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University of Otago Law Theses and Dissertations |
Last Updated: 22 September 2023
Patenting Pharmaceuticals? The Impact of a New Zealand Doctrine of Equivalents Following Actavis v Eli Lilly
Mikala Sydney Wright October 2021
A dissertation submitted in partial fulfilment of the requirements for the degree of Bachelor of Laws with Honours (LLB(Hons)) at the University of Otago
Acknowledgements
First and foremost, I would like to express my sincere gratitude to my supervisor, Dr Jeanne Snelling. Thank you for gently pushing me towards this research topic and for reading pages upon pages of my writing throughout. Thank you for your unwavering support, for your constant belief in me, and for your encouragement to do my best.
Thanks to Mum and Dad, for fielding all of my panicked phone calls. Thank you for reminding me how far I have come and for giving me the final push I needed to compete this research.
Thanks to my friends, and to Zac Arlidge, for believing in my capabilities. Completion of this paper was truly accomplished because of the support system I am constantly surrounded by.
Finally, thanks to Bianca Hawkins, my friend, library companion, and a fellow Honours student. Thank you for working alongside me and for procrastinating with me in the form of online shopping and gossiping about reality TV.
Contents
1.0 Introduction
In the 2017 case of Actavis v Eli Lilly1 (Actavis) the United Kingdom Supreme Court (UKSC) unanimously handed down a decision which threw a curveball for patent infringement cases. The decision, which focused on the well-established methods of patent interpretation from Catnic Components,2 Improver v Remington,3 and Kirin-Amgen,4 substantively departed from these decisions in favour of introducing a Doctrine of Equivalents (DoE) into United Kingdom patent law. The recognition of a DoE by the UKSC has enlarged the scope of patent protection in infringement cases. This generates differing views of the Doctrine both positive and negative, as the Doctrine arguably has the potential to undermine the justifications for the entire patent system. These views will be interrogated in this paper.
In New Zealand, patent law is governed by the Patents Act 2013 and the purposive construction approach to patent infringement from Catnic. There is currently no recognisable DoE in New Zealand. However New Zealand law is often shaped by United Kingdom law, so the question arises whether New Zealand will soon follow the United Kingdom and establish a DoE in infringement cases.
Actavis5 concerned a patented anti-cancer treatment drug and an allegedly patent-infringing variant. Eli Lilly owns a UK patent conferring rights to manufacture an anti-cancer medication comprising of pemetrexed disodium and vitamin B12, or a generic substitution of B12.6 Eli Lilly brought infringement proceedings alleging that Actavis, a competing pharmaceutical company, was infringing its patent either directly or indirectly with its own variant of a cancer treating medicament.7 The UKSC Actavis decision has several implications for the development of therapies in the healthcare industry. Pharmaceutical companies seeking patentability for therapies in the UK can now rely on the DoE to expand the scope of their
1 Actavis UK Ltd and others v Eli Lilly and Company [2017] UKSC 48.
2 Catnic Components Ltd and Another v Hill and Smith Ltd [1982] RPC 183 (UKCA).
3 Improver Corp v Remington Consumer Products Ltd [1982] RPC 69 (UKCA).
4 Kirin-Amgen Inc and others v Hoechst Marion Roussel Ltd and others [2005] 1 All ER 667 (HL).
5 Actavis, above n 1.
6 Actavis, above n 1, at [4].
7 At [8].
patent, encompassing infringing variants, and claiming a large monopoly to the detriment of other innovating pharmaceutical companies.
In an industry that relies heavily on generic pharmaceutical substitutions, the healthcare sector could become adversely affected by the introduction of Equivalents into patent infringement cases. Given the DoE expands a patent holder’s monopoly significantly, I will consider the implications of a DoE through the lens of established patent law principles to determine whether New Zealand should adopt a DoE.
This dissertation aims to evaluate the implications of a potential for a New Zealand DoE in patent infringement cases following Actavis. This chapter sets out the relevance of Actavis, the status quo of patent law in New Zealand, what this dissertation will cover, and finally, it will introduce you to the concept of a patent. Chapter Two provides an explanation of patent law theory, a historical account of patent law, and the New Zealand Patents Act 2013. Chapter Three then examines three historic cases that have influenced patent infringement interpretation; those being – Catnic, Improver and Kirin-Amgen. Chapter Four explains the concept underlying the DoE, before analysing the Actavis decision and its significance. Chapter Five then investigates jurisdictions that have been early adopters of the Doctrine and why they adopted the Doctrine, including the US, Germany and France. It also analyses the Australian and Singapore approaches to patent infringement interpretation following Actavis. Since Actavis, Australia and Singapore have also considered whether they should adopt a DoE for the first time. Chapter Six explains the status quo in New Zealand and examines the potential for a New Zealand DoE. Applying the principles of patent law, Chapter Six will consider the strengths and weaknesses of the arguments for adopting the Doctrine and will finely balance these arguments with arguments against the Doctrine. I will assert that the arguments against adopting a DoE in New Zealand are far stronger than the arguments for adopting a DoE. Chapter Six will further analyse the potential impact of Equivalents on the costs of developing pharmaceuticals and therapies in New Zealand and the follow on effects that this will have on affordable healthcare in New Zealand.
Patent law is an intricate web of rules and criterion. As part of the intellectual property class, a patent confers personal property rights upon the owner.8 For the duration of patent registration, the owner is the patentee of that patent, unless they choose to sell their patent which has the effect of transferring their title to a third person.9
A patent can be granted in relation to a process, a product, biotechnology, and electrical and computer apparatus among other things.10 This affords the patentee the absolute right to develop, manufacture, and sell their invention to the exclusion of others for a limited time period of 20 years.11
Patents are intrinsically economic,12 granting a limited monopoly to certain innovators who meet patentability criteria.13 Broadly speaking, patents are granted for “true patent inventions” that can be described as “new manners of manufacture” as per the United Kingdom Statute of Monopolies 1623.14
8 Susy Frankel and Jessica C Lai Patent Law and Policy (LexisNexis Wellington, 2016) at 7.
9 Paul Sumpter Intellectual Property Law: Principles in Practice (3rd ed, CCH New Zealand, Auckland, 2017) at 309.
10 Sumpter, above n 9, at 279.
11 Patents Act 2013, s 20(1).
12 Frankel and Lai, above n 8, at 7.
13 See discussion of patentability criteria in chapter 2.3.
14 Patents Act, s 6.
2.0 Theory of Patent Law
The patent system exists for the mutual benefit of both inventors and society in that it attempts to balance incentives for innovation with societal benefits of inventions being publicly available. Successfully registering a patent under the Patents Act 2013 confers upon the patentee a limited right to exclusively produce the subject matter of the patent.15 In return for the innovative exclusivity that a patent bestows upon a patentee, the features of the invention must be publicised. This public disclosure facilitates the general understanding of the patent scope, allowing others to innovate around the patent or improve upon the invention after patent expiration.16
The law allows for workable patent systems because at its core, patent protection provides inventors with an incentive to invest time, money and energy into researching and developing inventions, with the confidence that their work will not be exploited by their competitors.17 It is well-accepted, albeit largely presumptive, that without this property protection, inventors will be less inclined to innovate, fearful that third-parties will replicate their invention at a lower cost, and capitalize on their hard work.18 It is also feasible that a lack of protection will prevent inventors from disclosing the details of their inventions, and society will be unable to benefit from the invention being publicly available.19
The incentive to invent is also substantially connected to the societal benefits of inventions being publicly available. A patentee can disclose their invention to the public, giving the public an opportunity to utilise that invention, and a patentee can be confident that the patent system will protect them from the exploitation of other inventors throughout the duration of patent registrability.20 In that sense, there is a mutual benefit to inventors and society alike, both profiting from the fruits of inventive labour.
15 Sumpter, above n 9, at 271.
16 At 271.
17 At 271.
18 Above n 5, at 14.
19 Above n 6, at 272.
20 Above n 5, at 15.
Patents embody economic qualities,21 which Cooke J reiterated in Wellcome Foundation Ltd v Commissioner of Patents when he said that “the national economic interest lies at [the] heart” of patent law development.22 The patent system confers on patentees a limited monopoly right over their invention.23 The extent of the economic value and the subsequent monopolistic feature of a patent is determined by the scope of that patent protection.24 A wider patent scope will grant patentees a more extensive monopoly than would be afforded to patentees with narrow patent scope.25
Patents can appropriately be characterized as the intellectual property right that affords its owners the most robust monopoly protection.26 For that reason, patent protection that is too broad will fail to adequately balance the dual objectives of patent law just as equally as patent protection that is too scarce will fail to uphold the rationales of patent law. If the scope of a patent is too broad, enabling stronger patent protection, then a patentee will hold a large monopoly to the detriment of other inventors.
The patent register is a core legal mechanism that regulates patents in New Zealand. The legislated rationales for the patent register27 reflect the justifications for a patent system because the patent register essentially exists to facilitate the public’s knowledge of what patents are in force, who the patentee is, the scope of their patent and any other information relevant to the patent.28
To appreciate why the patent system was introduced, it is essential to go back to 16th and 17th century England. The Statute of Monopolies was enacted to address an escalating economic problem created by the Crown in the early 17th century. At that time, the monarchy was abusing its monopoly-granting prerogative by granting monopolies as consideration for unwavering
21 Frankel and Lai, above n 8, at 7.
22 Wellcome Foundation Ltd v Commissioner of Patents [1983] NZLR 385 (CA) at 389 and 391, n 4 as cited in Frankel and Lai, at 8.
23 Frankel and Lai, above n 8, at 7.
24 Robert P Merges and Richard R Nelson “On the Complex Economics of Patent Scope” (1990) 90(4) CLR 839 at [1].
25 At [1].
26 Susan Frankel and Geoff McLay Intellectual Property in New Zealand (1st ed, LexisNexis Butterworths, Wellington, 2002) at 324.
27 Patents Act, s 195.
28 Frankel and Lai, above n 8 at 15, citing Patents Act 2013, s 195.
loyalty to the Crown,29 protecting inventions and industries to an intolerable extent.30 Monopoly protection even extended to “many of the necessities of life”, and “monopolists were very oppressive in the enforcement of their rights”.31 Also, items such as playing cards were patented in 16th century England, creating a “monopoly illegal at common law”.32 Parliament passed the Statute to prevent the Crown from granting these limitless monopolies. An exception to this prohibition was legislated, allowing the Crown to grant monopolies for real patent inventions that could be described as “manners of new manufacture”.33
The concession that the Statute of Monopolies was the first manifestation of patent law is a mere fiction. The essence of patent law today was first recognized by Elizabeth I who constructed and enforced a workable “patent system” during her reign in the 16th century.34 Darcy v Allin was later heard in 1601,35 effecting the beginning of a common law patent system.36 Another historical case of great significance that predated the Statute of Monopolies is Matthey’s case37 which largely stated that the object of patent law is to protect unprecedented inventions.38
The Statute has been described by some scholars as a form of political peace-making,39 shaping patent law as it exists today, and still bearing reference in New Zealand patent legislation.40 King James and Parliament reached a compromise, James agreeing to a legislative solution to address the patent problem in exchange for financial aid.41 There was also a number of internal compromises, with the two Parliamentary Houses agreeing to legislate the Statute of Monopolies while maintaining a small number of pre-existing patents.42 These compromises
29 Frankel and Lai, above n 8, at 89.
30 Jarratt William “English Patent System” (1944) 26(11) JPOS 761 at 761.
31 Thomas A. Hill, “Origin and Development of Letters Patent for Invention,” (1924) 6 J. Pat. Off. Soc’y 405, at 407, n 78 as cited in Sa Yu “Political Privilege, Legal Right, or Public Policy Tool? A History of the Patent System” (2009) ATRIP 1 at 21.
32 Thomas A. Hill, “Origin and Development of Letters Patent for Invention,” (1924) 6 J. Pat. Off. Soc’y 405, at 407, n 89 as cited in Yu, above n 31, at 23.
33 Statute of Monopolies 1623 (UK), s 6.
34 E Wyndham Hulme “History of the Patent System Under the Prerogative and at Common Law” (1896) 12(2) LQR 141 at 144.
35 The Case of Monopolies [1572] EngR 398; (1601) 77 ER 1260 (CKB).
36 Hulme, above n 34 at 151. 37 Date of origin unknown. 38 Hulme, above n 34 at 152.
39 Chris Dent “‘Generally Inconvenient’: The 1624 Statute of Monopolies as Political Compromise” [2009] MelbULawRw 16; (2009) 33(2) MULR 415 at 438.
40 Patents Act, s 14.
41 Dent, above n 39, at 452.
42 At 452.
contributed to a legislative system that was, in its most simplified state, passed to prevent the creation of unjustified monopolies while still protecting innovative originality and any resulting economic development.43 This quality of historical patent legislation is the foundation of current patent law in New Zealand.
New Zealand patent law is currently regulated by the Patents Act 2013 (the Act). Replaced by the 2013 Act, the previous 1953 Act was materially modelled from the Patents Act 1949 (UK),44 and was interpreted using case law from the United Kingdom. The 2013 Act is also interpreted with reference to United Kingdom patent cases, and the New Zealand approach to patent infringement interpretation is derived from high profile United Kingdom cases.45
The practice of patenting an “invention” under the Act can be used for a wide variety of inventive concepts,46 though the variety of patentable inventions is not expressed within the Act.47 Most commonly, a new product or process can be patented, or an improved version of either of those aforementioned matter.48 Other patentable inventions include, but are not limited to, biotechnology, electronic appliances and computer machinery.49
Patentability criteria is governed by s 14 of the Act. Section 14 states:
An invention is a patentable invention if the invention, so far as claimed in a claim, –
(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 15 or 16.
43 Sumpter, above n 9, at 279.
44 Ian Finch James & Wells Intellectual Property Law in New Zealand (online ed, Thomson Reuters, 2017) at 9. 45 See chapters 3.4 and 6.1 for further discussion on the New Zealand approach to infringement interpretation. 46 Sumpter, above n 9, at 278.
47 At 279.
48 At 278.
49 At 279.
The novelty and inventive step requirements are assessed in relation to the prior art base,50 which the Act defines as all material (a product, a process or otherwise) that has been publicly communicated within New Zealand or worldwide either in writing, orally, by its physical use or in any other manner.51 Therefore, to be eligible for patentability an invention must be new in the sense that it is not already existing knowledge.52
The term “inventive step”, often interchanged with “non-obviousness”, requires that an invention seeking patentability must not be so foreseeable that a person with knowledge in that particular art would find the invention obvious.53 The inventive requirement is also analysed from the prior art base.54
The Act requires that an invention seeking patent registration must be “useful”,55 the definition of which is an invention with “specific, credible and substantial utility”.56
To facilitate public understanding of whether something is patentable, the Act helpfully provides a list of matter that is excluded from patentability. Section 15 excludes from patentability inventions that, if capitalized upon, would conflict with ‘public order or morality’ according to operative New Zealand law. The Act provides several examples of matter that would be covered by this section, including an inventive process for the purpose of cloning humans.57 Section 16 excludes specific subject-matter from patentability, including human beings and related biological processes, surgical or therapeutic treatment procedures, diagnostic procedures on human beings, and plant varieties as covered in s 2 of the Plant Variety Rights Act 1987.
50 Patents Act, s 14.
51 Section 8.
52 Sumpter, above n 9, at 285.
53 Sumpter, above n 9, at 287.
54 At 287.
55 Section 14.
56 Section 10.
57 Section 15.
New Zealand also has obligations under a number of international patent regimes, contributing to the increased harmonisation of patent law systems worldwide.58 The 2013 Act noticeably strays from United Kingdom patent legislation,59 creating a uniquely New Zealand approach to patents. In saying that, the New Zealand patent regime abides by international standards in discrete ways, including by adopting language from provisions in the European Patent Convention in the 2013 Act.60
New Zealand is a signatory to both the Patent Cooperation Treaty (PCT)61 and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).62 The PCT created an international regime that facilitates the filing of a single application by an innovator. Filing this one application gives the inventor’s application effect in all of the signatory states to the PCT, short of granting the applicant a patent.63 The TRIPS agreement provides that member states must impart patent protection upon inventions that are new, inventive, and are qualified for industrial protection, and as such, any signatory that falls behind may face punitive action from the World Trade Organisation.64
58 Sumpter, above n 9, at 273.
59 Frankel and Lai, above n 8, at 22.
60 Frankel and McLay, above n 26, at 323.
61 Patent Cooperation Treaty 1160 UNTS 231 (opened for signature June 19 1970, entered into force April 2002) (“PCT”) <www.wipo.int>.
62 Agreement Establishing the World Trade Organisation, Annex 1C: Agreement on Trade-Related Aspects of Intellectual Property Rights 1869 UNTS 299 (opened for signature 15 April 1994) (“TRIPS Agreement”)
63 Sumpter, above n 9, at 274.
64 Sumpter, above n 9, at 274.
3.0 History of Patent Law
This section explains the interpretive approaches to patent law that have been established by the courts and the current interpretive approach to patent infringement in New Zealand. In particular, three English cases have respectively paved the way of patent infringement interpretation in New Zealand; these cases are Catnic Components v Hill & Smith,65 Improver v Remington,66 and Kirin-Amgen Inc v Hoechst.67
Lord Diplock and the House of Lords in Catnic,68 a late-20th-century patent case, developed a cardinal rule for interpretation of patent infringement cases.69 This judge-made rule involves purposively constructing a patent claim to determine whether or not a competitor has breached a pre-existing patent whilst developing a variant of their own.70
In Catnic, the patent at the centre of proceedings was one registered by Catnic for steel lintels, a horizontal metal sheet that extends over a door or a window.71 Catnic’s first patent claim stated that the support arm at the back of the lintel was to “extend vertically” from the base of the invention, forming a “perpendicular” angle.72 The defendants, Hill & Smith Ltd, manufactured a variant of Catnic’s patented lintel that, rather than extending at a 90° angle from the base, extended about 6-8° from vertical.73 This variance altered the function of the lintel to a trivial extent,74 but did not breach the plaintiff’s patent claim in the literal sense.75 However, Lord Diplock noted that despite “vertical” being an unambiguous expression, context is imperative.76 While some occupations require the use of precise language, it is unnecessary and indeed unlikely for lintels used by tradesmen to be exactly 90°, as long as the lintels are
65 Catnic, above n 2.
66 Improver, above n 3.
67 Kirin-Amgen, above n 4.
68 Catnic, above n 2 per Lord Diplock (HL).
69 Frankel and Lai, above n 8, at 248.
70 Catnic, above n 2, at 243 per Lord Diplock (HL). 71 Catnic, above n 2, at 183 per Lord Diplock (HL). 72 At 184.
73 At 184.
74 At 184.
75 Frankel and Lai, above n 8, at 249.
76 Catnic, above n 2, at 244 per Lord Diplock (HL).
close enough to sufficiently perform the required function.77 Consequently, applying a purposive approach would find that Hill & Smith Ltd infringed Catnic’s patent with their variant.78
Prior to Catnic, infringement cases were approached using a literal interpretation of a patent claim, and a distinct consideration of whether a variant substantively produced the essence of a patent.79 This was commonly referred to as the “pith and marrow” of the patent, as devised by Lord Cairns.80 These separate causes of action were consolidated into one purposive approach by the House of Lords in Catnic which held that separating infringement issues was a catalyst for confusion.81
The all-in-one purposive approach adopted by the House of Lords naturally broadens the scope of patent protection. Variants that differ from a patent in an immaterial way will also breach the patent.82 Applying a purposive approach to patent infringement requires analysing the words of a patent claim in light of the innovator’s purpose as ascertained from the patent in its entirety.83 Their Lordships held that Hill & Smith Ltd’s variant was “vertical” for the purposes of being encompassed by Catnic’s patent due to its trivial functional difference.84
In Improver v Remington85 Hoffman J polished the “purposive construction” test coined by the House of Lords in Catnic. In doing so, he formulated three questions that courts should review to aid their purposive reading of patent claims.86 These questions have since achieved recognition as the “Improver questions” or the “protocol questions”.87 Hoffman J sets them out as:88
77 Catnic, above n 2, at 244 per Lord Diplock (HL).
78 Frankel and Lai, above n 8, at 249.
79 At 249.
80 Frankel and Lai, above n 8, at 249, citing Clark v Adie (1877) 2 App Cas 315 (HL) at 320.
81 Catnic, above n 2, at 242 per Lord Diplock (HL).
82 Frankel and Lai, above n 8, at 250.
83 Frankel and McLay, above n 26, at 357, citing 3M v Plastus Kreativ [1997] RPC 737, 743 (EWHC).
84 Crawford Jamieson “In Defence of a UK Doctrine of Equivalents” (2019) 41(3) EIPR 147 at 148.
85 Improver, above n 3.
86 Improver, above n 3, at 189.
87 Frankel and McLay, above n 26, at 357.
(1) Does the variant have a material effect upon the way the invention works? If yes, the variant is outside the claim. If no –
(2) Would this (ie that the variant had no material effect) have been obvious at the date of the publication of the patent to a reader skilled in the art? If no, the variant is outside the claim. If yes –
(3) Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended that strict compliance with the primary meaning was an essential requirement of the invention? If yes, the variant is outside the claim.
If, however, question three was answered in the negative then the variant is caught by the patent claim and will be found to be infringing the patent. In this instance it is clear that the patentee intended the claim description to be purely symbolic, providing the most fitting representation of the class.89
Questions one and two of the reworked purposive test are factual inquiries that can only be answered with reference to both the patent claim and the variant.90 Question three is a question of law which examines whether the wording of the claim would be interpreted by the person skilled in the art in such a way that the variant would be outside the claim.91
Improver92 concerned the “Epilady”, a hair-removal instrument invented by Improver Corporation. Improver’s “Epilady” functioned by the use of a revolving “helical spring” that extracted hairs as the device was maneuvered over the body.93 Remington manufactured a device that removed hair in a similar way to the “Epilady”, however, Remington’s invention notably incorporated the use of a rubber rod to achieve this similar end.94 Hoffman J and the court in Improver developed the “Improver questions” to assist them in purposively determining whether Remington’s variant infringed Improver’s patented “Epilady”. The court held that Remington’s hair removal device did not infringe Improver’s patent on the basis that “the rubber rod is not an approximation to a helical spring. It is a different thing which can in limited circumstances work in the same way”.95 Improver’s claim was unsuccessful, with
89 At 189.
90 David Koedyk “Actavis in the Antipodes – A doctrine of equivalents for New Zealand?” (2018) IPSANZ at 5.
91 At 5.
92 Improver, above n 3.
93 Koedyk, above n 90, at 4.
94 At 4.
95 Improver, above n 3, at 197.
Remington successfully evading an infringement finding against them due to Improver’s failure to satisfy the third limb of the Improver questions.
In the early 2000s, the House of Lords in Kirin-Amgen reaffirmed the Catnic purposive approach to claim construction in infringement cases.96 The House of Lords per Lord Hoffman observed that the meaning of the claim is that which the person skilled in the art would derive from the words of the patent specification, from an objective and contextual perspective.97
The House of Lords next considered whether as in the United States, a United Kingdom DoE was necessary. The Doctrine works by extending the patent scope to embrace technologies that “perform ‘substantially the same function in substantially the same way to obtain the same result’ as the patented invention”.98
Such inquiry was required because in the time since Catnic was decided in the House of Lords, article 69 of the European Patent Convention (EPC),99 a treaty to which the United Kingdom is a member state, was drafted and set to come into force.100 Article 69 and the Protocol on interpretation of article 69 are both incorporated into United Kingdom patent legislation,101 “prevent[ing] equivalence from extending outside the claims”,102 yet still enabling it to form part of the contextual background required for the inquiry conducted by the person skilled in the art.103 This is reaffirmed in the later addition of article 2 of the EPC, but in any event does not allow protection beyond the confines of the claims, effectively preventing a United Kingdom DoE.104 Articles 69(1) 105 and 2(2)106 of the EPC state:
Article 69
96 Kirin-Amgen, above n 4, at [33].
97 At [32].
98 Machine Co. v Murphy, 97 U.S. 129, 125 (1878), n 124 as cited in Shayana Kadidal “Plants, Poverty, and Pharmaceutical Patents” (1993) 103 YLJ 223 at 248.
99 European Patent Convention on the Grant of European Patents (European Patent Convention, EPC) 1065 UNTS 199 (adopted 5 October 1973, entered into force 7 October 1977).
100 Kirin-Amgen, above n 4, at [44].
101 Patents Act 1977 (UK), ss 60 and 125.
102 Kirin-Amgen, above n 4, at [49].
103 At [49].
104 Kirin-Amgen, above n 4, at [44].
105 EPC, above n 99, at Art 69(1).
106 EPC, above n 99, at Art 2(2).
(1) The extent of the protection conferred by a European patent or a European patent application shall be determined by the terms of the claims. Nevertheless, the description and drawings shall be used to interpret the claims.
...
Article 2
(2) The European patent shall, in each of the Contracting States for which it is granted, have the effect of and be subject to the same conditions as a national patent granted by that State, unless otherwise provided in this Convention.
The House of Lords also endorsed the Improver questions, but commented that the questions are “...only guidelines, more useful in some cases than in others”.107 The Court also compared the status of the Improver test to the Catnic approach, noting that while the Improver questions are insufficient in some instances, purposive construction “...is the bedrock of patent construction, universally applicable”.108
The approach that developed from Catnic, Improver, and Kirin-Amgen developed in light of the EPC and was accepted as the appropriate approach to patent infringement interpretation before Actavis was heard. The approach consisted of purposive construction as coined in Catnic, supplemented by the three Improver questions.
When Catnic was heard in the House of Lords, New Zealand patent law was governed by the 1953 Act, which largely mirrored the UK patent law under which Catnic was decided.109 Despite a number of legislative changes to patent law in both the United Kingdom and New Zealand, the “purposive construction” approach originating in Catnic still remains the approach to infringement in New Zealand under the 2013 Act.
Frankel and McLay indicated at a strong likelihood that New Zealand Courts would follow the United Kingdom approach and apply the Improver questions in New Zealand infringement cases,110 however, this has largely failed to come to fruition. In Peterson Portable Sawing
107 At [52].
108 At [52].
109 Frankel and McLay, above n 26, at 356.
110 Frankel and McLay, above n 26, at 357.
Systems Ltd (in liq) v Lucas111 the New Zealand Supreme Court omitted the Improver test from its infringement analysis, and in fact neglected to mention the Improver questions in any capacity.112 Gault J on behalf of the Supreme Court, noted that “a patent specification is to be read as a whole and given a purposive construction.113 It must be construed as it would be understood by the appropriate addressee – a person skilled in the relevant art”.114
Ten years later in the case of Assa Abloy v Allegion115 the High Court referenced and used the Improver test, discussing and applying the first two questions, but neglected to consider the third question.116 The Court determined that the only matter in which the third Improver question would be relevant did not require consideration of that question in order to be adequately addressed.117
Both Peterson v Lucas and Assa Abloy illustrate variable responses to the Improver questions in New Zealand. On the one hand, the New Zealand Supreme Court has completely overlooked Improver, while the High Court, a lower court, has utilised the Improver test to some degree. In saying that, Assa Abloy was decided no less than 10 years after Peterson v Lucas, in 2016, indicating that New Zealand may see more of the Improver questions in future patent infringement cases. What Assa Abloy establishes is that purposive construction remains the principal approach to infringement cases in New Zealand.118
111 Peterson Portable Sawing Systems Ltd (in liq) v Lucas [2006] NZSC 20, [2006] 3 NZLR 721.
112 Frankel and Lai, above n 8, at 252.
113 Terrell on the Law of Patents (16 ed 2005) at [6-101] et seq. as cited in Peterson v Lucas, above n 111, at [26].
114 Peterson v Lucas, above n 111, at [26].
115 Assa Abloy New Zealand Ltd v Allegion (New Zealand) Ltd [2016] NZHC 1738.
116 Koedyk, above n 90, at 13.
117 At 13.
118 Assa Abloy, above n 115, at [23], citing Catnic Components Ltd and Anor v Hill and Smith Ltd [1982] RPC 183 (HL) at 242.
4.0 Actavis v Eli Lilly in the UKSC
By formally introducing a DoE into UK patent interpretation, Actavis has changed the method of interpretation used for determining patent infringement, broadening the scope of patents in favour of patentees. This chapter begins with a brief overview of the DoE, including why it developed, what the Doctrine does, and an example of how the Doctrine works. A discussion of Actavis in the UKCA and UKSC, and the significance of the UKSC decision for patent law in general, follows.
The DoE is a judicially developed,119 equitable doctrine.120 The Doctrine was developed to address the perceived inadequacies of patent interpretation, whereby a vast number of cases had been held to be non-infringing upon patented technologies based on the wording of the claims, yet were functionally the same as a patented technology.121 In this situation, the Doctrine works by extending the patent scope to embrace such equivalent variants, technically affording the patentee more protection than their patent initially enabled.122
The role of the Doctrine is helpfully set out in International Nickel v Ford Motor Company, a 1958 case that applied an Equivalents Doctrine and established a finding of patent infringement.123 In that case Ford Motor was held to have infringed International Nickel’s patent via application of the DoE, after its variant invention fell outside the literal scope of International Nickel’s patent claims.124 International Nickel’s patent encompassed a composition of melted iron and magnesium at a rate of “‘about 0.04% as a minimum’” to create “‘nodular iron’”.125 Ford Motor then began making nodular iron using 0.02% of magnesium, less than International Nickel’s minimum threshold of magnesium. Even though there was no
119 Jamieson, above n 84, at 147.
120 George M Sirilla, Thomas P Feddo & Michael C Antone “The Doctrine of Equivalents: Both a Sword and a Shield” (2003) 13 FCBJ 75 at 77.
121 Merges and Nelson, above n 24, at 853.
122 Jamieson, above n 84, at 147.
123 Merges and Nelson, above n 24, at 853.
124 Merges and Nelson, above n 24, at 853.
125 Merges and Nelson, above n 24, at 853.
infringement on a literal approach, the DoE provided a mechanism for finding patent infringement by Ford.126
The exact function of the DoE is eloquently expressed by Judge Learned Hand in the 1948 US case Royal Typewriter v Remington Rand:127
A “proper occasion” being one where a variant technology uses the same method as the patented product or process to achieve the same outcome as the patented technology, despite all other differences between the two inventions.128 So, engaged when a variant cannot literally breach a patent by breaching the words of a patent’s claims, the DoE presents a middle ground between the objective of creating precise and certain patent claims, and on the other hand, protecting patentees from unsolicited breaches of their patent by competitors.129 On the contrary, Equivalents often works to excessively broaden the scope of a patent after a patentee has applied for registration of relatively narrow patent claims in order to satisfy the novelty requirement for patentability. A patentee will later use the DoE to claim a larger monopoly to the detriment of fellow inventors, undermining the equitable foundations of the Doctrine in practice.130 Consequentially, a wealth of uncertainty surrounds the use of the DoE.131
Rather than remedying the supposed inequities within various patent systems, the DoE has thus far merely heightened patentee protection, therefore further contributing to incentivizing patentees and disincentivizing third party competitors.132 Moreover, the force of the DoE grows stronger with each case that applies the Doctrine, and equally, the reasons for using the Doctrine are straying further away from its original intent. Now, the DoE is not only used to remedy the situation where a competitor essentially copies a patented technology, but is also
126 Merges and Nelson, above n 24, at 853.
127 Royal Typewriter Co. v. Remington Rand, Inc., 168 F.2d 691, 692, 77 U.S.P.Q. (BNA) 517, 518 (2nd Cir.), n 59 as cited in Merges and Nelson, above n 24, at 853.
128 Graver Tank & Mfg. Co. v. Linde Air Prods. Co., [1950] USSC 54; 339 U.S. 605, 608, 85 U.S.P.Q. (BNA) 328, 330 (1950) (quoting Machine Co. v. Murphy, [1877] USSC 129; 97 U.S. 120 (1877)), n 60 as cited in Merges and Nelson, above n 24, at 853. 129 Joseph S Cianfrani “An Economic Analysis of the Doctrine of Equivalents” (1997) 1 VJLT 1 at [29].
130 Antonia Kendrick “Actavis v Eli Lilly: Patent Medicine, Risk of Side Effects” (2019) OULJ 44, at 58.
131 Jamieson, above n 84, at 153.
132 Natalie Sturicz “Phillips v AWH, Corp., A Doctrine of Equivalents Case?” (2008) 12 MIPLR 385 at 395.
drawn upon “in the event of drafting errors, in the event language proved inadequate to capture their ideas, or in the event that they were simply unable to foresee an after-arising equivalent”.133
The Actavis134 litigation concerned a patented anti-cancer treatment drug and an allegedly patent-infringing variant. Eli Lilly and Company, an American pharmaceutical company, is the owner of a UK patent granting it rights to manufacturing an anti-cancer medication comprising of pemetrexed disodium and vitamin B12, or a generic substitution of B12.135 Eli Lilly brought infringement proceedings, alleging that Actavis, a competing pharmaceutical company, was infringing its patent either directly or indirectly with its own variant of a cancer treating medicament.136 Like Eli Lilly, Actavis’s prospective medicaments were also pemetrexed and vitamin B12 combinations. But rather than using one specific pemetrexed salt (pemetrexed disodium) as Eli Lilly’s patent protects, Actavis’s product uses different pemetrexed salts (ditromethamine or dipotassium) or a pemetrexed acid (diacid).137
To resolve this dispute, the court considered historic English patent cases to determine the correct approach to patent infringement claims. The UKSC stated that “any patent system must strike a balance between...two competing factors...namely ‘a fair protection for the patent proprietor [and] a reasonable degree of legal certainty for third parties’”.138
Eli Lilly’s patented medicament resolves the issue of the potentially life-threatening side effects cancer patients are exposed to when pemetrexed alone is administered.139 Eli Lilly’s patent has existed for some years now, and its existence has enabled successful widespread production and distribution of the patented medicament for the purpose of treating cancer.140 As such, Eli Lilly’s property rights must be balanced with a reasonable degree of certainty for Actavis in producing variants of Eli Lilly’s medicament.
133 Sturicz, above n 132, at 397-398.
134 Actavis, above n 1.
135 Actavis, above n 1, at [4].
136 At [8].
137 At [8].
138 Protocol on the Interpretation of Article 69 EPC, at Art 1 as cited in Actavis (SC), above n 1, at [53].
139 Actavis, above n 1, at [3].
140 At [3].
Essential to the resolution of Actavis, as with any patent infringement case, were the patent claims. Claim one was drafted rather specifically, and as such, reads:
1. Use of pemetrexed disodium in the manufacture of a medicament for use in combination therapy for inhibiting tumour growth in mammals wherein said medicament is to be administered in combination with vitamin B12 or a pharmaceutical derivative thereof [which it then specifies].
The Court of Appeal identified two issues of construction in Actavis.141 The first issue related to the alleged direct infringement of Eli Lilly’s patent, and was whether patent protection is confined only to pemetrexed disodium.142 The second issue concerned indirect infringement of the patent, and whether Eli Lilly’s patent restricted the use of pemetrexed disodium in its solid form only, as Actavis argued.143 In its decision, the Court of Appeal referenced Catnic, Improver and Kirin-Amgen, utilizing purposive construction supplemented by the Improver questions in coming to its decision concerning direct infringement. The Improver questions are:144
(1) Does the variant have a material effect upon the way the invention works? If yes, the variant is outside the claim. If no –
(2) Would this (ie that the variant had no material effect) have been obvious at the date of the publication of the patent to a reader skilled in the art? If no, the variant is outside the claim. If yes –
(3) Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended that strict compliance with the primary meaning was an essential requirement of the invention? If yes, the variant is outside the claim.
Floyd LJ for the Court of Appeal found in favour of Eli Lilly in regard to the first Improver
question, noting that it is “common ground that the variants represented by the various Actavis
141 Actavis UK Ltd and others v Eli Lilly & Company [2015] EWCA Civ 555, [2016] 4 All ER 666.
142 Actavis (EWCA), above n 141, at [61].
143 At [61].
144 Improver, above n 3, at 189.
AIs have no material effect on the way the invention works”.145 However Eli Lilly failed to convince the Court that Actavis’s variant satisfied the second and third Improver questions. Consequently, Floyd LJ held that Actavis did not directly infringe Eli Lilly’s patent.146
In respect of the second Improver question, Floyd LJ stated that if the person skilled in the art cannot anticipate that a variant will work sufficiently as an alternative to the invention, then it is clear that the variant is not obvious to the person skilled in the art. Thus, they are unable to conclude that “...the variant would have no material effect on the way the invention works”.147
Floyd LJ concluded that it is clear from the patent claims and in the context of the specification148 that Eli Lilly intended strict compliance with the language it adopted.149 At [72] Floyd LJ gave his reasons for answering the third Improver question in favour of Actavis:
145 Actavis (EWCA), above n 141, at [63].
146 Actavis (EWCA), above n 141, at [80].
147 Actavis (EWCA), above n 141, at [71].
148 At [73].
149 At [72].
limited to the sodium salt, there are great difficulties in ascertaining what the class might be. ...
Despite the Court of Appeal concluding there was no direct infringement of Eli Lilly’s patent, Floyd LJ for the Court found that Actavis indirectly infringed Eli Lilly’s patent because pemetrexed disodium is utilised in the Actavis products prior to their use.150
On appeal, the Supreme Court provided a comprehensive judgment in which it discussed the accepted approaches to infringement interpretation, including explanations of Catnic, Improver and Kirin-Amgen, but notably diverged from those accepted practices, as is its prerogative.
Of importance to the Supreme Court was article 69 of the EPC, and the Protocol on the interpretation of article 69. Article 69 states:151
Article 69
(1) The extent of the protection conferred by a European patent or a European patent application shall be determined by the terms of the claims. Nevertheless, the description and drawings shall be used to interpret the claims.
Lord Neuberger, who delivered the unanimous judgment of the Court, considered articles 1 and 2 of the Protocol highly significant insofar as they described competing principles to weigh
150 At [92].
151 EPC, above n 99, at Art 69(1).
in interpreting article 69 in infringement claims. Those principles being “fair protection for the patent proprietor [and] a reasonable degree of legal certainty for third parties”,152 and additionally, to consider “any element which is equivalent to an element specified in the claims”.153 Lord Neuberger stated that in balancing the principles from the Protocol noted above, there are clearly conflicting interests that require a choice “between the appropriateness of giving an inventor a monopoly and the public interest in maximizing competition”.154 Clearly these latter two interests lie at the heart of why the patent system exists, and to what extent a party’s interests shall extend.
Beginning with a discussion of the approach taken in Actavis, Lord Neuberger departed from Lord Diplock’s identification of one issue in Catnic and stated that there are in fact two interpretation issues that should not be fused into one.155 The Court identified the new test as:156
(i) Does the variant infringe any of the claims as a matter of normal interpretation; and, if not,
(ii) Does the variant nonetheless infringe because it varies from the invention in a way or ways which is or are immaterial?
If the answer to either issue is “yes”, there is an infringement; otherwise, there is not.
The first limb of the new test is a straight forward interpretation exercise, something that law professionals are already well versed with.157 Lord Neuberger applied limb (i) to Actavis, noting that “according to normal principles of interpreting documents, the Actavis products do not infringe the Patent”.158 Lord Neuberger demonstrated his point with reference to Improver. He stated that in the same way as a “robber rod” cannot be a “helical metal spring”, nor can pemetrexed diacid, pemetrexed ditromethamine or pemetrexed dipotassium be mistaken for pemetrexed disodium.159
152 Protocol on the Interpretation of Article 69 EPC, at Art 1 as cited in Actavis (SC), above n 1, at [31]. 153 Protocol on the Interpretation of Article 69 EPC, at Art 2 as cited in Actavis (SC), above n 1, at [31]. 154 At [32].
155 At [55].
156 At [54].
157 At [58].
158 At [58].
159 At [58].
The second limb is more convoluted than the first, but this can be mitigated by using the three Improver questions which Lord Neuberger sought to amend in his analysis of Actavis.160 Lord Neuberger was largely content with the first Improver question, merely identifying a drafting issue by Hoffman J.161 He then moved onto the second Improver question, deeming it to insufficiently protect patentees.162 The second question places an onus upon patentees that is difficult to satisfy as it requires the person skilled in the art or the notional addressee, to predict things that would not yet be in their breadth of knowledge at the time of the patent publication.163
Lord Neuberger was satisfied with the third Improver question, but was concerned about its potential to be misapplied, thus he provided four factors to consider when applying the third question.164 He laid these factors out as:165
160 At [59].
161 Actavis (SC), above n 1, at [60].
162 At [61].
163 At [61].
164 At [65].
165 At [65].
Following these changes to the Improver questions, the Court set out its modified questions to address when answering limb (ii) of the infringement test. These questions are:166
Applying the amended Improver questions, Lord Neuberger determined that Actavis’s variant products infringed Eli Lilly’s Patent.167 The first question is satisfied because the Actavis products undoubtedly work in the same way as Eli Lilly’s invention did.168 The Supreme Court also ruled in favour of Eli Lilly on the second Improver question, stating that “when it comes to different versions of pemetrexed medicaments, it is clear that the use of a free acid, and of ditromethamine and dipotassium salts was in each case well established as at the priority date”.169 As for the third Improver question, Lord Neuberger was of the opinion that the Court of Appeal treated that question as a matter of normal interpretation which he found nonsensical as, in his opinion, it negated the need for the Improver questions in the first place if one of the questions was just a matter of plain interpretation.170 Lord Neuberger noted that the Court of Appeal did not place sufficient emphasis on Article 2 of the Protocol, which requires consideration of “any element which is equivalent to an element specified in the claims”.171 The Supreme Court asserted that because Eli Lilly’s specification referred to both anti-folates in the general sense, and pemetrexed disodium specifically, this indicates that Eli Lilly did not
166 Actavis, above n 1, at [66].
167 At [68].
intend for strict compliance of the wording of its claims.172 Answering the three reformulated Improver questions affirmatively, the Court held that Actavis infringed claim 1 of Eli Lilly’s Patent.173
Turning to the issue of indirect infringement of the Patent, the Supreme Court also upheld the Court of Appeal’s ruling in favour of Eli Lilly.174 Lord Neuberger noted that there is indirect infringement “if Actavis know, or it is obvious in the circumstances, that ultimate users will dilute [their products] in saline”.175
Pith and marrow is back.176 The UKSC decision in Actavis was groundbreaking, introducing a DoE into the UK patent system once more.177 Lord Neuberger and the UKSC reformulated the three Improver questions which effectively introduced a DoE, creating the potential for erosion of the fundamental purpose of patent law. The Doctrine extends patent protection even when a variant product does not literally fit into the patent claims, but nonetheless operates in virtually the same way as the patented product to achieve a materially similar result.178 When Lord Neuberger formally introduced a UK DoE in Actavis, he did so with a focus on acting in accordance with the requirements of the EPC and the Protocol, and also intending to align UK patent law with other European patent systems.179
The UKSC’s judgment is a clear contribution to the extension of protection afforded to patentees, with variants more readily infringing patents through Equivalents via interpretation of the reformulated Improver questions,180 even if the variant includes an inventive act.181 This is significant because extensively broad patentee protection disincentivises innovation,182
172 Actavis (SC), above n 1, at [73].
173 At [75].
174 Actavis, above n 1, at [112].
175 At [112].
176 Jamieson, above n 84, at 152.
177 Nicole Jadeja, Hannah Smith-Willis & Heidi Hurdle “Cast Back into the Sea of Uncertainty – A Doctrine of Equivalents in UK Law? The Supreme Court Ruling in Actavis v Eli Lilly” (2018) 13 JIPLP 565 at 568.
178 Alexandra K Pechhold “The Evolution of the Doctrine of Equivalents in the United States, United Kingdom,
and Germany” (2005) 87 PTOS 411 at 412.
179 Kendrick, above n 130, at 51.
180 Tanvi Shah, Jason Raeburn & Hiroshi Sheraton “Actavis v Eli Lilly: English Supreme Court Shakes Up Approach to Patent Infringement by Equivalents” (2017) 39 EIPR 778 at 782.
181 Kendrick, above n 130, at 53.
182 Kendrick, above n 130, at 45.
increases the procedural uncertainty of patent interpretation and leads to the formation of extensive monopolies to the demise of third party innovators who wish to enter a market that is riddled with uncertainty, and arguably leaves a gap between the required standards of interpretation for infringement and for validity.183 Also, it is questionable whether the desire for judicial harmonization is substantively well-reasoned enough to impact matters of principle.184 Bear in mind also that the fundamental reason for the UK patent system was to extinguish monopolies. Additionally, as per Lord Neuberger’s judgment, variants that existed before Actavis was heard that were “designed around” already-patented inventions and were held to be non-infringing may actually infringe under the DoE due to the extensive patentee protection that Equivalents affords.185 So, a decision that was “an intentional shift to greater consistency in the approach to patent construction, and other issues of patent law governed by the EPC”,186 has actually in hindsight created inherent uncertainty in the UK patent system that did not previously exist.187 These concerns will be further explored in the following chapters.
183 Alisa Carter “Mind the Actavis v Eli Lilly Gap Please!” (2017) Mind the Actavis Gap MBB at 1.
184 Shah, Raeburn & Sheraton, above n 180, at 783. 185 Shah, Raeburn & Sheraton, above n 180, at 782. 186 Shah, Raeburn & Sheraton, above n 180, at 783. 187 Jamieson, above n 84, at 153.
5.0 The Doctrine of Equivalents in Overseas Jurisdictions
To further understand the DoE as it now applies in the UK following Actavis, it is helpful to analyse the Doctrine in other patent law systems, including in the US, Germany, Australia and Singapore. Understanding the policy rationales that justify having a DoE in other patent systems might provide insight into the impact of the Doctrine as a whole, and whether or not it is something that should be incorporated into New Zealand patent law.
The DoE is nothing new to the American patent system. The exact date of origin of the US Equivalents Doctrine is unknown,188 however, the judicially formulated Doctrine has been modified through the common law, with Winans v Denmead being the first identifiable case to have used an Equivalents Doctrine (albeit without explicitly stating so).189 Graver Tank was the first US case to describe the DoE.190 The Federal Circuit in Graver Tank stated that “the essence of the Doctrine is that one may not practice a fraud on a patent”.191 This vague statement has been strengthened by the Federal Circuit to state that:192
The Doctrine was established to make it impossible for “the unscrupulous copyist to make unimportant and insubstantial changes and substitutions in the patent which, though adding nothing, would be enough to take the copied matter outside the literal scope of the claim, and hence outside the reach of law.
Therefore, it is evident that the US Equivalents Doctrine evolved from the perceived need for greater patentee protection, because it enables patentees to broaden their patent to encompass infringing technologies and inventions. Although, other than presenting the need for an Equivalents Doctrine from a “fairness-based” approach, Graver Tank actually offered no solid
188 Michael J Meurer & Craig Allen Nard “Invention, Refinement and Patent Claim Scope: A New Perspective on the Doctrine of Equivalents” (2005) 93 GLJ 1947 at 1961.
189 Darcy August Paul “The Judicial Doctrine of Equivalents” (2003) 17 HJLT 247 at 250.
190 Paul, above n 189, at 256.
191 Graver Tank & Mfg. Co. v. Linde Air Prods. Co., [1950] USSC 54; 339 U.S. 605 (1950), at 1 as cited in Pechhold, above n 178, at 412.
192 Graver Tank & Mfg. Co. v. Linde Air Prods. Co., [1950] USSC 54; 339 U.S. 605, 607 (1950), at 3 as cited in Pechhold, above n 178, at 412.
principle for applying the Doctrine in that case.193 Fairness for patentees entirely contradicts one of the fundamental reasons for the existence of the patent system; to provide notice to competing companies of what protected inventions exist in the market, and enabling competitors to sufficiently invent around those pre-existing technologies.194 This was highlighted and mitigated to some degree in the case of Festo Corp.195 following recognition that “the confines of patent law should not waver to the hindsight reflection of a patentee that argues for greater coverage during litigation”.196 In Festo Corp. Justice Kennedy identified that there is just as great a need to protect a patentee’s proprietary interest as there is to protect certain outcomes to a degree for both competitors and the general public.197 So, although fairness for a patentee is valued, courts in the US have recognised that fairness is just one element of the patent system, and that the issue of using a DoE in the US does not begin and end with fairness.
Consequently, the modern US DoE is regulated by the judiciary using two rules, but the Doctrine is still largely incoherent.198 In the Festo Corp. litigation, the Supreme Court clarified the role of Prosecution History Estoppel in regulating the US approach to the Equivalents Doctrine.199 The Court explained that although an Equivalents Doctrine can compromise public certainty, the existence of that uncertainty is necessary as “the price of ensuring the appropriate incentives for innovation”.200 Therefore, the Court developed a method of Prosecution History Estoppel that was neither too pro-patentee nor anti-patentee – the Court essentially formed a compromise to ameliorate the effect of the Doctrine.201
The introduction of the Doctrine did not come without reservations, with Justice Kennedy subsequently highlighting the unnecessary waste that the Doctrine is a contributor of.202 For example, “the costs of the modern DoE to society...are immense (billions of dollars each year)”
193 Meurer & Nard, above n 188, at 1973.
194 Pechhold, above n 178, at 413.
195 Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. [2002] USSC 2405; 535 U.S. 722 (2002), at 15 as cited in Pechhold, above n 178, at 414.
196 Pechhold, above n 178, at 413-414.
197 Meurer & Nard, above n 188, at 1982.
198 Meurer & Nard, above n 188, at 1949.
199 Pechhold, above n 178, at 415.
200 Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. [2002] USSC 2405; 535 U.S. 722 (2002), at 175 as cited in Meurer & Nard, above n 188, at 1982.
201 Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. [2002] USSC 2405; 535 U.S. 722 (2002), at 175 as cited in Meurer & Nard, above n 188, at 1982.
202 Pechhold, above n 178, at 416.
and are still increasing,203 with litigation becoming “increasingly common”,204 yet roughly 85% of patent cases that result in litigation in the US are found in favour of “alleged infringers”, resulting in wasted litigation costs of up to $100 million each year.205 “Presumably, many of these patent cases would be resolved at substantially less expense or would not be brought in the first place” if there was no existing DoE.206 Three policy concerns have been identified in earlier US patent cases. First, that Equivalents Doctrines enable the judgment of fact finders to substitute the judgment of entities who are empowered to grant patents in the first place.207 Second, concern that having a DoE negates the purpose for patents being made publicly available, in that patents can be amended to incorporate hindsight considerations, deteriorating public knowledge and the subsequent ability for the public to invent around but very closely to, a patented invention.208 Third, the DoE leads to monopolistic practices that threaten competition.209 The Supreme Court in Festo also pointed to economic setbacks that the Doctrine would create, including uncertain patent scope, discouragement of competition, and needless litigation at high costs.210 The Supreme Court determined that the DoE inquiry is initiated with the presumption that “a narrowing amendment is a ‘general disclaimer of the territory between the original claim and the amended claim’”.211 This presumption acts as a rebuttable gatekeeper that allows the DoE to be used, however, if the presumption is not rebutted then a patentee cannot invoke the DoE.212 The presumption can be rebutted if the patentee can show that:213
At the time the application was filed, a person having ordinary skill in the art would have literally claimed the equivalent but did not because [1] [t]he equivalent may have been unforeseeable at the time of the application; [2] the rationale underlying the amendment may bear no more than a tangential relation to the equivalent in question; or [3] ... some other reason
203Joshua D Sarnoff “Abolishing the Doctrine of Equivalents and Claiming the Future After Festo” (2004) 19 BTLJ 1157 at 1196.
204 Schering Corp. v. Amgen Inc., [2000] USCAFED 130; 222 F.3d 1347, 1353 (Fed. Cir. 2000), n 162 as cited in Sarnoff, above n 203,
at 1197.
205 Sarnoff, above n 203, at 1199.
206 Sarnoff, above n 203, at 1199.
207 Meurer & Nard, above n 188, at 1953.
208 Meurer & Nard, above n 188, at 1953-1954.
209 Meurer & Nard, above n 188, at 1954.
210 Pechhold, above n 178, at 416.
211 Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. [2002] USSC 2405; 535 U.S. 722 (2002), at 175 as cited in Meurer & Nard, above n 188, at 1982.
212 Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. [2002] USSC 2405; 535 U.S. 722 (2002), at 175 as cited in Meurer & Nard, above n 188, at 1982.
213 Meurer & Nard, above n 188, at 1982-1983.
suggesting that the patentee could not reasonably be expected to have described the insubstantial substitute in question.
Some scholars recognise that patent law now operates in a fluid society and rather than creating limited, strict rules, patent systems across various jurisdictions aim to create a coherent and consistent approach to patent interpretation.214 It is questionable though whether achieving the desired coherency is best done using Equivalents. In saying that, given the DoE is well- accepted and is frequently altered to meet societal standards, patent systems have become “further entrenched in this meticulous doctrine”.215 This suggests that several patent law jurisdictions have become so familiar with the DoE that maintaining the Doctrine and constantly amending it to align with the justifications for patent law is far easier than eliminating the Doctrine altogether.
Although, having this Doctrine contributes to the growing amount of patent litigation in the US at extortionate costs which seem to further undermine the need for having a DoE at all.216 These costs are not relative to the amount of money at issue either – litigation costs are high, and the technology at issue is often not worth enough to justify expensive litigation.217
The fact that so many exceptions apply to the US patent system to enable a workable DoE, yet there is still ample instability in relation to the application of the Doctrine, suggests that the DoE is an undesirable feature of the patent system. The US DoE still contains more imperfections than having the Doctrine is worth. So, how far will the DoE develop and expand before the justifications for the why patent system become lost in translation?
Well-accepted in Germany218 for “innovative contributions to the art”, the DoE serves to extend the scope of patent protection.219 Compared with the UK approach which transpired to remedy the issue of monopolies in the UK, there is a greater chance of wide patent protection being
214 Pechhold, above n 178, at 435.
215 Pechhold, above n 178, at 436.
216 Pechhold, above n 178, at 436.
217 Pechhold, above n 178, at 436.
218 Philipp Widera “Convergence between Germany and UK” (2017) MIP 1 at 1.
219 Pechhold, above n 178, at 421.
awarded to prospective patentees in Germany, which clearly favours patentees more than the UK approach does.220
Where the UK approach to the DoE involves considering the three Improver questions as reformulated by Actavis, the German approach similarly involves considering the Schneidmesser Questions.221 These questions, all of which are to be answered in the affirmative in order to invoke the Doctrine are:222
The Schneidmesser approach also importantly involves a fourth step; the “Formstein objection”.223 This objection is invoked when a patent that is extended to cover an equivalent variant following three affirmative answers to the questions above is consequentially extended to cover products or processes in the prior art, therefore lacking the novelty requirement for patent protection.224 The Formstein defense “identifies the key policy concerns surrounding expansion of the scope of patent claims through equivalents”.225 When applied, Formstein finds that a patent cannot be expanded to include equivalents that are not novel or that form part of the prior art and are therefore unpatentable.226 This Formstein objection demonstrates that the German approach to the DoE consistently works to maintain the rationales for the patent system.
220 Pechhold, above n 178, at 421.
221 Paul England “A German Solution to Address UK Patent Scope” (2019) MIP 1 at 4.
222 England, above n 221, at 4.
223 England, above n 221, at 4.
224 England, above n 221, at 4.
225 Katherine E. White “Festo: A Case Contravening the Convergence of Doctrine of Equivalents Jurisprudence in Germany, the United Kingdom, and the United States” (2001-2002) 8 MTTLR 1 at 24.
226 Valentyna Chekanska “The Doctrine of Equivalents in Patent Law: The Impact of Actavis v Eli Lilly” (2019) 18 HLJ 68, at 83-84.
The Australian approach to patent interpretation is similar to the stance taken in New Zealand. Australian courts exhibit varying responses to the relevance and applicability of the Improver questions,227 as do New Zealand courts.228 Be that as it may, it is well accepted in Australia that the purposive construction coined in Catnic and endorsed by Improver and Kirin-Amgen, is directly relevant in Australia, having been frequently reaffirmed in Australian courts.229 At present, the Australian approach to patent interpretation can be holistically described as:230
A claim is to be construed from the perspective of a person skilled in the relevant art as to how such a person, who is neither particularly imaginative nor particularly inventive (or innovative), would have understood the patentee to be using the words of the claim in the context in which they appear... a “purposive rather than a purely literal construction” is to be given.
The DoE does not currently apply in Australia. Since Actavis was heard in the UK Supreme Court, some literature has discussed the potential for an Australian DoE. The Australian approach to Actavis may have no notable effect on the way in which Australian patent law operates and is enforced in the courts.231 Although Lord Neuberger thought it necessary to specify the two questions central to the new patent law approach and to reformulate the Improver questions to enable the Protocol to be sufficiently considered in UK law, some argue that “this may be a distinction without a difference”.232 In other words, the Australian position is contextually fluid enough.233 In saying that, the Australian approach provides unpredictable outcomes for inventors who find themselves in potential breach of a patent because of their variant.234 In that sense, Actavis may provide a workable adaptation to Australian patent law in the form of the amended Improver questions, making adaptation of Actavis into Australian patent law a prospective course of action.235 Irrespective of whether or not Australian courts will enforce the Actavis DoE, they will likely exhibit caution when considering the case due to
227 James Lawrence “Patent Infringement Post-Actavis v Eli Lilly: the Treatment of Equivalents in the United Kingdom and in Australia” (2018) 112 IPF:JIIPSANZ 8 at 11.
228 See discussion in chapter 3.4 on Improver in New Zealand.
229 Lawrence, above 227, at 11.
230 ESCO Corporation v Ronneby Road Pty Ltd [2018] FCAFC 46 at [144], n 29 as cited in Lawrence, above 227, at 11.
231 Lawrence, above 227, at 15.
232 Lawrence, above 227, at 15.
233 Lawrence, above 227, at 15.
234 Lawrence, above 227, at 15.
235 Lawrence, above 227, at 15.
the imbalance of patent scope between seeking initial patent protection at the novelty stage and when seeking to protect a patent from potential infringers.236
In 2018, the year following the UKSC’s adoption of a DoE, Singapore’s Court of Appeal rejected the application of Actavis in Singapore.237 In doing so however, the Court of Appeal noted that the consideration of a Singapore DoE is open for determination by Singapore’s legislators.238
One commentator has provided a wealth of arguments rationalizing the Court of Appeal’s decision not to adopt a DoE, the most prevailing justification being to uphold the consistently high standards that parties in unilateral agreements are held to in other disciplines of the law in Singapore.239 The DoE would significantly broaden protection for patentees and would therefore be irreconcilable with holding patentees to these high standards without appropriate justification.240
This decision by the Court of Appeal appears to logically follow Singapore’s approval of Kirin- Amgen, a case which expressly rejected a UK DoE, despite the fact that Singapore courts have never explicitly considered whether or not a DoE applies in Singapore.241 In saying that, arguments resembling Equivalents have been discreetly raised in Singapore cases and have been rejected.242
The first case in Singapore to consider Actavis to the extent of ruling on its applicability was Lee Tat Cheng v Maka GPS Technologies.243 In its decision not to adopt a Singapore DoE, the Court of Appeal offered three reasons.244 First, Singapore is not a member of the EPC, so the Convention and the Protocol are not applicable in Singapore, but were a primary reason for the
236 Lawrence, above 227, at 15.
237 Lee Tat Cheng v Maka GPS Technologies Pte Ltd [2018] 1 SLR 856 at [54], n 14 as cited in Ching Yu Jin Bryan “Retaining the Catnic/Improver Approach in Patent Law” (2018) 30 SALJ 871 at [3].
238 Lee Tat Cheng v Maka GPS Technologies Pte Ltd [2018] 1 SLR 856 at [53], n 16 as cited in Bryan, above n 237, at [3].
239 Bryan, above n 237, at [6].
240 Bryan, above n 237, at [6].
241 Bryan, above n 237, at [3].
242 Bean Innovations Pte Ltd v Flexon (Pte) Ltd [2001] 2 SLR(R) 116. Bryan, above n 237, at [29].
243 Lee Tat Cheng v Maka GPS Technologies Pte Ltd [2018] 1 SLR 856.
244 Bryan, above n 237, at [32].
decision by the UKSC to adopt a DoE.245 Second, the Singapore patent system values fairness, thus the Court of Appeal held that patentees should be held to the wording that they have chosen and have publicly registered.246 Thirdly, certainty is a strong value of the patent system and the Court of Appeal was of the opinion that the purposive approach to patent interpretation offers more certainty than the DoE does.247
Following Lee Tat Cheng, a commentator has stated that “the DoE should only be adopted if an assessment of these ‘competing interests’ (viz, fair protection to the patentee, innovation and certainty) leads to the conclusion that the DoE results in a more optimal balance as compared to the purposive approach”.248 The same commentator also analysed some of these competing interests, alongside the frequently used argument that having a DoE will lead to greater harmonisation between patent regimes internationally.249 The necessity for the argument for greater harmonisation is contentious though, because there is no general consensus for a movement towards harmonisation internationally and is in reality still an obvious upholding of the purposive approach to interpretation.250
In Singapore the need for a fair patent system is notable, however “fairness to the patentee does not justify adopting the DoE when the unfairness is said to result from a decision made during patent application or imprecise claims”.251 Further, as one of the justifications for the existence of patent regimes, incentive to innovate is often used to justify the need for a DoE. Although, there is no evidence to suggest an increased incentive to innovate following the introduction of a DoE. On the contrary, the presence of a DoE might result in decreased innovation as it limits competitors from contributing to the market by building upon patented inventions.252 Moreover, it readily follows that patentees will also be less incentivized to improve their own technologies if the prospect of competition is impeded by an Equivalents Doctrine.253
245 Bryan, above n 237, at [33].
246 Lee Tat Cheng v Maka GPS Technologies Pte Ltd [2018] 1 SLR 856 at [52], n 100 as cited in Bryan, above n 237, at [34].
247 Lee Tat Cheng v Maka GPS Technologies Pte Ltd [2018] 1 SLR 856 at [53], n 100 as cited in Bryan, above n 237, at [34].
248 Bryan, above n 237, at [48].
249 Bryan, above n 237, at [51].
250 Bryan, above n 237, at [51].
251 Bryan, above n 237, at [61].
252 Bryan, above n 237, at [63].
253 Merges and Nelson, above n 24, at 908.
The Court of Appeal also reasoned that the DoE will undermine certainty by allowing the potential for patent scope to expand beyond the words of the claims into a realm of unpredictability.254 Additionally, the Doctrine itself exists in an unstable manner; a multitude of limitations work to circumvent the potential harms presented by a DoE but such limitations are inconsistent across patent regimes.255 Arguably, the justifications often presented in favour of the DoE inadequately rationalize the existence of the Doctrine,256 thus Singaporean courts have declined to adopt a DoE, leaving the matter open to Parliament.257
254 Bryan, above n 237, at [67].
255 Bryan, above n 237, at [68].
256 Bryan, above n 237, at [76].
257 Lee Tat Cheng v Maka GPS Technologies Pte Ltd [2018] 1 SLR 856 at [53], n 95 as cited in Bryan, above n 237, at [31].
6.0 Following Actavis – Should New Zealand Adopt a Doctrine of Equivalents?
New Zealand patent law is, as aforementioned, primarily governed by the Patents Act 2013. Most importantly, the owner of a patent has “exclusive rights, during the term of the patent, to exploit the invention and to authorise another person to exploit the invention”.258 Section 14 of the Act sets out patentability requirements, stating that:
An invention is a patentable invention if the invention, so far as claimed in a claim, –
(e) Is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies; and(f) When compared with the prior art base –
(iii) Is novel; and
(iv) Involves an inventive step; and
(g) Is useful; and
(h) Is not excluded from being a patentable invention under section 15 or 16.
Sections 15 and 16 sets out the exemptions from patentability in New Zealand as follows:
(1) An invention is not a patentable invention if the commercial exploitation of the invention, so far as claimed in a claim, is contrary to –
(a) Public order (which in this section has the same meaning as the term ordre public
as used in Article 27.2 of the TRIPs agreement); or
(b) Morality.
(1) Human beings, and biological processes for their generation, are not patentable inventions.
(2) An invention of a method of treatment of human beings by surgery or therapy is not a patentable invention.
(3) An invention of a method of diagnosis practised on human beings is not a patentable invention.
258 Patents Act, s 18(1).
(4) A plant variety is not a patentable invention.
(5) ...
New Zealand courts are yet to address the issue of a New Zealand DoE, but current patent infringement interpretation in New Zealand turns upon the consideration of three historic UK cases; those being Catnic, Improver, and Kirin-Amgen. Without a DoE in New Zealand, “a patentee can only allege infringement of that which a patent claims”.259 To determine precisely what a patent claims in New Zealand, the patent must be interpreted according to the rules on purposive construction from Catnic.260 In Catnic, Lord Diplock stipulated that the test for patent interpretation is:261
Whether a person with practical knowledge and experience of the kind of work in which the invention was intended to be used, would understand that strict compliance with a particular descriptive word or phrase appearing in a claim was intended to be used, would understand that strict compliance with a particular descriptive word or phrase appearing in a claim was intended by the patentee to be an essential requirement of the invention so that any variant would fall outside the monopoly claimed, even though it could have no material effect upon the way the invention worked.
The relevance of Actavis to the New Zealand patent system is in contention. Given the New Zealand position on the application of the original Improver questions is as yet not fundamentally clear, it is equally unclear whether New Zealand will adopt the Actavis reasoning, including a future DoE in any future litigation. Although, it is arguably inevitable that New Zealand will eventually adopt its own DoE as the courts take account of international developments.262
259 Rodi & Weinberger AG v Henry Showell Ltd [1969] RPC 367 (HL) per Lord Morris, at 18 as cited in Frankel & Lai, above n 8, at 247-248.
260 Frankel & Lai, above n 8, at 248.
261 Catnic, above n 2, at [243].
262 Patents Act, s 3(e).
In Actavis, Lord Neuberger and the House of Lords placed considerable emphasis on the application of the EPC, particularly Article 69 of the EPC and Article 2 of the Protocol on interpretation of Article 69.263 The UKSC was undeniably attempting to align the UK patent system with other European patent systems that utilise a DoE in infringement interpretation cases. In saying that, the desire to align the UK with other European patent jurisdictions did not develop from an inadequacy of the Catnic purposive approach coupled by the original Improver questions, but actually derived from the UK’s insufficient consideration of equivalents as required under Article 2 of the Protocol of the EPC.264 Given New Zealand is not a party to the EPC, the relevance to New Zealand of the UKSC’s reasoning in Actavis becomes unsettled.
The Preamble of the EPC states that the EPC exists to achieve consensus across EPC signatories “by the establishment of certain standard rules governing patents”.265 Arguably, the best method for achieving this consensus is to incorporate the EPC and its articles and interpretive aids into current patent systems.266 However, the need to do this in New Zealand is arguably artificial. Although judicial harmonisation across different patent jurisdictions is desirable, New Zealand does not have international EPC obligations to comply with. That is not to say that the question of a DoE in New Zealand is to be ruled out entirely, but instead demonstrates that there is, as is clear from the UKSC’s reasoning in Actavis, no need for New Zealand patent law to immediately incorporate the judgment from Actavis. New Zealand patent law evidently shows that international patent developments are a relevant consideration.267
Turning now to consider whether New Zealand should adopt, the DoE adds considerable uncertainty to an intellectual property system that requires high levels of certainty in order to function.268 In allowing patent claims to expand beyond the original patent scope, a patentee is granted a stronger exclusive property right giving them a greater monopoly to the detriment of
263 Koedyk, above n 90, at 16.
264 Koedyk, above n 90, at 16.
265 Jamieson, above n 84, at 151.
266 Jamieson, above n 84, at 151.
267 Patents Act, s 3(e).
268 Cianfrani, above n 129, at [29].
other inventors.269 Some academics argue that this broadening of the scope of patents through Equivalents is a “serious drawback given that patents are very often justified on the grounds that they promote innovation”.270 By widening patent scope to heighten protection to patentees, the risk of improvements upon already-patented technology ending up in infringement litigation increases.271 This has the effect of reducing inventive incentives; conversely, when the scope of a patent more accurately reflects the invention, third party inventors know what the scope is and can more confidently innovate outside that scope, investing in research and development of technologies.272
The DoE aims to form a compromise between the rationales for patent law; on one hand ensuring that patents provide sufficient notice to the public of the specific bounds of a patent, and on the other hand protecting the exclusive rights afforded to a patentee through the registration of a patent.273 The patent system serves to promote two equally important purposes,274 purposes which are arguably curtailed by Equivalents Doctrines. These purposes are:275
To enable the public to make and use the invention once the statutory period has expired and to make use of the disclosure to develop improvements even before the patent expires. Second, the disclosure serves to provide notice to the public of the boundaries of the patent grant, thereby enabling parties to avoid infringement and to “design around” the patent. In this way, further advances in the field of the disclosed invention can be made even before the patent expires.
When a patent system employs a DoE, these core principles of patent law will be undermined because it is no longer possible to know the full bounds of patent protection to sufficiently innovate around the patent. In that sense, the DoE can act as a natural inhibitor to inventors who are thwarted by unpredictable claim construction,276 potential litigation, astronomical litigation costs, and the growing uncertainty of litigation outcomes.277 Society will
269 Cianfrani, above n 129, at [36].
270 Kendrick, above n 130, at 63.
271 Merges and Nelson, above n 24, at 916.
272 Merges and Nelson, above n 24, at 916.
273 Cianfrani, above n 129, at [29].
274 Cianfrani, above n 129, at [4].
275 Cianfrani, above n 129, at [4].
276 Kendrick, above n 130, at 64.
277 Cianfrani, above n 129, at [47].
consequentially lose out as innovators are less inclined to invent new technologies in the face of this growing uncertainty,278 and remember that the Statute of Monopolies was first introduced to increase innovation and prevent detrimental monopolies. These negative impacts of the DoE have been recognised in the US where the DoE has been amended with “exception added to exception, and presumptions rebutted by still newer presumptions”.279 Each exception is created to fix the wide scope of the DoE, but each exception equally adds to the growing uncertainty that the DoE creates. As a result, patent applicants rarely amend their claims, but do however “file more claims and more specific claims and opt for less precise functional claims in an attempt to include equivalents”.280 So, in the US innovators are developing technologies and are filing more claims to err on the side of caution in the hopes that their product will be well protected, defeating the purpose of the patent system which is to prevent monopolistic markets.
Additionally, in Actavis Lord Neuberger and the House of Lords held that new technologies involving an inventive step may still infringe a patent using the DoE.281 This is in complete contrast to Lord Neuberger’s assertion through the reformulated Improver questions that the UK’s DoE is engaged when a variant technology is “immaterial” to the patented technology.282 As such, “Lord Neuberger’s stance on inventive equivalents introduces a confusing element into the doctrine that may hinder innovation by weakening the position of competitors”.283
The social costs of reducing incentives to innovate are significant and particularly detrimental in the healthcare sector. This could adversely affect the amount of research and development of pharmaceuticals and treatment regimens in New Zealand.284 This also has an adverse impact on the pharmaceutical sector which involves a significant amount of “incremental innovation”, or simply, research and innovation building on pharmaceuticals already in existence.285 These concerns can arguably be avoided in New Zealand patent law if New Zealand rejects the application of Actavis and maintains distance from adopting any form of Equivalents Doctrine.
278 Cianfrani, above n 129, at [47].
279 Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. (“Festo III”)[2003] USCAFED 251; , 344 F.3d 1359, 1376 (Fed. Cir. 2003), n 66 as cited in Pechhold, above n 178, at 420.
280 Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. (“Festo III”)[2003] USCAFED 251; , 344 F.3d 1359, 1375 (Fed. Cir. 2003), n
68 as cited in Pechhold, above n 178, at 420.
281 Kendrick, above n 130, at 65.
282 Kendrick, above n 130, at 65.
283 Kendrick, above n 130, at 66.
284 Kendrick, above n 130, at 66.
285 Kendrick, above n 130, at 64.
Such rejection of Actavis and of a DoE will ensure that inventors know what constitutes the prior art and can innovate around that.286
Turning now to arguments often presented in favour of a DoE, the Doctrine was first introduced to provide fair protection for patentees following concerns that patent law inadequately protected patentees.287 As the majority in Winans v Denmead held, there is concern for “the fair treatment of the inventor and punishing the putative unscrupulous behaviour of the infringer”.288 In saying that, patentee protection should not be so strong that inventors are less inclined to innovate, because nor is this fair. Arguably, a fair patent system absent of a DoE will evenly balance the innovative rights of patentees and third-party competitors in the public.289 This balance is disrupted in a patent system where notice is removed due to the ambiguity that a DoE creates.290 This ambiguity arises in the form of there being “no objective way of determining when something is similar enough to an existing invention to warrant expanded protection, and there is no way of determining exactly how far to extend a patentee’s rights”.291
There is no need to protect patentees to an extent that the public is prevented from knowing the exact boundaries of a patent, because the rights of patentees do not exceed the rights of the public in having sufficient knowledge of existing property protection.292 In appropriately balancing the two sets of rights, competition will continue to thrive, with competitors being more certain of the legal limitations of patented inventions.293 For that reason, the Doctrine should not be introduced into New Zealand patent law.
The existence of an Equivalents Doctrine arguably incentivizes patentees to claim narrowly during the patent registration process in order to satisfy the novelty requirement for patent registration, and then later argue for a wider patent scope at the infringement stage by using
286 Sturicz, above n 132, at 405.
287 Sturicz, above n 132, at 394.
288 Winans v. Denmead, 56 U.S. 329, 342-43 (1853), n 60 as cited in Sturicz, above n 132, at 397.
289 Sturicz, above n 132, at 403.
290 Sturicz, above n 132, at 404.
291 Sturicz, above n 132, at 404.
292 Festo II[2002] USSC 2405; , 535 U.S. 722, 731-32 (2002), n 27 as cited in Aaron P Bowling “Just About Equivalent: A Comparative Analysis of the Doctrines of Equivalents in the United States and International Jurisdictions Shows that the Varying Doctrines are Strikingly Similar” (2013) 41 AIPLA QJ 553at 560.
293 Festo I, 234 F.3d at 597 (Lourie, J., concurring), n 31 as cited in Bowling, above n 292, at 560.
the DoE.294 This allows patentees to claim a patent scope they desired from the outset, but knew they might not achieve due to it breaching the requirement of novelty as compared to the prior art. It equally allows patentees to retroactively rectify their own drafting mistakes to the detriment of new inventors in the market who will be held to be infringing the patent by Equivalents.295 This is a completely unfair system of property rights and wholly undermines the rationales of having a patent system at all; ie the need to prevent injurious monopolies that result in one company being able to innovate, while others cannot. Whilst it is socially desirable for inventors to be incentivized to continue investing time, money and energy into inventing new technologies, this should not be achieved to the detriment of society benefitting from an abundance of available technologies. In allowing patentees to hold a greater monopoly right than they are entitled, one of the fundamental purposes in s 3(a)(i) of the Patents Act is undermined due to the failure to appropriately balance rights. In the UK, patent law supposedly favours the public interest, with the patent system being the only exception to monopolies in the UK,296 although since the decision in Actavis this is hardly the case. A DoE unequivocally favours patentees, and this is something that New Zealand should be wary of adopting, bearing in mind the desirability to prevent the formation of monopolies.
The rights of patentees and of third-party innovators are rights that need to be finely balanced, which is no easy feat.297 There are costs and benefits to patentees and society, whichever route taken.298 Although it is argued that balancing these costs and benefits is only made more difficult using a DoE, an interpretive approach that so clearly favours the interests of patentees. Ultimately, the need to prevent detrimental monopolies arguably outweighs any benefits of having the DoE.
294 Kendrick, above n 130, at 58.
295 Sturicz, above n 132, at 394.
296 Ray D Weston Jr A Comparative Analysis of the Doctrine of Equivalents: Can European Approaches Solve an American Dilemma?, 39 IDEA 35, 49 (1998), n 34 as cited in Bowling, above n 292, at 561.
297 Cianfrani, above n 129, at [29].
298 Cianfrani, above n 129, at [44]-[50].
299 Richard Miller QC, Guy Burkill QC, His Honour Judge Birss QC & Douglas Campbell Terrell on the Law of Patents (19th ed, Sweet & Maxwell UK, UK, 2021) at 9-[34].
is to be done from the perspective of “the person skilled in the art and that exercise involve[s] interpreting the words of the claim in context”.300 The context must therefore be informed by the purpose for having a patent, which is to describe and protect an invention.301 Traditionally, the method of claim construction has been the same whether it is validity or infringement in question.302 The fundamental justification for this consistency was the notion that a patentee should be tied to a firm meaning of their claims rather than allowing malleable claims that can be narrowed in order to achieve patent validity and expanded at the infringement stage to encompass variant technologies.303
Now following Actavis though, infringement is no longer assessed using principles of construction.304 If a variant does not infringe a patent on a literal basis then the Improver questions will be engaged, and answering the reformulated Improver questions is not a matter of construction.305 Consequentially, patent protection could be expanded beyond the claims of a patent, allowing a patentee to claim a wider scope of protection than they were granted at the validity stage.306 In a sense, this creates patent protection that can be molded enough that it is condensed or expanded depending on the proceeding in question; ie whether it is a validity or infringement proceeding, providing patentees optimal flexibility in patent protection.307
Following the substantial alterations made to the second Improver question, the person with knowledge in the prior art is bestowed more knowledge than they were in pre-Actavis times.308 Therefore, a patent’s scope is likely to expand overtime as the person skilled in the prior art is attributed with ever-increasing knowledge, with the result being each variant that enters the market is more obvious than the last.309 This is problematic because “it is conceivable that a prior art embodiment which was not obvious at the priority date later becomes obvious and therefore constitutes an infringement pursuant to the DoE”.310 This fundamentally weakens the
300 Generics (UK) Ltd v Yeda Research and Development Co Ltd [2017] EWHC 2629 (Pat) at [138] as cited in Miller, Burkill & Birss, above n 299, at 9-[35].
301 Generics (UK) Ltd v Yeda Research and Development Co Ltd [2017] EWHC 2629 (Pat) at [138] as cited in Miller, Burkill & Birss, above n 299, at 9-[35].
302 Miller, Burkill & Birss, above n 299, at 9-[43]. 303 Miller, Burkill & Birss, above n 299, at 9-[43]. 304 Jamieson, above n 84, at 152.
305 Jamieson, above n 84, at 152.
306 Jamieson, above n 84, at 152.
307 Miller, Burkill & Birss, above n 299, at 9-[43].
308 Jamieson, above n 84, at 153.
309 Jamieson, above n 84, at 153.
310 Jamieson, above n 84, at 153.
purpose for the patent system; namely to prevent injurious monopolies.311 If a patent can be expanded to encompass the prior art via infringement in post-Actavis UK patent law then that patent is not “truly inventive” and theoretically does not meet the legal requirements for patentability.312 This is not a risk that New Zealand should take by adopting Actavis into its patent system.
The desire for harmonisation across patent regimes internationally is well-recognised due to the wealth of possible advantages that harmonisation could bring.313 Arguably the most prevailing advantage is the increase in certainty that will follow this harmonisation.314 Once a patentee has secured patent registration, in a harmonised patent system, infringement should be assessed the same across different countries, achieving the same results.315
In saying that, harmonisation is a “weak” justification for introducing a DoE,316 it lacks any “substantive” reasoning,317 and is also arguably defective considering different jurisdictions already adopt their own individual national approaches to patent protection and to the DoE. Even in the context of the EPC and the Protocol, which “was intended to achieve harmonis[ation in] the treatment of patents across its signatories”,318 it is questionable whether harmonisation will be substantively achieved due to varying patent law regimes and DoE approaches across EPC states. Any judicial attempts to create this desired harmonisation will largely fall short of the intended goal, which is to create entirely harmonious regimes.319 In that sense, even if harmonisation is achieved on a surface level through the adoption of a DoE in all patent regimes, including in New Zealand, the likelihood of there being harmony between all patent regimes is remote due to the difference in each regime’s domestic and international patent obligations. Moreover, as mentioned above in chapter 6.2.5, New Zealand is not a signatory of the EPC; even if the harmonisation argument adequately justified adopting a DoE, this hardly applies to New Zealand, a state absent of any obligations to the EPC. To achieve
311 Jamieson, above n 84, at 153.
312 Jamieson, above n 84, at 153.
313 Walsh, above n 332, at 410.
314 Walsh, above n 332, at 410.
315 Walsh, above n 332, at 410.
316 Bryan, above n 237, at [51].
317 Bryan, above n 237, at [53].
318 Jamieson, above n 84, at 154.
319 Kendrick, above n 130, at 57.
optimal harmonisation within the international patent system, this must be attempted by some supreme authority,320 and for that reason, harmonisation through the DoE following Actavis fails to justify the need for Equivalents in New Zealand.
Several common law jurisdictions use some form of Equivalents Doctrine in their patent regimes, including the United States, Germany and France.321 In saying that, several other jurisdictions are wary of incorporating a DoE, including Australia, whilst Singapore has outright rejected the application of Actavis and the DoE altogether, unless incorporated through legislation.
Despite the fact that the US has utilised a DoE for some time now, the Doctrine has created significant problems in the US that have required further judicial intervention to delineate its scope.322 Such interventions include Prosecution History Estoppel as discussed above in chapter 5.2. The need to introduce PHE into US patent interpretation as a gatekeeper for use of Equivalents was emphasized in Festo, which stated that PHE is used to ensure that the DoE is used only for its intended purpose.323 This seems to suggest that Equivalents often exceeds its intended purpose, offering more protection than it should, which corresponds to complex litigation and inherent uncertainty in the patent system.
Furthermore, in Lee Tat Cheng, Singapore’s Court of Appeal outright rejected the application of Actavis in Singapore’s patent system for a number of reasons.324 These reasons include the fact that the EPC and the Protocol do not apply in Singapore;325 that the desire for fairness for patentees is a weak reason for adopting a DoE;326 and because of the increased uncertainty that having Equivalents creates.327
320 Kendrick, above n 130, at 62. 321 As discussed above in chapter 5. 322 Bryan, above n 237, at [42].
323 Festo Corp v Shoketsu Kinzoku Kogyo Kabushiki Co [2002] USSC 2405; 535 US 722 at 734 (2002), n 128 as cited in Bryan, above n 237, at [42].
324 Bryan, above n 237, at [29].
325 Bryan, above n 237, at [33].
326 Lee Tat Cheng v Maka GPS Technologies Pte Ltd [2018] 1 SLR 856 at [52], n 100 as cited in Bryan, above n 237, at [34].
327 Lee Tat Cheng v Maka GPS Technologies Pte Ltd [2018] 1 SLR 856 at [53], n 102 as cited in Bryan, above n 237, at [34].
Slightly closer to home, Australia too is suspicious of adopting a DoE because of the broad scope of protection that the Doctrine affords to patentees, creating a divergence in the scope of a patent when it is first registered by a patentee and when a new scope is later argued at the infringing stage.328 Ample literature exists which discusses the DoE in various patent systems, the majority of which focuses on the inadequacies of the DoE, and potential ways to remedy the Doctrine’s application. Ref such material In particular, the US appears to be moving away from any form of Equivalents through the implementation of Doctrine-limiting rules.329 It naturally follows that if there is a need for a multitude of means to limit the DoE, then this suggests Equivalents inadequately resolves the issues it was introduced to address. Adding rules upon rules in an attempt to rectify the problems created by the DoE is inefficient, this is a problem that the New Zealand patent system should avoid in order to protect the fundamental justifications for having a patent system. Those justifications are the need to prevent inventors from holding large monopoly rights, to the detriment of other innovators who will struggle to invent around a monopoly, and to the detriment of society who will notice an increase in the price of technologies owned by companies that hold strong monopoly rights.
In this section I have presented principle-based objections, as well as incorporating consequentialist arguments to support my critique of the DoE. Overall, for the reasons stated above, I am of the opinion that it would be more harmful than helpful if the New Zealand patent system adopted a DoE.
The DoE applies across all industries and all patentable inventions; however, this dissertation focuses particularly on the application of the DoE to the pharmaceutical industry. The pharmaceutical industry is a field with high stakes as every individual is a stakeholder in the healthcare realm; everyone interacts with the healthcare system at some point in their life. Therefore, there is a significant public interest in ensuring that pharmaceuticals and therapies are readily available and affordable to the general public. Pharmaceutical companies will arguably be disincentivised to innovate in the presence of a DoE due to the growing uncertainty that a DoE brings. This threatens to reduce rates of healthy competition.
328 Lawrence, above 227, at 215.
329 Eugene Lim, “Opening the ‘Pandora’s Box’ of Patent Claim Construction” (2016) 16 Asper Rev Int’l Bus & Trade L 155 at 169, n 157 as cited in Bryan, above n 237, at [52].
The healthcare sector substantially relies upon incremental innovation,330 ie innovation that results in “follow on drugs” improving upon pre-existing drugs.331 Consequently, the DoE will arguably inhibit the development of follow on drugs. There are an abundance of reasons demonstrating why incremental innovation is essential to pharmaceutical sector specifically. There are also a number of negative effects that will result from disallowing this incremental innovation, including effects that will arguably negatively impact affordable healthcare in New Zealand. Incremental innovation is valuable because it enables patients to undergo therapies most suitable to them. This in turn ensures that patients will maintain their treatment regimen, and pharmaceutical companies can also improve upon existing drugs to ensure they are up to modern standards.332 Finally, competition increases, decreasing drug prices.333 These benefits are likely to diminish in a patent regime that adopts Actavis and a DoE.334
The development of pharmaceuticals is an “inherently dynamic process” where “one innovation builds on another and improvements draw from a long history of earlier technological advances”.335 In fact, evidence shows that the bulk of all medical and pharmaceutical advancements are occurring through incremental innovation.336 The DoE has an adverse effect on the ability of inventors to incrementally innovate.337 Incremental innovation serves a beneficial purpose “to both patients and society, for both health and cost- saving reasons.338 One benefit is the fact that new pharmaceutical advances provide competition for originally existing medications, decreasing the price of these medications.339 Arguably, and even more importantly, these benefits will collectively result in better health results.340 “One of the primary advantages of the development of follow-on drugs is the price competition that results from multiple drugs in a single therapeutic class”.341 So, if incremental innovation results in more innovation, increasing competition and creating more competitive
330 Steven Globerman & Kristina M Lybecker “The Benefits of Incremental Innovation: Focus on the Pharmaceutical Industry” (2014) Fraser Institute 1 at 23.
331 Globerman & Lybecker, above n 330, at 23.
332 Globerman & Lybecker, above n 330, at 28.
333 Kendrick, above n 130, at 64.
334 Kendrick, above n 130, at 64.
335 Globerman & Lybecker, above n 330, at 23.
336 Globerman & Lybecker, above n 330, at 24.
337 Kendrick, above n 130, at 64.
338 Globerman & Lybecker, above n 330, at 25.
339 Globerman & Lybecker, above n 330, at 25.
340 Globerman & Lybecker, above n 330, at 26.
341 Globerman & Lybecker, above n 330, at 30.
drug prices, this will benefit healthcare users and society economically. If New Zealand adopted a DoE, this chain of events would subside due to the inability to incrementally innovate in the presence of a DoE. Allowing incremental innovation would undoubtedly “constrain the ‘monopoly power of patented drugs’”.342
Allowing incremental innovation to occur will increase pharmaceutical innovation, “increase price competition and lower launch prices ... convey[ing] significant savings to patients”.343 The issue of unaffordable healthcare as it stems from exorbitant pharmaceutical prices is present in both the developing and in the developed world, 344 thus New Zealand too experiences this. Further, only “23.5% of modern medicines registered in New Zealand are publicly funded”, compared to 84.3% in the UK.345 New Zealand is also far behind Australia, which has public funding for 46.4% of its registered medicines.346 The need for affordable healthcare in New Zealand is imperative, especially considering that out of 20 OECD countries, New Zealand has the lowest rates of access to drugs and therapies. Consequently, healthcare consumers face expensive healthcare bills, the necessary price of receiving care, “or do without” healthcare.347 When generic drugs enter the market, healthcare users can find treatment programmes more financially suitable to them and will more readily invest in their health.348
Rejecting the application of Actavis in New Zealand will hardly mean that pharmaceutical innovators will copy one another because patent registrability criteria must still be met,349 thus only incrementally invented therapies that “are valid and well deserved” will be patented.350 This will not change in a patent system absent of a DoE. Therefore, “policy makers should be particularly wary of any restrictive policies that exclude incremental innovation from intellectual property protection”,351 and the DoE is one such restrictive policy to be cautious of.
342 Elizabeth Siew Kuan Ng, “Balancing Patents and Access to Medicine” (2009) 21 SALJ 457 at [23].
343 Globerman & Lybecker, above n 330, at 31.
344 Siew Kuan Ng, above n 342, at [36].
345 “Comparable Countries” Medicines New Zealand <www.medicinesnz.co.nz>.
346 “Comparable Countries”, above n 345.
347 Siew Kuan Ng, above n 342, at [36].
348 Globerman & Lybecker, above n 330, at 25.
349 Patents Act, s 14.
350 Globerman & Lybecker, above n 330, at 36.
351 Globerman & Lybecker, above n 330, at 49.
Concerns about the DoE in New Zealand are particularly topical given the current instability that has arisen in light of the COVID-19 pandemic. On the whole, vaccines designed to prevent the spread of diseases fail on the profitability front when compared with pharmaceuticals that are developed to manage the presence of a health condition in a patient.352 The COVID-19 pandemic is an exemplary representation of the costs to society of low research and innovation rates in the vaccine arena.353 Research and development efforts of vaccines to combat the COVID-19 pandemic were often ceased in the early times of COVID-19 due to it being deemed “insufficiently profitable”.354 In saying that, efforts to develop COVID-19 vaccines have increased at speed, likely due to the sheer number of people affected by COVID-19.355 Although, by adding a DoE to patent law that can extensively protect innovation efforts, vaccine innovation will likely be further thwarted as innovators face increased uncertainty.
352 Qiwei Claire Xue & Lisa Larrimore Ouellette “Innovation Policy and the Market for Vaccines” (2020) 7 JLB 1 at 36.
353 Xue & Ouellette, above n 352, at 40.
354 Xue & Ouellette, above n 352, at 40-41.
355 Ana Santos Rutschman “The COVID-19 Vaccine Race: Intellectual Property, Collaboration(s), Nationalism and Misinformation” (2021) 64 WUJLP 167 at 176.
7.0 Conclusion
The UKSC decision in Actavis was a significant departure from the settled approach to infringement interpretation in the UK. Actavis signaled a shift away from purposive construction as coined in Catnic and supplemented by the three Improver questions. Since the 2017 decision in Actavis, the approach to patent infringement is a two-step approach involving questions of textual infringement and infringement under a DoE.356 The focus of this dissertation was to investigate the impact of Actavis on patent infringement, drawing on approaches and responses to the DoE in overseas jurisdictions. Then, focusing on the principles of patent law, and evaluating the arguments for and against a DoE, this dissertation determines whether or not New Zealand should adopt a DoE. Arguably, finding patent infringement via the DoE will lead to broad patent scope which will result in large monopolies, the very thing the Statute of Monopolies was enacted to prevent.357
The US and Germany both have a well-established DoE in their patent systems. However, the US DoE has been subject to a great deal of judicial intervention in an attempt to narrow its the confines,358 while the German approach has a strong focus on rewarding innovation.359 Slightly closer to home, Australian scholars are skeptical of the impact that a DoE will have on innovation.360 Also, the Singapore Court of Appeal declined to introduce a DoE into Singapore patent law, fearful of it undermining the strict approach that Singapore employs in unilateral contracts.361
I assert that New Zealand should not adopt a DoE for a number of reasons that are primarily centered around the idea that a DoE will expand the scope of a patent and will create injurious monopolies. Firstly, the UKSC primarily introduced a DoE in order to comply with the UK’s obligation to the EPC, to which New Zealand is not a party. Secondly, jurisdictions that have employed a DoE for some time have experienced ample judicial intervention to limit the DoE, as seen in the US.362 Thirdly, the DoE could result in hindsight claim modifications, widening
356 Actavis (SC), above n 1, at [54].
357 Sumpter, above n 9, at 279.
358 Bryan, above n 237, at [42].
359 Pechhold, above n 178, at 421.
360 Lawrence, above 227, at 215.
361 Bryan, above n 237, at [6].
362 Bryan, above n 237, at [42].
patent scope and potentially encroaching upon the prior art.363 Fourthly, the DoE can lead to inherent uncertainty in patent infringement cases, making it difficult for innovators to confidently innovate around existing patents.364 Finally, the DoE can also adversely impact incremental innovation, the primary method of researching and developing pharmaceuticals and therapies. Therefore, given the potential for the DoE to thwart innovation, New Zealand should refrain from adopting a DoE to ensure that it does not fall into the same monopoly- creating trap that other jurisdictions have.
363 Jamieson, above n 84, at 153.
364 Cianfrani, above n 129, at [29].
8.0 Bibliography
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“Comparable Countries” Medicines New Zealand <www.medicinesnz.co.nz>.
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