented within the current IPR regime if the government has the appetite to do so. Therefore, could it be the case that Māori might rely on patent law to effectively protect Māori traditional knowledge from commercial exploitation by university TTOs? If I examine this premise from a Māori perspective, the evidence above suggests that it is unlikely.

However, I intend to scrutinise this issue from an entirely new perspective not previously examined in New Zealand—a TTO perspective. When reviewing this perspective, I plan to do so using Māori medical knowledge in mānuka as an exemplar. First, mānuka is a taonga species

⁶² Ministry of Business, Innovation and Employment “What is Te Ara Paerangi Future Pathways?”

<https://www.mbie.govt.nz/science-and-technology/science-and-innovation/research-and-data/te-ara-paerangi- future- pathways/#:~:text=Te%20Ara%20Paerangi%20Future%20Pathways,take%20advantage%20of%20emerging%2 0opportunities.>.

⁶³ Above n 62.

with a long history of medical application by Māori. Second, mānuka is an indigenous plant of great commercial interest to New Zealand. Third, mānuka inventions already account for over half of all patents derived from indigenous plants, so they are already well exposed to the patent regime. Last, as stated above, inventions with a biomedical focus are more likely to be commercialised by TTOs, to become patented and attract external investment and investors than those not biomedically focused. Therefore, the focus of this thesis is: Can patent law effectively protect Māori medical knowledge in mānuka from commercial exploitation by New Zealand university TTOs?

B Thesis Scope

University technology transfer research dates from the 1970s.⁶⁴ Over the past 20 years, many literature reviews related to university technology transfer have been published, including the New Zealand context.⁶⁵ The deployment of knowledge in TTOs has been thoroughly investigated, as have invention disclosures.⁶⁶ Similar research has been conducted on knowledge infrastructure (as in medical schools and incubators).⁶⁷ Links between research funding and invention disclosure numbers have been substantiated in the literature⁶⁸ and positively relate to revenue generation from licence deals.⁶⁹ Revenue derived from TTOs does not correlate to the number of patent applications filed nor the volume of invention disclosures.⁷⁰

The most recent and comprehensive literature review on TTO performance encompassed a robust meta-analysis. Relationships between the management (within the University or TTO)

⁶⁴ C Hamilton and SP Philbin “Knowledge Based View of University Tech Transfer—A Systematic Literature Review and Meta-Analysis” (2020) 10(3) Administrative Sciences 62 at 13.

⁶⁵ Above n 64; A Collier and B Grey “The Commercialisation of University Innovations—A Qualitative Analysis of the New Zealand Situation” (2010) Research Report Centre for Entrepreneurship School of Business University of Otago.

⁶⁶ R Cardozo and others “Effectiveness of University Technology Transfer: An Organizational Population Ecology View of a Maturing Supplier Industry” (2011) 36 The Journal of Technology Transfer 173–202; M Hülsbeck and others “Performance of Technology Transfer Offices in Germany” (2013) 38 Journal of Technology Transfer 1–17.

⁶⁷ G Markman and others “Entrepreneurship and University-based Technology Transfer” (2005) 20 Journal of Business Venturing 241–63; B Van Looy and others “Entrepreneurial Effectiveness of European Universities: An Empirical Assessment of Antecedents and Trade-offs” (2011) 40 Research Policy 553–564.

⁶⁸ B Carlsson and A Fridh “Technology Transfer in United States Universities” (2002) 12 Journal of Evolutionary Economics 199–232.

⁶⁹ D Siegel and others “Assessing the Impact of Organizational Practices on the Relative Productivity of University Technology Transfer Offices: An Exploratory Study” (2003) 32 Research Policy 27–48.

⁷⁰ Above n 66.

and deployment (patent marketing and licensing) of knowledge, alongside startup success, were identified as where prospective commercial opportunities are most likely found.⁷¹

However, much of this scholarly endeavour tends to be narrow. It focuses on TTO operational practice, university intellectual property policies, the infrastructure supporting TTOs (such as government support, law and policy) and literary works examining commercialisation practice and TTO culture.⁷² Scholarly works seem to be also heavily weighted towards medical and pharmaceutical technologies. It is not surprising as many universities are a repository of medical and pharmaceutical inventions,⁷³ and these tend to be the domain of blockbuster technologies.⁷⁴

Legal perspectives on university technology transfers are rare (equally so for commercialisation of Indigenous peoples’ knowledge by TTOs). It has surprised some, mainly because statutory changes⁷⁵ have significantly influenced TTO practice, particularly in the United States.⁷⁶ The scope of this thesis has a “needle-like” focus—it is patent-centric, Māori medical knowledge in mānuka-centric and New Zealand university TTO-centric. From time to time, I lean on broader intellectual property law, both domestic and international, and reference the wider botanical and global technology transfer environment. Moreover, any applicability of this work relating to TTOs other than those in New Zealand universities, both domestic (such as Crown Research Institutes) and abroad, is merely coincidental unless I specifically reference it as such.

While this examination is a legal scholarly work, it also intends to offer practical advice to the operational field of technology transfer within New Zealand universities. Arguably, the intersection between scholarly works and practical application may at times not be synergistic. In cases where that occurs, the practical application takes precedence over scholarly works because I intend this research to be a catalyst for change in the technology transfer environment in New Zealand: a change to the benefit of both Māori and TTOs. I am Māori (Ngāi Tahu), hold a PhD in Botany, and have 25 years of business experience (nine commercialising

⁷¹ Above n 64, at 1.

⁷² CS Hayter and JH Rooksby “A Legal Perspective on University Technology Transfer” (2016) 41 J Technol Transf 270–289 at 273.

⁷³ Above n 72.

⁷⁴ A blockbuster is a technology that generates more than one billion dollars in revenue.

⁷⁵ In the United States, see Patent and Trademark Law Amendments Act 1980 (Pub. L. 96–517, December 12, 1980), commonly referred to as the Bayh–Dole Act 1980 [US].

⁷⁶ Above n 72, at 271.

inventions, including those derived from botanicals) within a New Zealand university TTO (Otago Innovation Ltd). I am well aware that what permeates from this work, no matter how small a measure, needs to be able to be applied practically on the ground if such a change is ever likely to occur. My background in science allows me to attempt to use that background to support my legal arguments. I developed extensive methodological examinations and graphical representations of data that are perhaps more science than law. For this reason, this work sits in Appendix II of this thesis and provides a supplementary description of my methods which will be of particular interest to the science-trained community.

The perspective I take is to examine the legal question I have posed through that lens— commercial exploitation of traditional knowledge by TTOs and whether patent law effectively protects Māori medical knowledge in mānuka from that commercial exploitation. Further, on occasion, I draw on my nine years of experience of working in a New Zealand university TTO (Otago Innovation limited; University of Otago). I often reference the University of Otago and Otago Innovation public policies, documents, processes and materials based on that experience. Though indicative of the technology transfer environment in general, they may not always reflect the policies, documents, processes and materials from other universities and TTOs. Experience and learnings may, on occasion, be case-specific, some of which may not be commonly known in the scholarly arena. As such, I may not always be able to directly reference such with a supporting publication, though I will attempt to do so where appropriate.

C Thesis Structure

This introductory chapter has stated the overall legal question being tested in this study. Specifically, from a university TTO perspective, does patent law effectively protect Māori medical knowledge in mānuka from commercial exploitation by University technology transfer offices?

I examine this by dissecting the legal question into a series of specific inquiries. These inquiries are divided into separate topics and interrogated separately in a series of explorative chapters. The explorative chapters are ranked as such.

Chapter II details the legal mechanisms to protect mātauranga Māori, including Treaty of Waitangi obligations and the Waitangi Tribunal Claim 262 (Wai 262). I outline the recommendations made by the Waitangi Tribunal on how to protect kaitiaki relationships, taonga species and mātauranga Māori and then examine whether those changes have been

adopted in law (or are currently being considered by the government). Lastly, I question whether those recommendations will deter TTOs from commercially exploiting Māori medical knowledge in mānuka.

Chapter III focuses on the commercial exploitation of mātauranga Māori by TTOs. I detail why patent ownership is important to TTOs, then outline other provisions in the Patents Act 2013 and extra-legal tools that TTOs and Māori should be aware of when commercially exploiting inventions derived from the Māori medical knowledge in mānuka.

Chapter IV is where I apply a thinking tool designed to determine the “effectiveness” of patent law. I extrapolate a clear understanding of the law’s four fundamental elements (1) purpose,

(2) substantive content, (3) results and (4) context to determine that the Patents Act is doing what it was designed to do. I support my assertions by applying empirical analysis examining patent activity for inventions derived from mānuka aligned with Māori medical knowledge in mānuka.

Last, in Chapter V, I bring this all together into a conclusion chapter and present a general discussion that considers whether patent law effectively protects Māori medical knowledge in mānuka from commercial exploitation by University TTOs.

Chapter II Protecting Mātauranga Māori

A Introduction

This thesis addresses the legal question—is patent law effective at protecting Māori medical knowledge in mānuka from commercial exploitation by University TTOs? The thesis answers this question using a New Zealand University TTOs Perspective. This chapter provides contextual content about the legal mechanisms to protect mātauranga Māori. It details the Treaty of Waitangi obligations and Wai 262 focus on protecting kaitiaki relationships, taonga species and mātauranga Māori, including Māori medical knowledge in mānuka. I outline the recommendations made by the Waitangi Tribunal on how to protect kaitiaki relationships, taonga species and mātauranga Māori and then examine whether those changes have been adopted in law (or are currently being considered by the government). Lastly, I question whether those recommendations may deter TTOs from commercially exploiting Māori medical knowledge in mānuka.

B The Treaty of Waitangi

On 6 February 1840, the Treaty of Waitangi⁷⁷ (“Treaty”) was signed between the British Crown and approximately 540 Rangatira (Māori Chiefs). The interpretation of the Treaty’s three Articles is characterised by a knowledge of English and Māori versions of the Treaty,⁷⁸ even though they are not equivalent translations of one another and do not convey the same meaning.⁷⁹

The Treaty of Waitangi gives the New Zealand government the ability to govern and is considered the country’s founding constitutional text.⁸⁰ Nonetheless, the Crown must safeguard iwi and hapū’s tino rangatiratanga over taonga katoa (all their treasures).⁸¹ This exchange of rights and obligations has been referred to as a partnership by the courts.⁸² The Treaty gives the Crown the right to implement intellectual property laws and policies. Still, it also requires the Crown to respect iwi and hapū authority over their taonga and knowledge to fulfil their

⁷⁷ Treaty of Waitangi 1840.

⁷⁸ Morag McDowell and Duncan Webb The New Zealand Legal System: Structures and Processes (4th ed, Butterworth, Wellington, 2006) at 5.3.2.

⁷⁹ New Zealand Māori Council v Attorney-General [1987] 1 NZLR 641 at 642.

⁸⁰ Above n 41, at 53.

⁸¹ Above n 40, art 2.

⁸² Waitangi Tribunal He Tirohanga o Kawa ki te Tiriti o Waitangi: A Guide to the Principles of the Treaty of Waitangi as Expressed by the Courts and the Waitangi Tribunal 74–106 at 77.

kaitiaki obligations (duty of care). A translation of the te reo Māori version of Article 2 of the Treaty (indicative of the Māori understanding of the text) states:⁸³

The Queen of England agrees to protect the chiefs, the subtribes and all the people of New Zealand in the unqualified exercise of their chieftainship over their lands, villages and all their treasures.

The Māori version guaranteed tino rangatiratanga (absolute authority) over all taonga which is implicit in the text and supported by the Waitangi Tribunal (“Tribunal”).⁸⁴ In contrast, the English version of Article 2 of the Treaty seems to recognise Māori authority over all taonga. However, authority seems to be expressed as “possession” rather than “chieftainship” as in the Māori version.

The Te Heuheu Tukino v Aotea District Māori Land Board case, decided by the Privy Council in 1941, is the foremost authority on the Treaty of Waitangi’s legal validity.⁸⁵ The principal finding of the case was that if the Treaty were not recognised in municipal law, it would remain unenforceable. That view has been reinforced through the courts, although recent court decisions indicate a move away from this restrictive interpretation of the Treaty.⁸⁶ However, that does not diminish the Treaty’s constitutional significance.⁸⁷ The New Zealand government cabinet manual lists the Treaty as one of the “major sources of the constitution”.⁸⁸ In the eyes of major constitutional players, these policies and practices demonstrate the Treaty of Waitangi’s extra-legal but constitutional relevance. Despite its legal but unenforceable status, the Treaty of Waitangi provides New Zealand’s government with an undeniable, legitimising base to govern.⁸⁹

Nevertheless, the Treaty is somewhat encumbered in that other than the direct reference in specific Acts of Parliament, it has little authority in New Zealand domestic law. In my view, encumbrance stretches even further in that the commission of inquiry, the Waitangi Tribunal, created under the Treaty of Waitangi Act 1975, also has little legal authority to compel

⁸³ Hugh Kawharu (ed) Waitangi: Māori and Pākeha Perspectives of the Treaty of Waitangi (Oxford University Press, Melbourne 1989) at 321.

⁸⁴ RD Mulholland Introduction to the New Zealand Legal System (9th ed, Butterworth, Wellington, 1999) at 68.

⁸⁵ Te Heuheu Tukino v Aotea District Māori Land Board [1941] NZLR 590 (PC).

⁸⁶ Huakina Development Trust v Waikato Valley Authority [1987] NZHC 130; [1987] 2 NZLR 188 (HG) at 210. For an example of a recent case, see Trans-Tasman Resources Limited v The Taranaki-Whanganui Conservation Board [2021] NZSC 127 (SC).

⁸⁷ New Zealand Māori Council v Attorney-General [1994] 1 NZLR 513 (PC) at 516.

⁸⁸ Cabinet Office Cabinet Manual 2017 at 2.

⁸⁹ Above n 41, at 53.

Parliament. While the Tribunal has the exclusive jurisdiction to determine the meaning and effect of the Treaty (including interpretations between the Māori and English versions), it can only make recommendations on claims brought by Māori that are alleged to breach the promises made in the Treaty and carries little direct legal influence. In saying that, over 2,000 claims have been lodged, resulting in significant legal settlements between Māori and the Crown.

C Waitangi Tribunal Claim 262 (Wai 262)

The Tribunal principally interprets and makes recommendations on the practical application of the Treaty of Waitangi.⁹⁰ Māori concerns regarding IPR are presented in the Waitangi Tribunal Claim no. 262 (“Wai 262”). The first statement of claim, filed in 1991 by six iwi—Ngāti Wai, Ngāti Kurī, Te Rarawa, Ngāti Porou, Ngāti Kahungunu and Ngāti Koata, exemplified the protection of Māori rights regarding indigenous flora and fauna.⁹¹ The original statement of claim focused on protecting Māori rights principally around indigenous flora and fauna. Specifically, the claim is concerned with the Crowns’ failure to protect these rights guaranteed under the Treaty. However, the claim was widened to encompass Māori traditional knowledge more broadly, as Māori recognised the threat also applied to traditional knowledge beyond that of indigenous flora and fauna.⁹² The claim comprises all New Zealand’s plant and animal species, Māori arts and designs, traditional knowledge, botanicals, and medicines. Concerns raised include genetic tampering of native flora and wildlife in the sense that Māori have a unique whakapapa or genealogical tie with native flora and fauna that is not acknowledged or understood by science, scientists, and the research studies that are being conducted within the New Zealand RSI system.⁹³ Wai 262, at its heart, is questioning who or what has control over mātauranga Māori (Māori knowledge system).⁹⁴

⁹⁰ Treaty of Waitangi Act 1875, see the Preamble.

⁹¹ Waitangi Tribunal Statement of Claim by Haana Murray (Ngati Kuri) and Dell Wihongi (Te Rarawa) and others

(9 October 1991) Wai 262, 1–2.

⁹² See Waitangi Tribunal Fourth Amended Statement of Claim on Behalf of Ngati Kahungunu (21 September 2001) Wai 262, 11; Waitangi Tribunal Second Amended Statement of Claim for Ngati Porou (19 October 2001) Wai 262, 9; Waitangi Tribunal Second Amended Statement of Claim on Behalf of Ngati Koata (October 2001) Wai 262, 9; Waitangi Tribunal Second Amended Statement of Claim on Behalf of Ngati Kuri, Te Rarawa and Ngati Wai (20 October 2001) Wai 262, 10.

⁹³ The background to Wai 262

<https://wai262.weebly.com/uploads/7/4/6/3/7463762/the_background_to_wai_262.pdf>

⁹⁴ Susy Frankel, “Mātauranga Māori and the Interface with the Intellectual Property Ecosystem” (Workshop TTOs & Indigenous Intellectual Property: Principles, Policies and Engagement: What to Do?, 22 June 2021). At the time of writing, Susy Frankel is a Professor of Law, Chair in Intellectual Property and International Trade, Director

It took 20 years of submissions and hearings before the Tribunal responded to Wai 262 through its comprehensive report titled “Ko Aotearoa Tēnei: A Report into Claims Concerning New Zealand Law and Policy Affecting Māori Culture and Identity” (Wai 262, 2011, Ko Aotearoa tēnei).⁹⁵

The report covered eight substantial chapters (across two volumes)—(1) taonga works and intellectual property, (2) genetic and biological resources of taonga species, (3) relationship with the environment, (4) taonga and the conservation estate, (5) Te Reo Māori, (6) Crown controls over mātauranga Māori, (7) rongoā Māori and (8) the making of international instruments. Ko Aotearoa tēnei introduces new terms to differentiate between “works” which would be offensive to Māori and works that would not. These new terms were (i) taonga works and (ii) taonga-derived works. The report defines these as:

• Taonga work:⁹⁶ “a work, whether or not it has been fixed, that is in its entirety an expression of mātauranga Māori; it will relate to ancestral connections and contain or reflect traditional narratives or stories”.
• Taonga-derived work:⁹⁷ “a work that derives its inspiration from mātauranga Māori, but does not relate to or invoke ancestral connections, nor contain or reflect traditional narratives or stories, in any direct way”.

Taonga works can be exclusively owned,⁹⁸ though they are considered sacred, embedded with mauri (life force) and have a living kaitiaki (custodians). In contrast, taonga-derived works less so (though still can be exclusively owned). By definition, they are Māori “in nature” but absent mauri or a living kaitiaki. No definition of mātauranga Māori was provided. However, it appears that reference to closely-held mātauranga Māori is mātauranga that attaches to a particular “iwi (tribe) or hapū (sub-tribe), has whakapapa (ancestral) connections and has living kaitiaki”.⁹⁹ Nevertheless, detachment of mauri or a living kaitiaki to a taonga-derived work

of the New Zealand Centre of International Economic Law at Victoria University of Wellington and a current member of the Waitangi Tribunal.

⁹⁵ It consists of three volumes and is considered a whole-of-government report: Te Taumata Tuatahi, Te Taumata Tuarua Volume 1 and Te Taumata Tuarua Volume 2. Te Taumata Tuatahi is the abridged form of the response, covering the key themes of the inquiry. In contrast, Te Taumata Tuarua is a complete form covering claimant and Crown arguments, the Tribunal’s deliberations and recommendations.

⁹⁶ Above n 39, Te Taumata Tuarua Vol 1 at 1.5.2 (1).

⁹⁷ Above n 96.

⁹⁸ Above n 96, at 78.

⁹⁹ AJ Park “Call for New Zealand Intellectual Property Framework to Incorporate Māori Customs and Protocols” (24 July 2020) <https://www.ajpark.com/insights/articles/call-for-new-zealand-intellectual-property-framework- to-incorporate-Māori-customs-and-protocols/>.

leaves it to be freely used for commercial purposes in the absence of prior informed consent or mutually agreed to terms on the use of that work.

The definition of taonga has constitutional significance in New Zealand because of its use in Article 2 of the Treaty, but its meaning has expanded over time. According to some, the great Ngāpuhi chief Hone Heke defined taonga as “property procured by the spear”,¹⁰⁰ suggesting the acquisition of taonga was achieved through acts of violence. Four years after signing the Treaty of Waitangi (1844), the Dictionary of the New Zealand Language author William Williams defined taonga simply as “property”.¹⁰¹ By 1871, William’s definition of taonga changed to “treasure”.¹⁰² Today, the meaning is more expansive, covering both property and treasure:¹⁰³

1. Property, goods, possession, effects, object
2. treasure, anything prized—applied to anything considered to be of value, including socially or culturally valuable objects, resources, phenomenon, ideas and techniques

For the claimants in Wai 262, taonga encompassed everything in a tribal group’s estate, “material and non-material, tangible and intangible”, and they expressed absolute authority (tino rangatiratanga) over that taonga.¹⁰⁴ That authority, in their view, carries decision-making, participatory and protective authority. That includes authority over natural resources, indigenous flora and fauna, cultural expressions, genetic material, medical and spiritual knowledge and commercial and non-commercial benefits.

However, when defining taonga species, the claimant’s response was impressively ambiguous. During the pre-hearing phase of the claim, claimants described taonga species in general as species that have “particular cultural or spiritual significance” to the claimants.¹⁰⁵ The Tribunal accepted that premise, though reiterated that the nature of the mātauranga Māori could test such a claim concerning specific species.¹⁰⁶ What is clear, though not particularly surprising, is that there is no generally accepted definition of taonga. However, it is conceded in law that the

¹⁰⁰ John Ansell “‘Taonga’ as Defined by Hongi Hika” (30 April 2012).

<https://treatygate.wordpress.com/2012/04/30/taonga-as-defined-by-hongi-hika/>.

¹⁰¹ William Williams A Dictionary of New Zealand Volume 1 (1st ed, C.M. Society, Paihia, New Zealand, 1844) at 128.

¹⁰² William Williams A Dictionary of the New Zealand Language (Williams and Norgate, London, 1871) at 255.

¹⁰³ Māori Dictionary “taonga” <https://maoridictionary.co.nz/search?keywords=taonga>.

¹⁰⁴ Te Puni Kokori “Te Pae Tawhiti: Wai 262” <https://www.tpk.govt.nz/en/a-matou-kaupapa/te-ao-Maori/wai- 262-te-pae-tawhiti>.

¹⁰⁵ Above n 96, at 115.

¹⁰⁶ Above n 96, at 176.

status of taonga, as used in the Treaty, can be tangible, intangible or of a form of cultural significance.¹⁰⁷ Some iwi have taken the step to declare which species they classify as taonga species, such as Ngāi Tahu through the Ngāi Tahu Claims Settlement Act 1998.¹⁰⁸ Moreover, the Tribunal identified harakeke, koromiko, pōhutukawa, kōwhai ngutukākā, puawānanga, poroporo, kawakawa, mānuka, kūmara and tuatara as species of particular cultural significance to Māori.¹⁰⁹

Because I am using mānuka as an exemplar, the Tribunal’s comments regarding taonga species are particularly relevant. The Tribunal recommended reform across three interrelated areas on the research and commercial exploitation of taonga species—bioprospecting, genetic modification and intellectual property. All three are part of a unified, interconnected process¹¹⁰ that begins with scientific enquiry and (occasionally) concludes with commercialising a patent- protected product,¹¹¹ a process not unfamiliar in the university environment. Claimants exemplified their concerns across three issues (1) unlawful use of mātauranga Māori in bioprospecting research, leading to unauthorised scientific or commercial use of taonga species genetic and biological resources; (2) interference with taonga species whakapapa through genetic modification (which Māori find offensive), and (3) leveraging the IPR regime to exploit rights in taonga species’ genetic and biological resources in ways that exclude kaitiaki and damage the kaitiaki-taonga species connection.¹¹²

According to the Tribunal, the greater the impact of bioprospecting, genetic modification and intellectual property on the kaitiaki relationship, the greater right of Māori to participate in decisions regarding taonga species research, development, and commercialisation.¹¹³ Despite increased interest from other hapū or iwi, the Tribunal emphasised that the source of the taonga species’ genetic and biological material would determine the choice of hapū or iwi as the right kaitiaki with which to engage.¹¹⁴ This information is beneficial for TTOs as it gives them confidence which hapū or iwi to engage in the commercialisation process.¹¹⁵

¹⁰⁷ See, for example, Waitangi Tribunal Report of the Waitangi Tribunal on the Kaituna River Claim (WAI 4, 1984) at 4.7; Waitangi Tribunal Motunui Waitara Report (WAI 6, 1983) at 8.3(3); Waitangi Tribunal Report of the Waitangi Tribunal on the Muriwhenua Fishing Claim (WAI 22,1988) at 10.22.

¹⁰⁸ Appendix II B.

¹⁰⁹ Above n 96, at 128.

¹¹⁰ Above n 96, at 140; above n 62.

¹¹¹ Above n 96, at 141.

¹¹² Above n 96, at 140.

¹¹³ Above n 96, at 194.

¹¹⁴ Above n 96, at 207.

¹¹⁵ Above n 96, at 195.

Underpinning these rights appear to be three areas of concern for Māori: (1) the kaitiaki-taonga species connection (responsibility of care for mānuka for example); (2) taonga species and its intrinsic value; and (3) mātauranga Māori (such as knowledge of mānuka’s medicinal application). The kaitiaki-taonga species connection is defined by a holistic view of the Māori universe (te ao Māori) and is founded on the concept of whanaungatanga. Whanaungatanga bestows rights and obligations on the living, acknowledges active connections with the deceased, and explains people’s interactions with the numerous components of creation, both living and inanimate. It provides the conceptual framework for all rights and obligations between those connected to it, whether human or otherwise. It explains why duty always trumps right, and that duty is embodied in practice by:¹¹⁶

• Whanaungatanga (extended family, relationships, responsibilities; whakapapa (genealogy) the glue holding the Māori world together; centrality of kinship)
• Mana (authority, control, influence, prestige, power leading to leadership)
• Tapu (sacred), respect (complementary opposite: noa) different roles, e.g., social (keeping safe), political (leadership, ceremony) and spiritual (wairua/life force)
• Utu: reciprocity, obligation
• Kaitiakitanga: (stewardship, guardianship to care for one’s own).

Though the Tribunal explicitly supported the kaitiaki relationships, it took a different view regarding the ownership of taonga: “While Māori can say they created taonga works and mātauranga Māori, they did not create taonga. In fact, at a cultural level at least, the relationship is the reverse—the taonga species created Māori culture”.¹¹⁷ The Tribunal went further to say that Māori have “valid rights in respect of the mātauranga Māori associated with their taonga species, even though such rights do not amount to exclusive ownership of that knowledge, at least where the knowledge is already publicly available”. This wording represents a nod from the Tribunal that they perceived the claim to be within the scope of the IPR regime, though under the Treaty’s principles, such control of genetic and biological resources by Māori is justified.¹¹⁸

¹¹⁶ Justice Joe Williams “Lex Aotearoa: An Heroic Attempt to Map the Māori Dimension in Modern New Zealand Law” (2013) Waikato Law Review 1 at 3. See also Merata Kawharu “Kaitiakitanga: A Māori Anthropological Perspective of the Māori Socio-environmental Ethic of Resource Management” (2020) 109(4) Journal of Polynesian Society 349–370 at 349.

¹¹⁷ Above n 96, at 192.

¹¹⁸ Above n 96, at 194.

Others state that Māori do own mātauranga Māori,¹¹⁹ though the concept of ownership as exemplified with the IPR regime is not embedded within mātauranga Māori.¹²⁰ Claimants characterised that control to mean controlling access and caring for taonga species as prescribed by tikanga practices and having veto rights over decisions regarding the use of taonga species for research and commercial purposes.¹²¹

Mātauranga Māori encompasses not only a method of knowledge generation (akin to what we might recognise as a scientific approach as employed within universities)¹²² but also a receptacle for that knowledge.¹²³ However, others perceive mātauranga Māori as more of a “philosophy of science, rather than as a form of ‘science’ itself” and inferior to an empirical scientific approach to knowledge acquisition.¹²⁴ Yet, mātauranga Māori medical knowledge in mānuka seems clinically sophisticated and efficacious, covering many medical applications.¹²⁵

Much of the plant was used. Leaves, bark, seed capsules, sap (gum), shoots and berries were commonly employed for medical practice. That approach would have been a holistic one through rongoā Māori, the traditional Māori healing system.¹²⁶ The delivery system and remedies varied depending on the targeted health application, supporting a considered and well-developed healthcare approach. Health benefits were delivered topically (an emollient applied directly to the skin), by decoction (a concentrated liquid resulting from boiling a liquid), through infusion (a drink or extract prepared by soaking leaves in liquid), the use of raw material (like the chewing of berries or shoots) and by steam inhalation.¹²⁷

It was common to find mānuka used solely or with other plant species as a health remedy, often collectively formulated to target specific ailments. Such formulations seemed to broaden the medical scope of mānuka. For example, an infusion containing kohekohe bark (Dysoxylum spectabile), manakura bark (Melicytus micranthus), puawānanga vine (Clematis paniculate),

¹¹⁹ D Broughton, T Te Aitanga-a-Hauiti, N Porou, K McBreen, KM Waitaha and N Tahu (2015). “Mātauranga Māori, tino rangatiratanga and the Future of New Zealand Science” (2015) 45(2) Journal of the Royal Society of New Zealand 83–88 at 83.

¹²⁰ Above n 96, at 192–194.

¹²¹ Above n 96, at 300.

¹²² Above n 96, at 123.

¹²³ Daniel Hikuroa “Mātauranga Māori—the ūkaipō of Knowledge in New Zealand” (2017) 47(1) Journal of the Royal Society of New Zealand 5–10 at 5.

¹²⁴ Georgina Tuari Stewart “Mātauranga Māori: a Philosophy from Aotearoa” (2022) 52(1) Journal of the Royal Society of New Zealand 18–24 at 22.

¹²⁵ “Indication” for a drug refers to the use of that drug for treating a particular disease.

¹²⁶ Glenis Mark, Amohia Boulton and Donna Kerridge “Rongoā māori is Not a Complementary and Alternative Medicine: rongoā māori is a Way of Life” (2019) 3(1) International Journal of Human Rights Education 12 at 2. ¹²⁷ Rob Tipa Treasures of Tāne: Plants of Ngāi Tahu (Huia Publishers, Wellington, Aotearoa New Zealand, 2018) 105 at 104.

harakeke stalk (Phormium tenax) and mānuka leaves was formulated to treat bleeding piles, general blood disorders and kidney issues.¹²⁸

Other medical uses of mānuka include both internal and external uses.¹²⁹ Leaves were boiled and drunk for internal complaints. The hot vapour was inhaled to relieve head colds, and the gum was applied as an emollient to treat burns. Children also chewed it as a laxative, and adults chewed it to ease a cough. Berries were chewed to relieve colic. The bark was boiled, and the liquid reduced down into a decoction for diarrhoea and dysentery issues. Seed capsules were chewed raw or boiled for the same purpose as were younger mānuka shoots. An infusion from boiled seed capsules was used to reduce inflammation. The liquid from boiling leaves and bark together could be applied topically for muscular pain relief. While an infusion of leaves made a refreshing tea, it could induce vomiting if too overpowering. However, it could be used internally as a mouthwash or throat gargle and a sedative in more severe cases. Decoction of leaves was used as a febrifuge to reduce fever, as was the combination of the inner barks of mānuka and tōtara (Podocarpus tōtara) boiled together.¹³⁰

I have mentioned mānuka honey previously and its well-known medical applications. In contrast, essential oils distilled from the leaves of mānuka have also received considerable attention during the last 20 years from both researchers and commercial entities. Previous research has identified some 100 different chemical compounds in mānuka oil,¹³¹ classified broadly into ß-triketones. These include approximately (~20 per cent) sesquiterpene hydrocarbons (~60–70 per cent) and monoterpene hydrocarbons (~5 per cent). The ß-triketones are considered highly valuable and are used in a range of commercial applications (such asessential oils, nutraceuticals and cosmetics). ß-triketones have been shown to have very high antimicrobial, anti-bacterial, anti-inflammatory and anti-oxidant benefits, where the higher the triketone level, the stronger the antimicrobial properties and benefits.¹³²

Douglas et al. (2004) examined the concentration of ß-triketones for mānuka across New Zealand. Higher ß-triketones concentrations were found to occur more likely in the North

¹²⁸ Anon; Department of Scientific and Industrial Research, Botany Division file 22/15 of 8/1/59, National Archives.

¹²⁹ Murdoch Riley Māori Healing and Herbal. New Zealand Ethnobotanical Sourcebook (Viking Sevenseas, Paraparaumu, New Zealand, 1994) at 278–283.

¹³⁰ Above n 127.

¹³¹ F Christoph and others “The Composition of Commercial Mānuka Oils from New Zealand” (1999) 11(6) Journal of Essential Oil Research 705–710.

¹³² F. Christoph and others “A Comparative Study of the in vitro Antimicrobial Activity of Tea Tree Oils with Special Reference to the Activity of β-triketones” (2000) 66(06) Planta medica 556–560.

Island mānuka and the northern tip of the South Island than in the majority of the South Island. The highest triketone enriched oil (>20 per cent) is from the Tairawhiti region (Ngāti Porou). This level of abundance is not found elsewhere in New Zealand. Plants with levels around 15– 20 per cent were found in the Malborough region and the odd place in Central North Island, but other than that, ß-triketones levels are quite low elsewhere.¹³³

In all, the medical uses of mānuka are comprehensive, with some 18 specific medical applications identified. Mānuka applications exist for anti-inflammation, wounds, burns, eye health, blood purifier, head cold, fever, urinary, sedatives, diarrhoea, diuretic, pain killer, dandruff, constipation, bruises, dysentery, colic and febrifuge.¹³⁴ However, the Tribunal also stressed that the commercial exploitation of mātauranga Māori must adequately acknowledge kaitiaki’s previous rights in that Māori are entitled to a fair degree of control over the use of mātauranga Māori.¹³⁵ Conversely, this is not a concept foreign to TTOs. Research projects with multiple contributors often include the recognition and contribution of background intellectual property or closely-held confidential information (like mātauranga Māori medical knowledge in mānuka), where contributors own, control and decide how that information might be used.

The Tribunal made several recommendations concerning IPR and taonga species in Ko Aotearoa tenei. First, the protection of the kaitiaki relationship and inclusion of mātauranga Māori as evidence to test against novelty and the inventive step in patent applications. Second, establishing a Māori Advisory Committee to advise the Commissioner of Patents regarding the contribution mātauranga Māori make to the inventive process. Third, public order and morality exclusions to patentability. Fourth, a process for kaitiaki to formally notify their interest in mātauranga Māori. Finally, a disclosure of origin requirement obligating patent applicants to disclose the provenance of mānuka used in the invention.¹³⁶

¹³³ Malcolm Douglas and others “Essential Oils from New Zealand Mānuka: Triketone and Other Chemotypes of Leptospermum scoparium” (2004) 65 Phytochemistry 1255–1264.

¹³⁴ Above n 127; above n 129.

¹³⁵ Above n 96, at 211.

¹³⁶ Above n 96, at 99.

D TTOs, Patents and Mātauranga Māori 1 Background

TTOs are frequently criticised as being patent-centric organisations.¹³⁷ As a result, non- patentable innovations are often dismissed as being commercially limited. Further, patent protection for university biomedical research improves the possibility that these medicinal methods will benefit patients.¹³⁸ Consequently, it enhances the possibility that patent-protected discoveries would be examined in clinical research trials and eventually commercialised, suggesting a higher financial return for the institution.¹³⁹

A patent gives its owner exclusive rights to offer to make, hire, sell, or otherwise dispose¹⁴⁰ of an invention for no more than 20 years¹⁴¹ in exchange for disclosing that invention¹⁴² to the public. It is a form of personal property.¹⁴³ A patent comes in two forms (1) a patent of invention (which may also include as a divisional or cognated (combined) patent application)¹⁴⁴ or (2) a patent of addition. The majority of patents are patents of invention, though I briefly cover patents of additions in Chapter III D1.

An inventor can file a patent application directly with the Intellectual Property Office of New Zealand (IPONZ) or file an “international application” under the PCT. Patent Applications¹⁴⁵ and granted patents, as a rule, comprise of three specific components: specifications, drawings, and patent claims. The specification and drawings are supporting material to define and understand the claimed invention. However, the claims outline the specific scope of property granted, and the specification explains the invention.

At the time of the Tribunal’s response, patent law¹⁴⁶ did not appear to recognise or encourage kaitiaki linkages, nor did it appear to protect against harmful or derogatory applications of mātauranga Māori such as unlicensed public and commercial usage. Patent law may have opened the door to unauthorised commercial exploitation of traditional knowledge by other

¹³⁷ Above n 13, at 9.

¹³⁸ Above n 16, at 250.

¹³⁹ Above n 17, at 209.

¹⁴⁰ Patents Act 2013, s 18(2)(a).

¹⁴¹ Section 20(1).

¹⁴² An invention as characterised under the Patents Act 2013 is either a product or a process: s 18(2)(a), (b).

¹⁴³ Patents Act 2013, s 17(1).

¹⁴⁴ Divisional (Patents Act 2013, s 34) and cognate (Patents Act 2013, ss 37(4) and 39(2)).

¹⁴⁵ Refers to an application for a patent under the Act. See Patents Act 2013, s 5.

¹⁴⁶ Patents Act 1953; repealed by the Patents Act 2013.

parties such as university TTOs. Indeed, the Act’s morality provision was the only way for Māori to address their concerns about the misuse of their medical knowledge in mānuka.¹⁴⁷

However, the evolution of patent law from 1953 to the 2013 Act began in 1990 by seeking to amend the Patents Act 1953. The then Ministry of Commerce (MBIE today) released a discussion document focusing on reviewing New Zealand’s intellectual property law; its outcome resulted in a process focusing on trade marks, patents and designs.¹⁴⁸ The paper’s purpose was to:¹⁴⁹

provide an economic background for policy making by presenting the theory and evidence on the economics of intellectual property. The objective is to guide policy makers in the development of efficient intellectual property law.

The report outlined options for the reform of intellectual property law. The key considerations for patent law were mainly around the statutory exclusions to patentability. The recommendations were (1) no exclusions (except those determined by case law or falling within the definition of the subject matter at the time), (2) the status quo¹⁵⁰ and (3) adding exclusions found in the Patent Cooperation Treaty or European Patent Convention 1973.¹⁵¹ The latter presents exclusions for inventions contrary to public order or morality, plant or animal varieties or biological processes.¹⁵² The report was silent on Māori traditional knowledge and the Treaty considerations.

The government initially began its review without consultation with Māori; consequently, it was suspended. In 1994, the then Ministry of Commerce released a further discussion document.¹⁵³ Its primary purpose was to “facilitate the four hui that are to be held in December 1994 to discuss the proposed Intellectual Property Reform Bill”.¹⁵⁴ It aimed to provide background information on critical issues. The issues for Māori, as understood by the Ministry,

¹⁴⁷ Patents Act 1953, s 17(1). See also Susan Young “The Patentability of Māori Traditional Medicine and the Morality Exclusion in the Patents Act 1953” (2001) 32 Victoria U. Wellington L. Rev. 255–275 at 255.

¹⁴⁸ Competition Policy and Business Law Division Review of Industrial Property Rights, Patents, Trademarks, and Designs: Possible Options for Reform. New Zealand Volume 2 (Wellington, Ministry of Commerce, 1990). ¹⁴⁹ Above n 148, at 1.

¹⁵⁰ Patents Act 1953, s 17.

¹⁵¹ Above n 148, at 33–34.

¹⁵² Above n 148, at 14.

¹⁵³ Ministry of Commerce New Zealand Business Policy Division Intellectual Property Law Reform Bill: Māori Consultation Paper (Business Policy Division, Ministry of Commerce, Wellington, 1994).

¹⁵⁴ Above n 153, at 3.

were the right to “define the nature and scope of their cultural and intellectual property; and the right to control and protect their taonga^”.155

Additionally, the intellectual property system did not prioritise collective ownership above individual ownership (Māori perspective). The limited duration of protection provided by several pieces of law did not fit with Māori’s desire for long-term protection. The Ministry acknowledged that it did not address all Māori concerns because the focus of the consultation was limited to the proposed Intellectual Property Reform Bill. At the time, the Tribunal’s response to Wai 262 was incomplete. Consequently, questions about genetic resource ownership could not be addressed.¹⁵⁶

The Ministry proposed that reforms to patent law should include changing the definition of invention to include novelty, inventive step and utility and that “there should be no exclusions from patentability”¹⁵⁷ (such as a morality exclusion). The Ministry also determined that these reforms would not adversely affect Māori interests despite not having consulted with Māori at that stage. In contrast, the report recognised that the Patents Act 1953 did not exclude patenting genetic manipulation of native plant and animal species, human DNA and traditional medicines (or derivatives of) obtained from information in the public domain. This issue was a significant concern for Māori as it precludes Māori from controlling the dissemination of mātauranga Māori.¹⁵⁸

However, the overall outcome focused on creating separate bills for trade marks and patents.¹⁵⁹ This separation led to the Ministry of Commerce establishing a Māori Trade Marks Focus Group for trade marks. After another two years of consultation and hui, in 1997, the group produced a background paper called “Māori and Trade Marks: A Discussion Paper”.¹⁶⁰ The paper’s goal was to report on the Focus Group’s deliberations relating to the registration as trade marks, Māori words, symbols, sounds or smells. Originally submitted to Cabinet in April of 1999, Cabinet agreed that the Act should establish a Māori Advisory Committee by that September. It is recognised now under sections 177–180 of the Trade Marks Act 2002.

¹⁵⁵ Above n 153, at 9.

¹⁵⁶ Above n 153, at 11.

¹⁵⁷ Above n 153, at 16.

¹⁵⁸ Above n 157.

¹⁵⁹ Paul Sumpter Intellectual Property Law: Principles and Practice (3rd ed, Wolters Kluwer, 2017) 254–255. ¹⁶⁰ Ministry of Commerce New Zealand Māori and Trade Marks: A Discussion Paper Māori Trade Marks Focus Group (Ministry of Commerce, Wellington, NZ, 1997).

For patents, a 1999 government discussion document entitled Māori and the Patenting of Life Form Inventions was produced by the Patenting of Life Forms Focus Group for the Ministry of Commerce. The group’s initial intent was to have input into the proposed Intellectual Property Law Reform Bill. However, three years had lapsed by that time, the Bill was not progressing as initially intended, and the report was reconfigured and put out as a discussion document.¹⁶¹

Māori concerns were primarily directed at the ownership, control, and protection of living forms, species, and mātauranga Māori, but also criticised the government’s piecemeal approach to protection without regard for the broader legislative framework.¹⁶² Nonetheless, the Focus Group made four recommendations to reform the patent system:¹⁶³

(1) Facilitate and promote an effective process for working with claimants and iwi on the resolution of claims to ownership, use, control and protection rights with respect to life forms such as indigenous plants and animals.

(2) Amend the principles of the Patents Act to require decision-makers to recognise and provide for Treaty of Waitangi and Māori interests and values in the granting of patents.

(3) Amend the Patents Act in general to better respond to Māori concerns.

(4) Amend the Intellectual Property Office practice to require practical input from iwi into the decision-making process for granting patents.

The Focus Group provided several options to address these. Specifically, exclusion of species of significant interest to Māori; patent rights to be subjected to provisions as recommended by the Tribunal; objections permitted for patents contrary to Māori values and mandatory disclosure of origin requirement on applicants. These options were very much aligned with the recommendations of the Tribunal in Wai 262. However, the debate continued. In 2002, another discussion paper was released titled “Review of the Patents Act 1953: Boundaries to

¹⁶¹ Ministry of Commerce New Zealand Competition and Enterprise Branch Patenting of Biotechnological Inventions: A Ministry of Commerce Paper on Issues for Discussion with Māori. Māori and the Patenting of Lifeform Inventions: An Information Paper (Patenting of Life Forms Focus Group, Ministry of Commerce, Wellington, NZ, 1999) at 3.

¹⁶² Above n 161, at 6.

¹⁶³ Above n 161, at 14.

Patentability”.¹⁶⁴ The report noted that granting patents might affect Māori traditional rights to land and taonga, including the genetic resources of native plants and animals.¹⁶⁵

Many people, including Māori, have questioned the morality of granting ownership rights such as patents over living things. Māori also consider that it is immoral to interfere with the integrity of plant and animal species. There are concerns that the possibility of obtaining a patent on life form from inventions may encourage investment, research and development in ethically dubious areas.

The report also recommended that a “Māori consultative committee” be established by the IPONZ.¹⁶⁶ Presumably, this was the precursor to Māori Advisory Committees.

By the early 2000s, there was a consensus that the Patents Act 1953 was due for reform. It led to creating a draft Patents Bill (235-2) seeking to repeal the 1953 Act, which was seen to offer over-extensive patents rights (due to a weak test for patentability). This proposed reform made obtaining patents in New Zealand easier than in other jurisdictions and was misaligned with international best practice. The Patents Bill was introduced in 2008.¹⁶⁷ The Bill attempted to strike a balance between technology transfer and Māori interests.

The push for change to patent law seemed to be strongly driven by Māori. There also appears to be consistency in the issues raised among the various discussion documents. On one level, recognition was made of those elements in the patent’s regime that Māori (1) find offensive (such as genetic modification) and (2) seek to protect and control (such as traditional knowledge). However, the limited nature of the intended MAC was also evident from the Bill’s first reading on May 5^th, 2009, introduced by the Hon. Christopher Finlayson (Attorney- General at the time) on behalf of the Minister of Commerce. The Attorney-General’s opening statement seems telling:¹⁶⁸

Also excluded are inventions whose commercial exploitation would be contrary to morality or public policy. It is likely that few patent applications would be refused on this ground. This provision is intended to be used only in relation to inventions where commercial exploitation is likely to be offensive to a significant section of the community,

¹⁶⁴ Ministry of Economic Development Review of the Patents Act 1953: Boundaries to Patentability Discussion Paper (Wellington, NZ, 2002) at 10.

¹⁶⁵ Ian Finch (ed) James and Wells Intellectual Property Law in New Zealand (Thomson Reuters, Wellington, 2017) at 14; above n 164, at 21–22.

¹⁶⁶ Above n 164, at 11 (recommendation 10.3).

¹⁶⁷ Patents Bill 2008 (235–1).

¹⁶⁸ (5 May 2009) 654 NZPD 2873.

including Māori. The Bill also provides for the establishment of a Māori advisory committee to advise the Commissioner of Patents in relation to applications for inventions involving traditional knowledge or indigenous plants and animals. The establishment of a Māori advisory committee was recommended by the Royal Commission on Genetic Modification.

Arguably, it hints that the MAC may not be heavily utilised at all. Under clause 276 of the Bill, the functions of MAC were drafted as:

The function of the Māori advisory committee is to advise the Commissioner (on request) on whether:

(a) an invention claimed in a patent application is derived from Māori traditional knowledge or from indigenous plants or animals; and

(b) if so, whether the commercial exploitation of that invention is likely to be contrary to Māori values.

Opposition to the Bill and the requirement around establishing the MAC stemmed principally from minor political parties, mainly the Green Party and the Māori Party. The opposition was characterised, in their view, by inadequate consultation with Māori over the previous decade and fragmented protection of indigenous species in the proposed Bill.¹⁶⁹

Ms Rahui Katene (MP for Te Tai Tonga) and the Māori Party did not support the Bill. They saw little sense in progressing the Bill while the matter of Wai 262 was still before the Waitangi Tribunal. Further, Ms Katene denounced the patent process as an inadequate tool to protect taonga, citing discomfort at the individualistic nature of patent rights to the expense of collective rights and kaitiaki obligations. Seeing this as a tool more akin to theft of traditional knowledge, Ms Katene preferred the recommendations in Wai 262 as a more “robust opportunity for the development of new mechanisms to enable ongoing protection of our knowledge and indigenous resources”. Nevertheless, Ms Katene acknowledged the willingness of Māori to share knowledge but emphasised that the way knowledge is shared, respected and controlled should remain with Māori.

Technology transfer did not escape mention. Ms Clare Curran MP, a Member of Parliament for the Labour Party (Dunedin South), supported the Bill and stated that “it provides an

¹⁶⁹ Kevin Hague—Green Party.

appropriate balance between adequate incentives for innovation and technology transfer and ensuring that the interests of the public and Māori are protected”. This somewhat counterargument to Ms Katene still squarely places technology transfer and Māori interests for equal consideration. This view carried the day, with Ayes 107; Noes 14.

In the second reading (12 September 2012), Stephan Browning MP (Green Party) cited the Bill as inadequate to protect Māori interest, particularly around deferment of addressing Māori concerns in further amendments of the Act.¹⁷⁰ Mr Browning further questioned why the advice of the MAC did not bind the Commissioner of Patents: “What is the purpose of this committee, which is appointed by the Commissioner, who may or may not even give it serious cognisance?” Browning points to the likely ineffectiveness of the MAC, with no discretionary or determinative powers. However, it seems the lack of exclusion of microorganisms weighed more heavily on the Green Party, so much so that Mr Browning tabled Supplementary Order Paper 124 (SOP-124)¹⁷¹ to attempt to exclude commercialisation of microorganisms. He cited that such an inclusion would lead to biopiracy, appropriation of Indigenous peoples’ knowledge and stifle scientific endeavour. This SOP was not adopted as it was felt that the Select Committee process adequately addressed the issue.

Additional SOPs were considered in the Bill’s third reading on 27 August 2013. Other than SOP-124 above, the other specific to the Māori Advisory Committee was Supplementary Order Paper 348 (SOP-348),¹⁷² attempting to take the word “advisory” out of “Māori Advisory Committee”¹⁷³ and replace the word “Commissioner” with “Minister”.¹⁷⁴ In the words of the author Ms Metiria Turei MP (Co-Leader—Green Party), the intent was to give effect to the Wai 262 claim and Ko Aotearoa Tēnei¹⁷⁵ (which had been released by the Tribunal by this time). Ms Turei asserted the current Bill did not address this and preferred that the MAC had determinative instead of advisory powers. She also sought to remove the Commissioner of Patents from appointing members to the MAC, preferring that authority lay with the Minister of Commerce. The aim of the SOP seemed to create a more co-decision-making authority between Māori and the Crown. She states:

¹⁷⁰ He cites the Commerce Committee report as source of that deferment.

¹⁷¹ Steffan Browning Supplementary Order Paper (House of Representatives, No:124 Patents Bill 11 September 2012).

¹⁷² Metiria Turei Supplementary Order Paper (House of Representatives, No:348 Patents Bill 27 August 2013.

¹⁷³ Clause 5(1).

¹⁷⁴ Clause 275.

¹⁷⁵ Above n 172.

...this is essentially about making sure that there is Māori decision making about whether patents should proceed, based on mātauranga Māori and the Māori connection—their obligation to be kaitiaki of those natural taonga—and that there is an obligation on those seeking patents to provide information about those patents from a Māori point of view.

This position is somewhat supported by Rino Tirikatene MP (Labour—Te Tai Tonga), who cites evidence from the Trade Marks Māori Advisory Committee (established a decade beforehand). The argument made is that the appointment process to the MAC is stagnant and not reflective of all of Aotearoa New Zealand—nor the vast number of iwi and hapū.

Still, SOP 348 was criticised by the Hon Trevor Mallard MP (Labour), initially not so much for its intent, but rather for the poor execution and drafting of the document and lack of consultation on the issue presented. However, it became clear that such an amendment would not receive support from the Labour Party “giving Māori a veto over patents is something we are not up to yet”.¹⁷⁶ What the SOP might achieve was further questioned by another Labour MP, Ms Clare Curran, who tabled a “let’s see” approach, suggesting time will tell if the proposed Bill and MAC need to be reconsidered. Adoption of the SOP failed (Ayes 15: Noes 106). In all, the debate had little effect on the drafting of the Bill: the text for the Functions of the Māori Advisory Committee remained the same.

The recommendations made by the Tribunal to accommodate Māori concerns (see Chapter II C) were made under the auspicious of the Patents Act 1953, which was repealed by the Patents Act 2013 and the Patents Regulations 2014 (LI 2014/275). To what extent might have these recommendations been implemented? Key differences between the 1953 and 2013 Acts are:

• Amended definition of the invention. Under the 1953 Act, an invention was broadly commercialised as a new method or process of manufacture.¹⁷⁷ In contrast to the 2013 Act, an invention must be a new method of manufacture as defined by section 6 of the Statute of Monopolies.¹⁷⁸

¹⁷⁶ Trevor Mallard Supplementary Order Paper (House of Representatives, No:348 Patents Bill 27 August 2013).

¹⁷⁷ Patents Act 1956, s 2(1).

¹⁷⁸ Patents Act 2013, s 14.

• Establishment of a Māori Advisory Committee: Not present in the 1956 Act and included in the 2013 Act over concerns regarding appropriation of traditional knowledge and Māori IPR.¹⁷⁹
• Public order and morality: Under the 2013 Act, inventions contrary to public order or morality are excluded from patentability.¹⁸⁰
• Methods of medical treatment of humans: Generally excluded under the 1953 Act, there were exceptions where cosmetic treatments were potentially patentable.¹⁸¹ The 2013 Act, aligns with The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), where surgical, therapeutic and diagnostic methods for treating human beings are not patentable.¹⁸²
• More stringent test for patentability: there is a consensus that the 1953 Act was more flexible in its testing of patents,¹⁸³ with the 2013 Act applying a more pragmatic approach entitled a “balance of probability approach”.¹⁸⁴

With these changes incorporated into the Patents Act 2013 in combination with the recommendations by the Tribunal, is it the case that these recommendations protect Māori medical knowledge in mānuka from commercial exploitation by University TTOs? Specifically:

• Do the tests for inventiveness in patent law protect Māori medical knowledge in mānuka from commercial exploitation from TTOs?
• Does the MAC have the authority to protect Māori medical knowledge in mānuka from commercial exploitation from TTOs?
• Is it immoral or contrary to public order for TTOs to patent inventions derived from and commercially exploit Māori medical knowledge in mānuka?
• Would a disclosure of origin requirement in the patent regime protect Māori medical knowledge in mānuka from commercial exploitation from TTOs?

¹⁷⁹ Finch, above n 165, at 14.

¹⁸⁰ Patents Act 2013, s 15.

¹⁸¹ Finch, above n 165, at 15.

¹⁸² Patents Act 2013, s 16.

¹⁸³ Finch, above n 165.

¹⁸⁴ Finch, above n 165.

2. Do the Tests for Inventiveness in Patent Law Protect Māori Medical Knowledge in Mānuka from Commercial Exploitation from TTOs?

To address this question, I consider two assertions. First, inventions targeting the traditional Māori medical treatment of using mānuka (or a derivative of), second, inventions using mānuka or a derivative of, but not targeting a medical treatment known to Māori, typically called Swiss- type claims.

(a) Patenting Traditional Uses of Mānuka

Section 14 of the Patents Act 2013 outlines the terms in which an invention (a composition of matter, a method, a machine or article of manufacture) must be described, defining the test for an invention. Specifically:

An invention, so far as claimed in a claim is

(a) is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies; and

(b) when compared with the prior art base—

(i) is novel; and

(ii) involves an inventive step; and

(c) is useful, and

(d) is not excluded from being a patentable invention under section 15¹⁸⁵ or 16¹⁸⁶ of the Act.

In short, the criteria for patenting an invention is that it needs to be a manner of manufacture, new, not obvious (i.e., inventive step), has utility and is not contrary to public order or morality. The concepts of novelty and inventive step are tested against the prior art base.

The Act defines prior art as:¹⁸⁷

¹⁸⁵ Inventions contrary to public order or morality are not patentable inventions.

¹⁸⁶ Other Exclusions. For example “Human beings, and biological processes for their generation, are not patentable inventions”, Patents Act 2013, s 16(1).

¹⁸⁷ Patents Act 2013, s 8.

means all matter (whether a product, a process, information about a product or process, or anything else) that has at any time before the priority date of that claim been made available to the public (whether in New Zealand or elsewhere) by written or oral description, by use, or in any other way.

Any document from the prior art base may be used as the starting point for an inventive step objection,¹⁸⁸ including mātauranga Māori. Publications of academic endeavour are a standard method of disclosing potential discoveries to the public domain. Such disclosures permeate the public domain (especially those published in high ranking journals), considerably increasing the likelihood of a patent examiner discovering them. The publication acts as prior art on such discovery. Therefore, any public information made available before the patent application priority date is considered prior art and seriously jeopardises an invention. Some countries have adopted a system of recording traditional knowledge through electronic databases and digital libraries¹⁸⁹ added to the prior art base. These systems make traditional knowledge more easily accessible to patent examiners.¹⁹⁰ That risk is examined against the tests for novelty and inventive step.

Novelty means “An invention, so far as claimed in a claim, is novel if it does not form part of the prior art base”.¹⁹¹ Regardless of the jurisdiction, novelty is a necessary condition for the patentability and validity of a claimed invention, and it is measured against a single piece of prior art knowledge. However, to overcome novelty, one cannot combine (called mosaicing) two or more documents together,¹⁹² though it may be used to combat obviousness characterised through an inventive step.¹⁹³

Inventive step means “An invention, so far as claimed in a claim, involves an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the prior art base”.¹⁹⁴ A whole body of case law elucidates what this might mean, defining more

¹⁸⁸ Pfizer Ltd’s Patent [2000] EWHC 49; [2001] FSR 16.

¹⁸⁹ Terri Janke “Managing Indigenous Knowledge and Indigenous Cultural and Intellectual Property” (2005) 36(2) Australian Academic & Research Libraries 95–107 at 101.

¹⁹⁰ Debashis Bandyopadhyay “Protection of Traditional Knowledge and Indigenous Knowledge” (2018) Securing Our Natural Wealth 59–70 at para 6.5.1.4.

¹⁹¹ Patents Act 2013, s 6.

¹⁹² Concentration Syndicate v Mineral Separation Ltd (1909) 26 RPC 124 (CA) at [147].

¹⁹³ Finch, above n 165, at 27.

¹⁹⁴ Patents Act 2013, s 7.

succinctly non-obviousness,¹⁹⁵ a person skilled in the art¹⁹⁶ and matter that forms part of the prior art base. An overview¹⁹⁷ is provided, but the critical case is Windsurfing International Inc. v Tabur Marine (Great Britain) Ltd, [1985] RPC 59. In this case, the Court set out a four- step approach to assess obviousness called the 4-step approach of windsurfing. The test was further elucidated in the Windsurfing/Pozolli approach.¹⁹⁸ Haberman v Jackel [1999] FSR 685 outlines an investigatory process to inventive step.¹⁹⁹ However, inventiveness requires recognising a defined problem and evidence of it being overcome.²⁰⁰

Usefulness is not tested against the prior art base. However, instead, “An invention, so far as claimed in a claim, is useful if the invention has a specific, credible, and substantial utility”.²⁰¹ This provision is new and not carried forward from the 1953 Act. Under the 1953 Act, the utility was established if the invention did as the patentee said it would—defined as classical utility. It is unclear whether s10 of the 2013 Act encompasses classical utility, raising questions about whether it might invalidate a patent due to a lack of surety in interpreting the Act. This point is raised in the 2019 MBIE discussion paper, though MBIE does not see this as problematic and recommends no change to the 2013 Act to accommodate this.²⁰²

Since novelty and inventive step are tested against the prior art base, an electronic or digital database of mātauranga Māori might be an effective means of preventing TTOs from patenting inventions derived from Māori medical knowledge in mānuka and commercially exploiting them. The Tribunal recommended the appointment of:²⁰³

a commission whose job it will be to administer these new objection processes...maintain a register of kaitiaki and their mātauranga Māori or taonga works, and publish best practice guidelines for the use, care, protection, and custody of mātauranga Māori, taonga works, and taonga derived works”.

¹⁹⁵ Boehringer Mannheim GmbH v Genzyme Ltd [1993] FSR 716 at 740; Jacob LJ St. Gobain v Fusion Provida

[2005] EWCA Civ 17.

¹⁹⁶ A notional person; neither an expert nor a dullard taken to have viewed all prior art, even if a real worker might not do so. Pfizer Ltd’s Patent [2000] EWHC 49; [2001] FSR 16, Laddie J.

¹⁹⁷ Lord Hoffmann in Biogen Inc v Medeva plc [1996] UKHL 18; [1997] RPC 1 at [34].

¹⁹⁸ Pozzoli SPA v BDMO SA [2007] EWCA Civ 588, Jacob LJ.

¹⁹⁹ At 699 to 701.

²⁰⁰ Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21, (2007) 235 CLR 173 at

[52].

²⁰¹ Patents Act 2013, s 10.

²⁰² Ministry of Business, Innovation and Employment Discussion Document: Intellectual Property Laws Amendment Bill—Patents Act 2013, Trade Marks Act 2002, Designs Act 1963 (2019).

²⁰³ Ko at 92.

The Tribunal anticipated the register to be a method of acknowledging kaitiaki’s connection with taonga works and mātauranga Māori, especially where commercial exploitation might occur. The register might make it easier for patent examiners to identify prior art. However, some Wai 262 claimants thought such a register might make traditional knowledge more accessible for unauthorised commercial exploitation and misappropriation.²⁰⁴ Moreover, Māori may not want sacred information to be published at all.²⁰⁵

From a TTO perspective, the register may be useful in identifying prior art that might challenge inventiveness, thus, saving significant time, money and effort in developing a technology that might fall foul of novelty provisions in the Act. As such, the register could act as a significant barrier to commercially exploiting Māori medical knowledge in mānuka. However, this would only be the case where the use of mānuka (or derivative) and the medical application were both known. However, TTOs have a way to avoid this where the medical application of mānuka is not known. TTOs could patent an invention derived from mānuka for a completely unknown medical application and do that through Swiss-type claims.

(b) Swiss-type Claims

Swiss-type claims are essentially a form of claim filed when someone finds a previously undiscovered medical usage for a recognised medicine.²⁰⁶ In 1990, the New Zealand Commissioner of Patents issued a practice note relating to Swiss-type claims in the following structure: “Use of a substance X for the manufacture of a pharmaceutical for the treatment of a medical condition Y in humans”,²⁰⁷ where X is known in the prior art base when the patent application was filed; Y is a new and previously unknown use of X, and therefore, novel and inventive.

It was followed up by a further practice note in July 1997 stating that Swiss-type claims were permitted, though treatment methods were not.²⁰⁸ Pharmac²⁰⁹ disagreed and applied for judicial review, arguing that the decision would lead to anticompetitive behaviour among

²⁰⁴ Maui Solomon and others “Closing Submissions for Ngati Kuri, Ngatiwai and Te Rarawa” (5 September 2007) Wai 262 <wai262.weebly.com> at [214].

²⁰⁵ Ko at 203.

²⁰⁶ Daniel Armstrong “The Arguments of Law, Policy and Practice against Swiss-type Patent Claims” (2001) 32 Victoria U. Wellington L. Rev. 201–254 at 203.

²⁰⁷ Above n 202, at 216.

²⁰⁸ Reinforcing Commissioner of Patents v Wellcome Foundation Ltd (1983).

²⁰⁹ Pharmac is a New Zealand government agency whose mandate is deciding which medical and related products are funded in New Zealand.

pharmaceutical companies and consequently higher drug prices. The High Court rejected the claim; Pharmac appealed to the New Zealand Court of Appeal.²¹⁰ The Commissioner of Patents, supported by three pharmaceutical companies, provided collective evidence that drug development is a costly enterprise. Therefore, subsequent use of the same drug for different applications is a legitimate means to maximise the return on investment for therapeutic drugs. The argument was compelling, and the appeal was dismissed. The court further endorsed that claims where the therapeutic effect was previously unknown are classified as inventive, despite the compound responsible for the therapeutic effect being known.²¹¹

In practice, university researchers test well-known chemicals against various health-related applications regularly.²¹² When such discoveries are made, TTOs may contact patent holders of existing pharmaceuticals to negotiate financial terms for the new application. They are sometimes perceived as easier to commercialise since drug research expenditures have already been absorbed in creating the medicine for its first health application. The drug has also undergone safety and toxicity testing.

For Māori, Swiss-type claims may present a more complex picture. Suppose an invention is derived from mānuka (or derivative of), and its therapeutic target mirrors traditional medical applications for mānuka (see Chapter II C). A claim in that invention might be in the following format (as outlined in the 1990 practice note): The use of [mānuka or derivative] for the production of pharmaceutical compositions for the treatment of [Y]. If that invention is patented, Swiss-type claims for a new target health application may look like: The use of [mānuka] for the production of pharmaceutical compositions for the treatment of [blood clotting].

²¹⁰ Pharmaceutical Management Agency Limited v Commissioner of Patents [1999] (New Zealand Court of Appeal (NZCA)) 330.

²¹¹ Swiss-type claims have not escaped the attention of MBIE. In a 2019 discussion paper, MBIE sought consideration on whether Swiss-type claims might best be replaced with a different format, the EPC2000-type claims (EPC refers to the European Patent Commission). The structure of the EPC2000-type claim is simple: “substance X for use in a method for treating medical condition Y”, which is still a method claim. Nevertheless, the EPC seeks for the most part to do away with Swiss-type claims and replace them with EPC2000-type claims. Traditionally, if X is known, the claim would not be novel, hence not patentable in New Zealand. Only a change to the Act could permit such a practice. MBIE argues that the EPC2000-type claims are broader in their application than Swiss-type claims since protection extends to therapeutic compounds alone (X), which need not be characterised by the target application (Y). Consequently, MBIE predicts a rise in costs to the public health system and consumers alike if the adoption of ECP2000-type claims occurred. Analysis of the advantages and disadvantages of adopting EPC2000-type claims has led MBIE to conclude that there is no advantage in adopting EPC2000-type claims. Consequently, there is no case to amend the 2013 Act.

²¹² Author’s personal experience working for Otago Innovation Ltd.

A new patent application may be filed if Y is previously unknown either as a natural treatment or discovered by scientific endeavour in a university laboratory. In the absence of Swiss-type claims, the fact that mānuka is already known to have anti-bacterial properties or knowingly used as traditional medicine (also known in the prior art base) would typically fall foul of novelty provisions. They restrict to some extent the commercial exploitation of the species. Swiss-type claims remove that barrier. The anti-bacterial qualities of the species (in mānuka honey or oil) may be continued to be exploited if new and unknown applications are found. The discovery of a new target application is inventive, therefore, patentable.

My analysis of the patent landscape of traditional medical applications in mānuka showed that 44 per cent of patent applications target non-traditional health applications (see Chapter IVB3). The fact that mānuka is known in the prior art base to treat specific applications is insufficient to protect Māori knowledge in mānuka from commercial exploitation through patents. Swiss- type claims allow the species to be exploited more broadly for other medical uses, and the Patents Act 2013 would permit TTOs to capture those inventions.

3. Does the MAC Have the Authority to Protect Māori Medical Knowledge in Mānuka from Commercial Exploitation from TTOs?

On receipt of an application, IPONZ identifies whether there is a Māori cultural element in the application. While there is no statutory requirement for applicants to declare a Māori cultural element in their patent application, the IPONZ application form stipulates that applicants declare whether the invention comprises “traditional knowledge” or if a “Māori Conflict” is possible. Neither term is defined.²¹³ However, that declaration is voluntary.

IPONZ decides (or not) to advise the MAC that such an application is received. Two processes then run in parallel—(1) the MAC receives the application and decides whether registration of the application is offensive to Māori, (2) the usual IPONZ process occurs in determining whether the application conforms to the provisions in the Act.

²¹³ On the IPONZ website it states, “Optional—select this if the invention is derived from Māori traditional knowledge or from indigenous plants or animals”. See the Intellectual Property Office New Zealand website: “Apply for a Patent” <https://www.iponz.govt.nz/about-ip/patents/apply/>.

The Act recognises the importance of Māori traditional knowledge, indigenous plants and animals and whether commercial exploitation is contrary to Māori values.²¹⁴ The Act does this through the functions of the Māori Advisory Committee, which must be appointed by the Commissioner²¹⁵ and be called the Māori Advisory Committee.²¹⁶ As such, there always needs to be a standing Committee that must have commensurate skills in mātauranga Māori and tikanga Māori.²¹⁷ Currently, there are three members of the Committee.²¹⁸ Moreover, in the case of patent applications, the Commissioner may seek advice from the MAC “or any person that the Commissioner considers appropriate”²¹⁹ regarding those inventions.

The Committee’s role is to advise the Commissioner on whether the commercial exploitation of an invention is contrary to Māori values, values that obligate Māori to act as kaitiaki. These values are tika (truth), pono (honesty) and aroha (love and compassion).²²⁰ The Commissioner may seek advice from the Committee but is not obligated to do so.²²¹ However, when the Commissioner does seek advice, they “must consider the advice given by the Committee” but are not bound by it. The Committee’s core function is an advisory one²²² and not determinate. Section 226 states:

The function of the Māori advisory committee is to advise the Commissioner (on request) on whether—

(a) an invention claimed in a patent application is derived from Māori traditional knowledge or from indigenous plants or animals; and

(b) if so, whether the commercial exploitation of that invention is likely to be contrary to Māori values.

²¹⁴ Patents Act 2013, s 226. Also see Table 4 in this thesis for comparison of codified and non-codified intellectual property, what it protects, its characteristics, references to a Māori Advisory Committee and maximum duration of the intellectual property in New Zealand.

²¹⁵ At the time of writing, Mr Ross van der Schyff is the Commissioner of Patents, Trade Marks, Designs and Plant Variety Rights. Mr Van der Schyff is the General Manager of Business Integrity Services, Market Services Group at the Ministry of Business, Innovation and Employment (MBIE).

²¹⁶ Patents Act 2013, s 225(1).

²¹⁷ Section 225(3).

²¹⁸ Intellectual Property Office of New Zealand IPONZ <https://www.iponz.govt.nz/about-ip/Maori-ip/Maori- advisory-committees/#patents>.

²¹⁹ Section 15(3).

²²⁰ New Zealand Intellectual Property Office “Protecting Intellectual Property with a Māori Cultural Element: User Guide: Intellectual Property” (Ministry of Business Innovation and Employment, 2016) 1–44 at 11.

²²¹ Patents Act 2013, s 15(3); or any other person the Commissioner deems appropriate.

²²² Section 227.

The relevance of taonga species cannot be understated. While “taonga” is not explicitly defined in the Patents Act, it seems eloquently characterised by the functions of the Māori Advisory Committee in section 226. If an invention is derived from an indigenous species, whether it is classified as a taonga species by kaitiaki or not, it falls under the ambit of the MAC under section 226 (a).

The term “indigenous” is problematic for inventions derived from mānuka, especially from a mātauranga perspective. That is because mānuka (Leptospermum scoparium [L. scoparium])²²³ is often classified as a near-endemic species. While the genus Leptospermum is found in Australia, South East Asia and New Zealand, mānuka is only found in Australia and New Zealand. Therefore, it is unclear if mānuka would fall within the definition of indigenous.²²⁴ The meaning of indigenous plants is potentially quite narrow, dependent on how the term is interpreted.²²⁵ Suppose that mānuka indeed falls outside the definition of indigenous, Māori would have to rely on whether an invention contained traditional knowledge for it to be considered for presentation to the MAC. Neither the Patents Act 2013 nor the guidelines for applying for a patent define what “traditional knowledge” or “mātauranga Māori” is. If mānuka is classified as near-endemic, then it seems the MAC lacks the jurisdiction to prevent the unlawful commercial use of Māori medical knowledge in mānuka. However, is it genuinely the case that mānuka is near-endemic and not indigenous to New Zealand?

The evidence that L. scoparium originally came from Australia to New Zealand seems compelling. The theory is that the species originated in Australia some 65–20 million years ago during the Cretaceous period,²²⁶ approximately 20 million years after New Zealand split away from Gondwanaland (the ancient supercontinent). By this time, the two countries were separated by approximately 2000 km of sea. A closer examination of the Australian flora shows that Australia is the epicentre of the genus Leptospermum. It has 86 species that share the genus, 83 of which are endemic to the continent. In contrast, New Zealand only has one representative of the genus, L. scoparium.

²²³ See Appendix I for a description of the species.

²²⁴ Jessica Lai “A Successful Recalibration of Patent Law vis-à-vis Mātauranga Māori? A Case Study of Mānuka (Leptospermum scoparium)” in S Frankel (ed) The Object and Purpose of Intellectual Property (Edward Elgar, 2019) 30–56 at 37.

²²⁵ Above n 224, at 35.

²²⁶ Peter Wardle Vegetation of New Zealand (Cambridge University Press, Cambridge, 2002).

It is theorised that the species arrived in New Zealand in the Pliocene period sometime between 5–3 million years ago.²²⁷ So, rather than a remnant of an ancient flora that happened to be present in what was to become New Zealand at the time separated from Gondwanaland, it is theorised that L. scoparium’s arrival was through the onset of some adverse weather event (like a cyclone). The more precise source of L. scoparium is the eastern areas of mainland Australia, perhaps Victoria and Tasmania. Therefore, the basic premise is that L. scoparium is an Australian species that migrated to New Zealand.

L. scopariums’ geographical distribution correlates well with the ecosystem disturbance caused by Māori.²²⁸ That disturbance was often characterised by burning vast areas of forest and grasslands. The species possesses morphological characteristics reminiscent of plants adapted to fire-prone ecosystems such as those found in Australia: features like fire-mediated serotiny²²⁹ or having unique structures called lignotubers. Therefore, it is not surprising to discover that the species thrived in such adverse events in New Zealand.

Based on the evidence presented so far, it would be fair and reasonable to conclude that L scoparium in Australia and New Zealand are indeed the same. This conclusion supports the premise that L. scoparium is a near-endemic species to New Zealand and not an indigenous plant. However, evolutionary divergence seems to be occurring between L. scoparium in New Zealand and Australia. That divergence is comprehensive and notable at a morphological, chemical and genetic level, so much so that it throws a level of confusion around the taxonomic similarities between New Zealand and Australian representatives of L. scoparium. This confusion casts doubt that the New Zealand and Australian species are indeed the same. A more defined examination of morphological, chemical and genetic differences to show the plants were distinct species might counter such problems.

Evidence shows the New Zealand species possess highly changeable intraspecific morphological variation²³⁰ and reduces reliance on those characteristics required to protect the

²²⁷ JMC Stephens and others “A Review of Leptospermum scoparium (Myrtaceae) in New Zealand” (2005) 43(2) New Zealand Journal of Botany 431–449 at 432.

²²⁸ WJ Bond and others “What Limits the Spread of Fire-dependent Vegetation? Evidence from Geographic Variation of Serotiny in a New Zealand Shrub” (2004) 13 Global Ecology and Biogeography 115–127 at 123. ²²⁹ Serotiny is an ecological adaptation exhibited by some seed plants, in which seed release occurs in response to an environmental trigger, rather than spontaneously at seed maturation. The most common and best studied trigger is fire, and the term “serotiny” is often used to refer to this specific case. Located at the trees’ base and noticeable by swelling of the stem, the lignotubers contain buds and starch reserves. Their purpose is to allow the tree to regenerate when fire destroys the main trunk, branches and stems.

²³⁰ Above n 130, at 433.

plant against fire damage.²³¹ Such evidence suggests a broader phenotypic response to the environment and taxonomic disparity than the Australian L. scoparium. That morphological variability also correlates well to differences in chemical compounds found in essential oils derived from L. scoparium.²³² Australian species have significantly higher eucalyptol²³³ and total monoterpene²³⁴ levels in their essential oils. Methylglyoxal (MGO) in mānuka honey and ß-triketones in mānuka oil, or derivatives of, are the most likely compounds used in new product formulations or critical ingredients in a honey or oil product. While chemical compound profiling of essential oil offers some insight into the difference between L. scoparium in New Zealand and Australia, examining genetic differences may prove the most enlightening.

Through genetic profiling, evidence of gene flow²³⁵ from Tasmania to New Zealand might be expected to support the premise that Australia is the origin of L. scoparium in New Zealand. While more research is needed, what evidence has been produced does provide startling insight into the debate that L. scoparium from these three areas (Tasmania, Victoria and New Zealand) are morphologically,²³⁶ chemically and genetically distinct. Most importantly, the genetic structure found in L. scoparium in New Zealand is more strongly correlated to its geographical location (i.e., New Zealand) than its morphological similarities with L. scoparium in Australia.²³⁷

It is not uncommon to find that morphological congruence does not accurately reflect evolutionary development.²³⁸ Therefore, it appears that using just morphological features to characterise similarities or differences between the New Zealand and Australian L. scoparium is inadequate. Current research into taxonomic evidence does raise the possibility that they may indeed be completely different botanical entities despite their morphological similarities. New Zealand only has one representative of the genus Leptospermum, while Australia has 86, which might support the argument that the New Zealand entity has been simply misclassified. It has

²³¹ Above n 228, at 121 (see Table 2).

²³² NB Perry and others “Essential Oils from New Zealand mānuka and kānuka: Chemotaxonomy of Leptospermum” (1997) 44 Phytochemistry 1485–1494.

²³³ “Eucalyptol” <https://www.dictionary.com/browse/eucalyptol>.

²³⁴ “Monoterpene” <https://www.dictionary.com/browse/monoterpene>.

²³⁵ The transfer of genetic variation from one population to another.

²³⁶ Above n 228.

²³⁷ MH Buys and others “The Phylogenomics of Diversification on an Island: Applying Anchored Hybrid Enrichment to New Zealand Leptospermum scoparium (Myrtaceae)” (2019) 191(1) Botanical Journal of the Linnean Society 1–17 at 13.

²³⁸ Above n 237, at 12.

arguably led to the conclusion that L. scoparium is endemic to New Zealand.²³⁹ Therefore, L. scoparium (mānuka) falls within the definition of indigenous.

I cannot say with absolute confidence that every inventor that derived their invention from mānuka did so by first sourcing Māori traditional knowledge to identify the target application. However, I have determined that mānuka is likely uniquely New Zealand in origin, and therefore, Māori medical knowledge in mānuka is also uniquely New Zealand in origin. The Commissioner of Patents may only seek advice from the MAC on inventions derived from indigenous plants from New Zealand. Mānuka is an indigenous plant of New Zealand. Therefore, the Commissioner of Patents may seek advice from the MAC regarding inventions derived from mānuka (irrespective of whether the invention is derived from Māori medical knowledge in mānuka).

However, the real crux of this section, as characterised by section 223 (b), is the commercial exploitation of an invention that is likely to contradict Māori values. The provision hangs on a balance between two perceived competing elements—commercial exploitation and Māori values. Commercial exploitation as a means to generate financial and non-financial benefit from the commercialisation of the invention; Māori values as an appropriate check and balance to ensure such exploitation is considered and measured and not offensive to Māori.

Section 223 (b) states, “whether the commercial exploitation of that invention is likely to be contrary to Māori values”. The conjunction “whether” seems to be critical here, implying an action to inquire or investigate something instead of defining what the outcome of that investigation may be. That suggests that measuring the intent rather than the extent of commercial exploitation supports what the substantive content aims to do.

However, it may not matter. Even if Māori are unaware of patent applications that draw on Māori medical knowledge in mānuka, patent applications have a low chance of being granted. Only 17 per cent of patent applications seeking to patent an invention derived from mānuka (approximately one in five) are granted (see Appendix II B). That statistic is of considerable interest to TTOs; being patent-centric, such a low chance of success may be a sufficient deterrent to abandon interest in mānuka technologies altogether. Why invest significant time, money, and expertise in developing technology and subsequent patent applications when the tests for novelty, inventive step and utility seem sufficient barriers to the appropriation of Māori

²³⁹ Above n 237, at 13.

medical knowledge in mānuka. Of course, the probability of success is weighted against commercial return. Tests for patentability are not 100 per cent effective at curbing misappropriation. However, perhaps they are sufficient to deter patentees from patenting inventions through the patent regime.

In light of Clare Curran’s MP “let’s see” approach,²⁴⁰ I submitted an Official Information Request to IPONZ (June 2020) to discover the extent to which the MAC has been involved in determining whether commercialisation of inventions derived from native plants or traditional knowledge is contrary to Māori values.²⁴¹ The Patents MAC has reviewed only eight patent applications since the inception of the Patents Act 2013 (see Table 3. Official Information Request information for Patents, Trade Marks, Geographical Indications and Designs presented to the Patent and Trade Mark Māori Advisory Committees.) less than one a year on average. Of the eight patent applications presented to the MAC, no objections were raised to four of them, while the other four applications attracted objections. One was amended and resubmitted to IPONZ, resulting in no further concern from the MAC. Three were still under review. However, it might also be the case that applicants may not have had their patent applicants examined by IPONZ. Applicants have five years from the date of filing to have their applicants examined and could leave it as long as possible before being examined.

For the one application reviewed and an objection advised, it was noted that examination was curtailed as the application contained no claims; therefore, no objection could be made under

s.15 of the Act.²⁴² The question is raised as to why this application was submitted to the MAC

in the first place. The Act is clear; a complete or provisional specification must accompany every patent application.²⁴³

When examining the Parliamentary debate regarding MACs, I noted that under SOP-348, Ms Metiria Turei MP raised concern over the MAC having an advisory instead of a determinative role, as an advisory role is only influential. The SOP was rejected. In contrast, Ms Clare Curran MP advocated a “let’s see” approach. Time has passed, and we observe that advice from MAC for patents is infrequently sought.

²⁴⁰ See Chapter II D 1.

²⁴¹ New Zealand Intellectual Property Office “Information Request” (12 October 2020) (obtained under Official Information Act 1982 request to the New Zealand Intellectual Property Office on behalf of the Commissioner of Patents, Trade Marks, Designs and Plant Variety Rights).

²⁴² As expected, this provision is intended to be used only in relation to inventions where commercial exploitation is likely to be offensive to a significant section of the community, including Māori (see Chapter II D1).

²⁴³ Patents Act 2013, s 36.

Does the MAC have the authority to protect Māori medical knowledge in mānuka from commercial exploitation from TTOs? It is encouraging that mānuka is classified as an indigenous species of New Zealand. Still, the MAC does not have the authority to compel the Commissioner of Patents to present all patent applications derived from mānuka or Māori medical knowledge in mānuka, nor have veto rights over patent applications. Applicants have a long time to have applications examined: they only need to declare whether an invention is derived from traditional knowledge voluntarily. In combination with the reliance on patent examiners having sufficient training and knowledge in identifying applications derived from traditional knowledge²⁴⁴ and the advisory role of the MAC, it does not seem to demonstrate that unauthorised exploitation of Māori medical knowledge in mānuka is a priority.

4. Is it Immoral or Contrary to Public Order for TTOs to Patent Inventions and Commercially Exploit Māori Medical Knowledge in Mānuka?

Morality exclusions in patent law are common.²⁴⁵ The current morality clause in the Patents Act 2013 in New Zealand has its origins in both the United Kingdom and New Zealand law.²⁴⁶ However, at the time of the Tribunal’s response to Wai 262, patent law did not appear to recognise or encourage kaitiaki connections, nor did it appear to safeguard against unauthorised or disparaging uses of traditional knowledge. Indeed, the Tribunal recognised that “domestic IP law provides only very limited protection for Māori cultural expressions. In particular, it fails to prevent the misappropriation and offensive use of taonga works and mātauranga Māori”.²⁴⁷ In reality, the limited protection in the Patents Act 1953 morality provision was the only means Māori have of addressing their concerns about the misappropriation of their mātauranga Māori.²⁴⁸

Under the Patents Act 2013, inventions contrary to public order or morality are not patentable.²⁴⁹ Section 15 states:

An invention is not a patentable invention if the commercial exploitation of the invention, so far as claimed in a claim, is contrary to—

²⁴⁴ Above n 96.

²⁴⁵ Young, above n 147, at 255.

²⁴⁶ Above n 245, at 262.

²⁴⁷ Above n 96, at 77.

²⁴⁸ Patents Act 1953, s 17(1).

²⁴⁹ Patents Act 2013, s 15(1).

(a) public order (which in this section has the same meaning as the term ordre public as used in Article 27.2 of the TRIPS²⁵⁰ agreement); or

(b) morality.

Non-patentable inventions subject to public order and morality include:²⁵¹

• an invention that is a process for cloning human beings:
• an invention that is a process for modifying the germ line genetic identity of human beings:
• an invention that involves the use of human embryos for industrial or commercial purposes:
• an invention that is a process for modifying the genetic identity of animals that is likely to cause them suffering without any substantial medical benefit to human beings or animals, or an invention that is an animal resulting from such a process.

While there is no specific reference to the genetic modification of taonga species (or plants) in the Patents Act 2013, Article 27.2 of the TRIPS agreement does refer to the protection of plant life:

Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.

Further, section 15(3) of the Patents Act, the “Commissioner may, for the purpose of making a decision under this section, seek advice from the Māori advisory committee or any person that the Commissioner considers appropriate”. Moreover, the provisions’ stated objective is to be applied in situations where commercial use of the innovation would likely be offensive to a sizable segment of the community, including Māori.²⁵² Since TTOs are commercially focused, this suggests the morality exclusion in the Patents Act 2013 might provide Māori with a means to protect against the misappropriation of traditional medical knowledge²⁵³ and commercial exploitation by TTOs.

²⁵⁰ The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights.

²⁵¹ Above n 249.

²⁵² See Chapter II D 1.

²⁵³ Above n 245, at 270.

Is it important for TTOs to take public order and morality exclusions seriously? To begin with, it is dependent on the innovation itself. Suppose a TTO files a patent application. There is no statutory requirement for applicants, including TTOs, to disclose innovations based on traditional knowledge, and no such requirement exists within the patent application process either. Even if there was, the derivation level is debatable.²⁵⁴ TTOs could claim that the idea behind the invention is not Māori in origin or that the information is so far removed that it cannot be classed as traditional knowledge. Even if the invention was clearly derived from Māori medical knowledge in mānuka, it seems unlikely that the Commissioner of Patents would seek advice on the application from the MAC.²⁵⁵ Suppose that did occur, the burden of proof would need to demonstrate that if the patent were awarded, its economic exploitation may “encourage offensive, immoral or antisocial behaviour”,²⁵⁶ which seems to mirror prevailing social beliefs. Moreover, the burden of proof would also need to demonstrate that the commercial exploitation of mānuka would be at such a level the species needed protection (as per Art. 27.2 of TRIPS). Therefore, while it is theoretically possible that the public order and morality provisions are something TTOs need to be mindful of, it seems unlikely to be a significant deterrent.

5. Would a Disclosure of Origin Requirement in the Patent Regime Protect Māori Medical Knowledge in Mānuka from Commercial Exploitation from TTOs?

To protect kaitiaki interest, the Waitangi Tribunal recommended mandatory disclosure of origin requirements in the patent regime for any mātauranga Māori, taonga species and traditional knowledge that may have contributed to the invention to safeguard against misappropriation.²⁵⁷ The Tribunal further recommended that a register be developed for kaitiaki to register their interest in a taonga species sourced from their rohe (area).²⁵⁸ Would a disclosure of origin requirement in the patent regime protect Māori medical knowledge in mānuka from commercial exploitation from TTOs?

²⁵⁴ “...the line between something that derives from TK [traditional knowledge] and something that is so distantly related to TK that it could be said to be different”. See Jessica C Lai “Māori Traditional Knowledge and New Zealand Patent Law: The 2013 Act and the Dawn of a New Era?” (2014) 17(1–2) The Journal of World Intellectual Property 34–46 at 38.

²⁵⁵ There are only eight at the time of writing. See Table 3.

²⁵⁶ New Zealand Intellectual Property Office The Patents Examination Manual

<https://www.iponz.govt.nz/about-ip/patents/examination-manual/current/inventions-contrary-to-public-order- or-morality-not-patentable-inventions/>.

²⁵⁷ Above n 39, vol 1 at 203.

²⁵⁸ Above n 257, at 207.

Currently, MBIE is investigating whether adopting disclosure of origin requirements in the patents regime is practical and affordable. MBIE produced a discussion document²⁵⁹ identifying two main problems that may be overcome by disclosure of origin requirements. First, inventions derived from native plants or animals or traditional knowledge would be more easily identified. As such, we might expect more referrals to the MAC (of course, that is still only as effective as the Commissioner’s willingness to put such patent applications before the MAC). Second, the collation of genetic resources used in inventions contributes to the patents register. Consequently, that register may act as a repository of information for third parties (somewhat aligned with the Waitangi Tribunal’s recommendations for Wai 262).

The Ministry classified four separate scenarios:²⁶⁰

• Status Quo—Voluntary disclosure.
• Option 1—Disclosure of country of origin if known. This is a high level mandatory disclosure of the country where the genetic material is sourced from, though IPONZ would not be obligated to check if the source is accurate.
• Option 2—Disclosure of origin and source. A more specific mandatory disclosure requiring country of origin information and in-country sources of genetic material. Regarding traditional knowledge, applicants need to disclose the Indigenous people and local communities.
• Option 3—Disclosure of ABS compliance. Similarly to Option 2 with the added requirement on IPONZ to be confident that the invention is also compliant with other countries’ ABS legislation. Failure to comply would lead to the refusal of a grant to patent.

The report states that no applicants have voluntarily disclosed whether an invention was derived from traditional knowledge or a native plant or animal between 2014 and 2018.²⁶¹ The Ministry recommended Option 2, striking a balance between Māori interests and compliance costs of implementing these changes. Option 3 is the most expensive.²⁶² However, on balance,

²⁵⁹ Ministry of Business, Innovation and Employment Discussion Paper: Disclosure of origin of genetic resources and traditional knowledge in the patents regime (September 2018).

²⁶⁰ Above n 259, at 13–14.

²⁶¹ Above n 259, at 66.

²⁶² Castalia Strategic Advisors Economic Evaluation of Disclosure of Origin Requirements (Report to Ministry of Business Innovation and Employment, April 2018) at 20.

an economic analysis commissioned by MBIE on all the options (except the status quo) showed the benefits outweighed the direct costs for all the proposed scenarios.²⁶³

The report has been criticised because the disclosure of origin requirement is not enough to create meaningful engagement with Māori in the patent system: instead, it gives the perception of being Treaty-compliant but is too economically focused and ignorant of “meaningful engagement, partnership, and rangatiratanga—on Māori terms”.²⁶⁴

However, Option 2 seems to align with the Tribunal’s recommendations, although it potentially adds layers of practical complexity on the ground for TTOs. It is challenging to discuss ownership if the kaitiaki relationship with the taonga species is unclear, despite the Tribunal recommending that the provenance of where biological and genetic resources are sourced is the key to identifying the right kaitiaki with which to work.²⁶⁵ Is that realistic?

Suppose a TTO submits a patent application for an invention derived from mānuka, and the mānuka was sourced in Ngāi Tahu’s rohe (area). Within the rohe, with whom does the TTO engage? The hapū or runanga where the genetic material was sourced from, as the Tribunal suggests? Who has the authority to engage with the TTO and make decisions about the commercialisation pathway of the technology on behalf of the kaitiaki, if indeed that is to happen at all?

What about the case where the genetic material of mānuka has initially been from one iwi’s rohe (say, Ngāti Porou) but sourced in the rohe of another iwi (say, Ngāi Tahu)? Which kaitiaki has authority? The Tribunal says Ngāi Tahu, but Ngāti Porou was the original source of the genetic material. What rights do they have? Is it possible to find an objective way to be confident of the exact location of mānuka and therefore, give TTOs confidence that they are engaging with the right kaitiaki?

Plant and Food Research²⁶⁶ have studied the chemical profile of mānuka across Aotearoa New Zealand, discovering geographical differences in the chemical profile of mānuka. Mānuka in Ngāi Tahu’s rohe is chemically distinct from that in Ngāti Porou’s rohe. Mānuka with a

²⁶³ Above n 262, at 26.

²⁶⁴ Brooke Marriner “Disclosure of Origin in the Patents Regime: A Call to Shift Towards Meaningful Engagement on Māori Terms” (2020) 51 Victoria U. Wellington L. Rev. 673–715.

²⁶⁵ Above n 114.

²⁶⁶ A New Zealand Crown Research Institute.

triketone enriched oil (>20 per cent) is indisputably from the Tairawhiti region (Ngāti Porou).²⁶⁷

Nearly 95 per cent of all patent activity occurs in just 11 taonga species; 75 per cent for just three—mānuka, miro and kānuka.²⁶⁸ Mānuka has already been examined. Chemical profiling of miro and kānuka in the first instance would aid significantly in solving the issue TTOs have in being confident about the source of origin. Combining these scientific tools with a kaitiaki register may be a relatively inexpensive, practical solution in the first instance that might go some way to abating TTO concerns around invention ownership and which kaitiaki have the authority to make decisions around commercialising an invention.

The consequences of disclosure of origin requirements in patent law have broader implications for TTOs and universities. First, disclosure of origin requirements should occur at the start of the research continuum at the bioprospecting stage, not at the patent application stage, where TTOs typically operate. Universities need to implement a more stringent biodiscovery policy alongside their intellectual property policies to ensure that kaitiaki interests are protected throughout the research continuum from biodiscovery to commercialisation.²⁶⁹

Second, universities are collaborative organisations. Their researchers collaborate with other researchers across the globe. Materials and ideas flow freely, and it is not uncommon for TTOs to work with universities and commercial partners based offshore when looking to commercialise technology. Disclosure of origin requirements are likely to complicate this relationship. New Zealand TTOs will need to work closely with their partners to ensure that they are not in breach of New Zealand’s disclosure requirements and their partner country’s ABS (Access and Benefit Share) requirements before a commercial deal is done. The disparity between country disclosure of origin requirements may impact patentability on new inventions. Implementing option three would be more beneficial to TTOs, as they are likely to have to do it anyway if disclosure of origin requirements are implemented for New Zealand.

Third, in the absence of the MAC having veto rights over inventions in which the commercial exploitation is contrary to Māori values, Māori rely heavily on the Commissioner of Patents to actively seek the advice of the MAC and then heed that advice. Even when disclosure of origin

²⁶⁷ Above n 232.

²⁶⁸ See Appendix I B.

²⁶⁹ Ministry of Business, Innovation and Employment “Disclosure of origin requirements in the patents regime” (8 April 2019) MBIE <https://www.mbie.govt.nz/business-and-employment/business/intellectual- property/disclosure-of-origin-requirements-in-the-patents-regime/>.

requirements proactively identifies an invention that might interest the MAC, the Commissioner of Patents is not obligated to disclose such inventions to the MAC. The effectiveness of the disclosure of origin requirement is only as effective as the willingness of the Commissioner of Patents to disclose inventions to the MAC.

E Summary

The legislation must reflect Article 2 of the Treaty of Waitangi at every level of the IPR system to genuinely address Māori concerns.²⁷⁰ The Treaty of Waitangi provides the New Zealand government with an undeniable, legitimising base to govern. The Waitangi Tribunal principally interprets and makes recommendations on the practical application of the Treaty of Waitangi. It raises concerns about the genetic tampering of native flora and wildlife. Wai 262, at its heart, is questioning who or what has control over mātauranga Māori (Māori knowledge system).

Māori have “valid rights in respect of the mātauranga Māori associated with their taonga species”, says the Tribunal.²⁷¹ But such rights do not amount to the exclusive ownership of that knowledge, at least where it is already publicly available. Others argue that Māori should control access and care for taonga species as prescribed by tikanga practices. The medical uses of mānuka seem comprehensive with some 18 specific medical applications identified—anti- inflammatory, wounds, burns, eye health, blood purifier, head cold, fever, urinary, sedative, diarrhoea, pain killer, dandruff, constipation, bruises.

The Tribunal made several recommendations to address Māori concerns in the IPR regime. However, while the recommendations made by the Tribunal are pragmatic, they do not appear to be fully implemented by the government and the tension between the Anglo-American IPR regime and mātauranga Māori persists. The problem Māori have with Wai 262 is that the Tribunal (and others) has said that the current intellectual property system could, for the most part, accommodate Māori concerns.²⁷² Māori disagree. Patent law does not recognise kaitiaki relationships with taonga. Therefore, a change in the law or an extra-legal requirement is required, like an ABS agreement between kaitiaki and the commercialising party to address the lack of Statutory requirements. Indeed, it is argued that the recommendations made by the Tribunal “fail to give kaitiaki absolute authority over taonga species and MMATS [mātauranga

²⁷⁰ Lai, above n 254, at 42.

²⁷¹ Above n 96, at 95.

²⁷² Above n 96, at 211. Also see Te Puni Kōkiri “Release of the Waitangi Tribunal Report in March/April 2010” (draft brief for Minister of Māori Affairs, 23 March 2010), paras. 43–4 (emphasis added) at 7 as cited in Houghton, above n 59, at 877.

Māori associated with taonga species]”,²⁷³ simply because those recommendations are being limited to the existing IPR regime.

Within the IPR regime, several current and proposed provisions—the test for inventiveness, the establishment of a Māori Advisory Committee, public order and morality exclusions, and a disclosure of origin requirement, as defences against patenting, may offer some protection against the commercial exploitation of Māori medical knowledge in mānuka by TTOs. The establishment of a register of mātauranga Māori might provide some deterrent, but it is not foolproof. First, not all mātauranga Māori is likely to be captured. Second, TTOs can find ways to “workaround” prior art and use Swiss-type claims to patent new inventions. Public order and morality provisions might offer some protection. Still, the burden of proof seems to rest with Māori to demonstrate the commercial exploitation of the invention is likely to be offensive.

Moreover, the MAC is an advisory committee, absent veto rights over patent applications the Committee might recognise as offensive. Even if the MAC agrees that is the case, the Commissioner of Patents does not need to act on their advice. Few patent applications have been presented to the MAC to date, anyway. Moreover, the disclosure of origin requirement may deter TTOs from filing patents in the fear that the patent application might be presented to the MAC. However, the fact is that no such requirement exists today. Until the MAC has veto power to decide whether a patent application is likely to be offensive, there appears to be a slim chance the MAC would be able to review it anyway. In conclusion, while these measures seem to offer some protection, none seems to offer any conclusive protection, either in isolation or collectively, against the commercial exploitation of Māori medical knowledge in mānuka by TTOs. Each measure can be avoided, worked around or simply ignored.

²⁷³ Above n 38, at 183.

Chapter III Commercial Exploitation of Mānuka by TTOs and Patent Law

A Introduction

This thesis addresses the legal question—is patent law effective at protecting Māori medical knowledge in mānuka from commercial exploitation by University TTOs?, adopting a New Zealand University TTOs perspective. Chapter II provided context for the legal systems currently in place to safeguard mātauranga Māori. This chapter expands on that by examining TTOs’ commercial use of Māori medical knowledge contained in mānuka. The notions of inventorship, ownership and benefit-sharing in connection with the commercialisation of an invention are included. Factors that TTOs and Māori may examine when determining whether they are co-owners of an invention and if Māori are entitled to seek compensation for their kaitiaki relationship with taonga species concerning the commercialisation of mātauranga Māori are also considered. I then analyse and contrast other sections of the Patents Act 2013 that TTOs and Māori may need to consider. I then discuss certain extra-legal concepts and mechanisms that TTOs should be aware of that Māori may exploit in protecting Māori medical knowledge in mānuka from commercial exploitation. Finally, I summarise the findings of this chapter.

B Commercial Exploitation of Inventions Derived from Mānuka

TTOs are the bridge between science and business, where staff have consummate skills in market validation, intellectual property management and industry communications, to name a few.²⁷⁴ TTO professionals are also becoming more involved in assisting universities with funding applications for principal investigators.²⁷⁵ These non-monetary type initiatives support the broad university environment²⁷⁶ and increasingly identify as “pivotal cross-level brokers within entrepreneurial and innovation ecosystems”.²⁷⁷ The success of a TTO depends on university leadership, the size of the TTO and the ability to connect across the RSI

²⁷⁴ Above n 7, at 421.

²⁷⁵ Above n 8, at 64.

²⁷⁶ Bryce Pilz “Modern Intellectual Property Valuation in the Academic Technology Transfer Setting” in Research Handbook on Intellectual Property and Technology Transfer (Edward Elgar Publishing, 2020) at Chapter 8.

²⁷⁷ Conor O’Kane and others “The Brokering Role of Technology Transfer Offices within Entrepreneurial Ecosystems: An Investigation of Macro–Meso–Micro Factors” (2021) 46(6) The Journal of Technology Transfer 1814–1844 at 1814.

continuum,²⁷⁸ although TTOs organise their efforts on the institution’s defined strategic research goals or technological platforms.²⁷⁹

When commercialising an invention, there is a conventional view that the licensing route is generally more comfortable than a spin-out.²⁸⁰ Still, there are several methods of transferring technology to third parties,²⁸¹ and no one approach fits all.²⁸² Fundamentally, the difference comes down to whether the intellectual property owner or a new company takes on developing the technology. The outcome is a balance of decisions made by the supply side (inventors, owners) and the demand side (companies, investors).

In a license scenario, the transferor or the licensor permits the receiver, the licensee, to use the invention for commercial gain. The rights may be exclusively globally or restricted by territory (such as specific countries), may cover a range of different fields (e.g., wound healing; anti- inflammatory), or limited to one or a few.²⁸³ Other commercial conditions may exist, but the agreement is usually presented as a written legal document, typically called a license agreement.²⁸⁴ Financial gain for the licensor is generally through royalty payments on sales of goods and services derived from the invention.

Revenue from commercialising inventions is frequently distributed using a cost-recovery model in which the TTO deducts all cossts associated with commercialising the technology, followed by a revenue distribution process based on the ⅓, ⅓, ⅓ model (university, inventor(s), and department the inventor(s) work for). Other models exist, but the one described above is the most prevalent in New Zealand, evidenced by the University of Otago’s IPR policy.²⁸⁵

²⁷⁸ Will Geoghegan, Conor O’Kane and Ciara Fitzgerald “Technology Transfer Offices as a Nexus within the Triple Helix: The Progression of the University’s Role” (2015) 68(3–4) International Journal of Technology Management 255–277 at 255.

²⁷⁹ James A Cunningham and others “Effective Technology Transfer Offices: A Business Model Framework” (Springer Brief in Business, Springer, 2020) at 45.

²⁸⁰ Oxford University Innovation “Oxford University Innovation. Spin-out versus Licence” (Oxford University, 2014) .

²⁸¹ Such as patent auctions. See Daniel R Cahoy “Intellectual Property Exchanges and Auctions: Non-traditional Mechanisms for Technology Transfer” in Research Handbook on Intellectual Property and Technology Transfer. (Edward Elgar Publishing, 2020) at Chapter 13.

²⁸² OECD Turning Business into Science: Patenting and Licensing at Public Research Organisations (OECD, Paris, 2003).

²⁸³ Author’s personal experience.

²⁸⁴ For an example of an exclusive licence agreement, see World Intellectual Property Organization “Exclusive License Agreement (sample) Harvard College, United States of America”

<https://www.wipo.int/tk/en/databases/contracts/texts/harvardexlic.html>.

²⁸⁵ For example, the University of Otago “Intellectual Property Right Policy”

<https://www.otago.ac.nz/administration/policies/otago003229.html> at s 5.

As I mentioned previously (see Chapter I), biomedical inventions are highly prized among TTOs, as they can provide significant revenue if successfully commercialised. Section 18 of the Patents Act 2013 outlines the exclusive rights given by a patent, specifically defining what exploiting an invention entails:

(1) A patent gives the patentee the exclusive rights, during the term of the patent, to exploit the invention and to authorise another person to exploit the invention.

(2) In this Act, exploit, in relation to an invention, includes,—

(a) if the invention is a product, to—

(i) make, hire, sell, or otherwise dispose of the product; or

(ii) offer to make, hire, sell, or otherwise dispose of the product; or

(iii) use or import the product; or

(iv) keep the product for the purpose of doing any of the things referred to in subparagraphs (i) to (iii); or

(b) if the invention is a process, to use the process or to do any act mentioned in paragraph (a) in respect of a product resulting from that use.

(3) This section is subject to subparts 5 and 6 of Part 4 (which relate to compulsory licences and the use of patented inventions for services of the Crown).

Exploitation typically includes making, selling, hiring or disposing of a product in another form. An example of the commercial exploitation of a biomedical invention was the recent announcement of a new biotech startup company, Amaroq, set up through Otago Innovation Ltd. to commercialise its prospective cancer drug treatment work. The firm has just secured an NZD 14 million investment through Brandon Capital, a trans-Tasman medical startup investment firm.²⁸⁶ However, the commercialisation of such technologies is not cheap. Some reports place the cost of developing a prescription drug as high as USD 2.6 billion.²⁸⁷ The USD

2.6 billion figure includes the sunk costs of discovery, testing clinical efficacy and opportunity costs. The failure rate is high. The chance of discovering a biologically active compound in

²⁸⁶ Chris Kaell “Dunedin Biotech Startup Amaroq Therapeutics Raises $14m for Revolutionary ‘Dark Matter’ Cancer Treatment” The New Zealand Herald (online ed. Auckland) 8 August 2021.

²⁸⁷ Jason Millman “Does it Really Cost $2.6 Billion to Develop a New Drug?” The Washington Post (on-line ed. Washington) 18 November 2014.

plants is meagre.²⁸⁸ It is no surprise then that up to 80 per cent of new drugs that enter clinical trials do not reach the market, usually due to being unsafe or simply ineffective.²⁸⁹ Typically, university TTOs lack the resources necessary to bring such ideas to market independently. Instead, they rely largely on commercial partners, often a public-private partnership like the one between Otago Innovation Ltd. and Brandon Capital.

Partners utilise their expertise, skills, and know-how in public-private partnerships to work collectively for a shared vision, often leading to new inventions, ideally protected through a patent. For partners, access to expertise in the university is a critical incentive for the biotechnology and pharmaceutical industries to engage in such partnerships.²⁹⁰

In New Zealand, perhaps arguably the most commercially significant public-private partnership involving a New Zealand natural product was the commercialisation of mānuka honey for wound healing, as referenced in the Introduction. Discovered in 1981, Professor Peter Molan²⁹¹ (from the University of Waikato) quantified the honey’s biological activity, which Waikatolink commercialised in partnership with Comvita. Waikatolink filed several patent applications that included using honey for anti-inflammatory purposes (US 2017/0157214 A1), treating of wounds (WO 2007/030023 A1) and honey-based wound dressings (US RE042755 E; CA 2397614 A1). Some patents have expired (such as US RE042755 E; CA 2397614 A1), some discontinued, and some are still active—two for the use of honey in medical dressings (WO 2001/041776 B1; WO 2001/041776 A3) and one for a honey-based wound dressing (WO 2001/041776 A2). Some have singular applicants (like Waikatolink), and others have many. For US RE042755 E, the owners were: Apimed Honey Research Limited, New Zealand, Waikatolink Limited New Zealand (a TTO), Apimed Medical Honey Limited, New Zealand and Derma Sciences, Inc., New Jersey.

Unfortunately, Professor Molan had not identified the specific compound responsible for these medical applications when the commercial terms were agreed upon. In February 2006, Professor Thomas Henle, at the Technical University of Dresden, identified methylglyoxal

²⁸⁸ K Hostettman and JL Wolfender “The Search for Biologically Active Secondary Metabolites” (1997) 51 Pesticide Science 471–482.

²⁸⁹ Derek Lowe “The Latest on Drug Failure and Approval Rates” (9 May 2019) Science Translational Medicine

<https://blogs.sciencemag.org/pipeline/archives/2019/05/09/the-latest-on-drug-failure-and-approval-rates>.

²⁹⁰ H Stevens and others “Intellectual Property Policies in Early Phase Research in Public-Private Partnerships” (2016) 34 Nat Biotechnol 504–510 at 504.

²⁹¹ Professor Peter Molan sadly passed away in 2015.

(MGO) responsible for the anti-bacterial action.²⁹² Court proceedings ensued.²⁹³ Comvita was convinced that its commercial decisions were made on representations of Waikatolink and those representations were knowingly false. Comvita sought remedy from Waikatolink through both the Fair Trading Act 1986 and the Contractual Remedies Act 1979. Waikatolink responded in kind, seeking to enforce the commercial agreement between the parties and seek the remaining sums of money owed. Justice Rhys Harrison (High Court) ruled in favour of Comvita and found Waikatolink engaged in misleading or deceptive conduct.

A detailed examination of the commercialisation of mānuka honey provided an unexpected insight not given in the preceding case. There is evidence that Māori knowledge about the use of mānuka honey for wound healing served as the impetus and source for Professor Molan’s study on mānuka honey. The discovery was not the result of a random scientific endeavour.

Professor Molan recognises this in an interview with Sciblogs:²⁹⁴

it turns out—some folk wisdom in New Zealand that Mānuka honey was particularly good. I’ve had Māori people tell me that their grandmothers used Mānuka honey on them. This is somewhat surprising because honey bees were only introduced to New Zealand in 1839, so Mānuka honey has not actually been around that long.

The patent applications filed by Waikatolink for the use of mānuka honey in wound care seem to mirror the practical application of mānuka honey by Kuia (Grandmother). Yet, recognition of such background knowledge seems absent, and the law (patent law) has proceeded on that basis. It is not uncommon. In Australia, for example, research revealed that universities are the principal source of identifying and developing medicines derived from traditional knowledge. They then partner with pharmaceutical companies to commercially exploit those discoveries.²⁹⁵

According to the World Health Organization, there are approximately 56 pharmacopoeias published worldwide.²⁹⁶ Many are derived from traditional practices like the Indian Traditional Ayurvedic System of Medicine or Chinese Traditional medicine. Others are perhaps less well-

²⁹² E Mavric and others “Identification and Quantification of Methylglyoxal as the Dominant Anti-bacterial Constituent of Mānuka (Leptospermum scoparium) Honeys from New Zealand” (2008) 52(4) Mol Nutr Food Res. 483–489 at 483.

²⁹³ WaikatoLink Ltd v Comvita New Zealand Ltd HC Tauranga CIV 2008-470-90 [2010] NZHC 862 (4 June 2010).

²⁹⁴ Above n 32.

²⁹⁵ Above n 20, at 38.

²⁹⁶ World Health Organization “Index of World Pharmacopoeias and Pharmacopoeial Authorities” (March 2021) at 2-3.

known, like the Russian Pharmacopoeia, described in 107 monographs,²⁹⁷ Most were not developed until the early 1800s,²⁹⁸ and they tend to be Asian or European in origin. There is no formal pharmacopoeia for New Zealand, though it is not uncommon to find Māori traditional use of native plants and animals through a simple internet search.

The indigenous influence on western pharmacopoeia has been substantial.²⁹⁹ For example, when the first United States pharmacopoeia was issued, 296 substances of various origins were described. Of these, 130 were plant-based drugs used by North American Indians. At its peak,

220 American Indian drugs were listed but steadily declined due to synthetic drug development. By 1965, just 30 remained on the pharmacopoeia. The issue is not one of utilising natural products or traditional knowledge in the development of new medicines or drugs, but of denying the “western reliance” on Indigenous peoples’ knowledge and indigenous native plants and animals in the development of pharmaceutical products, and of not compensating Indigenous peoples’ appropriately.³⁰⁰

Similarly, one may say the same thing about innovations generated from mānuka honey and mānuka oil. Lai and colleagues examined this in detail. They found 2,991 patent applications seeking protection over inventions derived from New Zealand indigenous species (over 1,972 patent families). Patent applications for L. scoparium are the most frequent, with 51 patent families and 161 patent applications.³⁰¹ The United States was the most often used jurisdiction for patent applications, the bulk of which were in the pharmaceutical field.³⁰² For New Zealand, 26 out of 33 mānuka patent applications asserted subject matter that seems to be related to or a derivative of mātauranga Māori.³⁰³

Further investigation of patent applications registered at IPONZ from 2013 to 2018 showed some 25 mānuka-derived patent applications were filed, 52 per cent of which were for

²⁹⁷ Alexander Shikov and others “Medicinal Plants from the 14th Edition of the Russian Pharmacopoeia: Recent Updates” (2021) 25 J Ethnopharmacol 268.

²⁹⁸ J Mark Wiggins and Joseph A Albanese “A Brief History of Pharmacopoeias: A Global Perspective” (2019) BioPharm International <https://www.biopharminternational.com/view/brief-history-pharmacopoeias-global- perspective-2>.

²⁹⁹ Virgil Fogel “American Indian Influence on the American Pharmacopeia” Paper presented at the American Association for the Advancement of Science” (Boston, Massachusetts, 24 February 1976) at 1.

³⁰⁰ Above n 20, at 35.

³⁰¹ Jessica Lai and others “Māori Knowledge under the Microscope: Appropriation and Patenting of mātauranga Māori and Related Resources” (2019) 22(3–4) The Journal of World Intellectual Property 205–233 at 212.

³⁰² Above n 301, at 213.

³⁰³ Above n 301, at 218.

pharmaceutical discoveries. While 76 per cent were granted, not all contained subject matter comparable to mātauranga Māori.³⁰⁴

Some iwi have even declared which plants and animals they classify as taonga. Te Runanga o Ngāi Tahu declared which species the iwi recognised as taonga in the Ngāi Tahu Claims Settlement Act 1998. The iwi professed an interest in 53 distinct plant species.³⁰⁵ Using these species as a starting point, I undertook a preliminary study of the patent application activity for these species. I found that 702 patent applications have been filed against 20 (38 per cent) of the 53 taonga species. Mānuka, miro, kānuka, wīwī, tutu, rātā, tōtara, rimu, mataī, kahikatea and kāmahi were the ten species that account for 98 per cent of all patent applications. Only three of these account for roughly three-quarters of all patent applications: mānuka, miro and kānuka (72 per cent). However, 371 patent applications have been filed for inventions developed from mānuka, accounting for 53% of all patent applications. The results are very similar to those of previous investigations.

The evidence is clear. Inventions derived from mātauranga Māori and mānuka are being captured in the patent regime, both in New Zealand and internationally, and presumably commercially exploited. By doing so, it seems the origin of that knowledge is denied.³⁰⁶ But who owns culture? Who owns the invention? Who is entitled to benefit from the commercial exploitation of that culture when it is appropriated?³⁰⁷

C Ownership

As I indicated previously, Wai 262 is really about who controls and owns mātauranga Māori.

The claimants assert that the IPR regime has failed to safeguard such rights in mātauranga Māori. But from a TTO perspective, who is the first and true inventor³⁰⁸ of the invention and who has the right of property in the commercial exploitation of an invention derived from Māori medical knowledge in mānuka?

³⁰⁴ Above n 224, at 44–48.

³⁰⁵ Appendix 13.

³⁰⁶ Mathias Siems “ The Law and Ethics of ‘Cultural Appropriation’” (2019) 15(4) International Journal of Law in Context 408–423 at 419.

³⁰⁷ Susan Scafidi’s book Who Owns Culture?, which predates the current debate, defines cultural appropriation as the “taking (...) of intellectual property, cultural expressions or artifacts, history, and ways of knowledge”. See S Scafidi “Introduction: New Dimensions of Cultural Property” (2009) 31 Fordham International Law Journal 684– 689.

³⁰⁸ The devisor of the invention, possibly an individual or a research team. See Finch, above n 165, at 59.

1. The Patent Inventor, Owner and Beneficiaries

In broad terms, inventorship establishes who has the right to file for a patent, ownership establishes who has the right to exploit the innovation, and beneficiaries receive compensation for their contributions to the inventions but may or may not be inventors or owners (who too are beneficiaries).

University ownership of inventions derived from publicly-funded research funds in New Zealand is characterised through three instruments (1) the Master Investment Contact with the New Zealand government, (2) the university intellectual rights policy and (3) the Patents Act 2013.

(a) The Master Investment Contract

There is no explicit legislation in New Zealand that grants universities ownership or exclusive rights to discoveries developed from public financing. Rather, ownership is transferred through an agreement between the institution and the government ministries responsible for providing research money (such as MBIE), the terms of which are specified in a Master Investment Contract.³⁰⁹

The preference is for New Zealand based contractors and beneficiaries to develop or commercialise the technology with the university,³¹⁰ and ownership resides with the university (the contractor).³¹¹ Under the Ministry’s contractual obligations in the Master Investment Contract:

The Ministry agrees that all IPR arising from this Contract and any Work Programme Agreement are the property of the Contractor, and will make no claim to ownership of any IPR arising from this Contract or any Work Programme Agreement.

For instance, while examining the Master Investment Contract between MBIE and potential contractors (such as a university), the contract stipulates that “The Intellectual Property Policies and Principles should ensure that cultural, Treaty of Waitangi and Māori issues are properly taken into consideration”.³¹² However, “should” means “In the following principles, ‘should’

³⁰⁹ Ministry of Business, Innovation and Employment “Master Investment Contract”

<https://www.mbie.govt.nz/dmsdocument/1268-science-investment-contract-template>.

³¹⁰ Above n 309, at s 5.

³¹¹ Above n 309, at s 4.4.

³¹² Appendix 2 at 4.

indicates a non-obligatory best practice”. In other words, no duty exists to guarantee that cultural, Treaty, nor Māori issues be effectively considered at all.

(b) University Intellectual Rights Policies

Similarly, universities seek to ensure ownership from academic discoveries made by their staff, usually through employment and IPR policies. The general principle of IPR policies ensures the university claims ownership over all intellectual property created by staff during their employment. They also retain control over it by ensuring staff do not commercially exploit any intellectual property the university owns unless permitted.³¹³ As long as the innovation is created while the employee is on the job and the employee is obligated to make the invention, the institution retains ownership of the innovation.³¹⁴

In the RSI system, ownership is conferred to the university from the funder through a Master Investment Contract. Academics relinquish their ownership right to their invention to the university under their employment contract, which obligates them to comply with the universities intellectual property policy. To overcome any issues with IPR policies inability to secure ownership, assignment of intellectual property from the academic to the university, then from the university to the TTO occurs.³¹⁵

Yet, New Zealand universities do not consistently account for mātauranga Māori within their IPR policies. Ayoubi (2019)³¹⁶ reported:

Reference to mātauranga Māori in the intellectual property policies of the eight NZ universities is varied. Some do not include any such references. Other policies express the university’s commitments to the principles of the Treaty of Waitangi, but do not elaborate on how Treaty principles are to be considered in the commercialisation of university research intellectual property. General references to Treaty obligations may not necessarily translate into consideration for mātauranga issues. Finally, others include more detailed provisions for protection of mātauranga in intellectual property commercialisation. However, lack of clear terminology or guidelines around the identification and assessment of mātauranga could lead to problems in applying these instructions.

³¹³ University of Otago “Intellectual Property Right Policy”

<https://www.otago.ac.nz/administration/policies/otago003229.html> at cl 2.

³¹⁴ Finch, above n 165, at 67.

³¹⁵ Author’s personal experience and practice.

³¹⁶ Lida Ayoubi “Intellectual Property Commercialisation and Protection of Matauranga Māori in New Zealand Universities” (2019) Summary report into a research project funded by the New Zealand Law Foundation at 7.

Do such policies act as a check and balance for considering mātauranga Māori in the inventive process? Certainly, at the University of Otago, no duty exists for researchers to consider as such.³¹⁷ In contrast, the University of Auckland recognises the Treaty in its IPR policy.³¹⁸ The University of Waikato is perhaps the most proactive in this space: “When dealing with intellectual property that includes mātauranga Māori, and in the context of the WAI262 claim report, the principles of Te Tiriti o Waitangi will be applied by the University”.³¹⁹

I outlined the significant contribution Indigenous peoples made to pharmacopeia above. However, after a simple Google search using the terms “Māori pharmacopeia” the following academic paper was identified—The Potential of Anti-Diabetic Rākau Rongoā (Māori Herbal Medicine) to Treat Type 2 Diabetes Mellitus (T2DM) Mate Huka: A Review.³²⁰ It was ranked on the first page of Google, published in 2020 and publicly available on the United States National Center for Biotechnology Information database. The authors were from the University of Waikato and the University of Auckland.

The review was focused on traditional rākau rongoā for the prevention and treatment of type 2 diabetes. The article teaches the anti-diabetic efficacy of three native New Zealand species— karamu, kūmarahou, and kawakawa, which have a documented effect on glucose metabolism, a critical component of diabetes. Additionally, the article teaches Māori medicinal knowledge, various traditional applications, and the species’ geographical range. It identifies the flavonoids (compounds) responsible for the medicinal benefit, comparing traditional knowledge to the literature to establish a link between traditional and western science. The article demonstrates that the stated efficacy was not supported by rigorous scientific research or clinical studies. It teaches that the mechanism of action is unclear or unproven scientifically. Yet, the writers assembled their own, revealing a possible therapeutic pathway. The writers include tikanga Māori in the creation of a novel type of diabetic therapy.

³¹⁷ University of Otago “Intellectual Property Right Policy”

<https://www.otago.ac.nz/administration/policies/otago003229.html>.

³¹⁸ The University of Auckland “The University of Auckland Intellectual Property Created by Staff and Students Policy” at s 1.3 (e) <https://www.auckland.ac.nz/en/about-us/about-the-university/policy-hub/research- innovation/conduct/intellectual-property-created-staff-students-policy.html>.

³¹⁹ University of Waikato “Intellectual Property Rights Policy” <https://www.waikato.ac.nz/official- info/index/docs/intellectual-property-rights-policy>.

³²⁰ Jonni Hazeline Koia and Peter Shepherd “The Potential of Anti-diabetic rākau rongoā (Māori Herbal Medicine) to Treat Type 2 Diabetes Mellitus (T2DM) mate huka: A Review” (2020) 11(935) Frontiers in Pharmacology 1– 14.

I appreciate that this is only one example, and it may be worth investigating further. However, despite the best intentions of the academic authors, this article discusses the crucial components necessary for developing a potential novel diabetes medication. It identifies indigenous species with established clinical usefulness, compounds derived from those species with documented therapeutic utility, and how those compounds may act in the body.

If Māori are unable to control or assert certain rights over their mātauranga Māori, their capacity to profit from such knowledge assets is constrained.³²¹ While this information is in the public domain, thus, disclosed and not patentable, this material provides anyone interested in developing a diabetic medicine or nutraceutical a significant “head start” on their drug development effort,³²² despite the universities’ declarations on mātauranga Māori. Pharmaceutical companies could develop a new formulation with one of the above species as an ingredient in that formulation and potentially protect that invention through the patents regime.

(c) Patents Act 2013

Thus far, I have demonstrated that ownership of inventions developed within universities is transferred via the Master Investment Contract, which promotes but does not oblige universities to adhere to Treaty principles. I have also shown that university IPR policies are organisation- specific in their treatment of mātauranga Māori, the Treaty and Wai 262, though they seem not to prevent that information from being added to the public arena. What does the Patent Act 2013 assert?

Consider a medical application derived from Māori medical knowledge in mānuka before colonisation. The exact same chemicals responsible for the medical application are now identified (similar to the paper discussed above) by a university researcher using the scientific method and protected under the IPR framework. According to the Patents Act 2013, who is the first and true inventor and owner of the invention? Māori or the academic researcher?

The Patents Act 2013 defines the inventor as “the actual devisor of the invention” (Section 5(1)), or “the person who made the inventive step to arrive at the invention”.³²³ Except for

³²¹ Susy Frankel Intellectual Property in New Zealand (2nd ed, LexisNexis, Wellington, New Zealand, 2011) at 133.

³²² I acknowledge that it is more complicated than that. Freedom to operate, patentability position and clinical study investigations need to be considered.

³²³ Above n 314.

section 9, where an inventor can be the actual devisor and owner of an invention, an “owner” differs from an inventor. Section 14 of the Act states an invention is denoted by its’ claims, but case law more broadly asserts that the claims and the patent specification define an invention.³²⁴

It is important to name the correct inventors on the patent and seek assignment from all the inventors or risk revocation of the patent.³²⁵ The patentee is the absolute owner of the invention “subject to any rights vested in other persons that are entered in the patents register”.³²⁶ Only an inventor or someone who has derived the title to the invention from the inventor may own it³²⁷ or apply for a patent.³²⁸

If the compounds identified in the invention are shown to be novel, or have inventive step and utility when compared to the prior art base, it is potentially patentable. There is no obligation on the researcher to acknowledge the contribution made by Māori, especially where the information is in the public domain, even if the universities IPR policy attest to consider such (see above as an exemplar). As such, it is the academic researcher who derived those compounds that is the deviser of the invention.

The Patents Act 2013 has no provision for employers’ rights in innovations made by employees during their employment, nor does it require employers to seek assignment from employees prior to the grant of a patent.³²⁹ As stated previously, if the innovation is made when the employee is doing their job duties and the person is required to make the invention, the institution retains ownership of the innovation. Ownership of inventions derived from mātauranga Māori, in the absence of any agreement between Māori and the university, “discovered” by an academic researcher in their employment duty is owned by the university.

2. Co-ownership of Patents

Collaboration is frequently the cornerstone of technological transfer. Working together for a single objective can be the difference between success and failure when commercialising technology. Consequently, it appears appropriate that the allocation of intellectual property should reflect that and be jointly held among the parties. It appears “fair” to do so frequently

³²⁴ I do not go into the breadth of case law here. For a comprehensive and historical account of case law, see Finch, above n 165, at 61–66.

³²⁵ Patents Act 2013, s 92(1)(b), (d).

³²⁶ Above n 325, s 23(1).

³²⁷ Above n 325, s 22(1).

³²⁸ Above n 325, s 31.

³²⁹ Above n 314.

because parties may only prefer to avoid difficult talks surrounding how the intellectual property may be divvied out between themselves.

It might seem fair and reasonable for a TTO and a Māori entity to seek co-ownership over a patent. However, the co-ownership of patents is complicated. Irrespective of the proportion of the contribution to technical development and drafting and prosecution cost either party may make, each “is entitled to an equal, undivided share in the patent”.³³⁰ It is of concern if the costs are disproportionally carried by one party and not the other, primarily since both parties can act as the sole owner of the intellectual property.³³¹ A minor contributor could significantly hamper the commercialisation of technology if co-owners disagree over commercialising the technology. Still, these are default provisions, and parties can contract out of these.

However, in the absence of such contractual arrangements and despite co-ownership, either party may execute licence deals independently of the other. The risk here is that the value in the patent is diluted if both parties enter licence agreements independently of the other. Moreover, if one party wish to divest themselves of the intellectual property, only their share in the intellectual property can be transferred, not the patent in its entirety. In both cases, consent is required from all parties to proceed.³³²

Also, co-owners have little control over the commercial activity of the other co-owners if two or more of the co-owners sell products derived from the patent to a client. Those co-owners not party to such a deal are obligated by that sale as if all co-owners sold it.³³³ Suppose co-owners cannot agree on commercialising a patent, like a sale or a licence. In that case, they may seek the Commissioners’ intervention, who can direct co-owners to undertake appropriate action.³³⁴ Moreover, joint ownership tends to degrade the profitability of commercialising an invention,³³⁵ making it less attractive to TTOs.

However, Māori may find that even if a patent is granted that targets traditional medical use of mānuka, for example, they are not locked out of using their traditional medicine. Consider the Gillette Defense—derived from Gillette Safety Razor Co v Anglo-American Trading Co Ltd.

³³⁰ Patents Act 2013, s 24(1), although this is the default and may be contracted out of.

³³¹ Section 24(2).

³³² Section 24(3).

³³³ Section 25.

³³⁴ Sections 26 and 27.

³³⁵ Priyanka Malhan “Joint Ownership of Intellectual Property: Is it a Profit or Loss” (2020) 19(1) Indian Journal of Economics & Business 1–18 at 13.

(NZ CASE). The case centred around Gillette alleging that the defendant’s product infringed their 1902 safety razor patent. The defendant denied this, stating that the Gillette patent was invalid due to a lack of novelty.³³⁶ The issue was that the alleged infringing product was very similar to an item already in the prior art base. If Gillette stated that the offending product was in breach of its patent because of similarity to its product, and the defendant’s product was similar to another product already known from the prior art base, then Gillette’s product would also be obvious. Consequently, the validity of the patent could be challenged. Gillett was in a difficult position. Either it continued with its allegation and risked having its patent invalidated due to lack of novelty or accepted that infringement did not occur and was outside the scope of their patent. In such a case, Judge Lord Moulton deduced that the defendant “must succeed either on invalidity or non-infringement”.³³⁷ Gillette lost.

The same may apply if Māori practising traditional medicine are challenged by patent holders who have derived an invention from mānuka that targets known Māori medical applications. The patent holder’s risk is that in an attempt to stop “infringement” by Māori, they risk being questioned around the connection between the prior art base and the traditional knowledge. Suppose there is a similarity between the invention and traditional knowledge and between traditional knowledge and the prior art base. As in the Gillette case above, there may be a significant risk that the patent is invalidated due to a lack of novelty. If not, they have to accept that there is no infringement. It is not something TTOs actively consider, but they should.

However, from a TTO perspective, if Māori are not owners of an invention, are Māori then entitled to benefit from the commercial exploitation of that invention? Are Māori entitled to compensation?

3. Māori Entitlement to Compensation

Compensation law seeks to reconcile two distinct legal perspectives: one based on employment law, which accounts for employer and employee rights and obligations to one another, and the other based on patent law, emphasising the inventor’s and owner’s rights to benefit from their invention through patent protection.³³⁸ Other than the references above, I am not going into the

³³⁶ Gillette Safety Razor Co v Anglo-American Trading Co Ltd. The Illustrated Official Journal (Patents) 465 Vol. XXX Reports of Patent, Design And Trade mark Cases [No. 18] 465 at 10.

³³⁷ Above n 336, at [40].

³³⁸ Jessica Mark “‘But It Was My Idea!’ A Statutory Compensation Scheme for Employee Inventors?” dissertation submitted in partial fulfilment of the degree of Bachelor of Laws (Honours), University of Otago, Dunedin, New Zealand, October 2007 at 4.

details of employment law. It is outside the scope of this thesis, and I have previously examined inventorship, ownership, and benefit-sharing under the patent regime. As a result, unless Māori invented, owned or contributed knowledge acknowledged by the TTO as essential to the invention, Māori are not entitled to compensation.

In this section, I will focus on the kaitiaki connection, which is not recognised under patent law, and this lack of recognition appeared to be the impetus for the Wai 262 claim.³³⁹ Moreover, there is no doubt that parties have likely benefited from the commercial exploitation of inventions derived from mānuka,³⁴⁰ and it is not surprising that compensation to indigenous peoples, when it occurs, is commercially focused.³⁴¹ However, the absence of recompense leads to increasing distrust from indigenous peoples.³⁴²

Yet, when considering the commercial exploitation of an invention derived from Māori medical knowledge in mānuka, I propose a third future consideration that may need to be reconciled by TTOs. Does the existence of the kaitiaki relationship with a taonga species (like mānuka) which is used in a patentable invention, whether accompanied with mātauranga Māori (like Māori medical knowledge in mānuka) or not, entitle Māori to compensation from the commercial exploitation of that invention?

I bring this question up at this juncture in my thesis because the New Zealand research and science sector is under review by the government, as I mentioned in my introduction. MBIE has released a “green paper” called “Te Ara Paerangi Future Pathways”. The goal of the paper is to seek feedback on what seems to be a significant shake-up of the sector:³⁴³

It is now time to consider how we best position our research system for the future. We want to create a modern, future focused research system for New Zealand. It needs to be adaptable for a rapidly changing future, resilient to changes, and connected; to itself, to industry, to users of research, and internationally.

There are five themes the government is seeking discussion on—(1) delivery on research priorities, (2) honouring the Treaty and enabling mātauranga Māori, (3) funding focused on

³³⁹ See Chapter II C.

³⁴⁰ See Chapter III B.

³⁴¹ Fundación Indígena and Brij Kothari “Rights to the Benefits of Research: Compensating Indigenous Peoples for Their Intellectual Contribution” (1997) 56(2) Human Organization 127–137 at 127.

³⁴² Darrell Posey “Intellectual Property Rights and Just Compensation for Indigenous Knowledge” (1990) 6(4) Anthropology Today 13–16 at 16.

³⁴³ Above n 62. See the factsheet <https://www.mbie.govt.nz/dmsdocument/17661-te-ara-paerangi-future- pathways-one-page-factsheet>.

research priorities, (4) connecting institutions and encouraging collaboration and (5) supporting and developing the workforce.³⁴⁴

TTOs will need to equip themselves appropriately if modifications to the RSI system are introduced. Indeed, if the Treaty’s principles are followed, are TTOs willing to cede tino rangatiratanga (complete authority) to iwi and hapū to grant them authority over taonga species and mātauranga Māori for Māori to fulfil their kaitiaki commitments as stated in Article 2 of the Treaty? Time will tell, but it may not be as far fetched as initially contemplated.

I have been involved in the review of The Plant Variety Rights Act 1987. There is currently no provision for Māori IPR in the current PVR regime, but this is potentially changing. There are two critical drivers for the review—(1) protecting kaitiaki interests in indigenous plants and

(2) New Zealand meeting its obligations under the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP). This agreement requires New Zealand to align the PVR regime with the International Convention on the Protection of New Varieties of Plants (UPOV 91). That alignment may completely accede to UPOV 91 and adopt its provisions or partially take into account UPOV 91.

After consultation with interested parties, the government decided to account for UPOV 91 and not accede. The law is not so much unrecognisable from its predecessor but has changed enough that some originality has been instilled into it. The Plant Variety Rights Bill³⁴⁵ is into its second reading.

This Bill replaces the Plant Variety Rights Act 1987, modernising the regime and implementing the Crown’s obligations under the Treaty of Waitangi in relation to the plant variety rights regime and New Zealand’s obligations under the Comprehensive and Progressive Agreement for Trans-Pacific Partnership.

The Bill proposes the establishment of a Māori Plant Varieties Committee.³⁴⁶ But interestingly, it also incorporates an additional test for a PVR right—the assertion of the kaitiaki relationship.³⁴⁷ The Bill define the kaitiaki relationship as:³⁴⁸

³⁴⁴ Above n 62.

³⁴⁵ Plant Variety Rights Bill (35-2).

³⁴⁶ Above n 345, ss 55 and 56.

³⁴⁷ Above n 345, s 61.

³⁴⁸ Above n 345, s 5.

kaitiaki relationship, in relation to a plant species, means the relationship that any particular iwi, hapū, individual of Māori descent, or Māori entity has, or Māori in general have, as guardian, trustee, or caretaker of—

(a) an indigenous plant species; or

(b) a non-indigenous plant species of significance

An indigenous plant species and a non-indigenous plant species of significance are also defined in the Bill.³⁴⁹ The kaitiaki condition’s nature was whether granting a PVR impacted negatively on kaitiaki relationships, and if so, can it be mitigated? If mitigations can be agreed upon or there is no adverse impact, the application will proceed to test.³⁵⁰

While recognising the kaitiaki relationship is an encouraging development, it falls short of giving Māori veto rights over PVRs. As per other intellectual property law in New Zealand, the Commissioner is not bound by the advice given the by Committee: “The Commissioner must consider, but is not bound by, the advice given by the Māori Plant Varieties Committee under section 56(c) and (d)”. Without Māori having veto rights over taonga species, it suggests that the tension between the existing IPR regime and Māori will continue to persist.

TTOs may be compelled to overcome the current tension between the existing IPR framework and mātauranga Māori in their day-to-day commercialisation operations. This process might involve acknowledging the kaitiaki link and compensating Māori appropriately when commercialising discoveries developed from Māori medical expertise contained in mānuka. The Master Investment Contracts strongly encourage accounting for the Treaty, but it is not obligatory (see Chapter III C(a)). There may not be any changes to the patent law to recognise the kaitiaki condition as it is currently under consideration for PVRs. However, if changes are made to the RSI as a whole, universities and TTOs might find that the government will contractually oblige them if they wish access to public funding. Further, TTOs may be

³⁴⁹ Above n 348.

³⁵⁰ To be granted a PVR, the variety is required to be (1) New—Classified as no sale of that variety in New Zealand 12 months before an application was made; Overseas: six years before that date if a woody plant, and four years before that date for other plants. (2) Distinct—characterised by having at least one characteristic different from any other variety known, (3) Homogeneous—determined by the Commissioner, but requires the Commissioner to take into account features of sexual reproduction or vegetative production. (4) Stable, characterised by the variety remaining “true to its description” further examined through the reproductive or vegetative production cycles of the plant. See Plant Variety Rights Act 1987, s 10.

obligated to compensate Māori (whether financial or non-financial) without any financial or non-financial input from Māori into the invention. Time will tell.

D Patents Act 2013 Provisions Māori may use to Protect Māori Medical Knowledge in Mānuka from Commercial Exploitation by TTOs

Suppose TTOs commercialise an invention derived from Māori medical knowledge in mānuka. Are there other provisions in the Act that Māori may leverage to protect that knowledge? I have identified five such provisions—(1) patents of addition, (2) opposition to the grant of a patent,

(3) infringement, (4) termination of a commercial agreement if the patent is no longer in force and (5) compulsory licences.

1. Patents of Addition

Patents of addition are given for improvements made to an already-protected invention.³⁵¹ The applicant may attempt to keep both the parent patent and the patent of addition. Alternatively, they may petition the Commissioner of Patents for authorisation to revoke the parent patent in favour of the patent of addition.

Pursuing improvements to an invention is a common strategy of extending the innovation’s commercial life. Patents of addition are a feasible method of accomplishing this. Assume a patent is issued for an innovation drawn from mānuka; the patentee receives 20 years of protection under the patent. Suppose five years after filing the first patent, the patentee improves the invention and is given another patent-based on that improvement. In that case, the patentee receives an additional 20 years of protection and so forth as improvements are made. Typically, TTOs seek ownership of such enhancements through contractual relationships with third-party licensees. Even if a licensee spends time, money and expertise improving the invention, the TTO will aspire to own those improvements.³⁵²

It is both a blessing and a source of anxiety for Māori. One benefit is that if Māori acquire a patent for a technology created from Māori medical expertise in mānuka, they may prolong the time of exclusivity to prevent other players from adopting that innovation, provided certain enhancements are made (i.e., provided they continue to hold patents for the parent patent and

³⁵¹ Section 106.

³⁵² Otago Innovation Ltd. practice.

additions). Conversely, another party may economically utilise such information for a longer period of time than anticipated using the same mechanism.

2. Opposition to Grant of Patent

Suppose an inventor attempts to appropriate Māori traditional knowledge in mānuka, completes a patent specification and files a provisional patent application. Māori can oppose the grant of patent.³⁵³ The opposition is likely due to the invention not being patentable by not meeting the tests of novelty, inventive step, or an exclusion applies. Moreover, it may be the case that the patentee is not entitled to the patent, the specification is incomplete, or an exclusion applies, leading to the opposition of the patent grant. Misrepresentations made by the patentee and the invention secretly being used before the priority date or found contrary to the law if granted are also grounds that could lead to opposing the grant of patent.³⁵⁴

While anyone may appropriate Indigenous peoples’ knowledge from the public domain, having such knowledge in the public domain may also be a legitimate defence against misappropriation. As stated previously, novelty and inventive step are tested against the prior art base.³⁵⁵ The more traditional knowledge in the prior art base, the more difficult it becomes to meet the novelty and inventive tests.

The patent application process requires sufficient public disclosure of the invention. That disclosure assists in determining the novelty and non-obviousness of the invention as measured against the prior art base. What is unclear is to what extent are traditional knowledge sources used by patent examiners in examining a patent for novelty and to what extent they consider such sources as prior art.³⁵⁶

Failure in the prior art search has resulted in significant cases of misappropriation; a compilation of public databases of traditional knowledge may be seen as a remedy against that (see Chapter III C). Two most notable examples include those of turmeric and the “neem” plant. Claims were based on biological resources and traditional knowledge of Indian and Amazon Indigenous peoples’ communities, respectively.³⁵⁷ Patentability was challenged

³⁵³ Patents Act 2013, s 92.

³⁵⁴ Section 92(1).

³⁵⁵ See Chapter II D 2.

³⁵⁶ Above n 96.

³⁵⁷ Manuel Ruiz The International Debate on Traditional Knowledge as Prior Art in the Patent System: Issues and Options for Developing Countries (October 2002) (Ruiz) [TE02-2] at 1.

because the traditional knowledge counted as prior art as the knowledge was readily available in the public domain. Hence, the invention was not new or non-obvious. That aside, what is clear is that the dissemination of traditional knowledge is a significant part of the prior art base (publications, databases, journals, periodicals, orally), conceived by academic endeavour and readily available through academic databases.³⁵⁸

3. Infringement

Universities are crucibles of experimentation. The academic curiosity of many of their researchers has led to significant discoveries and benefits for humanity (see Chapter I A). The Act permits anyone to experimentally examine how an invention works, determine the scope of that invention, check the validity of claims, and seek improvements to the invention, including new uses of the invention,³⁵⁹ without fear of infringing a patent.

On one level, this is a windfall for TTOs and universities, as it promotes the academic freedom principle upon which many universities are founded. Universities are not violating a patent if they do experimental studies for the aforementioned goals. In some respects, the defence is relatively narrow as it pertains only to the subject matter in the invention.³⁶⁰ Under section 140 of the Patents Act:

A person infringes a patent if (other than under a licence or with the consent or agreement of the patentee) the person does anything in the patent area, while the patent is in force, that the patentee has the exclusive right to do under section 18.

Although in the case where a university researcher might accidentally infringe a patent, ignorance of the existence of the patent or innocence of infringement may be legitimate means to limit the damages incurred by the infringing party.³⁶¹

On one level, this signals significant risk to the TTO if the TTO is the patentee. Any person may undertake experimental work to undermine the validity of the claims made in the patent application or simply rely on a Swiss-type claim to reap the benefits of the TTO’s initial work. That is a consideration for Māori who might seek to invalidate the patent application if they feel the invention is indeed contrary to Māori values. Detailed experimentation may reveal

³⁵⁸ Above n 20.

³⁵⁹ Patents Act 2013, s 143.

³⁶⁰ Section 143(1).

³⁶¹ Section 153.

weaknesses in previously understood claims that might invalidate the patent application. For Māori, this may be equally problematic. It may further contribute to the misappropriation of traditional medical knowledge in mānuka, especially when taken into account alongside Swiss- type claims. Experimental work seeking new invention applications is not considered an infringement until it is commercialised. Conversely, it might also signal significant benefits to TTOs and Māori. Any improvements made to an invention might significantly increase the strength and value of the patent.

4. Termination of Commercial Agreements If Patent No Longer in Force

TTOs aim to license or sell their technology to third parties; terms of that agreement are usually expressed in a sales or licence agreement. TTOs tend to transfer the technology well before PCT filing to avoid carrying the financial load of filing and prosecuting patents. Despite the claims made in a patent application, there is always a risk that a patent is not granted on examination. This is usually why a range of broad and progressively narrow claims occur in a patent application.

If patents are not granted (examination may take up to 7–8 years), or if indeed a patent runs its natural life (20 years), or is terminated in some other way, then the sale, lease or licence agreement is also terminated.³⁶² Provided either party gives the other three months’ notice, the patent is no longer in force. It is critical to be aware of this condition since it “applies despite anything to the contrary in the contract or in any other contract”.³⁶³ Regardless of any other arrangement, section 168 of the Patents Act 2013 supersedes it. When it is uncertain whether a patent will be awarded or not, TTOs aim to protect themselves against section 168 during the negotiating stage with third party licensees. If this occurs, TTOs will very certainly want to secure the royalty stream through a contractual arrangement, even if the partner continues to make revenue from the intellectual property (probably classified as know-how at this stage).

It may be advantageous for Māori. If traditional knowledge is captured, misappropriated, and expressed in a patent application and patents are not granted, the patent application owner cannot sue Māori for infringement of the patent because it no longer exists. In theory, it might only be 7–8 years a patentee can exclude Māori from using the invention instead of 20 years if a patent is granted. It is not ideal to be banned from using your own traditional knowledge for

³⁶² Section 168(2).

³⁶³ Section 168(3) (b).

any timeframe, but this provision may minimise the damage. The same applies if a granted patent expires. Nevertheless, in the rare case this might occur, Māori may also leverage the Gillette defence.

5. Compulsory Licences

Compulsory licences³⁶⁴ are granted by governments or a court giving a third-party non- exclusive rights to produce a patented product without the patent owner’s consent. Compulsory licensing permits third parties to use, produce, and import or export patented technologies in the public interest. It safeguards against a patent not being utilised to its full extent. Compulsory licences tend to be limited to the country the Act applies to, except for global health issues where compulsory licences may be granted to export pharmaceutical products to certain countries.³⁶⁵

Patentees tend to seek patent protection in various territories, usually because of their market opportunity—notably the United States, Europe and Asia. New Zealand is a small market; mānuka patent applications are more commonly filed in the US than in any other jurisdiction (see Table 2). Suppose a patentee has appropriated traditional knowledge and not sought protection in New Zealand³⁶⁶ or the product is not “being supplied on reasonable terms in New Zealand”.³⁶⁷ Then, any person may seek a compulsory licence to use the patent in New Zealand.

In the case where the court orders a compulsory licence for the export of pharmaceutical products to certain countries, the court needs to be satisfied that patented invention is “(i) a pharmaceutical product; or (ii) a process for making a pharmaceutical product”.³⁶⁸ Specific terms of the licence are detailed in section 173 of the Act. Some suggest that the threat of a compulsory licence for pharmaceutical patents could significantly curtail future pharmaceutical research.³⁶⁹

Why might compulsory licences be of interest to Māori? Māori might consider compulsory licences to credibly threaten TTOs and universities who may have misappropriated traditional

³⁶⁴ Section 169.

³⁶⁵ Section 171.

³⁶⁶ Section 169(2)(a).

³⁶⁷ Section 169(2)(b).

³⁶⁸ A pharmaceutical product includes a medicine or vaccine, an active ingredient of a medicine or vaccine that is necessary for its manufacture, or a diagnostic kit needed for the use of a medicine or vaccine. Patents Act 2013, Part 4.

³⁶⁹ A Fisch “Compulsory Licencing of Pharmaceutical Patents: An Unreasonable Solution to an Unfortunate Problem” (1994) 34(3) Jurimetrics 295–315 at 313.

medical knowledge in mānuka. Compulsory licenses are a credible strategy. Threatening to utilise a compulsory licence may be just as effective as issuing one formally.³⁷⁰ Since mānuka patent applications tend to focus on foreign markets, there may be some logic in Māori examining compulsory licence provisions in Patents Acts in other jurisdictions, precisely to weigh up if such a threat might be effective offshore.

If threats were ineffective, Māori might seek formal issuance of a compulsory licence. Māori would still need to enter a good-faith negotiation with the patentee licensor and only be awarded a compulsory licence if such negotiation fails.³⁷¹ Applications can only be made three years after the patent is granted or four years after the patent date.³⁷² The licence is not exclusive,³⁷³ and licensees are obligated to pay remuneration to the patentee.³⁷⁴

E Extra-Legal Concepts and Tools

In the absence of Māori being able to rely solely on statutory support to effectively protect Māori medical knowledge in mānuka from commercial exploitation by TTOs, there are many potential extra-legal concepts and tools Māori may utilise that TTOs may need to be mindful of.

1. Reputational Damage—Freedom, Permission and Social Licences to Operate

Universities consider it important to manage public perception, visual identity and reputation. University performance is heavily influenced by reputation, with prominent universities outperforming peers across the board.³⁷⁵ Public universities, in particular, are subject to peer rivalry, and reputation is a critical intangible asset for ensuring a lasting competitive advantage.³⁷⁶ Yet, I have discussed the issue of universities dismissing indigenous knowledge’s contribution to their research programmes (which might be characterised as misappropriation) and then collaborating with pharmaceutical corporations to patent and commercialise

³⁷⁰ G Ooms and J Hanefeld “Threat of Compulsory Licences could Increase Access to Essential Medicines” (2019) BMJ 365 at 3.

³⁷¹ Patents Act 2013, s 176.

³⁷² Section 169(1).

³⁷³ Section 170(3)(a).

³⁷⁴ Section 175.

³⁷⁵ RD Baltaru “Do Non-academic Professionals Enhance Universities’ Performance? Reputation vs. Organisation” (2019) 44(7) Studies in Higher Education 1183–1196 at 1183.

³⁷⁶ Giorgia Miotto, Cristina Del-Castillo-Feito and Alicia Blanco-González “Reputation and Legitimacy: Key Factors for Higher Education Institutions’ Sustained Competitive Advantage” (2020) 112 Journal of Business Research 342–353 at 350.

innovations drawn from that information (perhaps classified as patent-based biopiracy).³⁷⁷ In sum, Indigenous peoples’ sovereignty to retain, govern, safeguard and develop their cultural legacy, traditional knowledge, genetic resources, medical practices and intellectual property is being denied.

Māori have become incredibly competent at exposing “cultural appropriation” by companies and individuals.³⁷⁸ Such appropriation does have a significant impact on reputation. Research shows that “individuals who are caught appropriating ideas for themselves are deemed less competent and less trustworthy than individuals attributing someone’s idea to a third party”.³⁷⁹ As a result, universities and TTOs researching and commercialising Māori medical knowledge in mānuka may need to be cognisant of research and commercial operations that may adversely affect their reputation.

Despite that, commercial exploitation of intellectual property is not simply a matter of meeting the legislative criteria set out in a specific statute, such as the Patents Act 2013 in New Zealand. The process is more strategic than that. The ability to commercialise intellectual property is not only characterised by successfully obtaining a granted patent but also by (1) freedom to operate,

(2) permission to operate, (3) social licence to operate and (4) the regulatory environment.

Freedom to operate analysis determines whether the invention impinges on other patents in the chosen field and territory. It aims to avoid legal complications with other parties.³⁸⁰ If freedom to operate is not possible, technologies are often abandoned at this stage despite a likely invention meeting the criteria for patentability. Further, permission to operate ensures that if the invention relies on third party technologies to be commercialised, appropriate agreements are in place to use those technologies. The market’s sentiment characterises social licence to operate, usually, to promote communication, openness, benefit-sharing and good governance among interested parties.³⁸¹ Even if the technology has the freedom to operate, permission to

³⁷⁷ See Chapter I and Robinson, above n 27, at 80.

³⁷⁸ Tina Ngata “Cultural Appropriation of Māori Traditions is an Exercise in Entitlement and Privilege” The Guardian 4 December 2019 <https://www.theguardian.com/commentisfree/2019/dec/04/cultural-appropriation- of-maori-traditions-is-an-exercise-in-entitlement-and-privilege>; Mika Young “Tā moko and the Cultural Politics of Appropriation” (2018) 15(2) New Series; Lauren E Sweetman and Kirsten Zemke “Claiming Ka Mate: Māori Cultural Property and the Nation’s Stake” The Oxford Handbook of Musical Repatriation (2019) 700–722 at 700. ³⁷⁹ S Altay, Y Majima and H Mercier “It’s My Idea! Reputation Management and Idea Appropriation” (2020) 41(3) Evolution and Human Behavior 235–243 at 237 (see Table 1).

³⁸⁰ D Kleyn “Freedom to Operate Conundrum” (2021) 56(4) Les Nouvelles-Journal of the Licensing Executives Society 358–390 at 358.

³⁸¹ K Moffat, J Lacey, A Zhang and S Leipold “The Social Licence to Operate: A Critical Review” (2016) 89(5) Forestry: An International Journal of Forest Research 477–488 at 485; P Edwards and S Trafford “Social Licence in New Zealand—What is It?” (2016) 46(3–4) Journal of the Royal Society of New Zealand 165–180 at 174.

operate, and is patentable, the market might find it objectionable (such as genetically modified organisms), making it incredibly risky to commercialise. Lastly, the regulatory environment may significantly impact a technology’s commercialisation pathway. Academic researchers rarely consider regulatory impacts when designing their research programmes,³⁸² despite it being essential to whether the technology can meet the regulatory requirements to be developed, tested, and eventually sold in countries of commercial interest.

In light of that, TTOs may be best placed to be mindful of the amorphous distinction between partner and stakeholder when considering the above,³⁸³ especially regarding social licence to operate and managing their reputations. The term social licence to operate has found its way into a range of industries in New Zealand. At its core is trust between partners, particularly in the academic realm and, specifically, in a Māori environment.³⁸⁴ In particular, the degree to which partners are deemed trustworthy in their interactions with one another is important.³⁸⁵

The courts have referred to the exchange of rights and obligations in the Treaty as a partnership.³⁸⁶ For Māori, the grass-roots use of social permission to operate has been by leveraging the Treaty as a vehicle through which Māori may grant or deny consent to use mātauranga Māori.³⁸⁷ Suppose MBIE, in its review of the RSI system, successfully embed the protection of mātauranga Māori and give due consideration to the Treaty.³⁸⁸ Strategically, TTOs could apply the Treaty principles in their commercialisation processes (which could include ABS agreements), which if followed may lay the groundwork for effectively achieving a social licence to commercialise Māori medical knowledge in mānuka. The result could be the potential minimisation of unforeseen reputational damage by the unauthorised commercial exploitation of taonga species.

³⁸² Duong Cong Doanh and others “Academic Entrepreneurship: An Empirical Research of Invention Commercialisation” (2021) 10(2) Central European Business Review 33–62 at 52.

³⁸³ Partners being active participants in the commercialisation of a technology; stakeholders being interested parties.

³⁸⁴ Above n 381, at 175, see Table 2.

³⁸⁵ Peter Edwards and others “Trust, Engagement, Information and Social Licence—Insights from New Zealand” (2019) 14(2) Environmental Research Letters 024010 at 1.

³⁸⁶ See Chapter II B.

³⁸⁷ Katharina Ruckstuhl and others “Māori and Mining: Indigenous Perspectives on Reconceptualising and Contextualising the Social Licence to Operate” (2014) 32(4) Impact Assessment and Project Appraisal 304–314 at 306.

³⁸⁸ See Chapter I.

2. Biocultural Labels and Biocultural Notices

Biocultural labels are unique identifiers (similar to trade marks) that may be applied to Indigenous digital collections (such as databases of biological and genetic resources) to indicate which Indigenous peoples own and manage those resources and the permissions and consents required to use that data.³⁸⁹ These identifiers include provenance (origin of the data) permissions (or not) to use that data for research purposes and commercialisation.³⁹⁰ They appear to be a good way for researchers to determine whether the data they wish to use is associated with Indigenous peoples and, if so, whether they will require consent from the data owner before utilising the data for research or commercial purposes.

Biocultural notices accompany the biocultural labels. Biocultural notices are specialised tools that assist institutions and academics in recognising Indigenous rights to collections and data. They are machine-readable and visible, and their use is already being encouraged within the scientific community.³⁹¹ Four Notices are included. They are the Traditional Knowledge and Biocultural Notices and two Cultural Institution Notices: the Notice of Incomplete Attribution and the Notice of Availability for Collaboration.

The system is being trialled in New Zealand.³⁹² The system may provide research institutions and organisations with a means for scholars and institutional employees to identify Indigenous collections and interests in data early in the research formulation process. It may also be beneficial to TTOs as an early indicator of Indigenous peoples’ willingness to commercialise their data. As such, it enables TTOs to determine if it is worthwhile to commit time, money and experience to develop an idea.

3. Taonga Register

As I mentioned previously, the Tribunal recommended that a taonga register be established to identify kaitiaki’s connection with taonga works and mātauranga Māori. While I have acknowledged this previously (see Chapter II C), I elaborate further here. Knowledge databases are tools essentially aimed at making traditional information more easily available with the

³⁸⁹ ENRICH The Bicultural Labels Initiative <https://www.enrich-hub.org/bc-labels>.

³⁹⁰ Jane Anderson and Maui Hudson “The Biocultural Labels Initiative: Supporting Indigenous Rights in Data Derived from Genetic Resources” (2020) 4 Biodiversity Information Science and Standards e59230.

³⁹¹ Libby Liggins and others “Creating Space for Indigenous Perspectives on Access and Benefit‐sharing: Encouraging Researcher Use of the Local Contexts Notices” (2021) 2477–2482 and 2477.

³⁹² Above n 389.

intent of destroying novelty or obviousness criteria in patentability to stop others from making a direct claim of a new invention that relies on traditional knowledge.

They seem effective. Adopting inter alia interventions, such as India’s national registry of traditional knowledge, in response to patent-based biopiracy and misappropriation appears to be a common thread. Evidence from the Indian government states there have been more than 2,000 cases annually of misappropriation of Indian traditional medicinal knowledge.³⁹³ The traditional knowledge is deep, with over 25,000 traditional Indian medical formulations.³⁹⁴ In response, India established the Traditional Knowledge Digital Library. This database provides a digital repository of publicly available information on India’s traditional knowledge. That includes Ayurveda, Siddha, Unani and Yoga traditional knowledge. India has allowed access to the Traditional Knowledge Digital Library to several patent offices—European Patent Office (2009), German (2009), United States (2010), Japanese (2011), Canadian (2010) and

Australian (2011).³⁹⁵

Since the Traditional Knowledge Digital Library release, there has been a notable decline (44 per cent) in patent claims.³⁹⁶ Critics of the Traditional Knowledge Digital Library argue the database is limited in its use because it captures only a proportion of traditional knowledge and only protects codified knowledge. However, much traditional knowledge is orally passed on and not documented. It is merely incomplete, leaving much of its traditional knowledge in the public domain to be harnessed by those less inclined to recognise Indigenous peoples’ IPR.³⁹⁷ Similar databases have been developed in Korea, China, Venezuela and South Africa.³⁹⁸

Peru has adopted a more pragmatic approach by the marriage of a three-tiered registry system that houses Indigenous peoples’ collective knowledge accompanied by licencing considerations.³⁹⁹ First, the Public National Register of Collective Knowledge of Indigenous Peoples contains collective knowledge in the public domain. Second, the Confidential National Register of Collective Knowledge of Indigenous Peoples has knowledge that traditional

³⁹³ World Intellectual Property Organization, IGC, Report 42, WIPO Doc. WIPO/GRTKF/IC/14/12 (2009).

³⁹⁴ MM Pandey and others “Indian Traditional Ayurvedic System of Medicine and Nutritional Supplementation” (2013) Evidence-Based Complementary and Alternative Medicine, Epub Jun at 2.

³⁹⁵ D Ganesan “Sui generis is the Answer: Positive Protection of Traditional Knowledge in India” (2016) 11(1) Journal of Intellectual Property Law & Practice 49–55 at 50.

³⁹⁶ L Jishnu “Safeguarding Ancient Wisdom: Down To Earth” (2012) Muqbil, I., Ind in Poorna (see 149) at 1241. ³⁹⁷ Nicolai J Foss and Snejina Michailova Knowledge Governance: Processes and Perspectives (1st ed, Oxford University Press, United Kingdom, 2009).

³⁹⁸ Above n Error! Bookmark not defined.

³⁹⁹ Above n 395, at 54.

knowledge holders deem confidential. It is not publicly available to third parties but accessible through a licence agreement and consequent royalty payment. Third, a Local Register of Collective Knowledge of Indigenous Peoples where Indigenous peoples may develop a local register of traditional collective knowledge “in accordance with their practices and customs”.⁴⁰⁰ Again, this knowledge is accessible through a licence agreement and royalty payment. In the case of licencing, Indigenous peoples may authorise traditional knowledge use for commercial purposes, but not to exclude others (hence, it is not an exclusive right) or exclude Indigenous peoples from using and developing their traditional knowledge.⁴⁰¹

Secrecy is problematic. Knowledge may be imparted among one or two individuals or within an entire community, yet considered secret within the framework of that community, but not so within the intellectual property framework.

F Summary

TTOs serve as the link between science and business. A TTO’s success is contingent upon university leadership, the TTO’s size, and its capacity to link throughout the RSI continuum. TTOs value biomedical ideas since they may generate large revenues if successfully marketed, as demonstrated by Waikatolink’s commercialisation of technologies generated from mānuka honey in conjunction with Comvita. However, there is evidence that Māori knowledge on the usage of mānuka honey for wound healing provided as the incentive and source for Professor Molan’s study. Waikatolink’s patent filings appear to replicate Kuia’s actual application of mānuka honey. However, the problem is not incorporating natural products or traditional knowledge into creating new therapies or pharmaceuticals but rejecting the “western reliance” on Indigenous expertise.

The Patents Act 2013 provides restrictions that Māori may use to prevent commercial exploitation of Māori medical knowledge in mānuka. There are five such sections: patents of addition, opposition to patent grant, infringement, termination of a commercial agreement if the patent is no longer valid, and compulsory licences. Māori have the right to object to the award of a patent. The opposition is likely due to the invention not being patentable or not meeting the tests of novelty, inventive step, or an exclusion applies. Misrepresentations made by the patentee and the invention secretly being used before the priority date or found contrary

⁴⁰⁰ Above n 399.

⁴⁰¹ Above n 399.

to the law if granted are grounds for opposing a patent. Compulsory licencing enables third parties to utilise, produce, import, and export patented technology. It serves as protection against a patent being underutilised. Māori may explore compulsory licencing to undermine TTOs and universities. Threatening to use a compulsory licence instead of legally granting one may be just as effective. Given that mānuka patent applications are frequently directed at overseas markets, Māori examination of compulsory licencing arrangements in other jurisdictions may make sense.

In the absence of Māori medical knowledge in mānuka, there are potentially several extra-legal concepts and tools that TTOs may need to be mindful of. MBIE’s review of the science and innovation system could embed the protection of mātauranga Māori in TTOs’ commercialisation processes. However, are the above Patent’s Act provisions, extra-legal tools and concepts effective at protecting Māori medical knowledge in mānuka from commercial exploitation by university TTOs? In Chapter IV, I intend to further examine the question by using a thinking tool, the “effectiveness test”.

Chapter IV Determining Effectiveness of Patent Law

A Introduction

This thesis addresses a legal question. Does patent law effectively protect Māori medical knowledge in mānuka from commercial exploitation by university TTOs, specifically, from a New Zealand university TTO perspective? The preceding chapters establish the context for the legal systems in place to protect mātauranga Māori, before delving into commercial exploitation of mānuka and the issues surrounding invention ownership, as well as other provisions of the Patents Act 2013 that TTOs and Māori should be aware of. Finally, it discussed extra-legal mechanisms that Māori might utilise to safeguard Māori medical knowledge contained in mānuka.

In this chapter, I address the remaining portion of my thesis—the effectiveness of patent law. I acknowledge that there are several methods for determining the effectiveness of legislation, the most common being a review of current statutes and case law. Empirical research in law has a long history:⁴⁰² it is typically based on statistical analysis⁴⁰³ and, arguably, may be utilised to determine legislation’s effectiveness.⁴⁰⁴ Lawmaking is a less scientific and more deliberate decision-making process.⁴⁰⁵ Nonetheless, efficient lawmaking requires a methodology,⁴⁰⁶ a practical exercise, for determining whether legislation can perform the function for which it was enacted. I seek to “marry” the legal and TTO views in this chapter by employing a technique that relies on the self-correcting process of scientific investigation and legislative practice—an effectiveness test.

B The Effectiveness Test

The effectiveness test:⁴⁰⁷

is a conceptual tool to make lawmakers aware of relevant issues, engage them in a thinking process that will assist them in controlling and identifying—early on—potential critical points for their drafts. It is a logical exercise to support legislative decision making that

⁴⁰² F Bell, “Empirical Research in Law” (2016) 25(2) Griffith Law Review 262–282.

⁴⁰³ Above n 402, at 266.

⁴⁰⁴ Lee Epstein and Andrew D Martin An Introduction to Empirical Legal Research (1st ed, Oxford University Press, United Kingdom, 2014) at 1.

⁴⁰⁵ Maria Mousmouti Designing Effective Legislation (Edward Elgar Publishing, Cheltenham/Northampton, 2019) at 150.

⁴⁰⁶ At 120.

⁴⁰⁷ At 120.

can strengthen the operational aspects of an effective law, namely purpose, content, superstructure and results, and guide lawmakers, as the ‘designers’ of effective legislation, towards conscious decisions on critical points for their drafts. The effectiveness test is an ‘exercise’, a thinking process that can be used flexibly by lawmakers. It consists of a set of questions around the operational elements of effectiveness that can be useful if addressed in a consistent manner.

Effectiveness is the interplay between four elements present in every law—purpose, content, context and results. The effectiveness test consists of a series of questions centred on those components. These questions aid in decision-making. They are not rigorous nor exhaustive in their application, nor are they prescriptive in any manner, but are intended to ensure lawmakers cover the critical components that define efficacy.⁴⁰⁸ The relevant questions are: (1) Purpose— what does the law aim to achieve?, (2) Substantive Content—how does the law achieve its purpose?, (3) Results—what has been achieved? and (4) Context—how does the law integrate into the legal system and interact with it? Either in isolation or collaboration, these elements shape the invisible fundamentals that linger under the surface of any law.

The effectiveness test is not a theoretical tool; it is undeniably designed in such a way to expose weak points in the legislative process.⁴⁰⁹ It is also neutral in its application,⁴¹⁰ though not infallible. If applied rigidly and formally (such as using a checklist), its strength as a thinking tool diminishes.⁴¹¹ Moreover, it is not designed as a replacement for other tools to determine effectiveness (such as impact assessments), yet is flexible enough to be used at the inception of legislative drafting or indeed post-enactment as I intend to do.⁴¹² In all, “effectiveness adds to rational law making a layer of pragmatism and a concrete decision-making criterion with a painfully straightforward logic: does it work?”⁴¹³

By assessing the four factors of effectiveness—purpose, substantive content, results and context, I apply the effectiveness test to particular provisions of the Patents Act 2013. Wherever possible, I utilise my statistical and scientific expertise. The purpose of this expertise is to arm me with a tool, an approach, to assist me in resolving my legal issue: Does patent law effectively protect Māori medical knowledge in mānuka from commercial exploitation?

⁴⁰⁸ At 121.

⁴⁰⁹ At 124.

⁴¹⁰ At 27.

⁴¹¹ At 128.

⁴¹² At 128.

⁴¹³ At 151.

1. Purpose

The Patents Act’s purpose is multi-faceted as it has six purposes as outlined in section 3 of the Act.

The purposes of this Act are to—

(a) provide an efficient and effective patent system that—

(i) promotes innovation and economic growth while providing an appropriate balance between the interests of inventors and patent owners and the interests of society as a whole; and

(ii) complies with New Zealand’s international obligations; and

(b) ensure that a patent is granted for an invention only in appropriate circumstances by—

(i) establishing appropriate criteria for the granting of a patent; and

(ii) providing for procedures that allow the validity of a patent to be tested; and

(c) provide greater certainty for patent owners and the users of patented inventions that patents will be valid after they are granted; and

(d) address Māori concerns relating to the granting of patents for inventions derived from indigenous plants and animals or from Māori traditional knowledge; and

(e) ensure that New Zealand’s patent legislation takes account of developments in the patent systems of other countries; and

(f) regulate the provision of patent attorney services by giving effect to the joint registration regime with Australia.

Overall, the purpose clauses seem to be mixed-purpose clauses with both descriptive [(a(i)) (c), (d),] and policy-purpose clauses [(a(ii)), (b(i) & b(ii)), (e), (f)]. Clauses (a)(i), (c) and (d) are descriptive. They highlight key features of the legislation but do not point to any specific policy direction. While not a hard-and-fast rule, they are identified in this instance by their “soft” phrasing, using such words as “promote” and “address”. Those clauses that are policy-purpose clauses have phrasing that is more directional, such as “complies”, “ensure”, and “regulate”.

Moreover, despite their order, or the proportion of descriptive and policy-purpose clauses, none are more important than the others; they carry equal weight as reflected by the conjunction “and” at the end of each purpose. Hence, all are equally important, where we find descriptive- purpose clauses are equally recognised alongside policy-purpose clauses. This distinction is essential in terms of Māori IPR as two of these clauses specifically relate to my thesis. First, the criteria and tests for patentability (s 3(b)) and second, Māori concerns relating to the granting of patents for inventions derived from indigenous plants and animals or from Māori traditional knowledge (s 3(d)). The former is a policy-purpose clause, the latter a descriptive- purpose clause. Yet, both are given equal weight.

Regarding effectiveness, the question is whether there is alignment with the purpose clauses and the substantive content in the Act. Are these two clauses treated equally as the purposes above attests? They should be, or do we find misalignment between the purpose and substantive content in the Act?

2. Substantive Content

The substantive content of the law determines how the law will achieve its expected results. Substantive content has a two-fold purpose — to ensure alignment with the Act’s purpose and to generate results to qualify the real-world effect of the legislation. Mousmouti states: ⁴¹⁴

The importance of these elements is obvious: the choice of rules determines what rights are conferred, what obligations are imposed, what procedures or standards are regulated and how behaviours will be directed towards the desired goals; the choice of enforcement mechanism determines how the rules will be administered and implemented, how the subjects will be induced to comply, what consequences or motives are attached to them; last but not least, the way in which the ‘message’ of the law is expressed determines how the targeted audiences will be reached. These are the main ‘tools’ the lawmaker has at hand to design legislation. The way they are used (or misused) has an impact on the capacity of legislation to achieve results.

Concerning the Patents Act 2013’s two key purposes for this examination, the relevant substantive material is the patentability criteria and tests,⁴¹⁵ and Māori concerns over the award of patents for innovations derived from indigenous plants and animals or from Māori traditional

⁴¹⁴ At 40.

⁴¹⁵ Patents Act 2013, s 14.

knowledge.⁴¹⁶ The substantive material has been examined thoroughly in Chapters II and III, and I will not repeat that here. However, does the substantive content align with the Act’s purpose?

To begin, do the tests for patentability establish appropriate criteria for granting a patent and provide for procedures that allow the validity of a patent to be tested?⁴¹⁷ The conditions for issuing a patent and processes for determining validity are outlined and explained in the legislation, particularly Parts 2 to 4 of the Act.

Second, does the substantive content “address Māori concerns relating to granting patents for inventions derived from indigenous plants and animals or from Māori traditional knowledge”?⁴¹⁸ Indeed, it is argued that the recommendations made by the Tribunal fail to give Māori tino rangatiratanga over taonga species simply because those recommendations are being limited to the existing IPR regime.⁴¹⁹ In Chapter II, I found that patent defences, such as the test for inventiveness, the formation of a Māori Advisory Committee, public order and morality exclusions and disclosure of origin requirements, may protect against commercial exploitation of Māori medical expertise in mānuka by TTOs. Establishing a registration of mātauranga Māori might act as a deterrence. While these measures appear to provide some protection, none provide guaranteed protection against the commercial use of Māori medical knowledge in mānuka by TTOs, either individually or collectively. Each measure can be circumvented, evaded or disregarded. Arguably, it seems that Patents Act does not address Māori concerns relating to the granting of patents for inventions derived from indigenous plants and animals or from Māori traditional knowledge. The question remains whether that is reflected in what has been achieved by the Act.

3. Results

Real-world outcomes are critical in judging “effectiveness” as they aid in comprehending the Act’s goal and substantive content. My technique for examining the data is governed by (1) the patentability requirements and those described in the MAC’s functions, (2) my legal query and

(3) the practical application of an empirical method (mainly statistical) to discover important trends in the results.

⁴¹⁶ Above n 415, s 226.

⁴¹⁷ Above n 415, s 3 (b).

⁴¹⁸ Above n 415, s 3 (d).

⁴¹⁹ Above n 38, at 183.

For (1) above, I compiled data on mānuka publications (as a measure of the prior art base), patent applications and patents. I scrutinised this further by collecting patent application and patent data for “mānuka”, “mānuka honey” and “mānuka oil” criteria to reflect the various commercial applications for inventions derived from the species. Additionally, I compared this to the recognised medical uses of Māori medical knowledge in mānuka, discussed in Chapter II D. Finally, I gathered data on trade marks as a proxy for commercial exploitation, a frequently used method in knowledge-based organisations such as TTOs.⁴²⁰ Statistical methodology and results varied according to the data obtained and are summarised in this chapter. In contrast, detailed methodology and explanations of statistical findings are shown in Appendix II.

(a) Prior Art Base

Since the tests for inventiveness are tested against the prior art base, it appears necessary to assess publishing activity. I concentrated on article abstracts that included the terms mānuka, mānuka honey and mānuka oil (see Appendix II). Although the first mānuka publication goes back to 1959, publication activity has grown enormously in the interim. However, true scholarly interest in mānuka honey and mānuka oil did not arise until the 1980s (Error! Reference source not found.). The academic landscape is dominated by publications on mānuka honey, which peaked at 55 in 2018, over 14 years after Professor Molan published his first scholarly work on the subject. The publishing activity of mānuka oil has remained mostly constant. Indeed, it has stayed consistent over time, with a little increase in the early 2010s, but nowhere near the level exhibited for mānuka honey. Of course, further scientific research on mānuka has been undertaken, although I have not specifically highlighted this work. While publishing activity in the field of mānuka honey predominates in this space, it is by no means exclusive.

(b) Patent Applications and Granted Patents

I examined the number of patent applications and granted patents for mānuka. I focused on the keywords “mānuka”, “mānuka honey” and “mānuka oil” found in patent claims and matched these alongside keywords for traditional Māori medical knowledge in mānuka as outlined in Appendix II.

⁴²⁰ M Gotsch and C Hipp “Using Trade marks to Measure Innovation in Knowledge-Intensive Business Services” (2014) 4(5) Technology Innovation Management Review 18–30.

Some 371 patent applications identified mānuka in their claims; just 66 were granted. Overall, 83 per cent of all patent applications failed to meet the criteria for patentability—a 17 per cent success rate. A comparison between mānuka honey and mānuka oil inventions showed mānuka honey inventions were the most common (149 and 92 applications; 30 and 20 patents granted for honey and oil, respectively). The success rate was 20 per cent and 22 per cent, respectively, indicating other mānuka inventions might be responsible for the lower overall success rate. In all, 65 per cent of all mānuka patent applications had claims associated with mānuka honey and mānuka oil; 35 per cent (130) did not. Of this latter group, only 14 patents were granted, an 11 per cent success rate. In conclusion, patents targeting non-mānuka honey and oil inventions were successful 1 in 10 times, compared to mānuka honey and mānuka oil patent applications, which were successful approximately 1 in 5 times.

This data is useful for TTOs. First, interest in mānuka inventions has significantly increased over time (see Figure 3), suggesting demand for such products. Mānuka honey inventions fared best of all, though not until 2000 did patent activity commence in earnest. The highest number of patent applications filed was 35 in 2015 (20 were mānuka honey; eight were mānuka oil). The low success rate is concerning as inventions often require significant investment from TTOs in the early phase of technology development to attract interest from third parties. Such a low success rate may deem investment in inventions derived from mānuka unpalatable. However, what is not clear from the initial analysis is whether this success rate is influenced by the tests for patentability (novelty, inventive step, utility) or some other factor.

I can empirically examine this. I would not expect a linear relationship between the number of patent applications filed and the number of granted patents. However, statistical results showed precisely that for mānuka overall, mānuka honey and mānuka oil and significantly so (see Figure 4). These results indicate that the number of patent applications filed is a good predictor of the number of patents granted, especially for mānuka honey inventions.

However, this data is concerning, both commercially and legally. One possible implication is that the test for patentability may be opened to being “gamed” by applicants by simply filing many patent applications with the hope that some will eventually be granted. This strategy would be expensive, but depending on the potential commercial gain, it might be an attractive one nonetheless for TTOs. Yet, when considering such low success rates for granted patents, this linear trend seems to be more likely coincidental than actually revealing a compelling weakness in the law around the tests for patentability. There is a significant correlation between

patent applications filed and success rate for mānuka overall and mānuka honey, but not for mānuka oil. Moreover, statistical analysis revealed that the success rate is not highly predictable by the number of patent applications filed (see Figure 4). Merely flooding patent offices with new mānuka inventions in the absence of considerations for prior art, novelty, inventive step, and other exclusions to patentability is a reckless strategy for TTOs.

(c) Inventions Targeting Māori Medical Knowledge in Mānuka

Fifty-six per cent (217) of all mānuka patent applications make claims against medical applications that Māori traditionally identified with and used. Of these, 85 (39 per cent) make claims for inventions that use mānuka honey, 74 (34 per cent) for mānuka oil and 58 (27 per cent) target other uses of mānuka. As such, some 44 per cent of patent applications target other uses that were not traditional applications.

Of the 18 traditional medical applications described, 13 have patent applications filed targeting the same application used by Māori (see Table 1). However, the numbers vary according to whether inventions use honey, oil or another component of mānuka. Just three applications accounted for approximately 69 per cent of all patent applications—wound healing (31.8 per cent), anti-inflammatory (22.12 per cent) and burns (15.21 per cent). Other applications targeted are eye health, pain management, sedatives, head colds, blood purification and bruising. Despite being traditionally used by Māori, neither diarrhoea, diuretic, dysentery, colic and febrifuge applications attracted any attention. Nevertheless, only seven of the 13 applications had patents granted for them—wounds, anti-inflammatory, burns, pain, sedative, dandruff and constipation applications (Figure 5). This data suggests that while patentees sought protection for a broader range of invention types, success was varied. According to my analysis, those applications most likely to successfully have granted patents were (in order from highest to lowest)—sedative (33.33 per cent) > dandruff (33.32 per cent) > anti-inflammatory (29.23 per cent) > constipation (25 per cent) > pain (20 per cent) > wounds (19.27 per cent) > burns (18.6 per cent).

(d) Commercial Exploitation

The Patents Act 2013 defines what is meant by “exploit”. Typically, this entails repurposing, selling, hiring, or disposing of a product.⁴²¹ As I have stated, the examination of trade marks is

⁴²¹ Patents Act 2013, s 18.

a legitimate means of determining economic exploitation (aside from patent activity). Conversely, market intelligence provides vital background information for TTOs to grasp (where, what, and by whom the commercial activity is conducted). I will begin by looking at the market.

The United States is the most significant commercial market for mānuka inventions, accounting for 49 per cent of patent applications. Just over half of these are for mānuka honey inventions, with approximately a quarter filed for inventions derived from mānuka oil (see Table 2). The other two of relevance are WIPO and Australia. Critically, filing offshore removes the invention from being scrutinised by the MAC. TTOs could avoid the attention of the MAC simply by filing offshore. Potential partners are also likely offshore. Various companies are active in this space (see Figure 6). However, only four companies genuinely stand out: NanoBio Corp, American Sterilizer Co and Mānukamed Ltd and Comvita New Zealand Limited. NanoBio Corporation provides biopharmaceutical products, and American Sterilizer Company manufactures sterilisation equipment and medical treatment products. The latter two are New Zealand companies. Mānukamed manufactures natural health products made of pure mānuka honey from New Zealand and specialises in wound and skincare products. Comvita was discussed in Chapter II D1.

Data for mānuka-focused trade marks showed that some 726 trade marks were filed between 1963–2019 (see Figure 8). Of these, 377 were active (52 per cent), 200 were inactive, and 138 were still pending at the time of this examination. However, like for patent activity, it was not until the early 2000s that we observed a significant increase in mānuka trade mark activity. There was a dip in trade mark activity in 2006 but post 2007, interest spikes significantly. In 2018, there were nearly 80 trade marks filed with the word “manuka” in them.

There are 19 countries where trade mark filing was targeted, but 69 per cent of trade marks were filed in New Zealand, Australia, and the United States. Most are filed in New Zealand (293 or 40 per cent). When examining the trademark classes (i.e., fields that trade marks are seeking protection for), 80 per cent of all trade marks are in just three classes 30, 3 and 5: stable food products, cosmetic and cleaning products, and pharmaceutical products, respectively. This data is shown in Figure 8. Class 30 accounts for 27 per cent of all trade mark activity.

4. Context

Every law is part of a broader complex legal system. Mousmouti confirms this complexity:⁴²²

From the perspective of the lawmaker, the effort to sustain the coherence of the legal system and deliver a message that is accessible, intelligible and identifiable within a complex legal environment is not insignificant.

The legal environment in this field is complicated since it incorporates international and domestic intellectual property law, traditional rights, commercial law, and legislation that may affect a technology’s commercialisation. The challenge is to comprehend and succinctly convey all of this context with the findings stated thus far to make an impartial judgement of “effectiveness.” Consider the impact of further legislation on the economic exploitation of Māori IPR in mānuka. In that situation, I argue that I would anticipate a reduction in patent application activity and the number of granted patents at some point in time following the enactment of “significant” legislation, regulation or policy.

I mapped most of the relevant legislation (mentioned throughout this thesis) against the numbers of publications, patent applications, granted patents and trade marks from 1835 (the time of the Declaration of Independence of the United Tribes of New Zealand) to 2019. I have also incorporated factual content that I deem critical to the commercial exploitation of mānuka. Examples include the introduction of honeybees, when the first patent invention was filed in New Zealand, and when Professors Molan’s and Henle’s discoveries into mānuka honey were made. I have called it the “Mānuka IP Map” (see Figure 1).

Despite the development of intellectual property laws and regulations over time, the number of literary works contributing to the prior art base, the level of commercial exploitation (as shown by trade marks), and the number of patent applications and issued patents have all increased. While there are times when the number of patent applications, trade mark registrations and publications declines rapidly, this is not a consistent trend.

Since the 1980s, the international and domestic legal system has made a concerted effort to address Indigenous peoples’ challenges through several procedures. Conversely, patent activity has increased dramatically over the same period. While Professor Molan’s 1981 discovery is credited with initiating the mānuka honey industry, Professor Henle’s confirmation that MGO

⁴²² Above n 405, at 66.

is the essential component responsible for mānuka honey’s anti-bacterial qualities appears to have led to significant patent activity. While it took some time for the number of granted patents to increase significantly over time (numbers remained relatively stable between 2000 and 2012), the more favourable legal climate has had no adverse effect on the number of mānuka patent applications submitted and granted, particularly after 2012.

Figure 1. The mānuka map: an overlay of domestic intellectual property law, traditional rights and intellectual property law, commercially relevant law and regulations, and key facts against patent applications, publications, trade marks and granted patents.

The MAC does not appear to have had any influence on patent activity. At the very least, it is not immediately apparent. To be fair, the statistics are global (and so unaffected by the MAC) and restricted to mānuka. As a result, any effect MACs may have on the data is likely to be minor and imperceptible. A more thorough examination of the impact of MACs on Māori IPR is required.

I sent Official Information Requests to IPONZ requesting the MAC’s activity since the Act was enacted (see Table 3). I repeated the exercise to obtain similar information for trade marks, geographical indications and designs.⁴²³ Since 2016, 3,058 trade marks have been viewed by the trade mark MAC. Of these, the MAC either advised IPONZ to seek further information to make their assessment or found the trade mark offensive or likely to offend in 173 instances (6 per cent). In 94 per cent of cases, the MAC advised the Commissioner that the trade mark was not likely offensive to Māori. Since 2003, 39 trade mark applicants have successfully appealed to the MAC and the Commissioner to withdraw the objection after providing additional information supporting their trade mark application.

The trade marks MAC has also reviewed geographical indications and design applications, where the total number of applications reviewed are six and three, respectively. None of the geographical indications was deemed offensive to Māori; one design application was deemed as such. However, that application was amended. Once completed, it was no longer considered offensive to Māori.

However, the MACs evaluation of patent, geographical indication, and design applications is far lower than trade mark applications. It is possible that, because trade marks are a less expensive method of protecting intellectual property than patents, geographical indications, and designs, it is realistic to anticipate an increase in trade mark applications. Additionally, patent applicants may choose to submit their inspection applications late (they have five years to do so) or not at all. However, assuming all other factors remain constant, we might anticipate a comparable fraction of applications being evaluated by the MACs. That is not the case.

⁴²³ New Zealand Intellectual Property Office “Information Request” (1 March 2021) (obtained under Official Information Act 1982 request to the New Zealand Intellectual Property Office on behalf of the Commissioner of Patents, Trade Marks, Designs and Plant Variety Rights).

Data from IPONZ⁴²⁴ shows that from 2016 to 2020,⁴²⁵ 79,928 trade marks applications were filed in New Zealand, 3,058 were examined by the MAC; that is, 4 per cent of all trade mark applications had or were derived from a Māori image or word. The register shows that 27 geographical indications have been submitted since 2017.⁴²⁶ Some six (22 per cent) have been reviewed by the MAC. In contrast, from 2014 to 2020, 4,184 and 9,076 patent and design applications were filed in New Zealand, yet MACs reviewed only eight patent applications and three design applications. That corresponds to 0.002 per cent and 0.00001 per cent of all applications, respectively.⁴²⁷ The difference is stark and telling.

To be fair to IPONZ, we do not know how many patent applications were derived from native plants, animals, or traditional knowledge. However, if we take 4 per cent as an indicative measure, we would expect the MACs to have reviewed about 167 patent applications during this period and 363 design applications.

Cost, therefore, does not explain the discrepancy above. Perhaps the discrepancy is one of training. The Waitangi Tribunal recognised that “patent examiners are often trained in Western science but not in tikanga Māori, and so may not recognise the existence of the Māori interest in a particular patent application”. Patent examiners may simply be unaware that a particular technology would be of interest to Māori or not recognise mātauranga Māori as prior art.

Perhaps it comes down to the substantive content of the Acts in question. Under section 226 of the Patents Act, the MAC’s function is to advise the Commissioner (on request) on whether:

• an invention claimed in a patent application is derived from Māori traditional knowledge or from indigenous plants or animals; and
• if so, whether the commercial exploitation of that invention is likely to be contrary to Māori values.

⁴²⁴ Intellectual Property Office of New Zealand “Facts and Figures” IPONZ <https://www.iponz.govt.nz/about- iponz/facts-and-figures/>.

⁴²⁵ The time period I reviewed trade marks.

⁴²⁶ Intellectual Property Office of New Zealand “Geographical Indications” IPONZ

<https://www.iponz.govt.nz/about-ip/geographical-indications/register/?location=nz&sort=alphabet>.

⁴²⁷ I do not have data for Geographical Indications.

Compare that to section 178 of the Trade Marks Act:

The function of the advisory committee is to advise the Commissioner whether the proposed use or registration of a trade mark that is, or appears to be, derivative of a Māori sign, including text and imagery, is, or is likely to be, offensive to Māori.

Unlike the Patents Act, it is not the Commissioner who determines whether the MAC reviews a trade mark, but instead whether the mark “is or appears to be derivative of a Māori sign”. The test for whether the MAC reviews a trade mark is prescribed in the substantive content of the Act and not left up to the opinion of the Commissioner.

Despite being reviewed by the same trade mark MAC, the same cannot be said for geographical indications. Section 13A of the Geographical Indications (Wine and Spirits) Registration Act 2006 states:

The Registrar must not register a geographical indication if its use in relation to wine or spirits or its registration would, in the opinion of the Registrar, be likely to offend a significant section of the community, including Māori.

With geographical indications, it is up to the Registrar to determine whether a geographical indication be presented to the trade mark MAC.

However, the landscape becomes somewhat clouded when considering designs applications. There is a reference by IPONZ that the “Trade Marks Māori Advisory Committee may also consider design applications with Māori elements”.⁴²⁸ The Trade Marks Committee has reviewed design applications as outlined above under the morality clause within the Act.⁴²⁹

The subtlety with which these regulations were drafted appears to account for the variance in the MACs’ applications. When left to the discretion of the Commissioner for Patents (or the Registrar in the case of geographical indications), the MAC reviews a small percentage of applications. Given the low numbers evaluated, the same argument could be made for design applications. The number of applications assessed is large in the one situation (trade marks) where the substantive

⁴²⁸ Intellectual Property Office of New Zealand “Māori Advisory Committees” IPONZ

<https://www.iponz.govt.nz/about-ip/maori-ip/maori-advisory-committees/>.

⁴²⁹ Designs Act 1952, s 51(1).

nature of the Act determines whether the MAC analyses intellectual property or not. Trade marks that incorporate a Māori element must be brought to the trade mark MAC; patents, geographical indications, and designs are not required to be presented to the MAC. Their presentation is at the Commissioner’s or Registrar’s discretion.

C Summary

The Patents Act 2013 has six purpose clauses, all equally important. Two of these clauses are most relevant to this thesis. The first is the criteria and procedures for granting patents to allow the validity of a patent to be tested. In contrast, the second addresses Māori concerns about granting patents for inventions derived from indigenous plants or Māori traditional knowledge.

Let us begin with patents. The substantive content of the law seems to extrapolate the criteria and procedures for granting patents. It permits the filing of patent applications to test them against novelty, inventive step (as per the prior art base), utility, and several exclusion criteria such as public order and morality. Consequently, patent applications fail or succeed in meeting those criteria. My statistical examination of the relationships between patent success rate and the number of patent applications filed supports this premise quite clearly when considering inventions derived from Māori medical knowledge in mānuka.

The second issue is addressing Māori concerns relating to the granting of patents for inventions derived from indigenous plants or Māori traditional knowledge. Here, the purpose is a descriptive- purpose clause, less determinative than the policy-purpose clause for testing the validity of a patent application. The important question is whether the Act addresses Māori concerns and accomplishes its stated objectives.

Consequently, the authority to determine whether an invention is contrary to Māori values lies with the Commission of Patents and not Māori at all. That is reflected in the very low number of patent applications (just eight at the time of writing) reviewed by the MAC. Even accounting for the five-year time frame applicants have for their application to be examined, I have little option but to conclude that the Patents Act is not effective at addressing Māori concerns as its purpose intends.

That ineffectiveness seems somewhat compounded by most patent applications being filed offshore, where the MAC has no influence. Despite the significant inroads in this space both internationally and domestically, there appears to be no “legal check”, such as the MAC or equivalent, to patent activity targeting mānuka inventions. Scholarly works (contributing to the prior art base), patent applications, granted patents and trade mark activity (as a measure of commercial intent) have increased significantly over time. Yet, despite the intellectual property landscape becoming increasingly complex and crowded over time, the interest in mānuka has certainly not waned.

From a TTO perspective, several considerations might facilitate a “perfect storm” for misappropriation of Māori medical knowledge in mānuka. These are the New Zealand-centric nature and advisory role of the MAC, the comfort that the Commissioner of Patents is unlikely to present technologies to the MAC, and the trend to file the majority of patent applications offshore (outside the jurisdiction of the MAC). The effectiveness test has revealed there seem to be no significant barriers other than the standard tests to patentability to the commercial exploitation of Māori medical knowledge in mānuka through the patent’s regime.

Chapter V Conclusion

This thesis addresses the legal question from the perspective of New Zealand university TTOs: Does patent law effectively protect Māori medical knowledge in mānuka from commercial exploitation by university TTOs?

To begin, I introduce the problem I am trying to address. The role of the TTOs is to generate revenue for their university from the commercial exploitation of inventions. Medical inventions are highly prized due to the increased likelihood of attracting potential investment and increased chances of commercialisation. Many such inventions are derived from traditional knowledge or taonga species, such as mātauranga Māori. The issue is not one of using natural products or traditional knowledge to develop new medicines or drugs, but the denial of the “western dependency” on the contribution of Indigenous peoples’ knowledge. Māori concerns over the misappropriation of their traditional knowledge are exemplified in the Waitangi Tribunal’s Claim no. 262 (“Wai 262”). However, the government intends to fundamentally alter New Zealand’s RSI system to include Māori concerns. If such developments materialise, TTOs will need to confront the tensions between the present intellectual property framework and mātauranga Māori in their day-to-day commercialisation efforts. TTOs may be unprepared to deal with such a transition and need to alter their approach accordingly. While it appears that the current IPR system, including patent law, falls short of adequately protecting Mori traditional knowledge from “unauthorised” commercial exploitation, it appears that the majority of the Tribunal’s recommendations could be implemented within the current IPR regime if the government so desires. From a Māori viewpoint, the above indicates that this is highly improbable. However, I have examined this issue from a position that has not been studied previously in New Zealand—a TTO perspective using mānuka as an exemplar. The core question is whether patent law can effectively protect Māori medical knowledge in mānuka from commercial exploitation by university TTO offices?

First, I discussed the legal measures in place to safeguard mātauranga Māori. I then outlined the government obligations under the Treaty of Waitangi and the Waitangi Tribunal’s (Wai 262) emphasis on preserving kaitiaki connections, taonga species, and mātauranga Māori, especially Māori medical expertise in mānuka. I detail the Waitangi Tribunal’s proposals for protecting kaitiaki relationships, taonga species and mātauranga Māori, and then analyse whether those

reforms have been incorporated into legislation (or are currently being considered by the government). Finally, I considered whether such reforms would discourage TTOs from commercialising Māori medical expertise in mānuka.

I built on previous work by studying the commercial exploitation of mānuka, especially through patents. The concepts of inventorship, ownership and benefit-sharing are all incorporated in relation to the commercialisation of an invention. Elements that TTOs and Māori may consider when assessing whether they are co-owners of an innovation and if Māori are entitled to remuneration for their kaitiaki relationship with taonga species were discussed. I then contrasted and analysed further parts of the Patents Act 2013 that TTOs and Māori may wish to explore. Finally, I explained several extra-legal concepts and tools that TTOs should be aware of that Māori might use to safeguard their mānuka medical knowledge from commercial exploitation.

I then applied the effectiveness test, a thinking tool designed to extrapolate a clear understanding of law’s four fundamental elements (1) purpose, (2) substantive content, (3) results and (4) context to determine that the Act is doing was it was designed to do. Here, I applied an empirical analysis examining patent activity for inventions derived from mānuka that aligned with Māori medical knowledge in mānuka. I concluded that the Act was effective when considering the criteria and tests for patentability but ineffective at addressing Māori concerns in granting those patents.

Lastly, this chapter aims to examine all the separate elements in combination and draw a final conclusion. I do this from a TTO perspective, outline the limitations of this work and make recommendations for future research.

A Technology Transfer Office Perspective: Is Patent Law effective at protecting Māori medical knowledge in mānuka from commercial exploitation by University Technology Transfer Offices?

The RSI in New Zealand seems to be about to undergo significant reforms. These reforms appear to aim to integrate the Treaty of Waitangi and mātauranga Māori into institutions’ day-to-day operations. This approach is crucial for TTOs, which serve as the university’s commercialisation arm. The TTOs’ purpose is to generate income for their university by commercialising innovative ideas. Medical inventions are highly prized because they have a better probability of attracting investors and succeeding. Numerous examples of this type of creation are derived from taonga

species and/or traditional knowledge. TTOs seek to patent those concepts and then commercialise them in collaboration with pharmaceutical or nutraceutical companies. As a result, if modifications to the RSI system are enacted, it looks as though TTOs will be forced to reconcile the present IPR regime with mātauranga Māori in their day-to-day commercialisation activities. As such, this thesis explores, scrutinises, and assesses whether patent law properly protects Māori medical knowledge from commercial exploitation by TTOs from the perspective of a university technology transfer office. I use mānuka as an exemplar.

In New Zealand, the mānuka plant is arguably the most significant commercial native plant; products that utilise mānuka and mānuka derivatives are now a billion-dollar industry. The catalyst was accredited to research (done at the University of Waikato in the 1980s) into the anti-bacterial activity of mānuka honey for wound healing. Yet, I discovered that the initial idea to undertake this research was not a serendipitous scientific endeavour. Rather, the source seems to be Māori in origin. It is not uncommon to find Indigenous peoples’ knowledge contributing to significant medical and pharmaceutical discoveries, yet that is something patent law auspiciously seems not to account for. Indeed, some 80 per cent of Indigenous peoples’ medical knowledge appropriation occurs by investigating and screening academic literary databases, databases that university academics submit their publications to for peer review and publication kudos. In the absence of Indigenous peoples’ permission, this activity is more formally classified as misappropriation.

My research also reveals that academic publication activity focusing on mānuka research increased significantly over time and 53 per cent of all patent applications targeting inventions derived from New Zealand native plants list mānuka in their claims. Of these, 56 per cent target the same medical applications traditionally used by Māori in dispensing medical applications of mānuka, of which there are 18. Thirty-nine per cent of those inventions include mānuka honey in their patent claims, and 34 per cent include mānuka oil. The remaining inventions use some other component of mānuka. Most patent applications target offshore jurisdictions (mainly the United States), rendering them outside New Zealand’s patent law jurisdiction, despite evidence that points to mānuka being uniquely New Zealand in its geographical origin. Therefore, identifying such medical applications to target in patent applications could only have been sourced initially from Māori and not from other Indigenous peoples’ knowledge. Alternatively, the inventor serendipitously discovered it absent knowledge about rāonga Māori. In the former case, some

might call that purposeful patent-based biopiracy; in the latter case, one would need to confirm whether the inventor accounted for the taonga status and mauri of mānuka during the inventive process before accusations of biopiracy were laid.

Within the IPR regime, several current and proposed provisions—the inventiveness tests, the establishment of the MAC, public order and morality exclusions, and a disclosure of origin requirement—may provide some protection against TTOs commercial exploitation of Māori medical knowledge in mānuka. Although it is not foolproof, the development of a mātauranga Māori kaitiaki registry may act as a deterrent. To begin, not all mātauranga Māori is likely to be caught; moreover, TTOs can discover ways to “get around” prior art and patent new ideas using Swiss-type claims. While public order and morality clauses may provide some protection, Māori appear to have the burden of establishing that commercial exploitation of the innovation is likely to be objectionable. Additionally, the MAC is an advisory committee that lacks veto authority over patent applications that the MAC may deem objectionable. Even if the MAC concurs, the Commissioner of Patents is not required to follow their advice. Yet, the MAC has received an exceedingly small number of patent applications.

Additionally, the disclosure of origin requirement appears to have the potential to prevent TTOs from submitting patents out of fear of the patent application being given to the MAC. The problem is that such a condition does not exist now. Even if it did, until the MAC has veto authority over patent applications, there appears to be a minimal possibility the MAC would evaluate it. In conclusion, while these procedures appear to provide some protection, none provide definitive protection against the commercial exploitation of Māori medical information in mānuka by TTOs, either individually or collectively. Each can be circumvented, evaded, or simply disregarded. This raises the question of whether patent law on its own is sufficient to protect Māori medical knowledge in mānuka from commercial exploitation by university TTOs.

However, the Patents Act 2013 seems to impose some constraints on TTOs’ ability to commercialise medical inventions derived from mānuka. There are five sections: patents of addition, resistance to the grant of a patent, infringement provisions, termination of a commercial agreement if the patent is no longer valid and forced licencing. Moreover, MBIE’s examination of the RSI can potentially incorporate mātauranga Māori protection into the commercialisation

procedures of TTOs. As such, extra-legal concepts, especially social licence to operate, as a means for Māori to control mātauranga Māori may carry significant weight if changes to the RSI system are indeed implemented.

Applying an “effectiveness test” (a thinking tool designed to determine whether the law does what it is supposed to do) in parallel with empirical analyses confirmed that the MAC was an ineffective means to protect Māori traditional knowledge. Yet, applying the same lens to the substantive content of the law for tests for patentability (novelty and inventive step [as per the prior art base] and utility) confirmed that these tests were effective and did what they were designed to do. Evidence for this observation includes (1) a robust statistical examination of the relationships between patent success rate and the number of filed patent applications and (2) discovering that only 17 per cent of all patent applications filed for inventions derived from mānuka are successfully granted—a failure rate of 83 per cent.

On balance, when I applied a technology transfer lens to my discoveries, I concluded that when considering legal and extra-legal considerations in combination, patent law does effectively protect Māori medical knowledge in mānuka from commercial exploitation by university TTOs. Provisions of the Patents Act 2013 outlined above compounded the risk of significant reputation damage from commercialising Indigenous peoples’ knowledge. Not having permission and the high patent application failure rate (due to failing to meet the legal tests for patentability, hence unable to be protected nor monopolised by TTOs) makes investing in inventions aligned with Māori medical knowledge in mānuka incredibly risky. While each technology is assessed on its merits, TTOs would need an exceedingly compelling reason to commercialise such a technology in the absence of prior informed consent and access and benefit agreements in place with Māori. However, in the presence of such agreements, it becomes just a matter of whether the invention meets the criteria of patentability as stipulated under patent law. This is a persuasive reason for TTOs to engage early with Māori in the research-commercialisation continuum, potentially partnering together in commercialising university-derived technologies and inventions.

B Limitations

The scope of this thesis is “needle-like” in its focus—it is patent-centric, Māori medical knowledge in mānuka-centric and New Zealand university TTO-centric. I am aware these characteristics impose several constraints associated with this work.

To begin, while I defined TTOs as patent-centric, patents are not the only way to safeguard intellectual property developed in academic settings. Nor are they the only avenues for TTOs to collaborate with Māori on the commercialisation of mātauranga Māori. Conversely, patentable technologies are the most financially viable, which is why I focus on them. Second, my concentration on mānuka restricts my conclusions to commercial exploitation of mānuka only, and such results cannot be generalised to other indigenous New Zealand plant species. However, most patent activity is directed at mānuka since the species seems the most probable candidate for commercial exploitation. Third, my recommendations and findings are limited to New Zealand university TTOs and cannot be generalised to TTOs in non-university settings or other nations.

I acknowledge that the terms “mānuka” and “Leptospermum scoparium” are interchangeable to describe the species. I concentrated on the phrase “mānuka” in my patent search but recognise that by excluding the term “Leptospermum scoparium”, some patent applications may have been missed. However, patent applications tend to use the common name of mānuka as opposed to L. scoparium.⁴³⁰ Therefore, I am likely to have captured the majority if not all patent applications.

Patent claims against Māori medicinal uses of mānuka were analysed only at a high level to be applied against the effectiveness test. My analysis did not include an in-depth analysis of those claims. I acknowledge the importance of the claim type, what is being claimed, jurisdiction requirements, different patent office policies, the process for examination, and while beyond the scope of this thesis, recognise the value of this sort of in-depth examination for future research.

While the effectiveness test analysis looked at the Patents Act 2013, the patent analysis was not restricted to New Zealand but patent activity globally. I extrapolated the global data to a New Zealand context for the effectiveness test, which risks being be viewed as a weakness in the

⁴³⁰ Above n 224, at 44.

analysis since it is not jurisdiction-specific. Yet, to account for the TTO perspective, which is global, patent activity beyond New Zealand is relevant.

C Future Recommendations

In their 2020 publication, Cunningham and others undertook a significant literature review of the TTO space. They found that the most commonly stated impediment to commercialisation in the literature and their research was the cultural divide between the TTO, academic scientists, and industry.⁴³¹ A key success factor for TTOs is “a strong university culture of research, innovation, and entrepreneurship”,⁴³² but it must be embedded across the entire RSI system. Universities and industry are uneasy partners. Academic researchers value their freedom and independence; businesses value secrecy when it comes to commercialisation.⁴³³

The authors went on to state:⁴³⁴

Technology transfer will only occur when university faculty and representatives from business and industry work together for mutual gain and find mechanisms to manage the inherent conflict between openness, characteristics of the scientific community and privacy/secrecy, which belongs to the industrial world. Therefore, industry–university collaboration cannot be forced and cultural differences must be understood.

While it was not explicit in the authors’ findings, I would extend this conclusion to include engagement with iwi. Cultural differences must be understood, especially in light of the conclusions found in this thesis and the potential changes that may occur to the RSI system.

TTOs have started taking steps towards this goal. In March 2021 (with the support of my Chief Executive Officer (CEO) at Otago Innovation Ltd.), I approached all the CEOs of the university TTOs in New Zealand (and several senior managers within Crown Research Institutes). I asked if there was demand for a workshop on Indigenous peoples’ intellectual property and traditional knowledge. All TTOs except one agreed to be involved. I organised and facilitated the workshop to align TTO intellectual property policies on the Treaty of Waitangi, mātauranga Māori and Wai

⁴³¹ Above n 279, at 21.

⁴³² At 68.

⁴³³ Above n 432.

⁴³⁴ At 22.

262. There were 11 speakers from both New Zealand and Australia, including myself. The workshop ran for one day on 23 June 2021, through a hybrid physical-virtual presentation environment to maximise the number of participants and the level of engagement between participants. We set up eight “nodes” country-wide: seven physical locations, one virtual. Nodes were connected via the Zoom platform and managed by our commercialisation support organisation, Kiwinet, based in Rotorua, on the day. Approximately 140 people attended the workshop country-wide and included TTO staff, university staff (research offices; people in key Māori positions on university campuses) and other interested parties. Some 82 per cent of respondents agreed to a collaborative and collective approach. Tasks include aligning university intellectual property policies and establishing a collective biodiscovery framework to determine how research can incorporate and account for traditional knowledge and native plants. These might be the exact steps needed to check the misappropriation of traditional knowledge in universities. While this recommendation is not new, it is heartening that practical steps are being taken to address it.⁴³⁵

However, to account for those cultural differences, this approach needs to occur from the start of the research-commercialisation continuum before researchers apply for public funding to support their research. Ideally, researchers should be engaged with kaitiaki well before applying for research funding. Assuming that is the case, in practice, I suggest TTO’s consider the following:

First, collaborate with the university's research office to establish a procedure for academic researchers contemplating applying for public funding to find technologies that harness mātauranga Māori, taonga works, and taonga species. Second, be actively involved in formulating the research intellectual property plan. Within that plan include a clause to account for mātauranga Māori, taonga works, and taonga species. The following sentence is what I suggest (my own devising):

The partners shall ensure that any applications for the protection or commercialisation of new intellectual property disclose the provenance and origin of mātauranga Māori, taonga works, and taonga species (where applicable).[1] The parties acknowledge the kaitiaki link between

⁴³⁵ Above n 316.

iwi, hapū and taonga works and taonga species and ensure that cultural, Treaty of Waitangi (including tino rangatiratanga) and Māori issues are appropriately taken into consideration.

• [1] Taonga works, taonga species are as defined in the Waitangi Tribunal response to Claim

262. See Ko Aotearoa Tēnei: A Report into Claims Concerning New Zealand Law and Policy Affecting Māori Culture and Identity (Wai 262, 2011) at 33.

Third, actively seek a change in the university IP policy to account for the Treaty of Waitangi, mātauranga Māori, taonga works, and taonga species, but be very clear on what that actually means. For example, are universities prepared to give Māori tino rangatiratanga and veto rights over research programmes? Fourth, encourage the university to develop a bioprospecting policy, so researchers have a clear understanding of what is expected of them when sourcing biological and genetic resources for their research programmes. Lastly, develop a standard ABS agreement template that the university can use when discussing research programmes and commercial opportunities with Māori. That should include consideration of the kaitiaki connection and whether there are non-financial and financial benefits to Māori.

Bibliography

The bibliography lists reference material I use throughout this thesis. It covers cases, statutes, international conventions and protocols, treaties, regulations, books and book chapters, journal articles, government reports and parliamentary materials, other authorities and internet resources.

A Cases

1. New Zealand

Commissioner of Patents v Wellcome Foundation Ltd (1983)

Concentration Syndicate v Mineral Separation Ltd (1909) 26 RPC 124 (CA) Huakina Development Trust v Waikato Valley Authority [1987] NZHC 130; [1987] 2 NZLR 188 (HG) New Zealand Māori Council v Attorney-General [1987] 1 NZLR 641 (CA)

New Zealand Māori Council v Attorney-General [1994] 1 NZLR 513 (PC)

Pharmaceutical Management Agency Limited v Commissioner of Patents [1999] (New Zealand Court of Appeal (NZCA)) 330

Te Heuheu Tukino v Aotea District Māori Land Board [1941] NZLR 590 (PC)

Trans-Tasman Resources Limited v The Taranaki-Whanganui Conservation Board [2021] NZSC127 (SC)

WaikatoLink Ltd v Comvita New Zealand Ltd HC Tauranga CIV 2008-470-90 [2010] NZHC 862 (4 June 2010)

2. Australia

Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21, (2007) 235 CLR 173

3. United Kingdom

Biogen Inc v Medeva plc [1996] UKHL 18; [1997] RPC 1

Boehringer Mannheim GmbH v Genzyme Ltd [1993] FSR 716 Gillette Safety Razor Co v Anglo-American Trading Co Ltd Jacob LJ St. Gobain v Fusion Provida [2005] EWCA Civ 17 Pozzoli SPA v BDMO SA [2007] EWCA Civ 588

Windsurfing International Inc. v Tabur Marine (Great Britain) Ltd [1985] RPC 59

B Statutes

1. New Zealand

Biosecurity Act 1993 Contractual Remedies Act 1979 Copyright Act 1994

Designs Act 1953 Fair Trading Act 1986 Food Act 2014

Geographical Indications (Wine and Spirits) Registration Act 2006 Haka Ka Mate Attribution Act 2014

Medicines Act 1981

Ngāi Tahu Claims Settlement Act 1998 Patents Act 1953

Patents Act 2013

Plant Variety Rights Act 1987

The Tohunga Suppression Act 1907 Trade Marks Act 2002

Treaty of Waitangi Act 1975

2. South Africa

Protection, Promotion, Development and Management of Indigenous Knowledge Act 6 2019

3. United Kingdom

Statute of Monopolies 1623

4. United States

The Bayh-Dole University and Small Business Patent Procedures Act 1980 Patent and Trade Mark Law Amendments Act 1980

C International Conventions & Protocols

Agreement on Trade-Related Aspects of Intellectual Property Rights Berne Convention for the Protection of Literary and Artistic Works (1886) Convention on Biological Diversity

General Agreement on Tariffs and Trade International Registration of Marks (1891)

International Treaty on Plant Genetic Resources for Food and Agriculture Nagoya Protocol on Access to Genetic Resources

Paris Convention for the Protection of Industrial Property Universal Declaration of Human Rights

Universal Declaration of the Rights of Peoples

United Nations Declaration on the Rights of Indigenous Peoples

WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore

D Treatises

Declaration of Independence of the United Tribes of New Zealand 1835 European Patent Convention 1973

Patents Cooperation Treaty Treaty of Waitangi 1840

E Regulations

Dietary Supplements Regulations 1985 Patents Regulations 2014 (LI 2014/275) F Books and Book Chapters

Anon; Department of Scientific and Industrial Research, Botany Division file 22/15 of 8/1/59, National Archives.

Bryce Pilz “Modern Intellectual Property Valuation in the Academic Technology Transfer Setting” in Research Handbook on Intellectual Property and Technology Transfer (Edward Elgar Publishing, 2020).

Char. Gen. Pl., ed. 2. 72, t. 36 (1776).

Daniel F Robinson “Biopiracy and the Innovations of Indigenous Peoples’ and Local Communities” in Indigenous Peoples’ Innovation: Intellectual Property Pathways to Development (ANU Press, 2012) Chapter 4.

Daniel R Cahoy “Intellectual Property Exchanges and Auctions: Non-traditional Mechanisms for Technology Transfer” in Research Handbook on Intellectual Property and Technology Transfer (Edward Elgar Publishing, 2020).

David Williams “Te Kooti Tango Whenua”: The Native Land Court 1864–1909 (1st ed, Huia Publishers, Wellington, 1999).

Debashis Bandyopadhyay “Protection of Traditional Knowledge and Indigenous Knowledge” in Securing Our Natural Wealth: South Asia Economic and Policy Studies, 59–70 (Springer, Singapore, 2018).

Evana Wright Protecting Traditional Knowledge: Lessons from Global Case Studies (1st ed, Edward Elgar, Cheltenham, 2020).

HH Allan, Lucy B Moore, Elizabeth Edgar, AJ Healy, CJ Webb, WR Sykes, PJ Garnock-Jones, David R. Given, HE Connor and MI Dawson, Flora of New Zealand Volume 1 (New Zealand. Botany Division, Government Printer, Wellington, New Zealand, 1961–2000).

Hugh Kawharu (ed) Waitangi: Māori and Pākeha Perspectives of the Treaty of Waitangi

(Oxford University Press, Melbourne, 1989).

Ian Finch (ed) James and Wells Intellectual Property Law in New Zealand (Thomson Reuters, Wellington, 2017).

James A Cunningham, Brian Harney and Ciara Fitzgerald “Effective Technology Transfer Offices: A Business Model Framework” (Springer Brief in Business, Springer, 2020).

Jessica Lai “A Successful Recalibration of Patent Law vis-à-vis Mātauranga Māori? A Case Study of Mānuka (Leptospermum scoparium)” in S Frankel (ed) The Object and Purpose of Intellectual Property (Edward Elgar, 2019) 30–56.

Jessica Mark “‘But It Was My Idea!’ A Statutory Compensation Scheme for Employee Inventors?” dissertation submitted in partial fulfilment of the degree of Bachelor of Laws (Honours), University of Otago, Dunedin, New Zealand, October 2007.

Jonathan Curci “Positive Protection of Traditional Knowledge” in The Protection of Biodiversity and Traditional Knowledge in International Law of Intellectual Property (Cambridge Intellectual Property and Information Law, Cambridge University Press, 2009) Chapter 7.

Kerry Kate and Sarah Laird The Commercial Use of Biodiversity Access to Genetic Resources and Benefit-Sharing (1st ed, Routledge, United Kingdom, 1999).

Lauren E Sweetman and Kirsten Zemke “Claiming Ka Mate: Māori Cultural Property and the Nation’s Stake” in The Oxford Handbook of Musical Repatriation (2019) 700.

Lee Epstein and Andrew D Martin An Introduction to Empirical Legal Research (1st ed, Oxford University Press, United Kingdom, 2014).Maria Mousmouti Designing Effective Legislation (Edward Elgar Publishing, Cheltenham/Northampton, 2019).

Morag McDowell and Duncan Webb The New Zealand Legal System: Structures and Processes

(4th ed, Butterworth, Wellington, 2006).

Murdoch Riley Māori Healing and Herbal. New Zealand Ethnobotanical Sourcebook (Viking Sevenseas, Paraparaumu, New Zealand, 1994).

Nicolai J Foss and Snejina Michailova Knowledge Governance: Processes and Perspectives (1st ed, Oxford University Press, United Kingdom, 2009).

Paul Sumpter Intellectual Property Law: Principles and Practice (3rd ed, Wolters Kluwer, 2017).

Peter Wardle Vegetation of New Zealand (Cambridge University Press, Cambridge, 2002).

RD Mulholland Introduction to the New Zealand Legal System (9th ed, Butterworth, Wellington, 1999).

Rob Tipa Treasures of Tāne: Plants of Ngāi Tahu (Huia Publishers, Wellington, Aotearoa New Zealand, 2018).

Susy Frankel Intellectual Property in New Zealand (2nd ed, LexisNexis, Wellington, New Zealand, 2011).

Vincent O’Malley The Great War for New Zealand: Waikato 1800–2000 (eBook, Bridget Williams Books, 2016).

William Williams A Dictionary of New Zealand Volume 1 (1st ed, C.M Society, Paihia, New Zealand, 1844).

William Williams A Dictionary of the New Zealand Language (Williams and Norgate, London, 1871).

Witi Ihimaera Navigating the Stars: Māori Creation Myths (Penguin, Random House, New Zealand, 2020).

G Journal Articles

A Collier and B Grey “The Commercialisation of University Innovations—A Qualitative Analysis of the New Zealand Situation” (2010) Research Report Centre for Entrepreneurship School of Business University of Otago.

A Fisch “Compulsory Licencing of Pharmaceutical Patents: An Unreasonable Solution to an Unfortunate Problem” (1994) 34(3) Jurimetrics 295–315.

Alexander Shikov, Igor Narkevich, Elena Flisyuk, Vladimir Luzhanin and Olga Pozharitskaya “Medicinal Plants from the 14^th Edition of the Russian Pharmacopoeia: Recent Updates” (2021) 25 J Ethnopharmacol 268.

Anders Brantnell and Enrico Baraldi “The Roles of Academic Inventors in Medical Innovation Processes: Exploring the Influence of IPR Ownership and IP Nature” (2020) 25(5) International Journal of Innovation Management 1–48.

B Carlsson and A Fridh “Technology Transfer in United States Universities” (2002) 12 Journal of Evolutionary Economics 199–232.

B Looy, P Landoni, J Callaert, BV Pottelsberghe, Elefthérios Sapsalis and K Debackere “Entrepreneurial Effectiveness of European Universities: An Empirical Assessment of Antecedents and Trade-offs” (2011) 40 Research Policy 553–564.

Brooke Marriner “Disclosure of Origin in the Patents Regime: A Call to Shift Towards Meaningful Engagement on Māori Terms” (2020) 51 Victoria U. Wellington L. Rev. 673–715.

C Bloch and M Sørensen “The Size of Research Funding: Trends and Implications” (2015) 43 Science and Public Policy 30–43.

C Charters, J Ruru, T Olsen, J Pryor, K Kingdon-Bebb, W Ormsby, E Owen, N Soloman and G Williams “He Puapua. Report of the Working Group on a Plan to Realise the UN Declaration on the Rights of Indigenous People in Aotearoa/New Zealand” (Te Puni Kokori, 14 October 2020).

C Hamilton and SP Philbin “Knowledge Based View of University Tech Transfer—A Systematic Literature Review and Meta-Analysis” (2020) 10(3) Administrative Sciences 62.

C Kavelin “Universities as the Gatekeepers of the Intellectual Property of Indigenous Peoples’ Medical Knowledge” (2008) 37 Australian J of Indigenous Education 34–35.

Connor O’Kane, James A Cunningham, Matthias Menter and Sara Walton “The Brokering Role of Technology Transfer Offices within Entrepreneurial Ecosystems: An Investigation of Macro– Meso–Micro Factors” (2021) 46(6) The Journal of Technology Transfer 1814–1844.

Conor O’Kane “Technology Transfer Executives’ Backwards Integration: An Examination of Interactions between University Technology Transfer Executives and Principal Investigators” (2018) 76 Technovation 64–77.

Conor O’Kane, Vincent Mangematin, Will Geoghegan and Ciara Fitzgerald “University Technology Transfer Offices: The Search for Identity to Build Legitimacy” (2015) 44(2) Research Policy 421–437.

CS Hayter “A Social Responsibility View of the “Patent-Centric Linear Model” of University Technology Transfer” (2016) 54 Duq. L. Rev. 7.

CS Hayter and JH Rooksby “A Legal Perspective on University Technology Transfer” (2016) 41 J Technol Transf 270–289.

D Broughton, T Te Aitanga-a-Hauiti, N Porou, K McBreen, KM Waitaha and N Tahu “Mātauranga Māori, tino rangatiratanga and the Future of New Zealand Science” (2015) 45(2) Journal of the Royal Society of New Zealand 83–88.

D Ganesan “Sui generis is the Answer: Positive Protection of Traditional Knowledge in India” (2016) 11(1) Journal of Intellectual Property Law & Practice 49–55.

D Kleyn “Freedom to Operate Conundrum” (2021) 56(4) Les Nouvelles-Journal of the Licensing Executives Society 358–390.

D Siegel, D Waldman and A Link “Assessing the Impact of Organizational Practices on the Relative Productivity of University Technology Transfer Offices: An Exploratory Study” (2003) 32 Research Policy 27–48.

D Siegel, R Veugelers and M Wright “Technology Transfer Offices and Commercialization of University Intellectual Property: Performance and Policy Implications” (2007) 23(4) Oxford Review of Economic Policy 640–660.

Daniel Armstrong “The Arguments of Law, Policy and Practice against Swiss-type Patent Claims” (2001) 32 Victoria U. Wellington L. Rev. 201–254.

Daniel Hikuroa “Mātauranga Māori—the ūkaipō of Knowledge in New Zealand” (2017) 47(1) Journal of the Royal Society of New Zealand 5–10.

Darrell Posey “Intellectual Property Rights and Just Compensation for Indigenous Knowledge” (1990) 6(4) Anthropology Today 13–16.

Duong Cong Doanh, Tomasz Bernat, Nguyen Thanh Hieu, Nguyen Bich Ngoc and Nguyen Thi Phuong Linh “Academic Entrepreneurship: An Empirical Research of Invention Commercialisation” (2021) 10(2) Central European Business Review 33–62.

E Mavric, S Wittmann, G Barth and T Henle “Identification and Quantification of Methylglyoxal as the Dominant Anti-bacterial Constituent of Mānuka (Leptospermum scoparium) Honeys from New Zealand” (2008) 52(4) Mol Nutr Food Res. 483–489.

F Akena “Critical Analysis of the Production of Western Knowledge and Its Implications for Indigenous Knowledge and Decolonization” (2012) 6 Journal of Black Studies 599–619.

F Bell, “Empirical Research in Law” (2016) 25(2) Griffith Law Review 262–282.

F Christoph, K-H Kubeczka and E Stahl-Biskup “The Composition of Commercial Mānuka Oils from New Zealand” (1999) 11(6) Journal of Essential Oil Research 705–710.

F Christoph, P-M Kaulfers and E Stahl-Biskup “A Comparative Study of the in vitro Antimicrobial Activity of Tea Tree Oils with Special Reference to the Activity of β-triketones” (2000) 66(06) Planta medica 556–560.

Feng Li, Yongli Wang, Dapeng Li, Yilun Chen and Q Ping Dou “Are We Seeing a Resurgence in the Use of Natural Products for New Drug Discovery?” (2019) 14(5) Expert Opin Drug Discovery 417–420.

Fundación Indígena and Brij Kothari “Rights to the Benefits of Research: Compensating Indigenous Peoples for Their Intellectual Contribution” (1997) 56(2) Human Organization 127– 137.

G Markman, P Phanb, DB Balkinc and PT Gianiodisa “Entrepreneurship and University-based Technology Transfer” (2005) 20 Journal of Business Venturing 241–63.

G Ooms and J Hanefeld “Threat of Compulsory Licences could Increase Access to Essential Medicines” (2019) BMJ 365.

Gail A Van Norman and Roï Eisenkot “Technology Transfer: From the Research Bench to Commercialization. Part 1: Intellectual Property Rights—Basics of Patents and Copyrights” (2017) 2(1) JACC: Basic to Translational Science 85–97.

Georgina Tuari Stewart “Mātauranga Māori: A Philosophy from Aotearoa” (2022) 52(1) Journal of the Royal Society of New Zealand 18–24.

Giorgia Miotto, Cristina Del-Castillo-Feito and Alicia Blanco-González “Reputation and Legitimacy: Key Factors for Higher Education Institutions’ Sustained Competitive Advantage” (2020) 112 Journal of Business Research 342–353.

Glenis Mark, Amohia Boulton and Donna Kerridge. “Rongoā māori is Not a Complementary and Alternative Medicine: rongoā māori is a Way of Life” (2019) 3(1) International Journal of Human Rights Education 12.

H Stevens, G Van Overwalle, B Van Looy and I Huys “Intellectual Property Policies in Early Phase Research in Public-Private Partnerships” (2016) 34 Nat Biotechnol 504–510.

Jack Hood “Ko ngā take ture Māori: Our Significantly Indigenous Administrative Law: The Treaty of Waitangi and Judicial Review” (2013) 6 Auckland Law Review 53.

Jane Anderson and Māui Hudson “The Biocultural Labels Initiative: Supporting Indigenous Rights in Data Derived from Genetic Resources” (2020) 4 Biodiversity Information Science and Standards e59230.Jayden Houghton “The New Zealand Government’s Response to the Wai 262 Report: The First Ten Years” (2021) 25(5) The International Journal of Human Rights 870–893.

Jessica C Lai “Māori Traditional Knowledge and New Zealand Patent Law: The 2013 Act and the Dawn of a New Era?” (2014) 17(1–2) The Journal of World Intellectual Property 34–46.

Jessica C. Lai, Daniel F. Robinson, Tim Stirrup and Hai‐Yuean Tualima “Māori Knowledge under the Microscope: Appropriation and Patenting of mātauranga Māori and Related Resources” (2019) 22(3–4) The Journal of World Intellectual Property 205–233.

JMC Stephens, PC Molan and BD Clarkson “A Review of Leptospermum scoparium (Myrtaceae) in New Zealand” (2005) 43(2) New Zealand Journal of Botany 431–449.

Jonni Hazeline Koia and Peter Shepherd “The Potential of Anti-diabetic rākau rongoā (Māori Herbal Medicine) to Treat Type 2 Diabetes Mellitus (T2DM) mate huka: A Review” (2020) 11(935) Frontiers in Pharmacology 1–14.

Joris J Heus, Elmar S de Pauw, Leloux Mirjam and Morpurgo Margherita “Importance of Intellectual Property Generated by Biomedical Research at Universities and Academic Hospitals” (2017) 2 Journal of Clinical and Translational Research 3 250.

Justice Joe Williams “Lex Aotearoa: An Heroic Attempt to Map the Māori Dimension in Modern New Zealand Law” (2013) Waikato Law Review 1.

K Hostettman and JL Wolfender “The Search for Biologically Active Secondary Metabolites” (1997) 51 Pesticide Science 471–482.

K Moffat, J Lacey, A Zhang and S Leipold “The Social Licence to Operate: A Critical Review” (2016) 89(5) Forestry: An International Journal of Forest Research 477–488.

Katharina Ruckstuhl, Michelle Thompson-Fawcett and Hauauru Rae “Māori and Mining: Indigenous Perspectives on Reconceptualising and Contextualising the Social Licence to Operate” (2014) 32(4) Impact Assessment and Project Appraisal 304–314.

L Jishnu “Safeguarding Ancient Wisdom: Down To Earth” (2012) Muqbil, I., Ind.

Libby Liggins, Māui Hudson and Jane Anderson “Creating Space for Indigenous Perspectives on Access and Benefit‐sharing: Encouraging Researcher Use of the Local Contexts Notices” (2021): 2477–2482.

M Gotsch and C Hipp “Using Trademarks to Measure Innovation in Knowledge-Intensive Business Services” (2014) 4(5) Technology Innovation Management Review 18–30.

M Hülsbeck, E Lehmann and A Starnecker “Performance of Technology Transfer Offices in Germany” (2013) 38 Journal of Technology Transfer 1–17.

Malcolm Douglas, John Klink, Bruce, Smallfield, Nigel Perry, Rosemary Anderson, Peter Johnstone and Rex Weavers “Essential Oils from New Zealand Mānuka: Triketone and Other Chemotypes of Leptospermum scoparium” (2004) 65 Phytochemistry 1255–1264.

Manuel Guerrero Gaitán “Licensing as a Central Structure of Technology Transfer Agreements—Joint Venture and Franchising Agreements” (2021) 70(5) GRUR International 419–420.

Mathew S Clancy and GianCarlo Moschini “Incentives for Innovation: Patents, Prizes, and Research Contracts” (2013) 35(2) Applied Economic Perspectives and Policy 206–241.

Mathias Siems “The Law and Ethics of ‘Cultural Appropriation’” (2019) 15(4) International Journal of Law in Context 408–423.

Merata Kawharu “Kaitiakitanga: A Māori Anthropological Perspective of the Māori Socio- environmental Ethic of Resource Management” (2020) 109(4) Journal of Polynesian Society 349–370.

MH Buys, RC Winkworth, PJ de Lange, PG Wilson, N Mitchell, AR Lemmon, EM Lemmon, S Holland, JR Cherry and J Klápště, J. “The Phylogenomics of Diversification on an Island: Applying Anchored Hybrid Enrichment to New Zealand Leptospermum scoparium (Myrtaceae)” (2019) 191(1) Botanical Journal of the Linnean Society 1–17.

Mika Young “Tā moko and the Cultural Politics of Appropriation” (2018) 15(2) New Series.

MM Pandey, S Rastogi and AKS Rawat “Indian Traditional Ayurvedic System of Medicine and Nutritional Supplementation” (2013) Evidence-Based Complementary and Alternative Medicine Epub Jun 23.

NB Perry, NJ Brennan, JW Van Klink, W Harris, MH Douglas, JA McGimpsey, BM Smallfield and RE Anderson “Essential Oils from New Zealand mānuka and kānuka: Chemotaxonomy of Leptospermum” (1997) 44 Phytochemistry 1485–1494.

P Edwards and S Trafford “Social Licence in New Zealand—What is It?” (2016) 46(3–4) Journal of the Royal Society of New Zealand 165–180.

Peter Edwards, Aysha Fleming, Justine Lacey, Libby Lester, Elizabeth Pinkard, Katharina Ruckstuhl, Carel Bezuidenhout, Tim Payn, Karen Bayne and Tracy Williams “Trust, Engagement, Information and Social Licence—Insights from New Zealand” (2019) 14(2) Environmental Research Letters 024010.

Priyanka Malhan “Joint Ownership of Intellectual Property: Is it a Profit or Loss” (2020) 19(1) Indian Journal of Economics & Business 1–18.

R Cardozo, A Ardichvili and A Strauss “Effectiveness of University Technology Transfer: An Organizational Population Ecology View of a Maturing Supplier Industry” (2011) 36 The Journal of Technology Transfer 173–202.

RD Baltaru “Do Non-academic Professionals Enhance Universities’ Performance? Reputation vs. Organisation” (2019) 44(7) Studies in Higher Education 1183–1196.

S Altay, Y Majima and H Mercier, “It’s My Idea! Reputation Management and Idea Appropriation” (2020) 41(3) Evolution and Human Behavior 235–243.

S Scafidi “Introduction: New Dimensions of Cultural Property” (2009) 31 Fordham International Law Journal 684–689.

Susan Young “The Patentability of Māori Traditional Medicine and the Morality Exclusion in the Patents Act 1953” (2001) 10(32.1) VUWLawRw 255.

Tania Waikato “He Kaitiaki Mātauranga: Building a Protection Regime for Māori Traditional Knowledge” (2005) 8(2) Yearbook of New Zealand Jurisprudence 344–410.

Terri Janke “Managing Indigenous Knowledge and Indigenous Cultural and Intellectual Property” (2005) 36(2) Australian Academic & Research Libraries 95–107.

Will Geoghegan, Conor O’Kane and Ciara Fitzgerald “Technology Transfer Offices as a Nexus within the Triple Helix: The Progression of the University’s Role” (2015) 68(3–4) International Journal of Technology Management 255–277.

WJ Bond, KLM Dickinson and AF Mark “What Limits the Spread of Fire-dependent Vegetation? Evidence from Geographic Variation of Serotiny in a New Zealand Shrub” (2004) 13 Global Ecology and Biogeography 115–127.

Yao Dong “The Protection of Mātauranga Māori Associated with Taonga Species” (2019) 10(6) PILJNZ 183–212.

H Government Reports and Parliamentary Materials

Cabinet Office Cabinet Manual 2017.

Castalia Strategic Advisors Economic Evaluation of Disclosure of Origin Requirements (Report to Ministry of Business Innovation and Employment, April 2018).

Competition Policy and Business Law Division Review of Industrial Property Rights, Patents, Trademarks, and Designs: Possible Options for Reform. New Zealand (Ministry of Commerce, Wellington, 1990).

Metiria Turei Supplementary Order Paper (House of Representatives, No:348 Patents Bill Tuesday, 27 August 2013).

Ministry of Business, Innovation and Employment “Plant Variety Rights Act Review” (public presentation 29 September 2020).

Ministry of Business, Innovation and Employment Discussion Document: Intellectual Property Laws Amendment Bill—Patents Act 2013, Trade Marks Act 2002, Designs Act 1963 (2019).

Ministry of Business, Innovation and Employment Discussion Paper: Disclosure of Origin of Genetic Resources and Traditional Knowledge in the Patents Regime (September 2018).

Ministry of Business, Innovation and Employment What is Te Ara Paerangi Future Pathways?

<https://www.mbie.govt.nz/science-and-technology/science-and-innovation/research-and- data/te-ara-paerangi-future- pathways/#:~:text=Te%20Ara%20Paerangi%20Future%20Pathways,take%20advantage%20of% 20emerging%20opportunities.>

Ministry of Commerce Māori and Trade Marks: A Discussion Paper Māori Trade Marks Focus Group (Ministry of Commerce, Wellington, NZ, 1997).

Ministry of Commerce New Zealand Business Policy Division Intellectual Property Law Reform Bill: Māori Consultation Paper (Business Policy Division, Ministry of Commerce, Wellington, 1994).

Ministry of Commerce Patenting of Biotechnological Inventions: A Ministry of Commerce Paper on Issues for Discussion with Māori. Māori and the Patenting of Lifeform Inventions: An Information Paper Patenting of Life Forms Focus Group for the Ministry of Commerce (Patenting of Life Forms Focus Group, Ministry of Commerce, Wellington, NZ,1999).

Ministry of Economic Development Review of the Patents Act 1953: Boundaries to Patentability: A Discussion Paper (Wellington, NZ, 2002).

New Zealand Intellectual Property Office “Information Request” (12 October 2020) (obtained under Official Information Act 1982 request to the New Zealand Intellectual Property Office on behalf of the Commissioner of Patents, Trade Marks, Designs and Plant Variety Rights).

New Zealand Intellectual Property Office “Information Request” (1 March 2021) (obtained under Official Information Act 1982 request to the New Zealand Intellectual Property Office on behalf of the Commissioner of Patents, Trade Marks, Designs and Plant Variety Rights).

New Zealand Intellectual Property Office “Protecting Intellectual Property with a Māori Cultural Element: User Guide: Intellectual Property” (Ministry of Business Innovation and Employment, 2016) 1–46.

Patents Bill (235-2).

Plant Variety Rights Bill (35-2).

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Te Puni Kōkiri, ‘Review of the Crown’s Activities in Relation to Ko Aotearoa Tēnei (WAI 262)’ (briefing paper), 20 November 2015 [‘Review’ (Nov 2015)], para. 5.

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I Other Authorities

Chris Kaell “Dunedin Biotech Startup Amaroq Therapeutics Raises $14m for Revolutionary ‘Dark Matter’ Cancer Treatment” The New Zealand Herald (online ed. Auckland) 8 August 2021.

George Nicolas “When Scientists “Discover” What Indigenous People have Known for Centuries” Smithsonian Magazine (online ed., February 21, 2018).

Jason Millman “Does it Really Cost $2.6 Billion to Develop a New Drug?” The Washington Post

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Lida Ayoubi “Intellectual Property Commercialisation and Protection of Mātauranga Māori in New Zealand Universities” (2019) Summary report into a research project funded by the New Zealand Law Foundation.

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NZPA “Comvita in Honey Deal with Waikato University” The New Zealand Herald (online ed. Auckland, 6 December 2006).

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Susy Frankel “Mātauranga Māori and the Interface with the Intellectual Property Ecosystem” (Workshop TTOs & Indigenous Intellectual Property: Principles, Policies and Engagement: What to Do?, 22 June 2021).

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J Internet Resources

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Malin Lemurell AstraZeneca “A Big Future for Small Molecules: Targeting the Undruggable”

<https://www.astrazeneca.com/r-d/next-generation-therapeutics/small-molecule.html>.

Māori Advisory Committee <https://www.iponz.govt.nz/about-ip/maori-ip/maori-advisory- committees/>.

Māori Dictionary “taonga” <https://maoridictionary.co.nz/search?keywords=taonga>.

Māui Solomon and others “Closing Submissions for Ngāti Kurī, Ngatiwai and Te Rarawa” (5 September 2007) Wai 262 <wai262.weebly.com>.

Ministry for Culture and Heritage “Honey Bees Brought to New Zealand” (8 October 2020) New Zealand History <https://nzhistory.govt.nz/mary-bumby-brings-the-first-honey-bees-in-new- zealand>.

Ministry of Business, Innovation and Employment “Disclosure of Origin Requirements in the Patents Regime” (8 April 2019) MBIE <https://www.mbie.govt.nz/business-and- employment/business/intellectual-property/disclosure-of-origin-requirements-in-the-patents- regime/>.

Ministry of Business, Innovation and Employment “Funding Information and Opportunities”

<https://www.mbie.govt.nz/science-and-technology/science-and-innovation/funding- information-and-opportunities/>.

Ministry of Business, Innovation and Employment “Master Investment Contract”

<https://www.mbie.govt.nz/dmsdocument/1268-science-investment-contract-template>.

Ministry of Business, Innovation and Employment “PreSeed Accelerator Fund”

<https://www.mbie.govt.nz/science-and-technology/science-and-innovation/funding- information-and-opportunities/investment-funds/preseed-accelerator-fund/>.

“Monoterpene” <https://www.dictionary.com/browse/monoterpene>.

New Zealand Intellectual Property Office “Apply for a Patent”

<https://www.iponz.govt.nz/about-ip/patents/apply/>.

New Zealand Intellectual Property Office “Māori Advisory Committees”

<https://www.iponz.govt.nz/about-ip/Maori-ip/Maori-advisory-committees/>.

New Zealand Intellectual Property Office “The Patent Examination Manual” New Zealand Intellectual Property Office <https://www.iponz.govt.nz/about-ip/patents/examination- manual/current/inventions-contrary-to-public-order-or-morality-not-patentable-inventions/>.

New Zealand Intellectual Property Office “Whole-of-government Work Program Announced for Wai 262” <https://www.iponz.govt.nz/news/whole-of-government-work-program-announced- for-wai-262/>.

Te Puni Kōkiri “Release of the Waitangi Tribunal Report in March/April 2010” (draft brief for Minister of Māori Affairs, 23 March 2010).

Te Puni Kokori “Te Pae Tawhiti: Wai 262” <https://www.tpk.govt.nz/en/a-matou-kaupapa/te-ao- Maori/wai-262-te-pae-tawhiti>.

The University of Auckland “The University of Auckland Intellectual Property Created by Staff and Students Policy” at s 1.3 (e). <https://www.auckland.ac.nz/en/about-us/about-the- university/policy-hub/research-innovation/conduct/intellectual-property-created-staff-students- policy.html>.

Tina Ngata “Cultural Appropriation of Māori Traditions is an Exercise in Entitlement and Privilege” The Guardian 4 December 2019

<https://www.theguardian.com/commentisfree/2019/dec/04/cultural-appropriation-of-maori- traditions-is-an-exercise-in-entitlement-and-privilege>.

University of Otago “Intellectual Property Right Policy”

<https://www.otago.ac.nz/administration/policies/otago003229.html>.

University of Waikato “Intellectual Property Rights Policy” <https://www.waikato.ac.nz/official- info/index/docs/intellectual-property-rights-policy>.

World Intellectual Property Organization “Traditional Knowledge”

<https://www.wipo.int/tk/en/tk/>.

World Intellectual Property Organization “Database of Intellectual Property Policies from Universities and Research Institutions” <https://www.wipo.int/about- ip/en/universities_research/ip_policies/search.jsp?institution_id=&focus_id=&type_id=&territor y_id=134&language_code=>.

World Intellectual Property Organization “Exclusive License Agreement (sample)—Harvard College, United States of America”

<https://www.wipo.int/tk/en/databases/contracts/texts/harvardexlic.html>.

World Intellectual Property Organization “Exclusive License Agreement (sample) - Harvard College, United States of America”

<https://www.wipo.int/tk/en/databases/contracts/texts/harvardexlic.html>.

World Intellectual Property Organization “Inside WIPO” <https://www.wipo.int/about- wipo/en/#:~:text=WIPO%20is%20the%20global%20forum,%2C%20policy%2C%20informatio n%20and%20cooperation.&text=Our%20mission%20is%20to%20lead,for%20the%20benefit%2 0of%20all>.

World Intellectual Property Organization “Invention Disclosure Forms”

<https://www.wipo.int/edocs/mdocs/aspac/en/wipo_ip_bkk_17/wipo_ip_bkk_17_8.pdf>.

World Intellectual Property Organization “Traditional Knowledge”

<https://www.wipo.int/tk/en/tk/>.

World Intellectual Property Organization “WIPO-Administered Treaties”

<https://www.wipo.int/treaties/en/>.

World Intellectual Property Organization WIPO Global Brand Database

<https://www.wipo.int/branddb/en/>.

World Intellectual Property Organization, IGC, Report 42, WIPO Doc. WIPO/GRTKF/IC/14/12 (2009).

Appendix I Mānuka Nomenclature and Botanical Description

Conventional modern-day science follows a systematic plant classification and identification process through the science of taxonomy. Taxonomy is grounded in a well-defined hierarchy characterised by identifying, classifying and describing plants through the observation, examination and measurement of morphological, behavioural, genetic and biochemical characteristics. Plants are arranged into classifications; a standardised hierarchical system is defined broadly as Kingdom, Division, Class, Order, Family, Species. The goal is an organised system that allows for a standard method of identifying plants using their shared characteristics. The Swedish botanist Carl Linnaeus (23 May 1707–10 January 1778) is regarded as the founder of the current taxonomy system.

Essential to taxonomy is botanical nomenclature, the process of choosing a name, mainly derived from the Greek and Latin languages. It is governed by the International Code of Nomenclature for algae, fungi, and plants.⁴³⁶ Johann Reinhold Forster and Georg Forster (R. Forst. & G. Forst), father and son botanists,⁴³⁷ are credited as the first to formally classify mānuka in 1769 into the taxonomic system and name the species using that method. Indeed, the type specimen⁴³⁸ used to classify mānuka was from New Zealand. Undoubtedly, they would have used morphological characteristics of the plant to classify and identify the species under the taxonomic system since both genetic and biochemical marker technologies were not available at the time. The basic premise of identification would have been that if they look the same, they are the same.⁴³⁹

Morphologically, mānuka is characterised as an evergreen perennial shrub growing to about 2–5 metres tall, on occasion reaching up to 15 metres in height. Leaves tend to be small, but range from 7–20 mm long and 2–6 mm wide and are prickly to the touch. They contain oil glands and are very aromatic when crushed. Flowers are small (8–15mm), proliferate and typically white, though pink on occasion, particularly in the North Cape region of New Zealand. The flowering season is typically between 6–12 weeks, from September to March. The seed capsules tend to be large (5–

⁴³⁶ International Association for Plant Taxonomy (IAPT) <https://www.iapt-taxon.org>.

⁴³⁷ The botanists accompanied Captain Cook on his second voyage (1772–1775) to New Zealand. This 1769 reference, suggests that Mānuka (Leptospermum scoparium) was first identified from samples found in New Zealand, the year before Cook discovered Australia in 1770.

⁴³⁸ The specimen, or each of a set of specimens, on which the description and name of a new species is based.

⁴³⁹ I use the term “look” broadly here, to reflect so called common characteristics.

7 mm in diameter) and remain on the plant for several years. The seeds are small and thin, while the wood is very hard.⁴⁴⁰

Reinhold and Georg Forster classified the plant as Leptospermum scoparium (L. scoparium):

• Kingdom: Plantae
• Division: Magnoliophyta
• Class: Magnoliopsida Brongn.
• Order: Myrtales Juss. ex Bercht. & J.Presl
• Family: Myrtaceae
• Genus: Leptospermum J.R.Forst. & G.Forst.⁴⁴¹
• Species: scoparium

The generic name Leptospermum is derived from the Greek words “leptos”, meaning thin and fine, and “sperma”, which means seed, describing the appearance of the light seeds found in the seed capsule. The specific name, scoparium, is derived from Latin and means “like broom”. Interpreted then as a broom-like plant with fine thin seeds and has many common names such as mānuka, mānuka myrtle, kahikatoa, New Zealand tea tree and broom tea-tree.

⁴⁴⁰ HH Allan and others “Flora of New Zealand” Volume 1 (Government Printer, Wellington, New Zealand, 1961– 2000) at 320.

⁴⁴¹ Char. Gen. Pl., ed. 2. 72, t. 36 (1776).

Appendix II Methodology, Tables and Figures

Appendix II provides a supplementary description of my methodology and graphical representation of data generated for the thesis, particularly Chapter IV. I have characterised these into four parts: A prior art base, B patent applications and granted patents, C inventions targeting Māori medical knowledge in mānuka, D commercial exploitation and E Other. Sections A–D are for Chapter IV B 3 specifically. Section E is for Chapter II D. I discuss the approach utilised in this section and include any pertinent tables and statistics. Tables and figures may or may not be followed with commentary: they may be described in length in the main body of the thesis and referred to here, or they may be supplemented by more thorough descriptions where necessary. Additionally, I discuss and recognise any limitations associated with the studies in this Appendix. These tables and figures are all my own work.

A Prior Art Base 1 Methodology

Using the LENS⁴⁴² scholarly database, I examined the following literary works as a measure of

the prior art base—books, book chapters, conference proceedings, articles, dissertations, journal articles, preprints, reports and unknown sources from the time of the first publication to 2019.

I focused on mining content from abstracts as abstracts tend to summarise all the significant aspects of the content of the written material (such as the purpose, design, significant findings and summary of outcomes and results). Therefore, they are most likely to contain a reference to the content I am searching for. The critical search criteria within LENS was framed by whether the word or words “mānuka”, “mānuka honey” or “mānuka oil”⁴⁴³ were present within an abstract. This assumes that the author intended to focus on researching and disclosing their research activity concerning those terms. The “mānuka” search term captures all publication activity for mānuka, including honey and oil. I acknowledge three main limiting factors in this analysis. First, the

⁴⁴² LENS is a global patent and scholarly knowledge database. It ingests, cleans, aggregates, normalises and serves over 225 million scholarly works, over 127 million global patent records and over 370 million patent sequences.

<https://www.lens.org/>.

⁴⁴³ The specific search format within LENS is structure as such: abstract:(“Mānuka”), abstract:(“Mānuka honey”), abstract:(“Mānuka oil”).

analysis may not capture all literary works by focusing on abstracts only. Second, focusing on the word “manuka”, the analysis may not capture all literary works associated with the species (the search term “Leptospermum scoparium” was excluded). Third, by not targeting Māori medical applications for mānuka as prescribed in Chapter II, the analysis gives a more high level look at the prior art space than specific activity in the health domains.

2 Results

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Figure 2. Publication activity for written works using the words mānuka overall (blue), mānuka honey (orange) and mānuka oil (grey) over time from 1959 to 2019.

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B Patent Applications and Granted Patents 1 Methodology

I focus on patent claims in the patent application specifications to the exclusion of illustrations and supporting text. First, I investigated the overall patent applications and granted patents for the keywords “mānuka”, “mānuka honey” and “mānuka oil”. Second, I examined claims for “mānuka”, “mānuka honey” and “mānuka oil” keywords matched alongside the traditional Māori

mānuka health applications as outlined in Chapter II. Third, I examined trade marks as a means of measuring commercial exploitation.

In this analysis, the principal focus is to look for the words “mānuka” or mānuka honey” or “mānuka oil” to determine if one of the terms is present within a patent claim either in isolation or conjointly with the target application. If so, I assume that the claimant intended to seek the protection of an invention associated with those terms (again, the mānuka search captures all patent activity for the species). I acknowledge some limitations in this assumption. I do not know: (1) the number of claims within a patent application or patent, (2) the arranged order of scope for claims (the first claim being broadest, the last claim being most restrictive), (3) which claims were rejected or accepted that resulted in the patent being granted or abandoned, (4) the limitations of a claim,

(5) the use of the Māori name of the plant might not capture all patents that may claim that species. For example, in the case of mānuka where writers might use the term “L. scoparium” instead of “manuka”.

Search terms within LENS were:

• claims:(“Mānuka”)
• claims:(“Mānuka honey”)
• claims:(“Mānuka oil”)

When examining specific traditional health applications, specific search terms were:

• claims:(Target Application) AND claims:(“Mānuka honey”). For example:
• claims:(Wounds) AND claims:(“Mānuka”)
• claims:(Wounds) AND claims:(“Mānuka honey”)
• claims:(Wounds) AND claims:(“Mānuka oil”)

The analysis period was from the inception of the filing of the first patent application through to December 2019. Statistical significance was determined by linear regression and correlation analysis and set at the standard 5 per cent.

With trade marks, I examined the WIPO global brand database⁴⁴⁴ to specifically examine Mark Number, Brand, Source, Status, Relevance, Origin, Holder Number, Application Date, Image Class and Nice Class. As with previous analyses for the prior art base, I focus at a high level. If the word “mānuka” is present within the trade mark, I assume that the brand owner intended to protect a trade mark associated with mānuka. This approach would capture both word trade marks and combined word and image trade marks. The analysis was conducted from when the first trade mark for mānuka was filed until 2019. Of course, like previous analyses, I acknowledge limitations with this research in that it is unlikely to capture every single trade mark associated with the commercial exploitation of mānuka.

2 Results

Te Runanga o Ngāi Tahu declared which species in New Zealand the iwi classifies as tāonga species through the Ngāi Tahu Claims Settlement Act 1998. By matching these against the patent activity, I can determine where the commercial interest in tāonga species may be. In Appendix 13 of the Ngāi Tahu Claims Settlement Act 1998, the iwi identified 53 tāonga plant species. Patent analysis revealed that 20 (38 per cent) of the 53 taonga species have 702 patent applications filed against them. Ten species account for 98 per cent of all patent applications—mānuka, miro, kānuka, wīwī, tutu, rātā, tōtara, rimu, mataī, kahikatea and kāmahi. Of these, just three—mānuka, miro and kānuka—account for nearly three-quarters of all patent applications (72 per cent). But 52 per cent of all patent applications have been filed for inventions derived from mānuka—371 patent applications in all.

In analysing the relationship between patent applications and granted patents, there is a significant positive linear relationship for all three groups (mānuka overall (P<0.01, r² 0.70); mānuka honey (P<0.01, r² 0.73) and mānuka oil (P<0.05, r² 0.19)). These results indicate that the number of granted patents increases significantly with the number of patent applications filed (see Figure 4). The high r² value for both overall and honey analysis shows that patent application filing is a good predictor of the number of patents granted. That insight seems to support the premise that success in having a patent granted might be influenced by merely filing for more patent applications. Sooner or later, one of them will be granted irrespective of the tests for patentability. In short, the

⁴⁴⁴ World Intellectual Property Organisation WIPO Global Brand Database <https://www.wipo.int/branddb/en/>.

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variability in the number of patent applications filed is accounted for by the variability in the number of patents granted. In contrast, that does not seem to hold for mānuka oil patent applications. The low r² value indicates that the linear trend shown is not explained much by the variability in granted applications but rather a coincidence of filing many patent applications.

The analyses revealed a significant correlation between patent applications filed and success rate for mānuka overall (P<0.01) and mānuka honey (P<0.001), but not for mānuka oil (P<0.16) (see Figure 4). However, all had low r² values. Consequently, the variability in success rate is not highly predicted by the variability in the number of patent applications filed. The more patent applications filed does not guarantee a successfully granted patent. For mānuka oil, a lack of significance accompanied by a meagre r² value strongly suggests little predictive power of success rate based merely on the number of patent applications filed.

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Figure 3. Total number of patent applications and granted patents for mānuka overall, mānuka honey and mānuka oil over time.

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y = 2.7659x + 9.3639
R² = 0.7073

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20

y = 3.1131x + 2.9473
R² = 0.7303

Manuka Oil
15
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10

y = 1.0667x + 3.4833
R² = 0.1997

Linear (Manuka Honey)

Linear (Manuka Oil)
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50.00% 60.00%

20.00% 30.00% 40.00%

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0

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y = 4.6014x + 3.7362
R² = 0.1051

5

Manuka Honey

Linear (Manuka Overall)

Linear (Manuka Oil)

Linear (Manuka Honey)

²⁰ y = 34.749x + 3.279

R² = 0.4491
15

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Manuka Oil
25

y = 61.788x + 9.744
R² = 0.3703

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Figure 4. A comparison of the number of patent applications for mānuka overall, mānuka honey and mānuka oil against the number of granted patents for the same (top), and a comparison of the number of patent applications against the success rate (bottom). The linear analysis (including the formulae) also shows r² values.

C Inventions Targeting Māori Medical Knowledge in Mānuka 1 Results

Table 1. Total patent applications for traditional Māori medical applications for mānuka for mānuka overall, mānuka honey and mānuka oil groups. Medical applications are ranked from highest to lowest.

Figure 5. Patent applications and granted patents for inventions for traditional medical applications in mānuka that contain mānuka honey (M^honey), mānuka oil (M^oil) and other (M^other).

D Commercial Exploitation

Table 2. Patent application filing for the United States, World Intellectual Property Organization (WIPO), Australia and other jurisdictions across mānuka overall, mānuka honey and mānuka oil. Characterisation of mānuka honey and oil (honey + oil) combined and other is also presented.

Figure 6. Analysis cloud illustrating those companies most active at protecting inventions derived from mānuka.⁴⁴⁵ The number is the total number of patent applications filed by the applicant.

⁴⁴⁵ Source: LENS analysis.

Figure 7 shows examples of combined work and image trade marks identified in the trade mark search with trade marks. It is not unreasonable to deduce that marks such as these containing words like “safe”, “ointment”, “therapy”, “doctor”, “Pharm” and medical-like imagery (like a cross representing medical benefits) might purposefully give the impression of a health-claim associated with that mark. In other words, by default, or on purpose, the trade mark leverages the known health benefits of mānuka.

Figure 7. Examples of combined work and image trade marks identified in the trade mark search where the word “mānuka” was the key search term. The trade mark number, the application date (App Date), trade mark class and whether the trade mark was active or pending at the time of the analysis is also presented.

Mark EMTM.016450173; App Date: 09/10/2013. Class 5. 30. Active	Mark EMTM.018084090; App Date: 28/52018. Class 30. Pending.	Mark NZTM.1118627; App date: 16/04/2019, Class 5. Active
Mark NZTM.1067898; App Date: 30/05/2017. Class 5. Active.	Mark AUTM.1795347; App Date 08/09/2016. Class 30. Active.	Mark NZTM.1016951. App Date: 02/04/2015/ Class 3, 5, 30, 35. Active
Mark NZTM.993302; App Date: 27/02/2014. Class 3, 5. Active	Mark KRTM.402013000051728; App Date: 01/08/2013. Class 3, 5, 30. Active	Mark AUTM.2049334. App Date: 05/08/2019. Class 3, 5, 30. Pending.

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Figure 8. Total mānuka trademark applications over time (1963 to 2019).

Trade Mark Applications
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Figure 9. Jurisdictions and trade mark classes where mānuka trade marks have been filed from 1963 to 2019.

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Class 28: Toys and Sporting Goods Products

Class 41: Education and Entertainment Services Class 10: Medical Instrument Products
Class 14: Jewelry Products

: ...

Class 36: Insurance and Financial Services Class 16: Paper and Printed Material Products

Class 20: Furniture Products Class 44: Medical, Beauty, Agricultural Services Class 21: Houseware and Glass Products

Class 31: Natural Agricultural Products Class 43: Restaurant and Hotel Services
Class 42: Computer, Software, Scientific Services
Class 35: Advertising, Business and Retail Services

Class 33: Wines and Spirits Class 29: Meat and Processed Food Products Class 32: Light Beverage Products

Class 5: Pharmaceutical Products Class 3: Cosmetics and Cleaning Products Class 30: Staple Food Products

Number of Trade Mark Applications
250
200
150
100
50
0

Class 28: Toys and Sporting Goods Products
Class 41: Education and Entertainment Services
Class 10: Medical Instrument Products
Class 14: Jewelry Products

: ...

Class 36: Insurance and Financial Services Class 16: Paper and Printed Material Products

Class 20: Furniture Products Class 44: Medical, Beauty, Agricultural Services Class 21: Houseware and Glass Products

Class 31: Natural Agricultural Products Class 43: Restaurant and Hotel Services
Class 42: Computer, Software, Scientific Services Class 35: Advertising, Business and Retail Services

Class 33: Wines and Spirits Class 29: Meat and Processed Food Products Class 32: Light Beverage Products

Class 5: Pharmaceutical Products Class 3: Cosmetics and Cleaning Products Class 30: Staple Food Products

Trade Mark Class

Trade Mark Class

Table 3. Official Information Request information for Patents, Trade Marks, Geographical Indications and Designs presented to the Patent and Trade Mark Māori Advisory Committees.

^U since 2016.

E Other

Table 4. A summary of codified and non-codified intellectual property, what it protects, its characteristics, references to a Māori Advisory Committee and maximum duration of the intellectual property in New Zealand.

* if maintained as a Trade Secret; ê referred to the Trade Marks Māori Advisory Committee as per s 17(1)(c) of the Trade Marks Act 2002; U if used to register a patent, trademark, design or geographical indications; 5 as defined by WIPO: https://www.wipo.int/tk/en/tk.