Part C. Patents and Genetic Research

11. Publicly Funded Research and Intellectual Property

11–1 The Australian Research Council (ARC) and the National Health and Medical Research Council (NHMRC) should review the National Principles of Intellectual Property Management for Publicly Funded Research (National Principles)to ensure that publicly funded research, where commercialised, results in appropriate public benefit. (See also Recommendations 12–1 and 17–2.)

11–2 The ARC and NHMRC should develop guidelines to assist organisations receiving public funding for research in complying with the National Principles. The guidelines should, among other things:

1. provide guidance on what is meant by ‘public benefit’;
2. assist organisations in determining whether it is appropriate for particular research results to be commercialised; and
3. identify a range of approaches to the exploitation of intellectual property and the circumstances in which they might be used.

11–3 In exceptional circumstances, where the public benefit would clearly be served by broad dissemination of the results of publicly funded research, the ARC and the NHMRC should consider attaching conditions to the grant of funding. These conditions might include a requirement that research results be placed in the public domain, or that a patented invention be widely licensed.

11–4 Research organisations should ensure that their policies on intellectual property ownership cover research undertaken by visiting researchers, students and staff—whether undertaken solely within the organisation or jointly with other bodies. (See also Recommendation 17–4.)

12. Patents and Human Genetic Research

12–1 The Australian Research Council and the National Health and Medical Research Council, in implementing Recommendations 11–1 to 11–3, should recognise the public benefit in ensuring the wide dissemination of research tools.

13. An Experimental Use Exemption

13–1 The Commonwealth should amend the Patents Act 1990 (Cth) (Patents Act) to establish an exemption from patent infringement for acts done to study or experiment on the subject matter of a patented invention; for example, to investigate its properties or improve upon it. The amendment should also make it clear that:

1. the exemption is available only if study or experimentation is the sole or dominant purpose of the act;
2. the existence of a commercial purpose or objective does not preclude the application of the exemption; and
3. the exemption does not derogate from any study or experimentation that may otherwise be permitted under the Patents Act.

14. Research Culture, Patents and Commercialisation

14–1 Research organisations should continue to take steps to raise the awareness of researchers in health sciences and biotechnology about intellectual property issues and the commercialisation of research, and should provide relevant advice to researchers as required.

14–2 Universities should ensure that students undertaking degrees in health sciences or biotechnology are made familiar with intellectual property issues and the commercialisation of research.

14–3 The responsible Minister should initiate a review of the grace periodprovisions in the Patents Regulations 1991 (Cth) (Patents Regulations) to examine:

1. whether they are well understood by the research community; and
2. how they have affected the commercialisation of Australian research in Australia or overseas.

14–4 Research organisations should ensure that their researchers are fully informed about the operation of the grace period provisions in the Patents Regulations, particularly in relation to:

1. the effect of publication before filing a patent application; and
2. the effect of publication on the patentability of their inventions in countries that do not have equivalent provisions.

15. Stem Cell Technologies

15–1 IP Australia should develop examination guidelines, consistent with the Patents Act 1990 (Cth), the Patents Regulations 1991 (Cth) and existing case law, to explain how the criteria for patentability apply to inventions involving stem cells and related technologies.

15–2 As part of the independent reviews to be conducted under the Research Involving Human Embryos Act 2002 (Cth) and the Prohibition of Human Cloning Act 2002 (Cth), the responsible Minister and the National Health and Medical Research Council should require an examination of the exploitation of intellectual property rights over stem cells when considering the establishment of a National Stem Cell Bank.

Part D. Patents and Commercialisation of Biotechnology

17. Technology Transfer

17–1 Biotechnology Australia, in conjunction with its member departments, should collaborate with the peak national bodies with an interest in technology transfer from the public sector:

1. to further develop and implement programs to assist technology transfer offices in research organisations in commercialising inventions involving genetic materials and technologies; and
2. to develop strategies to ensure widespread participation of technology transfer offices in these programs.

17–2 The Australian Research Council (ARC) and the National Health and Medical Research Council (NHMRC), in implementing Recommendation 11–1, should recognise the importance of clear ownership of intellectual property resulting from collaborative or jointly funded research.

17–3 The ARC and NHMRC, in implementing Recommendation 11–2, should:

1. provide guidance on ensuring clear ownership of intellectual property resulting from collaborative or jointly funded research; and
2. identify a range of approaches to ensuring clarity of ownership.

17–4 Research organisations should ensure that their policies and practices address the problems of ownership of intellectual property resulting from collaborative or jointly funded research. (See also Recommendation 11–4.)

17–5 Biotechnology Australia, in conjunction with its member departments, should collaborate with the peak national bodies with an interest in technology transfer from the public sector to develop model materials transfer agreements for use by research organisations, along the lines of the models developed by the United States Association of University Technology Managers. (See also Recommendation 22–2.)

18. Patents and the Biotechnology Industry

18–1 Biotechnology Australia, in conjunction with its member departments, and in consultation with state and territory governments and other stakeholders, should:

1. develop further programs to assist biotechnology companies in commercialising inventions involving genetic materials and technologies; and
2. develop strategies to ensure widespread participation of biotechnology companies in these programs.

Part E. Patents and Human Health

19. Gene Patents and the Healthcare System

19–1 The Australian Health Ministers’ Advisory Council (AHMAC) should establish processes for:

1. economic evaluation of medical genetic testing and other new genetic medical technologies; and
2. examination of the financial impact of gene patents on the delivery of healthcare services in Australia.

19–2 AHMAC should examine options for using government funding and purchasing power to control the cost of goods and services that are subject to gene patents and used in the provision of healthcare.

19–3 Where particular gene patent applications, granted patents or patent licensing practices are considered to have an adverse impact on medical research or the cost-effective provision of healthcare, Commonwealth, state and territory health departments should consider whether to exercise any existing legal options to facilitate access to the inventions. These options should be exercised only with appropriate legal or patent attorney advice, and include:

1. challenging a patent application or granted patent by initiating proceedings to oppose a patent application; requesting re-examination of a patent; or applying for revocation of a patent under the Patents Act 1990 (Cth) (Patents Act) (see Chapter 9);
2. making a complaint to the Australian Competition and Consumer Commission where evidence arises of a potential breach of Part IV of the Trade Practices Act 1974 (Cth) (see Chapter 24);
3. exploiting or acquiring a patent under the Crown use and acquisition provisions of the Patents Act (see Chapter 26); or
4. applying for the grant of a compulsory licence under the Patents Act (see Chapter 27).

19–4 The proposed Human Genetics Commission of Australia (HGCA) should monitor the application of intellectual property laws to genetic materials and technologies, where these may have implications for medical research or human health, both generally and in specific cases. The HGCA should liaise with and provide advice to AHMAC, health departments, and other stakeholders about ways to facilitate access to inventions, in accordance with Recommendation 19–3. Pending the establishment of the HGCA, AHMAC should establish a mechanism to perform these functions.