In December 2002, the federal Attorney-General asked the ALRC to examine the laws and practices governing intellectual property rights over genetic materials and related technologies, with a particular focus on human health issues.
Given the diversity of interests and concerns encompassed by these three areas, the ALRC’s task was a complex and delicate one. For example, reforms that might facilitate access to genetic inventions to assist healthcare providers and researchers could adversely affect the growing Australian biotechnology sector and the development and marketing of new healthcare products.
The ALRC’s task was to examine whether the Australian patent system was meeting the challenges of the rapidly developing science associated with the sequencing of the human genome.
ALRC 99 Genes and Ingenuity makes 50 important recommendations for reform but it does not suggest any radical overhaul of the patents system.
Patent laws and practices
There are significant impediments to amending the Patents Act to exclude genetic materials from patentability, including the long history of patenting such inventions, international treaty obligations, and a biotechnology industry dependent on patents and inventions. The ALRC recommended that the Patents Act should not be amended to exclude genetic materials or technologies from patentability; or to provide a new medical treatment exclusion; or to expand the existing circumstances in which social and ethical considerations may be taken into account in decisions about granting patents.
The ALRC concluded that inventions involving genetic materials and technologies should be assessed according to the same legislative criteria as other inventions. However, gene patents highlighted an issue about the way the ‘usefulness’ of an invention is assessed under Australian law and the ALRC recommended reforms to this area.
The ALRC also concluded that the ‘manner of manufacture’ test in the Patents Act is ambiguous and obscure, and should be reviewed, with a particular focus on the requirement that an invention must not be ‘generally inconvenient’.
A number of recommendations relate to reforms to assist IP Australia in adapting its current practices to the challenges posed by inventions in new areas of technology such as those involving genetic materials and technologies.
Patents and genetic research
The ALRC recommended that research funding bodies provide guidelines on public benefit and commercialisation of research. Funding bodies should be able, in exceptional cases, to place conditions on funding to encourage wide dissemination of research results.
The Patents Act should be amended to provide for an experimental use exemption. The ALRC recommended that the new exemption be limited to protecting study or experimentation on the subject matter of a patented invention—that is, research with a focus on discovering more about the invention and its properties.
Research organisations should continue to raise the awareness of researchers about intellectual property issues to ensure that potentially valuable intellectual property is not lost. Similarly, universities should ensure that students in health sciences or biotechnology are made familiar with intellectual property issues and the commercialisation of research.
Patents and human health
The ALRC made recommendations with respect to: the economic evaluation of genetic medical technologies; examination of the financial impact of gene patents on the delivery of healthcare services in Australia; the possible role of government funding and purchasing power in relation to genetic materials and technologies; and how health departments, with advice from the proposed Human Genetics Commission of Australia, may better manage legal and other issues relating to gene patents.
Health departments need to be more active in monitoring the impact of gene patents and licences on the healthcare system. Where particular gene patent applications, patents or patent licensing practices are considered to have an adverse impact on medical research or the cost-effective provision of healthcare, health departments should consider whether to exercise any of the existing legal options to facilitate access to the inventions.
Licensing and commercial arrangements
Education programs about the licensing of inventions that involve genetic materials and technologies should be enhanced.
The peak biotechnology industry body, AusBiotech Ltd, should develop model licence agreements and consider whether additional industry initiatives are needed to facilitate the licensing of gene patents.
The Trade Practices Act should be amended to clarify the relationship between Part IV of the Act and intellectual property rights, and the Australian Competition and Consumer Commission (ACCC) should issue guidelines to provide further clarification.
Crown use provisions
Although they are rarely used, Crown use provisions are an important mechanism through which government and its agencies may, in specific cases, address concerns that gene patents are hindering research or the provision of healthcare. Policies should be developed about the circumstances in which it is appropriate for government to invoke Crown use for the purposes of promoting human health.
Although compulsory licences over patented inventions are rarely ordered by the courts, they are another mechanism for access to patented genetic materials and technologies. The ALRC recommended reforms to the Patents Act to add a competition-based test to the grounds for ordering a compulsory licence.
Copyright and databases
The inquiry also considered other intellectual property issues raised by genetic research and commercialisation. The ALRC recommended amendments to the Copyright Act to clarify the position of commercial research and to facilitate access to databases used in research.