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JOHN PAUL HINOJOSA[*]
‘The human genome is the heritage of humanity’[1]
This article highlights the revolutionary and dramatic implications brought about by the advances in genetics. Among the myriad of legal problems involved, gene patenting is regarded as one of the most controversial. In a critical evaluation of the current inquiry into gene patenting and human health, the author argues that the Australian Law Reform Commission falls short of a thorough recommendation by failing to grant due recognition to the Universal Declaration on the Human Genome and Human Rights. Starting with the fundamental premise that the human genome is the ‘heritage of humanity’, it is argued that the fruits of genetic research must flow back to humankind, and any law reform process must thereby ensure that the economic and health benefits of genetic research are available to all. Specifically, the Patents Act 1990 (Cth) should be amended to include the ‘medical treatment’ defence to patent infringement, following the lead of overseas jurisdictions. It should also incorporate an ‘experimental use’ defence to ensure an unhindered approach to research and development. In doing so, the patent law regime will be truly balancing the interests at stake, which will accommodate more fully Australia’s domestic needs and international obligations.
Few developments in science have had the impact on society, institutions, laws, and health care that genetics is having and, undoubtedly, will continue to have. We already have glimpses of what may come: a cure for cancer and many of the more than 4000 genetic diseases that afflict mankind;[2] cracking the ‘ageing’ gene;[3] and designing individuals to specification.[4] The Human Genome Project, one of the greatest scientific enterprises in history, has signalled the commencement of a new era in science. The revolutionary and dramatic implications of genetic research cannot be understated. The myriad of legal problems these developments entail have prompted ample discussion and a variety of responses from governments and institutions.[5] Among these legal problems, patenting is regarded as one of the most controversial issues raised by advances in genetics.[6] The Australian Government has therefore recently commissioned the Australian Law Reform Commission (ALRC) to review the intellectual property issues associated with genetic information. The aim of this paper is to evaluate critically this current inquiry into gene patenting and human health.[7] We seek to assess the extent to which the recommendations by the ALRC are consistent with the fundamental premise that the human genome is the ‘heritage of humanity’, as envisaged in the Universal Declaration on the Human Genome and Human Rights.[8] In particular, this paper argues that the Patents Act 1990 (Cth) should be amended to include the ‘experimental use’ and ‘medical treatment’ defences to patent infringement.
In December 2002, in the course of an inquiry into the Protection of Human Genetic Information,[9] the Attorney–General commissioned the ALRC to undertake a comprehensive review of whether Australia’s intellectual property
laws could cope with the rapid advances in genetic science and technology, with a particular focus on human health issues. The inquiry is certainly welcome news: many argue that patent law is struggling to meet the challenges posed by the advent of biotechnology.[10] Our patent law regime was designed close to 400 years ago,[11] for a ‘bricks and mortar world’,[12] when genetic information only existed in nature. Furthermore, the acquisition of proprietary rights in aspects of the human genome and its downstream products promises to be ‘the gold rush of the twenty-first century’.[13] A review was therefore imperative. The inquiry is comprehensive and complex. The Discussion Paper released includes 49 proposals and poses 19 questions. However, at this stage, the ALRC has not found real evidence that a radical overhaul of the patents system is warranted.14
In November 1997 the General Conference of UNESCO adopted the Universal Declaration on the Human Genome and Human Rights.[15] The Declaration is a major achievement in itself and is said to be ‘the first attempt of the international community to state the broad principles that should govern ethical and legal responses to which the Human Genome Project will give rise’.[16] Many of its articles have critical implications to any law reform process concerned with gene patenting.[17] It is thus rather discouraging that the ALRC has only given minor consideration to the Universal Declaration in its Discussion Paper. The Universal Declaration disappointingly receives no consideration in the chapter dedicated to consider Australia’s international obligations. It is submitted here that the ALRC should give greater weight to the Declaration and it should form part of the framework for law reform. By doing so Australia would ensure that it fulfils its obligation to promote the principles set forth in the Universal Declaration.[18]
The Universal Declaration begins with the fundamental premise that the genome is the ‘property of all’:
Article 1: The human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity.
This view has received widespread support.[19] But one may ask: what exactly does it mean that the human genome is the ‘heritage of humanity’ and what consequences flow from this assertion? Do we own it as tenants in common, all six or seven billion of us? And, what exactly do we own? One must begin by noting that the Declaration qualifies the fundamental premise by stating that the human genome, in a symbolic sense, is the heritage of humanity. One could thus argue that article 1, as such, does not have any direct legal application. Yet, the fundamental premise in article 1 must be of some consequence. It is more than a simple metaphor.[20] It is therefore here submitted that the concept that the human genome is the ‘heritage of humanity’ has the following two applications:
(a) Since the human genome belongs to humankind, it must follow that all the rights and benefits associated with research on the human genome, and any downstream applications derived from it, also belong to humankind. An analogy may help: when a person owns land, that person also owns the fruits of the land. The law must therefore ensure that the fruits of research in the human genome eventually reach their true owners: humankind.
(b) The human genome as the ‘property of all’ is a concept that underlies the rest of the articles in the Universal Declaration and therefore has indirect, but practical, applications. Article 4, for instance, provides that ‘the human genome in its natural state shall not give rise to financial gains’.
A patent law system is said to be in the interests of the public good in that ‘it stimulates industrial invention by granting limited monopoly rights to inventors and by increasing public availability of information on new technology’.[21] From an economic perspective it is the result of a cost-benefit analysis. Monopolies are an undesirable cost to society. But the benefits, in terms of progress and innovation, outweigh the cost of a monopoly. It may appear scandalous to suggest that a private corporation might one day have monopoly rights for 20 years on the cure for cancer. Yet, without a patent incentive, it may take hundreds of years longer to find the cure for cancer.
If the human genome is the ‘heritage of humanity’, and thus the ‘property of all’, does it follow that no monopoly rights should be granted over genetic materials and technologies? Some suggest that they should be completely excluded from patentability:[22] ‘genes are our collective property and should not be subject to ownership by individual intellectual property rights’.[23] However, this would ignore the reality that a fine-tuned patents regime may bring about more health and economic benefits to society sooner and better. Furthermore, to exclude genetic materials and related technologies from patentability could have detrimental effects on the Australian biotechnology industry.[24] It may also conflict with Australia’s international obligations under the Agreement on Trade Related Aspects of Intellectual Property Rights 1994.[25] The ALRC has therefore proposed that the Patents Act 1990 (Cth) should not be amended specifically to exclude genetic materials or technologies from patentability.[26]
It should also be noted that in Australia and most other jurisdictions patent law distinguishes between a gene in situ (in its natural state) and a gene that has been extracted from the body by a process of isolation and purification.[27] The former is not patentable subject matter. This distinction, in our view, marks a distinct boundary, consistent with the premise that ‘in its natural state the human genome shall not give rise to financial gains’.[28] It strikes the right balance between the notion of the human genome as ‘property of all’ and the convenience of granting intellectual property protection over genetic materials and technologies to further innovation and improve health.
The idea of the human genome as ‘property of all’ is thus consistent with intellectual property rights over genetic materials and technologies. However, it should be recalled that a patent law regime is the result a balancing exercise. Costs are weighed against benefits. The role of the current ALRC inquiry is precisely to identify the avoidable costs of gene patenting. The ALRC has correctly identified in its Discussion Paper two major areas of concern: access to health care and detrimental effects on scientific research. Underlying these concerns is the fundamental problem of ‘ensuring that the benefits of the completion of the first draft of the human genome sequence should be available to all humanity’.[29] In the next sections we explore these specific concerns, and we comment on possible solutions by amending the Patents Act 1990 (Cth).
Gene patenting can clearly have a detrimental effect on access to health care. It may lead to restricted availability and prohibitive costs of genetic testing, genetic therapy and pharmacogenetics, many which may be critical to public health.[30] In the complex area of health and patents, there can be clear overriding considerations in the interest of public health that may tip the balance against intellectual property rights. Humankind, the true owner of the human genome, must have access to the all health benefits brought about by genetic research and technology. Thus the Universal Declaration specifies that the applications of genetic research shall seek to offer relief from suffering and improve the health of individuals and human kinds as a whole.31 All Australians, rich and poor, must have equitable access to genetic testing and treatment.
The case of patenting BRCA1, the breast cancer gene, is often cited as an example confirming the fears that gene patents will restrict access to health care.[32] A private corporation, Myriad Genetic, currently holds various patents over genes, gene sequences and genetic tests associated with breast cancer. The patents on BRCA1 have led to a threefold, and in some instances higher, increase in the cost of genetic testing for breast cancer and have substantially restricted the number of laboratories able to provide the tests.[33] Similar criticisms have been made about Chiron Corporation’s patents over hepatatis C virus.[34]
While the ALRC has identified these potential problems, it has formed the view, based on submissions and consultation, that there is limited evidence to date that gene patents and licensing practices have had any significant adverse impact on the cost of healthcare provision in Australia.[35] Therefore, no legislative amendment is recommended. The recommendations so far canvassed concentrate on encouraging Commonwealth, state and territory health departments to undertake new roles in monitoring and challenging gene patents.[36] This, with respect, is a disappointing outcome. First, health departments already have the major burden of looking after public health. To ask them to divert time and resources to go to court in order to litigate and challenge patents is an inadequate solution. Secondly, the ALRC is basing its recommendations on past and present evidence. But law reform must concern the future. In the area of genetics, which arguably is in its infant stage, it is crucial to have regard for what the future may bring. It is not good policy to have to wait for a disaster to demonstrate that reform is needed.
In our view, introducing a ‘medical treatment’ defence is a suitable reform option. In broad terms, a statutory medical treatment defence would prevent patent holders from bringing an action for infringement against medical practitioners for providing medical services to patients. It would include diagnostic, therapeutical and surgical methods of treatment. The United States introduced a medical treatment defence in 1996.[38] Other jurisdictions, such as the United Kingdom,[39] New Zealand,40 and the Canadian province of Ontario,[41] provide even wider protection by excluding medical treatment from the scope of patentable subject matter. The ALRC, at this stage, is reluctant to recommend the introduction of a medical treatment defence.[42]
It is here submitted that a medical treatment defence should be included in the Patents Act 1990 (Cth), as part of Australia’s commitment to the Universal Declaration. As was discussed above, it is crucial that the benefits of genetic research flow to all humankind, the owners of the human genome. The case is at its strongest in the area of health care. A medical treatment defence will ensure that the applications of genetic research will offer relief from suffering and improve the health of individuals and humankind as a whole. Without a medical treatment defence we run the risk of restricting access to the benefits of genetic research, which should be for all, and not only for those with healthy pockets.
Another major concern over gene patents is that they may have a ‘chilling effect’ on the conduct of research. Justice Michael Kirby has correctly noted that the tradition of science has been turned ‘from a discipline that was open, at least in the field of pure science, to one which is now significantly affected by intellectual property imperatives’.[43] The adverse effect of patents is that research may be hindered by researchers’ concerns about infringing patents or about the difficulties of obtaining licenses to carry out research on patented inventions.
Research in genetics is essentially cumulative: ‘much basic research forms the foundation for later research and there are many steps between initial pioneering research … and end products’.[44] Thus, the patent system may in fact create a ‘patent thicket’ that researchers must hack their way through in order to carry out further research and eventually commercialise new technology.[45] This leads to deterioration in the open exchange of information, high transactional costs and inhibition of research.[46] The case of the BRCA1 gene patent has also been considered as an example of patents hindering further research into genetic tests and treatment of breast cancer.[47]
The Universal Declaration recognises that scientific knowledge can only move forward in an environment of intellectual freedom.[49] An ‘experimental use’ defence, it is here submitted, would effectively address the concern that patents may hinder research. Such a defence would protect researchers from claims of patent infringement based on the use of a patented invention to study or experiment on the subject matter of the invention. It is unclear whether such a defence exists at common law in Australia.[50] An experimental use defence is currently recognised in many jurisdictions.[51] The ALRC has thus recommended amending the Patents Act 1990 (Cth) to introduce an ‘experimental and research use’ defence.[52]
A number of justifications have been canvassed supporting the introduction of the experimental use defence.[53] In this paper we would like to highlight that this law reform proposal is commendable in that it is consistent with the fundamental premise that the human genome is ‘property of all’ and the underlying principle of freedom of research. According to the Human Genome Organisation Ethics Committee:
The collaboration between individuals, populations and researchers in the free flow, access, and exchange of information is essential not only to scientific progress but also for the present or future benefit of all participants.54
Furthermore, by introducing the defence, Australia will comply with article 12 of the Universal Declaration, which provides that states should take appropriate steps to provide the framework for the free exercise of research on the human genome.
The ALRC was asked to examine ways in which the patent system can be changed to ‘further the health and economic benefits of genetic research’.[55] But one may ask: whose benefits are to be furthered? The economic benefits of private corporations? The health benefits of wealthy individuals? This paper has highlighted the fundamental premise that the human genome is the ‘heritage of humanity’ and thus the fruits of genetic research must flow back to humankind. Any law reform process must conform to this premise and therefore ensure that the economic and health benefits of genetic research are available to all. In the proposed ‘experimental use’ and ‘medical treatment’ defences, Australia now has the opportunity of guaranteeing freedom of research and equitable access to health care. It is our hope that, in reforming the law of patents, our legislators will strike the right balance so as to bring about more health and economic benefits to all: sooner and better.
* BCom (UNSW), LLB Student, Faculty of Law, University of Sydney. The author wishes to thank Joellen Riley for much appreciated assistance and comments to this article.
[1] United Nations Educational, Scientific and Cultural Organization (UNESCO) Universal Declaration on the Human Genome and Human Rights, 11 November 1997 (hereinafter Universal Declaration). See also Human Genome Organisation Ethics Committee, Statement On The Principled Conduct Of Genetics Research (1996).
[2] See, for example, Ross Grant, Can Genetic Research Yield Cancer Cure?: <http://www.hon.ch/ News/ HSN/ 512232.html> (11 April 2003); and Human Genome Project Information, Understanding Our Genetic Inheritance: The US Human Genome Project: <http:// www.ornl.gov/sci/ techresources/Human_Genome/project/project.shtml> (29 October 2003).
[3] BBC News World Edition, Science Closing in on Ageing Gene: <http://news.bbc.co.uk/2/hi/ health/3483431.stm> (13 February 2004).
[4] Peter Aubusson & Eileen Kennedy, Biology in Context: The Spectrum of Life (2000) at 398.
[5] Some of the legal areas affected by genetics include: privacy law, medical law, intellectual property, discrimination law, employment law, insurance law, human rights law, family law, and criminal law. The Modern Law Review has devoted an entire issue to consider the broad range of legal problems presented by the Human Genome: see Modern Law Review, Volume 61: Issue 5, September (1998).
[6] Anne Finlay, ‘Gene Patenting: Seeking Benefits for All’ (2003) 82 Reform 52 at 53.
[7] The Australian Law Reform Commission released an issues paper in July 2003: Australian Law Reform Commission, Gene Patenting and Human Health: Issues Paper 27 (Sydney: ALRC, 2003) (hereinafter Issues Paper). It then released a discussion paper in February 2004: Australian Law Reform Commission, Gene Patenting and Human Health: Discussion Paper 68 (Sydney: ALRC, 2004) (hereinafter Discussion Paper). The ALRC is due to release the final report to the Attorney–General on 20 June 2004.
[8] Universal Declaration, above n1.
[9] Australian Law Reform Commission & Australian Health Ethics Committee, Essentially Yours: The Protection of Human Genetic Information in Australia, No 96 (2003).
[10] Julia Black, ‘Regulation as Facilitation: Negotiating the Genetic Revolution’ (1998) 61 Mod LR 621 at 646.
[11] The origins of our patent law regime can be traced back to the Statute of Monopolies (1623) 21 Jac 1 c3, which continues to have relevance in Australian patent law today: see Patents Act 1990 (Cth) s18(1)(a). Our current patent law regime has been substantially reformed since 1623, however no single piece of reform has addressed the issues raised by gene patenting.
[12] Rebecca Eisenberg, ‘Re-examining the Role of Patents in Appropriating the Value of DNA Sequences’ (2000) 49(3) Emory Law Journal 783 quoted in Luigi Palombi, ‘Patentable Subject Matter, TRIPS and the European Biotechnology Directive: Australia and Patenting Human Genes’ [2003] UNSWLawJl 53; (2003) 26(3) UNSWLJ 782 at 792.
[13] A Haas, ‘The Welcome Trust’s Disclosures of Gene Sequence Data into the Public Domain & the Potential for Proprietary Rights in the Human Genome’ (2001) 16 Berkeley Tech LJ 145 at
[145] .
[14] Australian Law Reform Commission, Press Release: ALRC Inquiry Reveals Confusion, Anxiety
Over Gene Patents (4 March 2004).
[15] Universal Declaration, above n1.
[16] Michael Kirby, ‘Genomics and Democracy – A Global Challenge’ [2003] UWALawRw 1; (2003) 31 (1) UWALR 1 at 8.
[17] Articles 1, 4, & 12–19 of the Universal Declaration, above n1, have direct implications on gene patenting law.
[18] Universal Declaration, above n1, Art 22: ‘States should make every effort to promote the principles set out in this Declaration and should, by means of all appropriate measures, promote their implementation.’
[19] It has been supported by the Council of Europe Parliamentary Assembly: Recommendation No 1425: Biotechnology and Intellectual Property (23 September 1999) rec 10; the Human Genome Organisation’s Ethics Committee: above n1; the United Kingdom’s Nuffield Council of Bioethics: The Ethics of Patenting DNA (2002) at 22–23; and numerous submissions to the ALRC inquiry: Discussion Paper, above n7.
[20] See suggestions by Professor Ryushi Ida in Michael Kirby, above n16 at 10–11.
[21] Patents Amendment Bill 1981 (Cth) (Second Reading Speech).
[22] See Patents Amendment Bill 1996 (Cth); Natasha Stott Despoja, Commonwealth of Australia, Parliamentary Debates (Hansard), Senate, 27 June 1996, 2332. See also submissions in Discussion Paper, above n 7 at 181–182.
[23] Geraldine Chin, ‘Is Gene Patenting in the Interests of Public Health? A Study of the Ethical and Public Policy Implications of Patenting Gene Sequences’ [1999] ALSA Academic Journal 1 at 5.
[24] See Discussion Paper, above n7 at 182; Dianne Nicol & J Nielsen, Patents and Medical Biotechnology: An Empirical Analysis of Issues Facing the Australian Industry (2003) Centre for Law and Genetics Occasional Paper No 6 at 232. It may also be detrimental to the Australian Government’s current strategy for promoting research, development and innovation: see Commonwealth of Australian, Backing Australia’s Ability: An Innovation Action Plan for the Future (Canberra: 2001).
[25] See Discussion Paper, above n7 at 183.
[26] See Proposal 7–1 in Discussion Paper, above n 7 at 184.
[27] Kiren-Amgen Inc v Board of Regents of the University of Washington [1995] APO 61; (1995) 33 IPR 557. See also Discussion Paper, above n7 at 127–131.
[28] Universal Declaration, above n1 Article 4.
[29] Michael Kirby, ‘The Human Genome and Patent Law’ (2001) 79 Reform 10 at 11.
[30] UNESCO, ‘The Human Genome and the Patent Boom Challenge’, Press Release, 11 September 2001: <http://www.unesco.org/bpi/eng/unesco – press/2001/01 – 97e.shttml> (6 January 2003).
[31] Universal Declaration, above n1, art 12(b).
[32] Anne Finlay, above n6 at 56; Dianne Nicol, ‘Gene Patents and Access to Genetic Tests’ (2003) 11(7) Australian Health Law Bulletin 73; and Matthew Rimmer ‘Myriad Genetics: Patent Law and Gentic Testing’ [2003] 1 European Intellectual Property Review 20.
[33] Rimmer, above n32 at 28; and Nicol, above n 32 at75.
[34] Chin, above n23.
[35] Discussion Paper, above n7 at 602.
[36] The ALRC has also canvassed other proposals that may indirectly address concerns over access to healthcare. For example, changes to Patent Office Practices; and clarification of the Crown use and compulsory licensing provisions in the Patents Act.
[37] For a comprehensive discussion of the medical treatment defence see Discussion Paper, above n7, chapter 22: Medical Treatment Defence.
[38] 35 USC–287(c).
[39] See Patents Act 1997 (UK) s4(2).
[40] See Wellcome Foundation Ltd v Commissioner of Patents [1893] 2 NZLR 385.
[41] See Canadian Patent Office, Manual of Patent Office Practice (1998) [16.04(b)].
[42] See Discussion Paper, above n7 at 616–617.
[43] Michael Kirby, above n29 at 11.
[44] D Nicol & J Nielsen, quoted in Discussion Paper, above n7 at 346.
[45] Advisory Council on Intellectual Property, Patents and Experimental Use: Issues Paper (Canberra: 2004) at 14. See also Michael Helter and Rebecca Eisenberg, ‘Can Patents Deter Innovation? The Anticommons in Biomedical Research’ (1998) 128 Science 689.
[46] Kate Murahige, ‘Patents and Research – An Uneasy Alliance’ (2002) 77 (12) Academic Medicine 1329.
[47] Rimmer, above n32 at 27–28.
[48] For a comprehensive discussion of the experimental use defence see Discussion Paper, above n7, chapter 14: Experimental and Research Use Defences; Craig Smith, ‘Experimental Use Exception to Patent Infringement – Where Does Australia Stand?’ (2003) 53 Intellectual Property Forum 14.
[49] Universal Declaration, above n1, art 14. See also M Kirby, ‘Human Genome Project – Legal Issues’, paper presented at the Australian Lawyers’ Conference (Hanoi, Vietnam) 10–12 July 1999.
[50] Smith, above n 48; Discussion Paper above n7 at 378–380.
[51] United Kingdom: Patents Act 1977 (UK) s60(5); New Zealand: Smith Kline & French Laboratories v Attorney General (NZ) [1991] 2 NZLR 560; United States: RocheProducts Inc v Bolar Pharmaceutical Co [1984] USCAFED 216; (1984) 733 F 2d 858; Canada: Micro Chemicals Ltd v Smith Kline & French Inter-American Corporation (1971) 25 DLR (3d) 79.
[52] Discussion Paper, above n7, proposal 14–1 at 412.
[53] See Craig Smith, above n48 at 15–18; Discussion Paper, above n7 at 395–398.
[54] Human Genome Organisation Ethics Committee, above n1.
[55] Attorney–General, Terms of Reference: Intellectual Property Rights Over Genetic Materials and Genetic and Related Technologies, in Discussion Paper above n7.
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