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Gene patents in Australia subject to major new Australian Law Reform Commission inquiry

In brief: Allens Lawyer Erica Davis and Allens PTA Partner Dr Trevor Davies (view CV) discuss the terms of reference of the ALRC's new inquiry into Intellectual Property Rights Over Genetic Materials and Genetic Related Technologies announced on 18 December 2002.

 The gene patenting debate is set to intensify as the Australian Law Reform Commission (ALRC) embarks on a major new inquiry. The competing views in relation to the appropriate protection and use of IP in genetic material and technologies will be placed under the microscope of the ALRC over the next 18 months. The inquiry will particularly focus on issues relating to human health.

The ALRC's final report, due by 30 June 2004, may have implications for research scientists, biotechnology companies, genetic testing laboratories and health and medical service providers, as well as the general public. The outcomes of this inquiry may also impact on the provision of health services and pharmaceuticals.

Background to the inquiry

The driving force behind the establishment of this inquiry was the need to address concerns in relation to human gene patents. Concerns of this nature have been raised to the ALRC and the Australian Health Ethics Committee (AHEC) during their current inquiry into the protection of human genetic information, which is focussing on issues in relation to ethics, privacy and discrimination. In response, the ALRC and the AHEC recommended to the Attorney-General and the Minister for Health and Ageing that these issues be dealt with under a separate inquiry. 

Policy issues and objectives that played a part in setting the scope of this inquiry included:

  • the goal of using patent protection to promote innovation in a way which benefits both the inventors and the users of the invention;
  • the continuing rapid developments in genetic technology capable of improving human health;
  • the issues surrounding access to genes and genetic and related technologies;
  • the national interest in the use of genetic patents, particularly in the context of agriculture and industry;
  • trade and investment issues; and
  • the objective of an international level playing field for the patent protection of gene technologies and the need to comply with international obligations.

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The terms of reference of the inquiry

The terms of reference of the inquiry, issued by the Attorney-General on 17 December 2002, require the ALRC to seek widespread public consultation, and identify and consult with key stakeholders including government agencies, the research community, the health and medical sector, the biotechnology sector and industry bodies.

Current patenting laws and practices related to genes and genetic and related technologies in Australia, including licensing, will be the subject of the inquiry and the focus will be issues of human health. The task set for the ALRC is to investigate the impact of such laws and practices on the conduct of research and commercialisation, the Australian biotechnology sector, and the cost-effective provision of healthcare in Australia. 

To the extent that the ALRC determines that changes are required to the current legal framework to encourage the creation and use of IP in the interests of both human health and economic gain, the ALRC is to recommend options for reform. 

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Current gene patenting laws in Australia

Genes and uses of genetic material are patentable in Australia – subject to the normal criteria of novelty, inventive step and utility under the Patents Act 1990 (Cth). No specific limitations apply and human genes are no exception. Human beings and the processes for their generation, however, are specifically excluded from patentability under the Patents Act. 

In fact, as a member of the World Trade Organisation (WTO), Australia is not permitted to specifically exclude human genes per se from patentability, as it would be contrary to the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). However, WTO members are permitted to exclude from patentability diagnostic, therapeutic and surgical methods for treatment of humans or animals. 

Information released by IP Australia discusses the patentability of genetic material and technologies in detail.

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Interested in the outcomes of the inquiry?

Interest in IP rights over genetic materials and genetic related technologies is unlikely to subside in the near future, but this inquiry is likely to promote more informed debate. The outcomes of the inquiry could potentially have an impact on the biotechnology and health sectors in particular. There is no doubt that an effective patent system is vital to these sectors.

A major challenge for the ALRC will be to identify the relevant interests and concerns through consultation with industry and the public. If you would like to have your say on these issues, you should consider being involved in the public consultation process and/or making a submission to the ALRC. You can also register your interest in the inquiry.

Allens will continue to keep abreast of legal developments in this area and can provide you with any help you may need to understand the issues under consideration.

For further information, please contact:

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