3. Gene Patents
Social and ethical dimensions
3.29 The goals of the patent system, whether applied to genetic materials and technologies or other patentable subject matter, are fundamentally economic. However, as noted in Chapter 2, the social or ethical impact of gene patents cannot be ignored when considering reform of the patent system. This section examines some of the social and ethical dimensions of gene patenting, including the concerns of Indigenous peoples.
The conduct of research
3.30 Gene patents may promote genetic research by providing an incentive for investment in research and development. At the same time, it has been argued that gene patents may have a ‘chilling effect’ on research and innovation, rather than promoting them. For example, research may be hindered by researchers’ concerns about infringing patents or by difficulties in obtaining licences to use patented inventions on reasonable terms. Researchers may be reluctant to put information about research outcomes into the public domain because of concerns that this might undermine the potential to commercialise their own research.
3.31 In research areas where commercial incentives are less important, patents may be seen as creating more problems than benefits. For example, much medical research is not conducted solely to reap the commercial rewards of patenting and marketing new treatments. Rather, it is undertaken because governments, researchers and clinicians seek to improve community health. In this context, patents may drive up the cost of new products that would have been developed regardless of patent protection.
3.32 The economic rewards of patenting may channel investment into the more profitable areas of research and away from other important goods and services, such as medical treatments for rare diseases. Concerns have been raised that an increasing emphasis on the commercialisation of public sector research may skew basic research priorities. Chapter 12 discusses the general impact of gene patents on research and describes the specific subject matter and claims of gene patents that are most likely to hinder research.
Access to healthcare
3.33 Gene patents may encourage the development of new products and processes with important healthcare applications. The prospect of obtaining a patent over a new or improved diagnostic test or therapeutic product provides incentives to invest the time and resources necessary to develop the invention.
3.34 However, it is also possible that gene patenting may have an adverse impact on the cost and quality of healthcare services. A patent holder may be able to set a higher price than would otherwise apply because patents award monopoly rights over the patented product or process. A patent holder that adopts restrictive licensing practices may limit access to a particular test, therapy or drug.
3.35 Chapter 19 discusses both the use of patented genetic materials and technologies in healthcare and the implications of this for the cost and funding of healthcare. It contains several proposals for reform to address concerns about cost and access. Chapter 20 discusses the impact of gene patenting on medical genetic testing and other healthcare services.
Ethics and the grant of gene patents
3.36 Ethical concerns about gene patenting can be divided into two broad categories—ethical objections to granting patents over genetic materials, and ethical concerns about the exploitation of gene patents. This section outlines a range of ethical concerns that have been expressed about granting gene patents.
3.37 When gene patents were a relatively new phenomenon, ethical concerns focused mainly on whether it was acceptable to patent human genetic materials—although the distinction between natural and isolated genetic materials was seldom made. Concerns about whether it is ethical to patent genetic materials are no longer as prominent as they once were. In part, this may be because existing gene patents are unlikely to be revoked. Many such patents have been issued in numerous countries, including Australia, and the practice of patenting isolated human genetic materials appears to be more widely accepted.
3.38 A variety of ethical objections have been made to granting patents on human genetic materials. Although the ‘genetics horse’ may have bolted, there remain those in the community who are not persuaded that the patent system adequately takes account of ethical concerns. Many submissions to the Inquiry raised ethical objections to granting gene patents.
3.39 Critics of gene patents have asserted that these patents are morally wrong because they are incompatible with: the view that the human genome is the common heritage of humanity; respect for human dignity; self-determination and self-ownership; and certain religious beliefs.
3.40 The human genome is often described as the common heritage of humanity, a view that has been supported by the Human Genome Organisation’s (HUGO) Ethics Committee and by the United Nations Educational, Scientific and Cultural Organization (UNESCO). Patents on human genetic materials are sometimes criticised because they are thought to grant exclusive rights over this common heritage to a limited number of entities. This objection rests in part on concern for fair distribution of the benefits of genetic research. This view was expressed in a number of submissions.
3.41 Another objection to patents on genetic materials is that they may engender a lack of respect for human life and dignity. On this view, to grant a proprietary right over something suggests that it is an appropriate subject for such rights. Consequently, patents on genetic materials are thought to commodify parts of human beings by treating them as objects, or as something to be placed in the stream of commerce for financial gain. Others suggest that genetic materials have a unique significance, which requires them to be treated with special respect.
3.42 These objections rest on the principle of respect for persons and promotion of individual autonomy. Commodification of parts of human beings is ethically problematic because it might affect how we value people. It is said to be incompatible with respect for human dignity because it reduces human beings to things to which no respect is owed, and is ethically unacceptable because it precludes respect for individual autonomy. Concern about the potential commodification of the human genome was expressed in many submissions. Others emphasised the need for the human genome to be treated with particular respect. For example, Dr Graeme Suthers stated that ‘our genetic code is our heritage. It deserves this degree of respect. It is not merely a commercial resource’.
3.43 Commodification arguments have been criticised on the basis that treating parts of humans (such as natural genetic materials) as objects does not necessarily equate with treating whole persons as objects or commodifying individuals. Critics further suggest that it is not apparent that the widespread grant of patents on isolated human genetic materials has led to a change in how human beings are perceived and treated.
3.44 It has also been argued that patents over genetic materials are incompatible with respect for an individual’s self-determination because they grant ownership rights over genetic material, and consequently over parts of human beings, to someone other than the person from whom the genetic material was taken. On this view, self-determination—the right to make one’s own choices about how to live—is fundamentally linked to self-ownership—the right to choose how one’s body is used. A number of submissions objected to gene patenting on the ground that it shifted ownership of genetic material away from the person from whom it was obtained.
3.45 Critics suggest that these arguments confuse intangible intellectual property rights with physical property rights. Stephen Crespi points out that ‘intellectual property provides a quite different type of ownership and lack of clarity about this can easily skew the whole debate’ about gene patents. Patents grant intangible property rights over isolated genetic material and inventions for analysing, sequencing, manipulating or manufacturing genetic sequences. Patents do not grant physical property rights in or over parts of a person’s body, and so do not enable one person to exert control over how another individual uses his or her own body.
3.46 Patents on genetic materials are sometimes criticised on religious grounds. Some religions maintain that human worth—including the genetic basis for life—derives from the divine aspect of creation. Religious critics argue that patents on genetic materials attribute ownership of the basis of life to someone other than God, suggesting that human worth derives from something other than divine creation. In 1998, Bruce Lehman, then United States Patent Commissioner, responded to religious objections to patents by stating: ‘We are not patenting life. God, I suppose, has a patent on life. We are patenting technology’.
Ethics and the exploitation of gene patents
3.47 Increasingly, ethical concerns have focused on the exploitation of gene patents, rather than on the grant of patents. It has been suggested that individuals or groups who provide tissue samples for use in genetic research have an ethical right to control the use of those samples, or to control or share in the ownership of any patented genetic inventions resulting from the research. It has also been suggested that tissue donors have an ethical right to share in the benefits of research and development using their genetic material. This view may be based on the ethical principles of respect for the person, justice and beneficence.
3.48 The HUGO Ethics Committee has recommended that all humanity should share in, and have access to, the benefits of genetic research. It also recommended that, at a minimum, all research participants should receive information about general research outcomes and an indication of appreciation; and that profit-making entities should dedicate a percentage (for example, 1–3%) of their annual net profit to healthcare infrastructure or to humanitarian efforts.
3.49 There are several barriers to a research participant asserting a legal right to control or share in the benefits of genetic research in Australia. These include the fact that the law is uncertain about the nature of property rights in human tissue and prohibitions on the sale of human tissue in the Human Tissue Acts, which may make it unlawful to provide financial benefits in exchange for tissue donation.
3.50 The Patents Act 1990 (Cth) provides that a patent may be granted only to a limited category of persons, which does not specifically include research participants. It is possible, however, for research participants to enter into contractual arrangements with researchers that provide some form of control or benefit, in exchange for participation in a research program.
3.51 Gene patenting has led to significant concerns about research participants’ rights to control and share in the benefits of research results, as evidenced by litigation in the United States. In IP 27, the ALRC asked whether there was any need to make special provision for individuals or groups, whose genetic samples are used to make a patented invention, to benefit from any profits from the patent.
3.52 Some submissions responded that the patent system is not the appropriate vehicle to address issues of benefit sharing and control. The reasons for this view included that there are mechanisms other than the patent system to ensure that the rights of tissue donors are paramount, and because inventions generally result from researchers’ expertise, skill, time and expense.
3.53 However, some submissions stated that benefit sharing should be addressed by the patents system, for example, by introducing additional requirements for the grant of a patent. Other submissions supported some form of benefit sharing for research participants, but considered that these arrangements should be negotiated between the researcher and participant directly.
3.54 Leaving aside concerns about indigenous genetic resources (which are discussed below), the ALRC recognises that individuals and organisations who participate in genetic research may consider they have an ethical right to control or own the results of that research, or share in the benefits of the research in some way. Approaches to allowing for such control, ownership and benefit sharing could take several forms, including legal recognition as joint inventors of the patented invention, social recognition of their contribution to research and development, or some form of financial or other benefit in exchange for participation.
3.55 However, the ALRC considers that issues of control and benefit sharing are better addressed outside the patent system, for example through the established system of ethical review of medical research, and through contractual arrangements between researchers and research participants.
3.56 Indigenous peoples have expressed particular concerns about the practice that has become known as ‘bioprospecting’—that is, the collection, screening, and use for commercial purposes of indigenous knowledge, and of genetic and biological products taken from Indigenous peoples and from their land.
3.57 In Australia, an existing mechanism for ethical review of research involving Indigenous communities—including genetic research—involves the use of indigenous subcommittees working in conjunction with Human Research Ethics Committees. These subcommittees review proposed research projects to ensure that the subject group has given informed consent to the proposed project. In 2003, the National Health and Medical Research Council (NHMRC) released a new set of guidelines for ethical conduct in indigenous health research. The NHMRC has stated that, in addition to the National Statement on Ethical Conduct in Research Involving Humans, these guidelines are the authoritative statement on health research involving Aboriginal and Torres Strait Islander people.
3.58 Submissions referred to the importance of taking into account the cultural values and wishes of Indigenous people in the conduct of genetic research. Aboriginal and Torres Strait Islander Services (ATSIS) stated that Indigenous people have ‘a unique attachment to their genetic resources since they are a vital part of their spiritual and cultural existence (cosmology)’, and submitted that ‘sui generis (specific or stand alone) legislation is required to protect Indigenous peoples’ rights’ with respect to gene patenting. ATSIS suggested two fundamental principles in relation to Indigenous peoples’ participation in genetic research: (a) Indigenous people whose resources are used must be properly consulted, and their genetic material may only be used with their informed consent; and (b) Indigenous people should have a legal right to own, control the use of, and benefit fairly from, their genetic resources (including DNA extracted from skeletal remains), and any person seeking to use their resources in any way must enter into a benefit sharing agreement to do so.
3.59 Similarly, the Research Unit of the Jumbunna Indigenous House of Learning at the University of Technology, Sydney (Jumbunna) submitted that the particular relationship Indigenous people have to their genetic materials through cultural and spiritual beliefs should be acknowledged in the ALRC’s recommendations:
We hope that the rights inherent in the status as first peoples with an entitlement to self determination can be recognized within the patent system by respecting Indigenous people’s wishes in relation to past present and future collection use of their human genetic material and traditional knowledge.
3.60 Jumbunna suggested reforms to patent law that would ‘anticipate implementation of sui generis systems for the protection of Indigenous genetic materials and traditional knowledge’. It was suggested that these reforms should include: (a) an exclusion from patentability for indigenous human genetic materials, pending the development of mechanisms for protecting customary practices and indigenous rights; and (b) the incorporation of Indigenous peoples’ concerns into models for the operation of genetic databases. Jumbunna referred to the progress of indigenous working groups and committees of the Convention on Biological Diversity, the World Intellectual Property Organization (WIPO) and the World Trade Organization. It also noted Australia’s obligations under the Convention on Biological Diversity to protect indigenous genetic materials and encourage equitable benefit sharing.
3.61 The ALRC acknowledges that the preservation and management of indigenous genetic resources—and benefit sharing with respect to its exploitation—are issues of critical and growing importance, in Australia and internationally. These issues are of great breadth and extend beyond human genetic materials to plant genetics and the protection of associated traditional knowledge. Policy making in this area involves consideration of benefit sharing through contractual agreements, administrative policies, legislative measures, and multilateral instruments.
3.62 Importantly, these issues are currently being considered in international fora. An international regime to promote the fair and equitable sharing of benefits arising out of the utilisation of genetic resources is being negotiated within the framework of the Convention on Biological Diversity, to which Australia is a party. One of the objectives of the Convention on Biological Diversity is the:
fair and equitable sharing of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding.
3.63 In October 2000, WIPO established an Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore as an international forum for debate and dialogue concerning the interplay between intellectual property and traditional knowledge, genetic resources, and traditional cultural expressions (folklore). The Committee’s work is intended to complement that of other bodies, including the Secretariat of the Convention on Biological Diversity. In February 2004, a conference of the parties to the Convention directed a Working Group to ‘elaborate and negotiate an international regime on access to genetic resources and benefit-sharing’.
3.64 The issues being dealt with by these international bodies cut across conventional areas of intellectual property law and involve a much wider range of subject matter than human genetic material. It is not clear that intervening in the patents system to deal with indigenous concerns—for example, by excluding indigenous human genetic material from patentability—would usefully or coherently advance this agenda.
3.65 The ALRC has not been in a position to conduct the kind of extensive consultation and research that would have been necessary to support recommendations about gene patents and indigenous genetic resources specifically. However, the ALRC believes that social and ethical concerns can be addressed most effectively through direct regulation of the use and exploitation of patented inventions, or through regulation of research activities that lead to the development of inventions, rather than through excluding particular subject matter from patentability (see Chapter 7).
 See Intellectual Property and Competition Review Committee, Review of Intellectual Property Legislation under the Competition Principles Agreement (2000), 137.
 See House of Representatives Standing Committee on Industry Science and Technology, Genetic Manipulation: The Threat or the Glory? (1992), [7.91]–[7.96], rejecting the suggestion that patenting would distort research priorities.
 For a discussion of what is meant by ‘ethics’, see Australian Law Reform Commission, Gene Patenting and Human Health, DP 68 (2004), [3.37]–[3.42].
 Cancer Council New South Wales, Submission P1, 5 June 2003; South Australian Government, Submission P51, 30 October 2003. Some submissions disputed community acceptance of gene patenting: G Suthers, Submission P30, 2 October 2003.
 Cancer Council New South Wales, Submission P1, 5 June 2003.
 National Health and Medical Research Council, Submission P52, 31 October 2003.
 HUGO Ethics Committee, Statement on the Principled Conduct of Genetics Research (1996); Universal Declaration on the Human Genome and Human Rights, 11 November 1997, UNESCO, art 12(a).
 Nuffield Council on Bioethics, The Ethics of Patenting DNA (2002), 22–23.
 G Suthers, Submission P30, 2 October 2003; South Australian Government, Submission P51, 30 October 2003; S Karpeles, Submission P44, 20 October; Human Genetics Society of Australasia, Submission P31, 3 October 2003; Australian Association of Pathology Practices Inc, Submission P10, 24 September 2003; New South Wales Health Department, Submission P37, 17 October 2003.
 D Resnik, ‘The Morality of Human Gene Patents’ (1997) 7 Kennedy Institute of Ethics Journal 43, 55‑57.
 For example, it has been suggested that ‘body parts, including genes, are not like other materials to be owned and traded in the market place as common commodities’: Commonwealth of Australia, Parliamentary Debates, Senate, 27 June 1996, 2332 (N Stott Despoja), 2333. See also Howard Florey/Relaxin  EPOR 541, [6.4].
 N Holtug, ‘Creating and Patenting New Life Forms’ in P Singer and H Kuhse (eds), A Companion to Bioethics (1998), 206, 213.
 T Claes, ‘Cultural Background of the Ethical and Social Debate about Biotechnology’ in S Sterckx (ed) Biotechnology, Patents and Morality (2nd ed, 2000), 179, 182.
 G Suthers, Submission P30, 2 October 2003; South Australian Government, Submission P51, 30 October 2003; D McFetridge, Submission P23, 30 September 2003; Caroline Chisholm Centre for Health Ethics Inc, Submission P38, 17 October 2003; Breast Cancer Action Group NSW Inc, Submission P8, 19 September 2003; B Fenelon, Submission P68, 10 March 2004.
 G Suthers, Submission P30, 2 October 2003. See also W Neville, Submission P50, 29 October 2003; Caroline Chisholm Centre for Health Ethics Inc, Submission P38, 17 October 2003.
 D Resnik, ‘DNA Patents and Human Dignity’ (2001) 29 Journal of Law, Medicine & Ethics 152, 155‑159.
 N Hildyard and S Sexton, ‘No Patents on Life’ (2000) 15 Forum For Applied Research and Public Policy 69.
 Australian Association of Pathology Practices Inc, Submission P10, 24 September 2003; Royal College of Pathologists of Australasia, Submission P26, 1 October 2003; A Johnston, Submission P15, 30 September 2003; D McFetridge, Submission P23, 30 September 2003.
 R Crespi, ‘Patenting and Ethics: A Dubious Connection’ (2001/2002) 5 Bio-Science Law Review 71. Professor Jill McKeough has stated that ‘ownership of life’ and ‘commodification’ objections about gene patenting ‘misconceive the function and use of the patent system’: J McKeough, ‘Patenting Genetic Material: What are People Concerned about?’ (1997) 30 Intellectual Property Forum 12, 15.
 For example, in 1995 a group of religious leaders in the United States issued a public statement asserting that ‘humans … are creations of God, not humans, and as such should not be patented as human inventions’: quoted in S Goldberg, ‘Gene Patents and the Death of Dualism’ (1996) 5 Southern California Interdisciplinary Law Journal 25, 27.
 Danish Council of Ethics, Patenting Human Genes (1994), 32.
 D Slater, ‘HuMouse’, Legal Affairs, Nov-Dec 2002, 21, 26.
 Benefit sharing could take many forms, including a financial benefit (such as an upfront payment, or a share in any profits or royalties made from the patent), or access to free medical care, treatment or therapy.
 HUGO Ethics Committee, Statement on Benefit Sharing (2000).
 See Australian Law Reform Commission and Australian Health Ethics Committee, Essentially Yours: The Protection of Human Genetic Information in Australia, ALRC 96 (2003), Ch 20.
 See Human Tissue Act 1983 (NSW) s 32(1), (5) and cognate state and territory legislation.
 Patents may be granted to a person who is the inventor; would be entitled to have the patent assigned to him or her; derives title to the invention from the inventor or an assignee; or is the legal representative of a deceased person who falls within these categories: Patents Act 1990 (Cth) s 15(1).
 See, eg, Moore v Regents of the University of California 51 Cal 3d 120 (1990); Greenberg v Miami Children’s Hospital Research Institute (Unreported, District Court for the Southern District of Florida, Moreno J, 29 May 2003), discussed in Australian Law Reform Commission, Gene Patenting and Human Health, DP 68 (2004), [3.65]–[3.67].
 Australian Law Reform Commission, Gene Patenting and Human Health, IP 27 (2003), Question 4–3.
 Walter and Eliza Hall Institute of Medical Research, Submission P39, 17 October 2003; Genetic Technologies Limited, Submission P45, 20 October 2003; National Health and Medical Research Council, Submission P52, 31 October 2003.
 National Health and Medical Research Council, Submission P52, 31 October 2003.
 Queensland Government, Submission P57, 5 January 2004.
 M Rimmer, Submission P73, 15 April 2004; B Hocking, Submission P113, 3 May 2004; Australian Centre for Intellectual Property in Agriculture, Submission P81, 16 April 2004. ACIPA recommended that the Patents Act be amended to ‘provide the mandatory requirement a patent can only be granted if there was evidence of informed consent and benefit sharing’.
 Royal College of Pathologists of Australasia, Submission P26, 1 October 2003; GlaxoSmithKline, Submission P33, 10 October 2003; Genetic Technologies Limited, Submission P45, 20 October 2003; Human Genetics Society of Australasia, Submission P31, 3 October 2003; A Johnston, Submission P72, 14 April 2004.
 See generally, M Davis, Indigenous Peoples and Intellectual Property Rights (1996-7), 4. The Human Genome Diversity Project (HGDP) has been widely criticised by Indigenous peoples: M Dodson, ‘Human Genetics: Control of Research and Sharing of Benefits’ (2000) 1 Australian Aboriginal Studies 56, 56. See also T Janke, Our Culture, Our Future: Report on Australian Indigenous Cultural and Intellectual Property Rights (1998), 29.
 M Dodson, ‘Human Genetics: Control of Research and Sharing of Benefits’ (2000) 1 Australian Aboriginal Studies 56, 61.
 National Health and Medical Research Council, Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research (2003).
 National Health and Medical Research Council, National Statement on Ethical Conduct in Research Involving Humans (1999).
 The guidelines assist researchers in the conception, design and conduct of research. The guidelines are based on six values: spirit and integrity; reciprocity; respect; equality; survival and protection; and responsibility.
 Royal College of Pathologists of Australasia, Submission P26, 1 October 2003; Aboriginal and Torres Strait Islander Services, Submission P55, 4 November 2003; B Hocking, Submission P113, 3 May 2004; Research Unit of Jumbunna Indigenous House of Learning, Submission P100, 20 April 2004.
 Aboriginal and Torres Strait Islander Services, Submission P55, 4 November 2003.
 Informed consent was said to be particularly important in relation to genetic databases: Research Unit of Jumbunna Indigenous House of Learning, Submission P100, 20 April 2004.
 Aboriginal and Torres Strait Islander Services, Submission P55, 4 November 2003.
 Research Unit of Jumbunna Indigenous House of Learning, Submission P100, 20 April 2004.
 As discussed in Ch 7, the ALRC has concluded that the Patents Act should not be amended to exclude any category of genetic materials or technologies from patentable subject matter.
 Convention on Biological Diversity,  ATS 32, (entered into force on 29 December 1993).
 Research Unit of Jumbunna Indigenous House of Learning, Submission P100, 20 April 2004.
 Intergovernmental Committee on Intellectual Property and Genetic Resources Traditional Knowledge and Folklore, Initial Report on the Technical Study on Disclosure Requirement Related to Genetic Resources and Traditional Knowledge (2002), World Intellectual Property Organization, <www.wipo.int/ documents/en/meetings/2002> at 18 June 2004.
 Secretariat of the Convention on Biological Diversity, Access to Genetic Resources and Benefit-Sharing: International Regime on Access and Benefit-Sharing, <www.biodiv.org/programmes/socio-eco/ benefit/regime.asp> at 16 June 2004.
 Convention on Biological Diversity,  ATS 32, (entered into force on 29 December 1993), art 1.
 See, eg, World Intellectual Property Organization, Intergovernmental Committee (IGC), World Intellectual Property Organization, <www.wipo.int/tk/en/igc/index.html> at 16 June 2004.
 Secretariat of the Convention on Biological Diversity, Access to Genetic Resources and Benefit-Sharing: International Regime on Access and Benefit-Sharing, <www.biodiv.org/programmes/socio-eco/benefit/regime.asp> at 16 June 2004.