The Federal Government has announced the commission of an expert panel to review the “appropriateness of the extension arrangements for pharmaceutical patents.”

On 15 October 2012, the Hon Mark Dreyfus QC MP, the Parliamentary Secretary for Industry and Innovation announced the formation of an expert panel to review the “appropriateness of the extension arrangements for pharmaceutical patents” in Australia.

“In certain circumstances, pharmaceutical patents can be extended by up to five years beyond the normal patent term. These provisions were introduced back in 1998, and are due for review,” said Mark Dreyfus, Parliamentary Secretary for Industry and Innovation.

Mr Dreyfus said concerns had been raised about a number of aspects of pharmaceutical patents, including bringing generic pharmaceuticals to market and the effect of patent terms on innovation.

The review will consider:

  • issues that impact on competition in the pharmaceutical industry, for example, the ability of generic medicines to enter the market
  • issues around fostering innovation and bringing new pharmaceuticals to market
  • the importance of the patent system in providing employment and investment in research and industry
  • the impact of pharmaceutical patent provisions on Government health expenditure
  • international approaches to extensions of term for pharmaceutical patents
  • Australia’s obligations under international agreements (including free trade agreements and World Trade Organisation agreements)
  • Australia’s position as a net importer of patents and medicines

The review panel will be chaired by Mr Tony Harris with members, Dr Nicholas Gruen and Professor Dianne Nicol. A public consultation process will form part of the review. The panel’s final report is due to be provided to the Government in April 2013.

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 will form part of the review to help ensure this balance is achieved that will include industry and consumers.

This review is part of a range of current Australian Government measures to ensure that the patent system is delivering effective outcomes for consumers and industry. For more information visit IP Australia’s website.