7.13 The existing exclusions from patentability do not place any significant constraints on the patenting of genetic materials or technologies. It has been suggested that some types of inventions involving genetic materials and technologies should not be patentable subject matter. This section discusses possible new exclusions from patentability relevant to genetic materials and technologies.
Reform proposals in Australia
7.14 One way to exclude genetic materials and technologies, or a subset of them, from patentability would be through an exclusion directed specifically to genetic inventions. Such an exclusion was proposed in 1990 during consideration of the Patents Bill 1990 (Cth). The amendment, which was rejected by the Senate Standing Committee on Industry, Science and Technology, would have presumptively excluded genes, genetic material and genetically modified organisms from patentability.
7.15 A similar amendment to the Patents Act was proposed in 1996. The proposed amendment provided that naturally occurring genes, gene sequences, or descriptions of the base sequence of a naturally occurring gene or gene sequence would not be regarded as novel or inventive for the purposes of s 18 of the Patents Act.
Reform proposals in other jurisdictions
7.16 There have been suggestions in other countries that some genetic materials should not be patentable. In 2001, the Canadian House of Commons Standing Committee on Health (the Canadian Standing Committee) expressed concern that the Patent Act 1985 (Canada) did not specifically disallow patenting of human genes, DNA sequences and cell lines. The Canadian Standing Committee recommended that the patenting of ‘human materials’ should be prohibited.
7.17 However, in general, such a sweeping approach to reform has been rejected. For example, the Ontario Government report, Genetics, Testing & Gene Patenting: Charting New Territory in Healthcare (Ontario Report) rejected the Canadian Standing Committee’s call for a complete ban on gene patents and instead suggested a range of proposals to achieve an ‘appropriate balance between the public interest in accessing the health benefits offered by genetic technologies and maintaining the economic and commercial incentives that fuel this research’.
7.18 There have also been international statements suggesting that genes and genetic sequences should be excluded from patentability. The United Nations Educational, Scientific and Cultural Organisation (UNESCO) Universal Declaration on the Human Genome and Human Rights states that ‘the human genome in its natural state shall not give rise to financial gains’. Similarly, the International Bioethics Committee of UNESCO has stated ‘there are strong ethical grounds for excluding the human genome from patentability’.
7.19 In March 2000, the European Parliament called on the European Patent Office (EPO) to ensure that patent applications in the European Union do not violate the principle of non-patentability of human genes or cells ‘in their natural environment’. This resolution, originally made in the context of concerns about human cloning, was subsequently reiterated in connection with the patenting of the BRCA1 and BRCA2 genes associated with predisposition to breast and ovarian cancer. However, as discussed in Chapter 6, genetic materials are generally considered to be patentable if they have been isolated from nature.
Submissions and consultations
7.20 In DP 68, the ALRC indicated that it did not support amending the Patents Act specifically to exclude genetic materials and technologies from patentable subject matter. Many submissions and consultations supported this position. Some submissions indicated that technology-specific exclusions from patentability are undesirable because such an approach limits the ability of patent law to adapt flexibly to new technologies as they arise. It was said that such an approach might ultimately increase the complexity and cost of obtaining patent protection. Further, a few submissions commented that technology-specific exclusions might not be effective. IP Australia submitted:
Such measures invariably lead to uncertainty over the bounds of the subject matter, involved debate over individual cases, and increased cost and uncertainty for users of the system. Such measures may eventually prove at least partially ineffective, as it may be possible to draft claims to avoid the intent of the exclusion. Defining the bounds of a technology is a non-trivial issue.
7.21 Submissions also commented on the potential negative effects of excluding genetic materials and technologies from patentability. Some submissions were concerned about the potential for detrimental effects on the biotechnology industry and the development of new genetic products and technologies, if genetic materials were not patentable. Others indicated that it would be undesirable to adopt a position that differed greatly from the approach to patenting genetic inventions in other countries.
7.22 However, a small number of submissions to the Inquiry considered that genetic materials—particularly genetic sequences—should not be patentable. In general, these submissions did not specifically endorse an amendment to exclude genetic materials from the scope of patentable subject matter. Rather, they encouraged the ALRC to review whether genetic materials should be patentable, or focused on the application of the existing patentability requirements to genetic materials and technologies—including the question whether the subject matter of some gene patents constitutes a ‘discovery’ or an invention.
7.23 In the ALRC’s view, there are significant impediments to amending the Patents Act to exclude genetic materials from patentability. In Canada, it has been said of such an exclusion that ‘the momentum of the biotech industry, the long history of patentability of gene sequences and the impact and complexity of existing international trade agreements make this, at present, an impractical and unrealistic option’.
7.24 Similar considerations apply in the Australian context. Importantly, excluding genetic materials from patentability could have detrimental effects on the Australian biotechnology industry. Jurisdictions that have substantial biotechnology research and commercialisation programs appear to agree that patents on inventions involving gene sequences should generally be permitted. While the fact that other jurisdictions generally accept patents on genetic sequences is not conclusive of the approach that should be adopted in Australia, it is reason to question whether amending the Patents Act to implement such an exclusion from patentability is desirable.
7.25 Submissions encouraged the ALRC to consider the global nature of the biotechnology industry and patent rights. The Australian biotechnology industry relies on foreign investment and partnerships with overseas entities to commercialise the results of research involving genetic materials and technologies. Australia’s adoption of a position that diverges from the general international consensus would likely have adverse implications for Australia’s participation in the global biotechnology market. For example, it might affect adversely the extent to which foreign entities participate in, and provide capital investment for, research and commercialisation of genetic materials and technologies in Australia.
7.26 Further, excluding genetic materials from patentability may conflict with Australia’s international obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights 1994 (TRIPS Agreement). As discussed in Chapter 4, the TRIPS Agreement provides that patents shall be available for any inventions, and that patent rights shall be enjoyable without discrimination as to ‘the field of technology’. Excluding genetic materials from patentability may be inconsistent with these provisions.
7.27 Even assuming that the express exclusion of genetic materials from patentability is consistent with Australia’s international obligations, it may be argued that such an exclusion would not provide a complete, or even a satisfactory, solution to the problems said to be associated with the grant of some gene patents. There would be considerable difficulty involved in defining the scope of any exclusion relating to genetic materials—for example, would proteins produced by genetic materials be covered? Excluding inventions involving gene sequences from patentability may only ‘invite patent attorneys to engage in creative drafting’.
7.28 The ALRC does not consider that the Patents Act should be amended to exclude genetic materials or technologies from patentability. Such a reform would pose a significant risk to Australia’s biotechnology industry, raise problems for Australia’s compliance with the TRIPS Agreement, and be difficult to implement effectively.
 By Senator Coulter (Australian Democrats).
 Senate Standing Committee on Industry Science and Technology, Report on the Consideration of the Patents Bill 1990 (1990), 2; Commonwealth of Australia, Parliamentary Debates, Senate, 20 September 1990, 2653 (J Coulter). The Senate Standing Committee adopted an alternate provision proposed by Senator Brian Harradine, which is now embodied in s 18(2) of the Patents Act. See further Ch 15.
 By Senator Stott Despoja (Australian Democrats): Patents Amendment Bill 1996 (Cth); Commonwealth of Australia, Parliamentary Debates, Senate, 27 June 1996, 2332 (N Stott Despoja). Senator Stott Despoja put forward the proposal again in 2001, as a proposed amendment to the Patents Amendment Bill 2001 (Cth): Commonwealth of Australia, Parliamentary Debates, Senate, 27 September 2001, 28195 (N Stott Despoja). The proposed amendments were re-tabled in 2002. There has been no further parliamentary consideration of them: Parliament of Australia, Senate Daily Bills Update, 15 June 2004, <www.aph.gov.au/parlinfo/billsnet/billsupd.pdf> at 16 June 2004.
 The terms were not defined, but the amendment was apparently intended to apply to both human and non-human genetic material.
 House of Commons Standing Committee on Health, Assisted Human Reproduction: Building Families (2001), rec 34.
 Ontario Ministry of Health and Long-Term Care, Genetics, Testing & Gene Patenting: Charting New Territory in Healthcare: Report to the Provinces and Territories (2002), iii, 31–32.
Universal Declaration on the Human Genome and Human Rights, 11 November 1997, UNESCO, art 4.
 International Bioethics Committee of UNESCO, Advice of the IBC on the Patentability of the Human Genome (2001).
 European Parliament, Bulletin EU 3-2000 Human Rights (5/11): Parliament Resolution on the Decision by the European Patent Office (EPO) with Regard to Patent No EP 695 351 Granted on 8 December 1999, <http://europa.eu.int/abc/doc/off/bull/en/200003/p102005.htm> at 16 June 2004.
 European Parliament, Bulletin EU 10-2001 Human Rights (3/9): Parliament Resolution on the Patenting of BRCA1 and BRCA2 Genes, <http://europa.eu.int/abc/doc/off/bull/en/200110/p102003.htm> at 16 June 2004.
 Australian Law Reform Commission, Gene Patenting and Human Health, DP 68 (2004), Proposal 7–1.
 Walter and Eliza Hall Institute of Medical Research, Submission P71, 13 April 2004; Medicines Australia, Submission P75, 15 April 2004; Commonwealth Department of Health and Ageing, Submission P79, 16 April 2004; Australian Centre for Intellectual Property in Agriculture, Submission P81, 16 April 2004; Royal College of Pathologists of Australasia, Submission P82, 16 April 2004; GlaxoSmithKline, Submission P85, 16 April 2004; IP Australia, Submission P86, 16 April 2004; Department of Health Western Australia, Submission P89, 16 April 2004; Department of Industry Tourism and Resources, Submission P97, 19 April 2004; Cancer Council Victoria, Submission P101, 20 April 2004; Queensland Government, Submission P103, 22 April 2004; Centre for Law and Genetics, Submission P104, 22 April 2004; G Suthers, Submission P116, 4 May 2004; Department of Industry Tourism and Resources, Consultation, Canberra, 25 March 2004; Walter and Eliza Hall Institute of Medical Research, Consultation, Melbourne, 1 April 2004.
 A McBratney and others, Submission P47, 22 October 2003; Davies Collison Cave, Submission P48, 24 October 2003.
 G Suthers, Submission P30, 2 October 2003; Human Genetics Society of Australasia, Submission P31, 3 October 2003; A McBratney and others, Submission P47, 22 October 2003.
 IP Australia, Submission P56, 4 November 2003. See also Australian Centre for Intellectual Property in Agriculture, Submission P12, 29 September 2003; Centre for Law and Genetics, Submission P104, 22 April 2004.
 Cancer Council Victoria, Submission P16, 30 September 2003; G Suthers, Submission P30, 2 October 2003.
 R Barnard, Submission P32, 7 October 2003; GlaxoSmithKline, Submission P33, 10 October 2003; Department of Industry Tourism and Resources, Submission P97, 19 April 2004.
 Department of Industry Tourism and Resources, Submission P97, 19 April 2004; Centre for Law and Genetics, Submission P104, 22 April 2004.
 D McAndrew, Submission P14, 30 September 2003; G De Ruyter, Submission P3, 14 August 2003; J Graham, Submission P5, 26 August 2003; L Palombi, Submission P28, 1 October 2003; Research Unit of Jumbunna Indigenous House of Learning, Submission P100, 20 April 2004. Luigi Palombi submitted that isolated genetic material should be excluded as patentable subject matter under the Patents Act, and that a new sui generis intellectual property right should be created (to be known as a ‘genetic sequence right’). Another submission advocated an exclusion from patentability for ‘indigenous human genetic materials’, pending the development of mechanisms for protecting customary practices and indigenous rights: Research Unit of Jumbunna Indigenous House of Learning, Submission P100, 20 April 2004.
 Caroline Chisholm Centre for Health Ethics Inc, Submission P69, 2 April 2004; Cancer Council Australia, Submission P96, 19 April 2004; Nuffield Council on Bioethics, Submission P102, 22 April 2004.
 These submissions are discussed in detail in Ch 6.
 T Caulfield and others, ‘Genetic Technologies, Health Care Policy and the Patent Bargain’ (2003) 63 Clinical Genetics 15, 16.
 D Nicol, ‘Gene Patents: The Ultimate Snatch’ (Paper presented at Hatching, Matching, Snatching and Dispatching, AIHLE 7th Annual Conference, Newcastle, 27–30 June 2002), 9; D Nicol and 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, 232.
 G Suthers, Submission P30, 2 October 2003; Human Genetics Society of Australasia, Submission P31, 3 October 2003; GlaxoSmithKline, Submission P33, 10 October 2003; S Karpeles, Submission P44, 20 October; A McBratney and others, Submission P47, 22 October 2003; South Australian Government, Submission P51, 30 October 2003; Queensland Government, Submission P57, 5 January 2004; AusBiotech Ltd, Submission P58, 7 November 2003; D Weston, Submission P62, 12 November 2003; Department of Industry Tourism and Resources, Submission P97, 19 April 2004; Centre for Law and Genetics, Submission P104, 22 April 2004.
Agreement on Trade-Related Aspects of Intellectual Property Rights (Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization),  ATS 8, (entered into force on 1 January 1995).
 TRIPS Agreement, art 27(1). A similar provision is included in Australia and United States, Australia–United States Free Trade Agreement, 18 May 2004, art 17.9.1.
 D Nicol, ‘Gene Patents: The Ultimate Snatch’ (Paper presented at Hatching, Matching, Snatching and Dispatching, AIHLE 7th Annual Conference, Newcastle, 27–30 June 2002), 9; D Nicol and 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, 161.
 D Nicol and 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, 232. See also IP Australia, Submission P56, 4 November 2003.