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D’Arcy v. Myriad Genetics: A Demand for the “Made” or “Non-Information” and Clear Subject Matter?

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Abstract

In October 2015, the High Court of Australia (HCA) handed down D’Arcy v. Myriad Genetics and overturned the Full Court of the Federal Court of Australia by holding that key product claims from Myriad Genetics’ BRCA1 gene patent did not constitute manners of manufacture. Two years earlier, the Supreme Court of the United States (SCOTUS) had similarly ruled against certain product claims from Myriad Genetics’ BRCA1 and BRCA2 patents, finding that simply isolated genetic sequences are not patentable subject matter. From their results, one could easily make the mistake of seeing the two decisions as being identical and placing Australia and the US at odds with Europe. However, as this article highlights, Australian law is conceptually different from US law and, strictly speaking, the HCA did not rule that isolated genetic sequences can never constitute patentable subject matter. However, at the end of the day, it is arguable that the laws are very similar in effect. This article examines the HCA decision and compares and contrasts it to that of SCOTUS.

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Notes

  1. For a general overview of relevant concerns, see Gold and Carbone (2010). See also Eisenberg (2002); Dreyfuss and Evans (2011); Berman and Dreyfuss (2006).

  2. See Gold and Carbone (2010).

  3. In chronological order: The University of Utah Research Foundation v. Sozialdemokratische Partei der Schweiz and Ors (Breast and Ovarian Cancer) (2007) T 1213/05 (EPO Board of Appeal); The University of Utah Research Foundation v. Institut Curie (Mutation) (2008) T 0666/05 (EPO Board of Appeal); The University of Utah Research Foundation v. Institut Curie (Method of Diagnosis) (2008) T 0080/05 (EPO Board of Appeal); and The University of Utah Research Foundation v. Institut Curie (Method of Diagnosis) (2008) T 0080/05 (EPO Board of Appeal). For discussion, see Matthijs et al. (2013), at p. 707; Benowitz (2002).

  4. EC Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions, OJ L 213/13 30.7.98, Art. 5.2 [hereinafter EC Biotech Directive]; EPC Implementing Regulations (last amended 1 April 2014), Rule 29(2); and “Guidelines for Examination in the European Patent Office” (November 2015), Part G, Chpt. II-2.

  5. Convention on the Grant of European Patents (European Patent Convention, EPC), 1065 UNTS 199 (adopted 5 October 1973, entered into force 7 October 1977).

  6. Association for Medical Pathology v. Myriad Genetics (2013) 569 US ___, slip op.

  7. Association for Medical Pathology v. Myriad Genetics (2013) 569 US ___, at pp. 13–15 Thomas J for the Court (SC). 35 USC  § 101 states: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”

  8. Association for Medical Pathology v. Myriad Genetics (2013) 569 US ___, at p. 17 Thomas J for the Court (SC).

  9. D’Arcy v. Myriad Genetics Inc [2014] FCAFC 115. For an analysis of the FCA’s decision, see Lai (2015a).

  10. The HCA is the highest court in Australia.

  11. D’Arcy v. Myriad Genetics Inc [2015] HCA 35.

  12. Diamond v. Chakrabarty (1980) 447 US 303, 309 Burger CJ for the Court. For the statutory definition, see supra note 7.

  13. Pub L 112–29 (US), § 33(a), 16 September 2011, 125 Stat 340. This applies for any patent application pending, filed on or after the date of enactment of the Act. It does not affect the validity of patents issued prior.

  14. “Guidelines for Examination in the European Patent Office” (November 2015) (EPO Guidelines), Part G, Chpt. II-1, which states that inventions must have both a concrete and technical character, dependant on the content of the claims, not the form or kind of claim.

  15. For a comparison of the US and European situations, see Lai (2016a).

  16. Australia has “standard patents” (with full examination and for a 20-year term) and “innovation patents” (with no examination because they have lower inventiveness, lasting only 8 years). Both require that the invention be a “manner of manufacture”; Patents Act 1990 (Cth), Sec. 18(1)(a) and 18(1A)(a). The Australian legislator deliberately chose to maintain the standard when the 1990 Act replaced the former 1952 Act. Australia traditionally followed UK law quite closely and the Australian 1952 Act was heavily influenced by the UK Patents Act 1949. However the legislature decided not to follow the changes that have taken place within UK patent legislation since 1949, viewing it as being too influenced by the EU and EPC. The question of whether the subject matter can constitute an “invention” is often referred to as the “patent-eligiblity” or “inherent patentability” inquiry. The terms “patentable” and “patentable subject matter” are broader in meaning, including the other patent standards, such as novelty, non-obviousness and utility. For example, a mechanical machine is patent-eligible or inherently patentable; however, if it not novel, is obvious or has no utility, it will not be patentable or patentable subject matter. On the introduction of the term “inherent patentability”, see infra note 47.

  17. The term “manner of new manufacture” is no longer in the UK Patents Act 1977 (nor is any reference to the Statute of Monopolies 1623). The 1977 Act was heavily amended in 1995, 2000 and 2001 to implement the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 UNTS 299; 33 ILM 1197 (adopted on 15 April 1994, entered into force 1 January 1995), and the EC Biotech Directive, n 4.

  18. The Statute of Monopolies uses the term “manner of new manufacture”, whereas the Patents Act 1990 (Cth) uses “manner of manufacture”. This is similar to the case under the Patents Act 2013 (NZ). Whether “manner of new manufacture” and “manner of manufacture” have the same meaning is unclear; see Ricketson, Richardson and Davison (2013) at p. 712; and Lai (2015a), at pp. 184–185. Notably, the Australian courts have had ample opportunity to indicate whether the terms have different meanings. That they have not done so, but continue to apply NRDC (which was rendered over “manner of new manufacture”), would suggest that they do not believe that there is a difference in meaning. While the HCA noted the difference in D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [12] French CJ et al., they did not discuss it further.

  19. (1959) 102 CLR 252 (hereinafter NRDC). For a history of the invention at issue in NRDC, see Hubicki and Sherman (2009), at pp. 73–79. Interestingly, Hubicki and Sherman argued that the concepts that the HCA adopted are recycled from old cases that had been rejected in recent years. In other words, there was no modernisation. For a thorough discussion on development of the concept of “invention” before and between the passing of the Statute of Monopolies and NRDC, see Pila (2003) at pp. 111–148. See also Ricketson (2013) pp. 97–130, who tracks pre- and post-NRDC case law relating to method patents.

  20. NRDC, n. 19, p. 271.

  21. NRDC, n. 19, p. 269.

  22. NRDC, n. 19, p. 269. See also Hubicki and Sherman (2009), at pp. 89–90.

  23. NRDC, n. 19, p. 276.

  24. NRDC, n. 19, p. 277 (emphasis added).

  25. NRDC, n. 19, pp. 263–264.

  26. Hubicki and Sherman (2009), at pp. 84–85. As noted by Christine Godt, inquiries into biotechnologies compared to their natural counterparts inherently raise philisophical and theological questions; Godt (2007), at p. 133.

  27. Frankel (2008), at p. 83.

  28. Dent (2009), at pp. 444–446 and 453. See also Ricketson (2003), at pp. 119–123, who notes the difficulties in assessing the public interest this way in the courts; and Ricketson, Richardson and Davison (2013), at p. 778. The policy interests that can be protected via terms like “generally inconvenient” can clearly change; see also Boehm (1967). See also Pila (2001), who undertook a historical analysis to find that “be not contrary to law” meant “substantially and essentially newly invented” (p. 221) and “generally inconvenient” was with respect to the patent effect on the public, such as when an invention was not sufficiently different from the prior art (p. 222). In another text, Pila discusses The Gas Light and Coke Company (1875) LR 2 ChD 821 (CA), which also used the proviso to restrict patentability for public policy reasons; Pila (2003), at p. 129.

  29. Pila (2003), at p. 157. She also discusses that one could argue that the Sec. 6 proviso no longer has any application in contemporary patent law, as the NRDC distinction between the useful and fine arts drew the relevant line (p 166).

  30. Introns are not “junk” DNA (as once believed). They are called “non-coding” because they do not code for the specified protein in a given context. Strictly speaking, they can be coding, because they may code for another protein or for a shorter polypeptide seqeuence, or for another kind of RNA. They, thus, play a very important role; see Ewen Callaway, “‘Junk’ DNA Gets Credit for Making Us Who We Are”, New Scientist (19 March 2010), available at http://www.newscientist.com/article/dn18680-junk-dna-gets-credit-for-making-us-who-we-are.html. On the controversy that was caused by Genetic Technologies (which also happened to be Myriad Genetics’ exclusive licensor in Australia and New Zealand) with respect to patents over “junk DNA”, see Rimmer (2006); ABC, “Genius of Junk (DNA)”, Four Corners (10 July 2003); ABC, “Patently a Problem”, Four Corners (11 August 2003). Carina Dennis, “Geneticists Question Fees for Use of Patented “Junk” DNA”, Nature (22 August 2012), available at http://www.nature.com/drugdisc/news/articles/423105a.html; Zina Moukheiber, “Junkyard Dogs”, Forbes OutFront (29 September 2003), available at http://www.forbes.com/forbes/2003/0929/052.html.

  31. Kirin-Amgen Inc v. Board of Regents of University of Washington (1995) 33 IPR 557, 569 (IP Australia). This case was appealed, but not on the grounds of “manner of manufacture”; Genetics Institute Inc v. Kirin-Amgen Inc (1996) 34 IPR 513 (FCA). See also Simmons and Wickham (2012).

  32. ABC, “Body Corporate” (6 September 2010) Four Corners; Rimmer (2006), and Rimmer (2012–2013).

  33. The Patent Cooperation Treaty (PCT) allows for an international application (or PCT application) to be filed. It does not remove the role of national authorities to examine and determine patentability within their territory, but establishes a filing (or priority) date. Applicants must enter the national phase within a prescribed time from the filing date (usually 30 months). WIPO, PCT (adopted on 19 June 1970), as amended on 28 September 1979, modified on 3 February 1984 and on 3 October 2001.

  34. Australian Patents Nos. 686004, 691331, 691958 and 773601.

  35. New Zealand Patents Nos. 291330, 291621, 291624 and 326525.

  36. Australian Patent No. 773601, specification AU-B2.

  37. Australian Patents Nos. 686004, 691331 and 691958.

  38. Australian Patent No. 686004, specification AU-B. Claims 1–3 were challenged as not being manners of new manufacture.

  39. The analogous Australian patent (No. 691958) was not in dispute.

  40. At issue were also Claims 1, 6 and 7 of US Patent 5,837,492 (entitled “Chromosome 13-linked Breast Cancer Susceptibility Gene,” relating to BRCA2) and Claim 1 of US Patent No. 5,693,473 (entitled “Linked Breast and Ovarian Cancer Susceptibility Gene”, relating to BRCA1).

  41. Association for Medical Pathology v. Myriad Genetics (2013) 569 US ___, at pp. 5–6 Thomas J for the Court (SC).

  42. The University of Utah Research Foundation v. Sozialdemokratische Partei der Schweiz and Ors (Breast and Ovarian Cancer) (2007) T 1213/05 (EPO Board of Appeal).

  43. The University of Utah Research Foundation v. Institut Curie (Mutation) (2008) T 0666/05 (EPO Boards of Appeal). Specifically, Myriad Genetics narrowed the patent to the “185delAG → ter39” mutation, which means deletion of the nucleotides “AG” at position 185, which would result in a stop codon in codon number 39. Myriad Genetics did not lose priority for this particular mutation and a related probe, as the errors made in priority document did not affect the detection of this particular mutation or the nucleotides of a related probe (para. 40).

  44. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [37], French CJ et al.

  45. See, e.g. the First Instance of the FCA, Cancer Voices Australia and Yvonne D’Arcy v. Myriad Genetics Inc and Genetic Technologies Ltd [2013] FCA 65; and CCOM Pty Ltd v. Jiejing Ptd Ltd (1994) 51 FCR 260.

  46. Monotti (2006), at pp. 465–466.

  47. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [20] French CJ et al. Cf. [276] Gordon J, who went so far as to say that NRDC’s exact formulation for the facts of that case were for process claims and not appropriate for considering product claims. Note: the term “inherent patentability” is not a legal term, i.e. one does not find it in the Australian Patents Act. The HCA used to term to refer to subject matter that is simply considered to be patentable and for which no inquriy into subject-matter eligiblity needs to be made. The term was presumably taken from a seminal article written by Pila (2003), which is cited by the Court in footnote 29.

  48. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [5] French CJ et al. See also [226] Gordon J.

  49. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [5] French CJ et al. Cf. Gageler and Nettle JJ did not take policy interests into consideration; and Gordon J also did not take policy concerns into account, stating that the “fundamental questions” for determining patent-eligibility are “what is the subject matter of the claim”, “what is the invention” and “what are the facts and matters which are relied upon to justify a conclusion that the claim contains an invention?” [278].

  50. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [23] French CJ et al.

  51. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [23] French CJ et al.

  52. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [28] French CJ et al.

  53. See Lai (2015a), at p. 191; and Sherman (2015), at pp. 141–142, who attributes this to the fact that the patent eligibility inquiry is “based in a specific model of the inventive process. Under this model, the invention is a product of a process in which a human agent (or inventor) exercises their inventive skills to build on, modify or adapt pre-existing natural materials.” The inventor is thus expected to “individualise” nature (pp. 137–138).

  54. Under Art. 53(b) of the EPC, European patents shall not be granted in respect of “plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof”. According to EPC Implementing Regulations (last amended 1 April 2014), Rule 26(5), “[a] process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection.” On the degree of human intervention necessary, see Lubrizol (Hybrid Plants) (1988) T 320/87, at para. 6 (EPO Board of Appeal): “whether or not a (non-microbiological) process is to be considered as ‘essentially biological’ within the meaning of Article 53(b) EPC has to be judged on the basis of the essence of the invention taking into account the totality of human intervention and its impact on the result achieved. It is the opinion of the Board that the necessity for human intervention alone is not yet a sufficient criterion for its not being ‘essentially biological’. Human interference may only mean that the process is not a ‘purely biological’ process, without contributing anything beyond a trivial level. It is further not a matter simply of whether such intervention is of a quantitative or qualitative character.” This decision was followed in Plant Genetic Systems N.V. (1995) T 356/93, paras. 27–28 (EPO Board of Appeal). See also “Guidelines for Examination in the European Patent Office” (November 2015), Part G, Chpt. II-18−20.

  55. See e.g. ZymoGenetics, Inc (Hematopoietic Receptor) (2006) T 0898/05, at para. 4 (EPO Board of Appeal), which states that “the criterion of ‘industrial applicability’ requires that a patent application describes its subject invention in sufficiently meaningful technical terms that it can be expected that the exclusive rights resulting from the grant of a patent will lead to some financial or other commercial benefit.” See also Max-Planck-Gesellschaft zur Förderung der Wissenschaften eV (BDP1 Phosphatase) (2005) T 0870/04, para. 21 (EPO Board of Appeal), which states that there must also be a “profitable use for which the substance can be employed”; and Human Genome Sciences, Inc v. Eli Lilly & Co. [2012] RPC 6 (UKSC). The European concept of “industrial applicability” is discussed in Lai (2015b), at pp. 454–465.

  56. Regarding the EPO situation, Geertrui Van Overwalle has noted that the industrial applicability requirement should not be equated with the requirement that there be a technical contribution to find that there is an “invention”; see Van Overwalle (2011), at pp. 465–466.

  57. See e.g. one of the concurring opinions in D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [128] and [131] Gageler and Nettle JJ, who stated that “it is necessary that the inventive concept be seen to make a contribution to the essential difference between the product and nature” and “the subject matter of a claim [must] have about it a quality of inventiveness which distinguishes it from a mere discovery or observation of a law of nature”. See also Association for Medical Pathology v. Myriad Genetics (16 August 2012) No. 2010-1406 Unreported, wherein each of the three Judges use either the novelty, non-obviousness or utility standards to bolster their patent-eligibility analyses. Indeed, many have argued that we should abandon the patent-eligibility question altogether and instead focus on the other patent standards. E.g. Sherman (2015), at pp. 145–146.

  58. Note: while both novelty and non-obviousness are assessed relative to an external reference point, novelty is a purely quantative standard, whereas the non-obviousness standard is – like utility – qualitative. Additionally, the standard of utility or industrial application sometimes requires evidence.

  59. MacLeod (1988), at p. 205. See also Dent (2009), at pp. 418–420; Ricketson et al. (2013); Biagioli (2006); Ricketson (2003), at p. 113; and Pila (2001), at p. 214.

  60. This states that: “Subject to subsection (2), an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim: (a) is a manner of manufacture within the meaning of Sec. 6 of the Statute of Monopolies; …”.

  61. This is also the case in New Zealand. See e.g. Wellcome Foundation Ltd v. Commissioner of Patents [1983] NZLR 385, 391–393 Cooke J (CA), who held that to open “manner of new manfuacture” up to methods of medical treatment was of such ambit and great consequence that it had to be left to parliament.

  62. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [28] French CJ et al.

  63. Apotex Pty Ltd v. Sanofi-Aventis Australia Pty Ltd [2013] HCA 50, [282] Crennan and Kiefel JJ; see also [44] French CJ. This was consistent with an earlier judgement of the Full Court of the FCA, which held that it would be illogical to say that products, but not methods, for treating the human body are patentable; Bristol-Myers Squibb Co v. FH Faulding & Co Ltd (2000) 46 IPR 553, [14]–[18].

  64. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [28] French CJ et al. Cf. [284] Gordon J, who stated that the fact that the Court’s decision may put Australia out of step with other jurisdictions was “a matter for the legislature” and “no basis to extend s 18(1) of the Act to claims 1–3.”

  65. WTO, Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 UNTS 299; 33 ILM 1197 (adopted on 15 April 1994, entered into force 1 January 1995).

  66. Apotex Pty Ltd v. Sanofi-Aventis Australia Pty Ltd [2013] HCA 50, [243]–[275] Crennan and Kiefel JJ.

  67. Wellcome Foundation Ltd v. Commissioner of Patents [1983] NZLR 385; Pfizer Inc v. Commissioner of Patents (2004) 60 IPR 624 (CA); and Patents Act 2013, Sec. 16(2) and (3). In contrast, the Australian Patents Act 1990 does not have an excception from patentability for diagnostic, therapeutic and surgical methods for the treatment of humans or animals.

  68. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [34]–[35] and [90] French CJ et al.

  69. “In Conversation with Prof. Brad Sherman: D’Arcy v. Myriad Genetics Inc (2015) and the Future of Australian Patent Law”, Interview by Jocelyn Bosse, Justice and the Law Society (20 October 2015).

  70. “In Conversation with Prof. Brad Sherman: D’Arcy v. Myriad Genetics Inc (2015) and the Future of Australian Patent Law”, Interview by Jocelyn Bosse, Justice and the Law Society (20 October 2015).

  71. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [28] French CJ et al.

  72. President and Fellows of Harvard College v. Canada (Commissioner of Patents) [2000] 4 FC 528, [36], [111] and [117] Rothstein J.

  73. President and Fellows of Harvard College v. Canada (Commissioner of Patents) (2002) 4 SCR 45, [144]–[146] Bastarache J.

  74. President and Fellows of Harvard College v. Canada (Commissioner of Patents) (2002) 4 SCR 45, [155] and [158] Bastarache J.

  75. See 35 USC § 101; and Patents Act 1985 (Can), Sec. 2 definition of “invention”.

  76. Diamond v. Chakrabarty (1980) 447 US 303, 309 Burger CJ.

  77. Diamond v. Chakrabarty (1980) 447 US 303, 315 Burger CJ.

  78. Diamond v. Chakrabarty (1980) 447 US 303, 321–322 Brennan J.

  79. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [25] French CJ et al.

  80. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [28] French CJ et al.

  81. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [6] French CJ et al. (emphasis added). See also [248]–[249] Gordon J, who stated that there was no patentable product in part because “Myriad did not create, make or alter any of the nucleic acid seuence in the BRCA1 gene. Myriad did not create, make or alter any one of the mutations and polymorphisms listed in the tables spcifified in the claim.”

  82. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [16] French CJ et al., citing Blanco White, Patents for Inventions, 2nd edn (1955) at 12.

  83. For a critique of the natural/unnatural dichtomy, see Dan L. Burk, “Edifying Thoughts of a Watcher (2013).

  84. Diamond v. Chakrabarty (1980) 447 US 303.

  85. Association for Medical Pathology v. Myriad Genetics (2013) 569 US ___, at p. 12 Thomas J for the Court (SC).

  86. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [91] French CJ et al. (emphasis added). See also [111–112] Gordon J, who rejects the use of the discovery/invention dichotomy and terms such as “work of nature” and “laws of nature”, or “nturally accurring” or “principle of nature”. Cf. [126]–[128] Gageler and Nettle JJ, who state that the “essence of invention inheres in its artificuality or distance from nature” and the question is “whether the subject matter of the claim is sufficiently artificial, or in other words different from nature, to be regarded as patentable.” Furthermore, “the artificiality of a product may be perceived in a number of factors, including the labour required to create it and the physical differences between it and the raw natural material from which it is derived.” The Justices ultimately held that the claims were for naturally occuring phenomenon [137]. They went so far as to state that “even when isolated, they are naturally occurring and therefore not new” [169].

  87. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [91] French CJ et al. The Justices further noted (at [85]) that “the process of ‘isolation’[] does not disclose a pathway to patentability of the invention as described in Claims 1 to 3. … The economic significance necessary to the patentability of an ‘artificially created state of affairs’ in the sense used in NRDC is not demonstrated by stating that the artificially created state of affairs is a step along the way to a process or method itself claimed as an artificially created state of affairs of economic significance.”

  88. Association for Medical Pathology v. Myriad Genetics (2013) 569 US ___, at pp.14–15 Thomas J for the Court (SC).

  89. Association for Medical Pathology v. Myriad Genetics (2013) 569 US ___, at p. 15 Thomas J for the Court (SC) (emphasis in original).

  90. Association for Medical Pathology v. Myriad Genetics (2013) 569 US ___, at p. 18 Thomas J for the Court (SC).

  91. On the double information/chemical-compound character of genetic sequences and the propertisation of information via patents generally, see Godt (2007) at Chpts 3 and 6, esp. pp. 462–468; Lai (2016b) (forthcoming).

  92. Association for Medical Pathology v. Myriad Genetics (16 August 2012) No. 2010-1406 Unreported, at pp. 48–49 Lourie J for the Court (CAFC); and D’Arcy v. Myriad Genetics Inc [2014] FCAFC 115, at para. 143.

  93. Association for Medical Pathology v. Myriad Genetics (2013) 569 US ___, at pp. 14–15 Thomas J for the Court (SC).

  94. Julie Cohen and Mark Lemley have called this the “Doctrine of Magic Words”, highlighting the fact that patentability today depends a lot on how a claim is drafted and whether it is with the “magic words”; Cohen and Lemley (2001), at p. 10.

  95. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [88] French CJ et al.

  96. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [89] French CJ et al. See also [144]–[147] Gageler and Nettle JJ, who were also concerned with promoting form over substance and who stated that Myriad had simply discovered a natural correlation, which was not patentable; and [249] Gordon, who stated that “the specific mutations and polymorphsisms are indicative of a predisposition to breast cancer and ovarian cancer is a fact. That fact existed before Myriad worked it out. It is unsurprising that Myriad does not seek to patent that fact. A fact is not a manner of new manufacture withint the meaning of s 6 of the Statute of Monopolies. More is required.”

  97. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [89] French CJ et al. (emphasis added).

  98. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [73] French CJ et al.

  99. Association for Medical Pathology v. Myriad Genetics (2013) 569 US ___, at pp. 14–15 Thomas J for the Court (SC): “Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule. Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes.” French CJ et al. cited and endorsed the final two sentence of this quote “so far as it emphasises the focus of the claims on genetic information” [90].

  100. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [73] French CJ et al. (emphasis added). See also [280] Gordon J, who stated that “Myriad did not and cannot delineate the bounds of the class of compounds by reference to the chemical composition of every possible product. Instead, Myriad sought to delineate the boundaries of each claim by reference to what it described as the ‘characteristics identified within the claim’ – the specific mutations and polymorphisms, represented by the code.”

  101. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [90] French CJ et al. See also [158] Gageler and Nettle JJ; and [279] Gordon J.

  102. “In Conversation with Prof. Brad Sherman: D’Arcy v. Myriad Genetics Inc (2015) and the Future of Australian Patent Law”, Interview by Jocelyn Bosse, Justice and the Law Society (20 October 2015). See also Godt (2007) at p. 465–468, who notes that, in contrast, the “isolation theory” that is often used to justify patentability in chemical compounds isolated from their natural environment makes us blind to the fact that genetic sequences are carriers of information. She states: “The isolation theory transforms ‘the gene’ into a ‘product’ and hides the double character of ‘genes’ as materiality and information.” (own translation).

  103. See also Jessica C. Lai, “Myriad Genetics and the BRCA Patents in Europe: The Implications of the US Supreme Court Decision” (2015) UC Irvine Law Review, 5 (forthcoming).

  104. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [191] Gordon J (emphasis added).

  105. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [71] French CJ et al. (emphasis added).

  106. See Eisenberg (2002).

  107. Generics (UK) Ltd and Ors v. H Lundbeck A/S [2012] UKHL 12, [25] Lord Walker (emphasis added): “A single chemical compound is a product for the purposes of UK patent law. … It is moreover a product of a special character, since it is a product which, simply as a chemical compound (as in claim 1 of the patent in suit), can have only one embodiment (though if it is used in a pharmaceutical preparation it can of course have numerous embodiments in terms of dosages and non-active ingredients. … Statements of general principle relating to inventions with many embodiments may be irrelevant to an invention which consists of a single chemical compound.”

  108. That chemical compounds are an exception to this was noted by Lord Walker, see ibid. It is unclear what exactly the “idea” is that is embodied in product claims for chemical compound. On the idea/embodiment dichotomy in chemical compounds, see Lai (2016b) (forthcoming).

  109. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [70] French CJ et al. The specification describes the invention as including isolated polynucleotides ranging from 8 to 100,000 bases, but the claims do not make any such limitation. This is discussed by French CJ et al., at [62]–[71].

  110. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [269] Gordon J.

  111. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [8] French CJ et al. See also [154] Gageler and Nettle JJ; and [231]–[239] Gordon J.

  112. E.g. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [29] and [66]–[67] French CJ et al. See also [240]–[243] Gordon J. These statements about potential effects on innovation were made without any reference to relevant data. This led to Sherman stating that the HCA D’Arcy v. Myriad Genetics Inc decision was “not an example of evidence-based decision-making; “In Conversation with Prof. Brad Sherman: D’Arcy v. Myriad Genetics Inc (2015) and the Future of Australian Patent Law”, Interview by Jocelyn Bosse, Justice and the Law Society (20 October 2015). There is little empirical evidence that patents really do hinder research. See, e.g. Bessen and Meurer (2008), at Chpt. 6, who conclude from empirical evidence that patents are a “brake” or “drag” on innovation (including research and development), not a “roadblock” (pp. 145–146). We also lack evidence that biotech patents cause the hold up of research; Australian Law Reform Commission (ALRC) (2004); Nicol (2011); Dianne Nicol and Jane Nielsen, “Patents and Medical Biotechnology” (2003) Centre for Law and Genetics, Occassional Paper No. 6; Gaisser et al. (2009); and Hawkins (2011). The exception is perhaps in the US with respect to gene-related diagnostics and research tools. Nicol (2011), at pp. 25–27; Joly (2007), at p. 396; and van Zeebroeck et al. (2008), at p. 258. See also Eisenberg (2009), at pp. 1071–1075, 1079–1081 and 1084–1088, who concluded that biotech research tools that are hard for researchers to produce themselves potentially have a greater effect on research. This is because potential users must seek the tools from the owners, such that the owners always know about third-party use, lowering the cost of the owners who then do not have to detect use nor enforce their patents. Though many patents have to be considered to determine the freedom to operate, the number of patents that actually create obstacles are much fewer; OECD, “Genetic Inventions, Intellectual Property Rights and Licensing Practices: Evidence and Policies” (2002); Eisenberg (2009), at pp. 1078–1079; Joly (2007), at pp. 395–398; and Huys et al. (2009).

  113. This could have been on the ground of insufficiency of the description of the invention, which must make the nature of an invention clear (Patents Act 1990, Sec. 40(2)(a)), lack of clarity (Patents Act 1990, Sec. 40(3)), or that the claims were not fairly based on or were unsupported by the matter disclosed in the specification (Patents Act 1990, Sec. 40(3)). On these grounds, see Bodkin (2004), Chpt. 5

  114. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [6] French CJ et al. See also [138]–[139] and [162] Gageler and Nettle JJ.

  115. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [259]–[260] Gordon J.

  116. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [261]–[264] Gordon J.

  117. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [93] French CJ et al.

  118. Cf. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [250]–[258] Gordon J, who was concerned that the claims to isolated nucleotide sequences that code for certain mutations or polymorphisms did not embody Myriad’s idea (which was “that specific mutations or polymorphisms in that sequence suggest a predisposition to breast cancer and ovarian cancer”). Gordon J was, thus, not so much concerned with abstractness per se, but the fact that the claims as drafted did not correspond to the purported idea. Note, however, his finding that the correlation between specific mutations and polymorphisms and a predisposition to breast cancer and ovarian cancer was Myriad’s idea, is questionable. This is particularly in light of the fact that Gordon J repeatedly stated throughout his opinion that it was “a fact” that the specific mutations and polymorphisms are indicative of a predisposition to breast cancer and ovarian cancer; e.g., [173] and [249]. Possibly he meant that the idea was the use of that fact to diagnose a predisposition for breast or ovarian cancer.

  119. E.g. in Bilski v. Kappos (2010) 561 US 593; Mayo Collaborative Services et al v. Prometheus Laboratories Inc (2012) 132 S.Ct. 1289; and Alice Corporation v. CLS Bank International (2014) 134 S.Ct. 2347.

  120. Lemley et al. (2011), at p. 1346.

  121. Lai (2016b) (forthcoming).

  122. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [7] French CJ et al.

  123. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [94] French CJ et al.

  124. ALRC (2004). The Senate rejected a proposed amendment to the Patents Bill 1990 and a Private Members’ Bill (Patent Amendment (Human Genes and Biological Materials) Bill 2010) that would have made genes non-patentable subject matter. See D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [36], French CJ et al.

  125. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [37] French CJ et al. Cf. [171] Gageler and Nettle JJ, who note that the “most that can legitimately be drawn from the legislative history is a repeated legislative acceptance that, unlike the position in the European Union, issues of patentability in biotechnology and genetic engineering in Australia will continue to be resolved, consistently with NRDC, according to the principles which have developed for the application of s 6 of the Statute of Monopolies”.

  126. ALRC (2004); and Australia, Senate,, Parliamentary Debates (Hansard) (21 September 2011), pp. 6748–6749 (Bill Heffernan). See also Rimmer (2006), at pp. 576–586; Rimmer (2012–2013), at pp. 25–33.

  127. On the “pseudo” nature of the policy analysis, see supra note 112.

  128. E.g. Bristol-Myers Squibb Co v. FH Faulding & Co Ltd (2000) 46 IPR 553, [141] Finkelstein J (FCA); and President and Fellows of Harvard College v. Canada (Commissioner of Patents) (2002) 4 SCR 45, [144]–[146] Bastarache J.

  129. See “In Conversation with Prof. Brad Sherman: D’Arcy v. Myriad Genetics Inc (2015) and the Future of Australian Patent Law”, Interview by Jocelyn Bosse, Justice and the Law Society (20 October 2015), where Sherman states that “it’s really pleasing that the Court would engage in a way which it has never done with patent jurisprudence.”

  130. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [94] French CJ et al.

  131. In Europe, claims have also become narrower because of the strict way in which the inventive step standard has been policed, meaning that simply isolated genetic materials are often claimed as part of method claims rather than product claims. See e.g. Novel Seven-Transmembrane Receptor V28 (2002) OJ EPO 6 293–308 (Opposition Division); and Monokine MIG induced by INF-γ (2002) T0111/00 (Board of Appeal). The European inventive-step standard is generally considered to be stricter than the US non-obviousness standard. This is because it uses a problem-and-solution approach, whereby an examiner or court has to ask whether the invention would have been an obvious solution to an “objective technical problem” to a person skilled in the art, in light of the “closest prior art”; see “Guidelines for Examination in the European Patent Office” (November 2015), Part G, Chpt. VII-2−3; cf. KSR Int’l Co v. Teleflex Inc (2007) 550 US 398 (reaffirming Graham v. John Deere Co (1966) 383 US 1. See also Huys et al. (2012), at p. 446, who state that we might see a decrease in product claims for genes because many genetic sequences have been published and are part of the public domain and because most readily identifiable correlations between mutations/polymorphisms and diseases have already been identified. They further note that gene patents have been severely criticised by the public and challenged in courts, such that that economic and social selective pressure could result in a “Darwinian fate of patents on genes, genetic sequences and methods”.

  132. Association for Medical Pathology v. Myriad Genetics (16 August 2012) No. 2010-1406 Unreported, at pp. 55–59 Lourie J for the Court (CAFC), applying Mayo Collaborative Services et al v. Prometheus Laboratories Inc (2012) 132 S.Ct. 1289.

  133. See also Ariosa Diagnostics v. Sequenom (2015) Nos 2014-1139, 2014-1144 Unreported (CAFC), which held unpatentable a method for detecting a paternally inherited cell-free fetal DNA (cffDNA) of foetal origin performed on a maternal serum or plasma sample from a pregnant female, comprising the amplification of a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample. The Court applied Mayo Collaborative Services et al v. Prometheus Laboratories Inc (2012) 132 S.Ct. 1289 and found that the claims were directed to a product of nature (the nucleic acid of foetal origin) and that the additional elements or method steps were well known and conventional.

  134. D’Arcy v. Myriad Genetics Inc [2015] HCA 35, [168] Gegeler and Nettle JJ. None of the method/process claims were at issue; Australian Patents No. 686004, specification AU-B, methods of producing mutant or polymorphic BRCA1 polypeptides (claims 8–9), preparations and uses of polypeptides (claims 10–16) and various methods of diagnosis (claims 17–30). See also Gordon J at [191], who implied that the method claims were patent-eligible subject matter because they “are to various applications arising from the fact that Myriad located the BRCA1 gene and concluded that specific mutations or polymorphisms in the BRCA1 gene are indicative of a predisposition to breast cancer and ovarian cancer.”

  135. Examples are discussed in Huys et al. (2012), at p. 444; Huys et al. (2011), at pp. 1106–1107. One way in which method-claim patentability is still wider in the US is through claims for methods of medical treatment, which are not patentable in Europe; Convention on the Grant of European Patents (European Patent Convention, EPC), 1065 UNTS 199 (adopted 5 October 1973, entered into force 7 October 1977), Art. 53(c).

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  1. Max Planck Institute of Innovation and Competition Law, Munich, Germany

    Jessica C. Lai (Dr. iur., LL.B. Hons, M.Sc. (chem), B.Sc.; Senior Researcher, Faculty of Law, University of Lucerne, (Switzerland); Guest Researcher,)

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Correspondence to Jessica C. Lai.

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This article was written with the financial support of the Swiss National Science Foundation. Thanks to Roberto Romandini for his comments on an earlier draft of this article and to the peer reviewers for their thoughtful suggestions.

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Lai, J.C. D’Arcy v. Myriad Genetics: A Demand for the “Made” or “Non-Information” and Clear Subject Matter?. IIC 47, 537–568 (2016). https://doi.org/10.1007/s40319-016-0486-5

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