Federal Government announces Review of Pharmacuetical Patents 

October, 2012 - Daniel Fuller and Peter Kearney

On 15 October 2012, the Federal Government announced the appointment of an expert panel to review pharmaceutical patents in Australia (Review).  

The Review will focus particularly on the extension of term provisions in Chapter 6, Part 3 of the Patents Act 1990 (Cth). Those provisions currently allow the extension of pharmaceutical patents up to five years beyond their standard 20-year term. Medicines Australia has expressed concern that current patent terms are too short given the time taken for patent applications to pass through the Government's administrative processes. On the other side is the Generic Medicines Industry Association, whose view is that too lengthy patent terms and too regular extensions stifle innovation and competition.

The Terms of Reference of the Review specifically require it to 'consider whether there is evidence that the patent system is being used to extend pharmaceutical monopolies at the expense of new market entrants'. If such evidence is found, the Review must consider its impact on competition, innovation and investment. The panel must have particular 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
The Review comes as the Australian Government's Advisory Council on Intellectual Property (ACIP) continues its review of the innovation patent system in Australia. That review has also emphasised issues around patent terms, particularly the practice of 'evergreening' to effectively extend terms using secondary derivative patents. It is expected to produce an interim report this month.

The Review of Pharmaceutical Patents also comes in the wake of a number of other on patents that have commenced since the 'Raising the Bar' reforms passed in March this year.

The Review panel is chaired by Tony Harris (former New South Wales Auditor-General and Parliamentary Budget Officer). Its other members are Professor Dianne Nicol (Associate Dean, Research, Faculty of Law at the University of Tasmania) and Dr Nicholas Gruen (CEO of Lateral Economics). 


The panel will begin consulting stakeholders and invite public submissions in the coming months, before reporting in early 2013.

 



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