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In the Aftermath of D’Arcy v. Myriad Genetics Inc: Patenting Isolated Nucleic Acids in Australia

Published online by Cambridge University Press:  20 January 2017

Emanuela Gambini
Emanuela Gambini*
Affiliation:
Queen Mary-University of London
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Abstract

On 7 October 2015 the High Court of Australia unanimously allowed the appeal on D’Arcy v. Myriad Genetics Inc and ordered that claims 1, 2 and 3 of Australian Patent No 686004, entitled “In vivo mutations and polymorphisms in the 17q-linked breast and ovarian cancer susceptibility gene”, be revoked.

The High Court's judgment overturned the decisions of Justice Nicholas of the Federal Court, at first instance, and the Full Federal Court. This case note provides an overview of the High Court's decision and discusses its meaning and implications for patenting isolated nucleic acids in Australia.

Type
Case Notes
Information
European Journal of Risk Regulation , Volume 7 , Issue 2 , June 2016 , pp. 451 - 459
Copyright
Copyright © Cambridge University Press 2016

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References

1 In Australia, Myriad was granted Aus. Patent No. 691958 “17qlinked breast and ovarian cancer susceptibility gene” and Aus. Patent No. 686004 “In vivo mutations and polymorphisms in the 17q-linked breast and ovarian cancer susceptibility gene”, which was challenged in D’Arcy v. Myriad Genetics Inc.

2 On Myriad's foundation, see Myriad's history webpage, available on the Internet at <https://www.myriad.com/about-myriad/inside-myriad/history/> (last accessed on 15 March 2016).

3 The BRCA1 gene was discovered in 1990, and is a tumor-suppressor gene, linked to genetic breast and ovarian cancer. Women who have a mutation of this gene tend to have a high incidence of breast cancer, as well as ovarian cancer. In 1995 the BRCA2 gene was mapped and sequenced. While BRCA1 affects only women and also carries an increased risk of ovarian cancer, BRCA2 raises the risk of breast cancer alone, and it can affect both women and men. Wert, Guido De, Meulen, Ruud Ter, Roberto Mordacci and Mariachiara Tallacchini, Ethics and Genetics. A Workbook for Practitioners and Students (Oxford-New York: Berghahn Books, 2003).Google Scholar On the discovery of BRCA1 and 2 genes see also Parthasarathy, Shobita, Building Genetic Medicine. Breast Cancer, Technology, and the Comparative Politics of Health Care (Cambridge MA: The MIT Press, 2007), at pp. 3–7.Google Scholar

4 In the United States the “product category” of the challenged patents before the Courts included: (a) claims that covered the isolated BRCA genes (claim 1 of the ‘282 patent, claim 1 of the ‘473 patent, and claims 1 and 6 of the ‘492 patent); (b) claims that covered only the BRCA cDNA (claims 2 and 7 of the ‘282 patent and claim 7 of the ‘492 patent); claims that covered portions of the BRCA genes and cDNA as small as 15 nucleotides long (claims 5 and 6 of the ‘282 patent). The “method category” encompassed method claims directed at comparing or analyzing a patient's altered BRCA sequence with the normal one or wildtype one to identify the presence of cancer-predisposing mutations (e.g. claim 1 of the ‘999 and ‘001 patents)

5 For example, Aus. Patent No. 686004.

6 For example, European Patent EP699754.

7 For example, European Patent EP705902.

8 In the United States the Association of Molecular Pathology (AMP), The American College of Medical Genetics (ACMG), The American Society for Clinical Pathology (ASCP), The College of American Pathologists (CAP), several cancer researchers and genetic counselors, as well as some women potentially carrying BRCA1 and 2 mutated genes.

9 On the opposition to Myriad's patents concerning BRCA1 and 2 genes, see Jordan Paradise, “European Opposition to Exclusive Control Over Predictive Breast Cancer Testing and the Inherent Implications for U.S. Patent Law and Public Policy: A Case Study of the Myriad Genetics’ BRCA Patent Controversy”, 59 Food & Drug Law Journal (2004), pp. 133 et sqq. See also Gert Matthijs and Gert–Jan B. Van Ommen, “Gene Patents: From Discovery to Invention. A Geneticist's View”, in Geertrui Van Overwalle (ed.), Gene Patents and Collaborative Licensing Models. Patent Pools, Clearinghouses, Open Source Models and Liability Regimes (Cambridge: Cambridge University Press, 2009), pp. 311 et sqq.

10 Jordan Paradise, “European Opposition to Exclusive Control Over Predictive Breast Cancer Testing and the Inherent Implications for U.S. Patent Law and Public Policy: A Case Study of the Myriad Genetics’ BRCA Patent Controversy”, cit., at pp. 138 et sqq.

11 Supreme Court of the United States, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., 13 June 2013, 569 U.S. 12-398 (2013), available on the Internet at <http://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf> (last accessed 15 March 2016).

12 High Court of Australia, D’Arcy v Myriad Genetics Inc, 7 October 2015, [2015] HCA 35, available on the Internet at <http://eresources.hcourt.gov.au/downloadPdf/2015/HCA/35> (last accessed on 15 March 2016).

13 Full Court of the Federal Court of Australia, D’Arcy v Myriad Genetics Inc [2014] FCAFC 115, 107 IPR 478.

14 The term “an isolated nucleic acid”, as defined in the complete specification, includes DNA, RNA or a mixed polymer, “which is substantially separated from other cellular components which naturally accompany a native human sequence or protein”. See High Court of Australia, D’Arcy v Myriad Genetics Inc, 7 October 2015, [2015] HCA 35, supra note 12, at p. 2.

15 See Cancer Voices Australia's website, available on the Internet at <http://www.cancervoicesaustralia.org/about-us/> (last accessed on 15 March 2016).

16 Federal Court of Australia, Cancer Voices Australia and Another v Myriad Genetics Inc and Another, 15 February 2013, [2013] FCA 65, 99 IPR 567.

17 Section 138(3)(b) of Patents Act 1990 sets out as ground of revocation “that the invention is not a patentable invention”. Patents Act 1990 (Cth), s 138(3)(b), available on the Internet at <http://www.austlii.edu.au/au/legis/cth/consol_act/pa1990109/s138.html> (last accessed on 15 March 2016).

18 Australian Patent No 686004, “In vivo mutations and Polymorphisms in the 17q-linked breast susceptibility gene”, available on the Internet at <http://pericles.ipaustralia.gov.au/ols/auspat/applicationDetails.do;jsessionid=1hyrWyKdDdtMTG4qJL31qJLpx3yfrpj9MJch7ZTpCQ7ctskbhhlp&excl;-1718864290>.

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21 Federal Court of Australia, Cancer Voices Australia and Another v Myriad Genetics and Another, 15 February 2013, [2013] FCA 65, 99 IPR 567.

22 Full Court of the Federal Court of Australia, D’Arcy v Myriad Genetics and Another, 5 September 2014, [2014] FCAFC 115, 107 IPR 478.

23 Full Court of the Federal Court of Australia, D’Arcy v Myriad Genetics and Another, 5 September 2014, [2014] FCAFC 115, 107 IPR 478.

24 Full Court of the Federal Court of Australia, D’Arcy v Myriad Genetics and Another, 5 September 2014, [2014] FCAFC 115, 107 IPR 478.

25 Patents Act 1990 (Cth), s 138(3)(b), available on the Internet at <http://www.austlii.edu.au/au/legis/cth/consol_act/pa1990109/s138.html> (last accessed on 15 March 2016).

26 Patents Act 1990 (Cth), s 18(1)(a), available on the Internet at <http://www.austlii.edu.au/au/legis/cth/consol_act/pa1990109/s18.html> (last accessed on 15 March 2016).

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40 World Trade Organization, Agreement on Trade-Related Aspects of Intellectual Property Rights or TRIPs Agreement, art. 27 Patentable Subject Matter, available on the Internet at <https://www.wto.org/english/tratop_e/trips_e/t_agm3c_e.htm#5> (last accessed on 15 March 2016).

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