Part F. Licensing and Commercial Arrangements

22. Licensing of Patent Rights

22–1 Biotechnology Australia, in conjunction with its member departments, should develop and implement programs to assist research organisations and biotechnology companies in licensing and commercialising inventions involving genetic materials and technologies. The programs should be developed in collaboration with state and territory governments, peak national bodies with an interest in licensing and commercialisation of intellectual property, and other relevant stakeholders. (See also Recommendations 17–1 and 18–1.)

22–2 AusBiotech Ltd, as the peak industry body in the biotechnology sector, should develop model agreements and interpretative guidelines for patent licences involving genetic materials and technologies. The model agreements should be developed in collaboration with Biotechnology Australia, state and territory governments, and other relevant stakeholders as a non-binding model of desirable licensing practices. (See also Recommendation 17–5.)

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

24. Competition Law and Intellectual Property

24–1 The Commonwealth should amend s 51(3) of the Trade Practices Act 1974 (Cth) (Trade Practices Act) to clarify the relationship between Part IV of the Act and intellectual property rights.

24–2 The Australian Competition and Consumer Commission (ACCC) should develop guidelines to clarify the relationship between Part IV of the Trade Practices Act and intellectual property rights. The guidelines should address:

1. when the licensing or assignment of intellectual property might be exempted under s 51(3) or might breach Part IV; and
2. when conduct that would otherwise breach Part IV might be authorised under Part VII of the Trade Practices Act.

The guidelines should extend to the exploitation of intellectual property rights in genetic materials and technologies, including patent pools and cross-licensing.

24–3 As the need arises, the ACCC should 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.

24–4 Commonwealth, state and territory health departments, and other stakeholders, should 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.

25. Prices Oversight

25–1 If evidence arises that the prices of patented genetic materials and technologies have adversely affected access to healthcare services in Australia, the responsible Minister should consider whether to:

1. refer the matter to the Productivity Commission for a study or inquiry pursuant to the Productivity Commission Act 1998 (Cth); or
2. direct the Australian Competition and Consumer Commission, or another body, to conduct an inquiry pursuant to Part VIIA of the Trade Practices Act 1974 (Cth).