ALRC’s views

12.78 The ALRC believes that there is little evidence that gene patents have had any significant adverse effect to date on the conduct of genetic research in Australia. Consistently with the conclusions of a literature review conducted in 2003 for the United Kingdom Department of Health, the evidence that does exist is limited and anecdotal.[103] In relation to concerns about the impact of a proliferation of fragmented and overlapping patent rights on biotechnology research, it has been stated that ‘five years on from its publication, there is no evidence to support the existence of Heller and Eisenberg’s tragedy of the anticommons on anything other than an anecdotal scale’.[104]

12.79 International empirical studies suggest that patent holders and those in the research and biotechnology sectors are capable of developing ‘a robust combination of working solutions’ for dealing with problems that emerge.[105] These solutions sometimes take time to work out, and may not be optimal, but research generally moves forward.

12.80 However, the current position may change, particularly if patent holders become more active in enforcing patent rights. It is not possible to rule out future problems, including those resulting from patents currently under review, court decisions, new technology, and assertions of patents on foundational discoveries.[106] While this potential justifies ongoing monitoring of the position, it is difficult to assess the nature and extent of future problems for the conduct of genetic research, and whether existing legal mechanisms to address them provide appropriate and effective remedies.

12.81 In view of the equivocal nature of evidence about any present or future impact on research, the ALRC considers that it should adopt a cautious approach towards recommending radical changes in patent law and practice in this area. However, the ALRC’s recommendations are intended to result in a pattern of laws and practices that is flexible enough to anticipate and respond to future problems. Some of these reforms are intended to ensure that problems are identified at an early stage, for example, through the monitoring activities of the Human Genetics Commission of Australia (Chapter 19). Other recommendations encourage the use of existing mechanisms through which problems might be addressed if they emerge.

12.82 In particular, in Chapter 19, the ALRC recommends that, where particular gene patent applications, granted patents or patent licensing practices are considered to have an adverse impact on medical research, Commonwealth, state and territory health departments should consider whether to exercise any existing legal options to facilitate access to the inventions.[107] These existing mechanisms include rights of Crown use and compulsory licensing under the Patents Act 1990 (Cth) (Patents Act),[108] and recourse to laws dealing with anti-competitive conduct.[109]

12.83 With some limitations,[110] there is nothing to prevent research organisations from examining these same options where gene patents are considered to be hindering the conduct of genetic research. There are overseas precedents for intervention by research organisations. For example, many European research organisations and professional associations contributed to opposition proceedings concerning European gene patents granted to Myriad Genetics Inc over the BRCA1 mutation.[111]

12.84 Elsewhere in this Report, the ALRC has made recommendations to address the potential for harm arising from the exploitation of gene patents, including harm to genetic research. These recommendations include changes to laws and practices concerning patentability (Chapter 6); the development of new Australian Research Council (ARC) and NHMRC principles and guidelines on intellectual property management for publicly funded research (Chapter 11 and below); enacting a new experimental use exemption (Chapter 13); the development of model agreements and interpretative guidelines for patent licences involving genetic materials and technologies (Chapter 22); and amendments to clarify the compulsory licensing provisions of the Patents Act (Chapter 27).

[103] See, W Cornish, M Llewelyn and M Adcock, Intellectual Property Rights (IPRs) and Genetics (2003), 43. See also 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, 251.

[104] M Stott and J Valentine, ‘Gene Patenting and Medical Research: A View from a Pharmaceutical Company’ (2004) 3 Nature Reviews Drug Discovery 364, 368, referring to M Heller and R Eisenberg, ‘Can Patents Deter Innovation? The Anticommons in Biomedical Research’ (1998) 280 Science 698.

[105] J Walsh, A Arora and W Cohen, ‘Effects of Research Tool Patenting and Licensing on Biomedical Innovation’ in W Cohen and S Merrill (eds), Patents in the Knowledge-Based Economy (2003), 285, 335.

[106] Ibid, 335.

[107] See rec 19–3.

[108] See Ch 26–27.

[109] See Ch 24.

[110] For example, in relation to the entities that may constitute ‘an authority of the Commonwealth or of a State’ for the purposes of the Crown use provisions: see Ch 26.

[111] See Ch 19. The parties to the opposition included the Institut Curie, the Institut Gustave-Roussy, the Belgian Society for Human Genetics and the Associazione Angela Serra per la Ricerca sul Cancro: European Patent Office, ‘“Myriad/Breast Cancer” Patent Revoked after Public Hearing’, Press Release (Munich), 18 May 2004.