Gene patenting

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. See Terms of Reference.

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.

Key recommendations

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.

Compulsory licences

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.

Implementation

The recommendations in ALRC 99 are addressed to a wide range of parties and not merely the Australian Government. For this reason, the report contains an implementation schedule listing the action required of different bodies to implement the recommendations in ALRC 99.

Recommendation 28–3 states that prior to the implementation of Article 17.4.7 of the Australia-United States Free Trade Agreement (AUSFTA) which deals with obligations in relation to copyright, the Australian Government should assess the need for an exception for researchers engaging in fair dealing for the purpose of research or study in relation to databases protected by copyright. This assessment was undertaken by the House of Representatives Standing Committee on Legal and Constitutional Affairs as part of its February 2006 report Inquiry into technological protection measures (TPM) exceptions. 

In March 2009, the ALRC made a submission to the Senate Standing Committee on Community Affairs Inquiry into Gene Patents. The ALRC drew on its experience from the ALRC Inquiry into the intellectual property aspects of genetic material and technologies, which culminated in ALRC 99. The Committee's Report of the Inquiry into Gene Patents was presented to Government on 26 November 2010. It recommended that the government make a number of amendments to the Patents Act 1990 in line with recommendations in ALRC 99.

On 22 June 2011, the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (Cth) was introduced to the Senate. The Bill, if passed, would substantially implement ALRC 99. ALRC recommendations adopted by the Bill include:

• requiring patent examiners to be satisfied on the balance of probabilities when assessing all statutory requirements for patentability that are relevant at the stage of examination;
• including ‘usefulness’ as a criterion for acceptance of a patent during the examination or certification;
• a new exemption from infringement for acts done for experimental purposes; and
• providing that an invention will satisfy the requirement of ‘usefulness’ only if the patent application discloses a ‘specific, substantial and credible use’.

On 23 November, the Federal Government tabled its response to ALRC 99. As well as addressing recommendations in the ALRC Final Report, the Government also responded to the recommendations of the 2010 Senate Community Affairs Committee's report on Gene Patents and the 2011 Advisory Council on Intellectual Property's report on Patentable Subject Matter. The response accepts the majority of the recommendations in all three reports, including the ALRC's recommendation to introduce a statutory research exemption into the Patents Act 1990. 

See the complete Government response >>

See full media release by Minister for Innovation Senator Kim Carr >>