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Gene Patents and Cancer Voices Author: Matthew Rimmer EAP Date (Approved for Print): 11 December 2013 DOI: 10.5778/JLIS.2013.22.Rimmer.1

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Gene Patents and Cancer Voices Author: Matthew Rimmer EAP Date (Approved for Print): 11 December 2013 DOI: 10.5778/JLIS.2013.22.Rimmer.1 Title: The Empire of Cancer: Gene Patents and Cancer Voices Author: Matthew Rimmer EAP Date (approved for print): 11 December 2013 DOI: 10.5778/JLIS.2013.22.Rimmer.1 Note to users: Articles in the ‘Epubs ahead of print’ (EAP) section are peer reviewed accepted articles to be published in this journal. Please be aware that although EAPs do not have all bibliographic details available yet, they can be cited using the year of online publication and the Digital Object Identifier (DOI) as follows: Author(s), ‘Article Title’, Journal (Year), DOI, EAP (page #). The EAP page number will be retained in the bottom margin of the printed version of this article when it is collated in a print issue. Collated print versions of the article will contain an additional volumetric page number. Both page citations will be relevant, but any EAP reference must continue to be preceded by the letters EAP. ISSN-0729-1485 Copyright © 2013 University of Tasmania All rights reserved. Subject to the law of copyright no part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means electronic, mechanical, photocopying, recording or otherwise, without the permission of the owner of the copyright. All enquiries seeking permission to reproduce any part of this publication should be addressed in the first instance to: The Editor, Journal of Law, Information and Science, Private Bag 89, Hobart, Tasmania 7001, Australia. [email protected] http://www.jlisjournal.org/ Electronic copy available at: http://ssrn.com/abstract=2368067 Electronic copy available at: http://ssrn.com/abstract=2368067 The Empire of Cancer: Gene Patents and Cancer Voices * MATTHEW RIMMER ‘The empire of cancer spread/across the wrinkled sheets.’ Derek Walcott, Omeros1 In his book, The Emperor of All Maladies, Siddhartha Mukherjee writes a history of cancer — ‘It is a chronicle of an ancient disease — once a clandestine, “whispered-about” illness — that has metamorphosed into a lethal shape-shifting entity imbued with such penetrating metaphorical, medical, scientific, and political potency that cancer is often described as the defining plague of our generation’.2 Increasingly, an important theme in the history of cancer is the role of law, particularly in the field of intellectual property law. It is striking that a number of contemporary policy debates over intellectual property and public health have concerned cancer research, diagnosis, and treatment.3 In the area of access to essential medicines, there has been much debate over Novartis’ patent application in respect of Glivec, a treatment for leukaemia.4 India’s Supreme Court held that the Swiss company’s patent application violated a safeguard provision in India’s patent law designed to stop evergreening.5 In the field of tobacco control, the Australian Government introduced plain * Dr Matthew Rimmer (BA/LLB ANU, Phd UNSW) is an Australian Research Council Future Fellow; an Associate Professor at the ANU College of Law; and an Associate Director of the Australian Centre for Intellectual Property in Agriculture (ACIPA). 1 Derek Walcott, Omeros, (Noonday Press, 1992). 2 Siddhartha Mukherjee, The Emperor of All Maladies: A Biography of Cancer, (Fourth Estate, 2011) xiii. 3 Antony Taubman, A Practical Guide to Working with TRIPS, (Oxford University Press, 2011). 4 ‘Protecting Patents or Patients?’, Inside Story, Al Jazeera (online) 2 April 2013, <http://www.aljazeera.com/programmes/insidestory/2013/04/201341112023248 57.html>. 5 Novartis AG v Union of India (2013), Supreme Court of India, Civil Appeal Nos 2706-2716, 2013, <http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212>. For a commentary, see Hans Lofgren, ‘India’s Novartis Patent Ruling Puts Health Before Profits’, The Conversation (4 April 2013) <http://theconversation.com/indias-novartis-patent-ruling-puts-health-before- profits-13198>. EAP 1 The Empire of Cancer: Gene Patents and Cancer Voices packaging for tobacco products in order to address the health burdens associated with the tobacco epidemic.6 This regime was successfully defended in the High Court of Australia.7 In the area of intellectual property and biotechnology, there have been significant disputes over the Utah biotechnology company Myriad Genetics and its patents in respect of genetic testing for BRCA1 and BRCA2, which are related to breast cancer and ovarian cancer. The Federal Court of Australia handed down a decision on the validity of Myriad Genetics’ patent in respect of genetic testing for BRCA1 in February 2013.8 The Supreme Court of the United States heard a challenge to the validity of Myriad Genetics’ patents in this area in April 2013, and handed down a judgment in July 2013.9 Such disputes have involved tensions between intellectual property rights, and public health.10 This article focuses upon one of these important test cases involving intellectual property, public health, and cancer research. In June 2010, Cancer Voices Australia and Yvonne D’Arcy brought an action in the Federal Court of Australia against the validity of a BRCA1 patent11 — held by Myriad Genetics Inc, the Centre de Recherche du Chul, the Cancer Institute of Japan and Genetic Technologies Limited.12 Yvonne D’Arcy — a Brisbane woman who has had treatment for breast cancer — maintained: ‘I believe that what they are doing is morally and ethically corrupt and that big companies should 6 Tobacco Plain Packaging Act 2011 (Cth). 7 JT International SA v Commonwealth of Australia; British American Tobacco Australasia Limited v The Commonwealth [2012] HCA 43; Matthew Rimmer, ‘Cigarettes will Kill You: The High Court of Australia and the Plain Packaging of Tobacco Products’ (2013) 1 WIPO Magazine 20 <http://www.wipo.int/wipo_magazine/en/2013/01/article_0005.html>; Sam Ricketson, ‘Plain Packaging Legislation for Tobacco Products and Trade Marks in the High Court of Australia’ (2013) 3(3) Queen Mary Journal of Intellectual Property 224; and Jonathan Liberman, ‘Plainly Constitutional: The Upholding of Plain Tobacco Packaging by the High Court of Australia’, (2013) American Journal of Law and Medicine 361. 8 Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65. 9 Materials associated with the case are documented here: Association for Molecular Pathology v Myriad Genetics Inc (2013), the Supreme Court of the United States, 12- 398 <http://www.scotusblog.com/case-files/cases/association-for-molecular- pathology-v-myriad-genetics-inc>; and the judgment is here: Association for Molecular Pathology v Myriad Genetics, Inc, 133 S Ct 2107 (2013). 10 Thomas Pogge, Matthew Rimmer and Kim Rubenstein (eds), Incentives for Global Public Health: Patent Law and Access to Medicines (Cambridge University Press, 2010). 11 Donna Shattuck-Eidens, Jacques Simard, Francine Durocher, Yusuke Nakamura, and Mitsuri Emi (inventors) and Myriad Genetics Inc (Assignee), ‘In vivo mutations and polymorphisms in the 17q-linked breast and ovarian cancer susceptibility gene’, (1994) Australian Patent number 686004. 12 Cancer Voices Australia et al v Myriad Genetics Inc et al (2010), Federal Court of Australia, Statement of Claim, 8 June. EAP 2 Journal of Law, Information and Science Vol 22(2) 2012-2013 not control any parts of the human body.’13 She observed: ‘For my daughter, I've had her have [sic] mammograms, etc, because of me but I would still like her to be able to have the test to see if the mutation gene is in there from me.’14 The applicants made the following arguments: Genes and the information represented by human gene sequences are products of nature universally present in each individual, and the information content of a human gene sequence is fixed. Genetic variations or mutations are products of nature. The isolation of the BRCA1 gene mutation from the human body constitutes no more than a medical or scientific discovery of a naturally occurring phenomenon and does not give rise to a patentable invention.15 The applicants also argued that ‘the alleged invention is not a patentable invention in that, so far as claimed in claims 1–3, it is not a manner of manufacture within the meaning of s 6 of the Statute of Monopolies’.16 The applicants suggested that ‘the alleged invention is a mere discovery’.17 Moreover, the applicants contended that ‘the alleged invention of each of claims 1–3 is not a patentable invention because they are claims for biological processes for the generation of human beings’.18 The applicants, though, later dropped the argument that the patent claims related to biological processes for the generation of human beings. In February 2013, Nicholas J of the Federal Court of Australia considered the case brought by Cancer Voices Australia and Yvonne D’Arcy against Myriad Genetics. The judge presented the issues in the case, as follows: The issue that arises in this case is of considerable importance. It relates to the patentability of genes, or gene sequences, and the practice of “gene patenting”. Briefly stated, the issue to be decided is whether under the Patents Act 1990 (Cth) a valid patent may be granted for a claim that covers naturally occurring nucleic acid — either deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) — that has been “isolated”. In this context, the word “isolated” implies that naturally occurring nucleic acid found in the cells of the human body, whether it be DNA or RNA, has 13 Meredith Griffiths, ‘Breast Cancer Sufferers Take Gene Patents to Court’, AM ABC (8 June 2010) <http://www.abc.net.au/am/content/2010/s2921053.htm>. 14 Ibid. 15 Cancer Voices Australia et al v Myriad Genetics Inc et al (2010), Federal Court of Australia, Statement of Claim, 8 June. 16 Ibid. 17 Ibid. 18 Ibid. EAP 3 The Empire of Cancer: Gene Patents and Cancer Voices been removed from the cellular environment in which it naturally exists and separated from other cellular components also found there. The genes found in the human body are made of nucleic acid.
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