This schedule lists the action required of different bodies to implement the recommendations in ALRC 99. The required action is identified in summary form; full details may be found in the List of Recommendations and in the corresponding chapter. The schedule does not list bodies whose role in relation to a proposal is only to be consulted by another body that has primary responsibility for implementing the proposal.

AusBiotech Ltd

22–2 Develop model agreements and interpretative guidelines for patent licences involving genetic materials and technologies.

22–3 Consider whether additional industry initiatives are necessary or desirable to facilitate the licensing of patent rights over genetic materials and technologies.

Australian Competition and Consumer Commission

24–2 Develop guidelines to clarify the relationship between Part IV of the Trade Practices Act 1974 (Cth) and intellectual property rights.

24–3 As the need arises, review the conduct of firms dealing with genetic materials and technologies protected by intellectual property rights to determine whether their conduct is anti-competitive within the meaning of Part IV of the Trade Practices Act.

Australian Government

6–3 Amend the Patents Act 1990 (Cth) to: (a) include ‘usefulness’ as a requirement in the examination of an application for a standard patent and in the certification of an innovation patent; (b) provide that an invention will satisfy the requirement of ‘usefulness’ only if the patent application discloses a specific, substantial and credible use; (c) require the Commissioner of Patents to be satisfied on the balance of probabilities that the criterion of usefulness is made out; and (d) include ‘lack of usefulness’ as a basis upon which an accepted application for a standard patent may be opposed.

8–3 Amend the Patents Act to require 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.

9–2 Amend the Patents Act to require courts to give written notice to the Commissioner of Patents when a legal proceeding to challenge or enforce a patent is commenced, and when a decision or judgment is given in any such proceeding.

13–1 Amend the Patents Act to establish an exemption from patent infringement for acts done to study or experiment on the subject matter of a patented invention.

24–1 Amend s 51(3) of the Trade Practices Act to clarify the relationship between Part IV of the Act and intellectual property rights.

26–2 Amend the Patents Act to clarify that, for the purposes of the Crown use provisions, an invention is exploited ‘for the services of the Commonwealth or of a State’ if the exploitation is for the provision of healthcare services or products to members of the public.

26–3 Amend the Patents Act to provide that, when a patent is exploited under the Crown use provisions, the remuneration that is to be paid by the relevant authority must be paid promptly and must be just and reasonable having regard to the economic value of the use; and that when a patent is acquired under the Crown acquisition provisions, compensation must be paid promptly and must be just and reasonable having regard to the economic value of the patent.

27–1 Amend the provisions of the Patents Act relating to compulsory licences by (a) inserting the competition-based test recommended by the Intellectual Property and Competition Review Committee as an additional ground for the grant of a compulsory licence; and (b) clarifying the scope of the ‘reasonable requirements of the public’ test.

28–1 Amend the Copyright Act 1968 (Cth) to provide that research with a commercial purpose or objective is ‘research’ in the context of fair dealing for the purpose of research or study.

28–2 Amend the Copyright Act to provide that, in relation to databases protected by copyright, the operation of the provisions relating to fair dealing for the purpose of research or study cannot be excluded or modified by contract.

28–3 Prior to implementing art 17.4.7 of the Australia–United States Free Trade Agreement, assess the need for an exception to the prohibition on the circumvention of access control measures for researchers engaging in fair dealing for the purpose of research or study in relation to databases protected by copyright; and once the prohibition has been implemented, periodically review the impact of the anti-circumvention provisions on the practical exercise of fair dealing for the purpose of research or study in copyright works.

Australian Health Ministers’ Advisory Council

19–1 Establish processes for: (a) economic evaluation of medical genetic testing and other new genetic medical technologies; and (b) examination of the financial impact of gene patents on the delivery of healthcare services in Australia.

19–2 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.

19–4 Pending the establishment of the Human Genetics Commission of Australia, 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.

26–1 Develop a policy regarding the circumstances in which it may be appropriate for the Commonwealth or a State to exploit a patented invention under the Crown use provisions of the Patents Act for the purposes of promoting human health.

Australian Research Council

11–1 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.

11–2 Develop guidelines to assist organisations receiving public funding for research in complying with the National Principles.

11–3 Consider, in exceptional circumstances, attaching conditions to the grant of funding where the public benefit would clearly be served by broad dissemination of the results of publicly funded research.

12–1 In implementing Recommendations 11–1 to 11–3, recognise the public benefit in ensuring the wide dissemination of research tools.

17–2 In implementing Recommendation 11–1, recognise the importance of clear ownership of intellectual property resulting from collaborative or jointly funded research.

17–3 In implementing Recommendation 11–2, provide guidance on ensuring clear ownership of intellectual property resulting from collaborative or jointly funded research; and identify a range of approaches to ensuring clarity of ownership.

Biotechnology Australia

17–1 Further develop and implement programs to assist technology transfer offices in research organisations in commercialising inventions involving genetic materials and technologies; and develop strategies to ensure widespread participation of technology transfer offices in these programs.

17–5 Develop model materials transfer agreements for use by research organisations.

18–1 Develop further programs to assist biotechnology companies in commercialising inventions involving genetic materials and technologies; and develop strategies to ensure widespread participation of biotechnology companies in these programs.

22–1 Develop and implement programs to assist research organisations and biotechnology companies in licensing and commercialising inventions involving genetic materials and technologies.

Commonwealth, state and territory health departments

19–3 Consider whether to exercise any existing legal options to facilitate access to genetic inventions, 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.

24–4 Make use of existing complaint procedures under the Trade Practices Act where evidence arises of conduct that may breach Part IV and have an adverse impact on medical research or the cost-effective provision of healthcare.

Courts exercising jurisdiction under the Patents Act

9–2 Amend Rules of Court, as necessary, to require notification to be given to the Commissioner of Patents of legal proceedings to challenge or enforce a patent.

10–1 Continue to develop practices and procedures for dealing with patent matters in order to promote the just, efficient and cost effective resolution of patent disputes.

10–2 Continue to develop procedures and arrangements to allow judges to benefit from the advice of assessors or scientific advisors in litigation involving patents over genetic materials and technologies.

Department of Health and Ageing

See also under ‘Commonwealth, state and territory health departments’.

26–1 Develop a policy regarding the circumstances in which it may be appropriate for the Commonwealth to acquire a patent for the purposes of promoting human health.

Human Genetics Commission of Australia

19–4 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.

IP Australia

5–1 Assess the impact of patent fees on the actual term of Australian patents; and periodically review the structure and quantum of patent fees to ensure that fees are set at levels appropriate to discourage patent holders from maintaining patents that lack real commercial value.

6–4 Develop guidelines to assist patent examiners in applying the ‘usefulness’ requirement.

8–1 Enhance efforts to provide patent examiners with education and training in areas of technology relevant to their particular specialty; and review and update these programs regularly.

8–2 Develop examination guidelines to explain how the criteria for patentability apply to inventions involving genetic materials and technologies.

9–1 Develop and regularly update a searchable online database comprising patents and published patent applications.

9–2 Include information about legal proceeding to challenge or enforce a patent in the file of a patent and make this information readily available, when notified by a court.

15–1 Develop examination guidelines to explain how the criteria for patentability apply to inventions involving stem cells and related technologies.

Minister for Health and Ageing

15–2 Require the forthcoming review of the Prohibition of Human Cloning Act 2002 (Cth) to examine the exploitation of intellectual property rights over stem cells when considering the establishment of a National Stem Cell Bank.

Minister for Industry, Tourism and Resources

6–2 Initiate an independent review of the appropriateness and adequacy of the ‘manner of manufacture’ test as the threshold requirement for patentable subject matter under Australian law, with a particular focus on the requirement that an invention must not be ‘generally inconvenient’.

14–3 Initiate a review of the grace period provisions in the Patents Regulations to examine: (a) whether they are well understood by the research community; and (b) how they have affected the commercialisation of Australian research in Australia or overseas.

National Health and Medical Research Council

11–1 Review the National Principles to ensure that publicly funded research, where commercialised, results in appropriate public benefit.

11–2 Develop guidelines to assist organisations receiving public funding for research in complying with the National Principles.

11–3 Consider, in exceptional circumstances, attaching conditions to the grant of funding where the public benefit would clearly be served by broad dissemination of the results of publicly funded research.

12–1 In implementing Recommendations 11–1 to 11–3, recognise the public benefit in ensuring the wide dissemination of research tools.

15–2 Require the forthcoming review of the Research Involving Human Embryos Act 2002 (Cth) to examine the exploitation of intellectual property rights over stem cells when considering the establishment of a National Stem Cell Bank.

17–2 In implementing Recommendation 11–1, recognise the importance of clear ownership of intellectual property resulting from collaborative or jointly funded research.

17–3 In implementing Recommendation 11–2, provide guidance on ensuring clear ownership of intellectual property resulting from collaborative or jointly funded research; and identify a range of approaches to ensuring clarity of ownership.

Research organisations

11–4 Ensure that 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.

14–1 Continue to take steps to raise the awareness of researchers in health sciences and biotechnology about intellectual property issues and the commercialisation of research.

14–4 Ensure that researchers are fully informed about the operation of the grace period provisions in the Patents Regulations 1991 (Cth), particularly in relation to: (a) the effect of publication before filing a patent application; and (b) the effect of publication on the patentability of their inventions in countries that do not have equivalent provisions.

17–4 Ensure that policies and practices address the problems of ownership of intellectual property resulting from collaborative or jointly funded research.

Treasurer

25–1 If evidence arises that the prices of patented genetic materials and technologies have adversely affected access to healthcare services in Australia, consider whether to: (a) refer the matter to the Productivity Commission for a study or inquiry pursuant to the Productivity Commission Act; or (b) direct the Australian Competition and Consumer Commission, or another body, to conduct an inquiry pursuant to Part VIIA of the Trade Practices Act.

Universities

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