New principles and guidelines on patents and research tools

12.85 A particular focus of this chapter has been on genetic materials or technologies used as research tools. In addition to recommendations made elsewhere in this Report, the ALRC recommends a specific initiative in relation to research tools, aimed at using the leverage of the Australian Government’s research funding to encourage and maintain widespread access.

12.86 One model for such an approach is found in the NIH’s Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (NIH principles and guidelines), which apply to recipients of NIH research grants and contracts.[112] With specific reference to research tools, the NIH guidelines provide, among other things, that:

  • exclusive licences for research tools should generally be avoided except in cases where the licensee undertakes to make the research tool widely available to researchers through unrestricted sale, or the licensor retains rights to make the research tool widely available;

  • when an exclusive licence is necessary to promote investment in commercial applications of a subject invention that is also a research tool, the recipient should ordinarily limit the exclusive licence to the commercial field of use, retaining rights regarding use and distribution as a research tool;

  • recipients are expected to avoid signing agreements to acquire research tools that are likely to restrict a funding recipients’ ability to promote broad dissemination of additional tools that may arise from the research;

  • in determining the scope of licence or option rights that are granted in advance to a provider of materials, recipients should balance the relative value of the provider’s contribution against the value of the rights granted, the cost of the research, and the importance of the research results; and

  • recipients should reserve the right to negotiate licence terms that will ensure the continuing availability to the research community of any resulting new invention that is a unique research resource.[113]

12.87 DP 68 proposed that the ARC and NHMRC should develop principles and guidelines for researchers to ensure that the public interest in encouraging commercial exploitation of inventions is balanced with the public interest in the wide dissemination of important research tools.[114] It was noted that such an approach would be consistent with the conclusions of the OECD Report, which suggested that governments should give attention to the development, in consultation with industry, of guidelines on acceptable licensing practices.[115]

12.88 This proposal was broadly supported in submissions to the Inquiry.[116] For example, the Centre for Law and Genetics agreed that the NIH principles and guidelines were an appropriate model and suggested that:

Key features might include directions to engage in non-exclusive licensing in most instances and ensuring that the research community has access to fundamental research resources. However, the guidelines must also reflect commercial realities. For example, in some circumstances broad non-exclusive licensing will not be appropriate. The guidelines should be cast in terms that allow for the best technology transfer options to be pursued, based on all relevant considerations, including the broader public benefit.[117]

12.89 A number of submissions opposed, or expressed reservations about, the proposal on the basis that it implied that the commercial exploitation of research tools is necessarily inimical to the public benefit.[118] This was not the intent of the proposal and the ALRC recognises that patent protection, and the prospect of commercialisation, may encourage the development and dissemination of research tools.[119]

12.90 In Chapter 11, the ALRC recommended that the ARC and the NHMRC should review the National Principles of Intellectual Property Management for Publicly Funded Research, and should develop related guidelines, to ensure that publicly funded research, where commercialised, results in appropriate public benefit.[120] The ALRC also recommended that, 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.[121] These conditions might include a requirement that new research tools be freely available or widely licensed.

12.91 In implementing these recommendations, the ARC and NHMRC should recognise the public benefit in ensuring the wide dissemination of research tools—a consideration of particular importance to genetic materials and technologies and the conduct of genetic research.

Recommendation 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.

[112] National Institutes of Health, ‘Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources’ (1999) 64 FR 72090.

[113] Ibid.

[114] Australian Law Reform Commission, Gene Patenting and Human Health, DP 68 (2004), Proposal 13–1.

[115] See Organisation for Economic Co-operation and Development, Genetic Inventions, Intellectual Property Rights and Licensing Practices: Evidence and Policies (2002), 82. As discussed in Ch 22, the OECD’s Working Party on Biotechnology has established a steering group of experts to develop best practice guidelines for the licensing of genetic inventions.

[116] Caroline Chisholm Centre for Health Ethics Inc, Submission P69, 2 April 2004; Commonwealth Department of Health and Ageing, Submission P79, 16 April 2004; Australian Centre for Intellectual Property in Agriculture, Submission P81, 16 April 2004; Royal College of Pathologists of Australasia, Submission P82, 16 April 2004; Cancer Council Victoria, Submission P101, 20 April 2004; Queensland Government, Submission P103, 22 April 2004; Centre for Law and Genetics, Submission P104, 22 April 2004; National Health and Medical Research Council, Submission P107, 19 April 2004; Australian Research Council, Submission P108, 19 April 2004. One submission stated that principles and guidelines would not be needed if there were a ‘clear experimental use provision’: Walter and Eliza Hall Institute of Medical Research, Submission P71, 13 April 2004.

[117] Centre for Law and Genetics, Submission P104, 22 April 2004.

[118] See, eg, Western Australian Department of Industry and Resources, Submission P90, 16 April 2004; Department of Industry Tourism and Resources, Submission P97, 19 April 2004; Queensland Government, Submission P103, 22 April 2004.

[119] See rec 11–3.

[120] Rec 11–1 and 11–2.

[121] Rec 11–3.