Australia’s pharmaceuticals patents under review

The Australian Government has announced a review of the pharmaceutical patents system to establish whether it is “effectively balancing the objectives of securing timely access to competitively priced pharmaceuticals, fostering innovation and supporting employment in research and industry” and, in particular, whether the system “is being used to extend pharmaceutical monopolies at the expense of new market entrants”. Importantly, according to the terms of reference, evaluation of the provisions of the Australian Patents Act 1990 (Cth) governing patent term extensions (PTEs) will be central to the process. The review will also 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.

The expert panel appointed to conduct the review consists of three members, namely:

  • 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).

Following a public consultation process, the panel is required to make recommendations relating 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) and
  • Australia’s position as a net importer of patents and medicines.

We will advise the due date for submission of comments to the review panel once an invitation issues. Given the broad terms of reference and the differing interests of stakeholders in the Australian pharmaceutical industry, we expect submissions to be many and diverse. Two press releases in response to the Government’s announcement of the review provide a glimpse of the discussions which will no doubt ensue during the public consultation period: the first by Medicines Australia calls for longer patent terms and quotes the CEO of Medicines Australia, Dr Brendan Shaw, as saying that the review “should consider the compelling case to extend the patent life of innovative medicines”; while the second by the Generic Medicines Industry Association (GMiA) advises “[m]arket exclusivity must ONLY be provided for truly innovative medicines” and “it is imperative that the legal framework support appropriate, timely and efficient market entry of follow-on generic medicines”.

The final report of the panel is to be provided to the Government in early 2013.

We welcome requests for further information regarding the review, Australia’s provisions governing pharmaceutical patents/PTEs and the preparation of submissions to the review panel.