FOR IP PROFESSIONALS

Review of pharmaceutical patents in Australia

On 15 October 2012, the then Parliamentary Secretary for Innovation, the Hon Mark Dreyfus QC MP, announced a review of pharmaceutical patents.

Terms of reference

The review will evaluate whether the system for pharmaceutical patents is effectively balancing the objectives of securing timely access to competitively priced pharmaceuticals, fostering innovation and supporting employment in research and industry.

Central to this will be an analysis of the pharmaceutical extension of term provisions of the Patents Act 1990 (s.70).

The review will also consider whether there is evidence that the patent system is being used to extend pharmaceutical monopolies at the expense of new market entrants. In doing this, the review will consider how patents for new formulations are granted, consider the treatment of new methods of manufacturing and new uses of known products, the impact of contributory infringement provisions and the impacts of extending patent monopolies on entry of generic pharmaceuticals into the market.

Should such evidence be found, the review should provide an assessment of the subsequent impact on competition, innovation and investment.

In conducting the review and making recommendations the panel is to have regard to:

  • The availability of competitively priced pharmaceuticals in the Australian market
  • The role of Australia's patent system in fostering innovation and hence to bringing new pharmaceuticals and medical technologies to the market
  • The role of the patent system in providing employment and investment in research and industry
  • The range of international approaches to extensions of term and arrangements for pharmaceutical inventions
  • Australia's obligations under international agreements (including free trade agreements and the World Trade Organisation agreements)
  • Australia's position as a net importer of patents and medicines

Conduct of the review

A public consultation process was conducted as part of the review.

The Review Panel members were: 

  • Mr Tony Harris, former NSW Auditor-General and Parliamentary Budget Officer, as Chair;
  • Professor Dianne Nicol, Associate Dean, Research, Law Faculty at the University of Tasmania; and
  • Dr Nicholas Gruen, CEO of Lateral Economics.

The Panel provided its final report to the previous government in May 2013. The current government has made the final report available in response to stakeholder interest.

The Panel released its Draft Report on 2 April 2013. Written responses to the Draft Report closed at 5pm on 30 April 2013.

The panel released a Background and Suggested Issues Paper on 21 November 2012. Submissions closed on 21 January 2013. Public hearings were held in Canberra, Sydney and Melbourne on 11, 12 and 15 February 2013 respectively.

Last Updated: 20/3/2014

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