Patent Term Extensions are here to stay … for now

Patent Term Extension (PTE) provisions in Australia have recently been the subject of an extensive review. The Government has recently announced, however, that it has no plans to release the Final Report.

As previously reported (see Australia’s pharmaceutical patents under review and Australia’s pharmaceutical patents under review – submissions due by 21 January 2013) a Government review of the Australian pharmaceutical patents system was set up in 2012 to determine 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”. A Review Panel was formed and a Background and Suggested Issues Paper issued in November 2012. Following written submissions and public hearings in Sydney, Melbourne and Canberra, the Review Panel issued a Draft Report in April 2013 and provided its Final Report to the Government in May 2013. Shelston IP attended the Sydney hearings and made submission that were cited in the Draft Report (Shelston IP was the only patent attorney firm mentioned in the Draft Report). The Draft Report contained several recommendations, including reducing the length of PTEs and, instead, providing direct subsidies for research and development. PTEs are intended to compensate patentees for the time taken to obtain regulatory approval and, in the case of blockbuster drugs, can be worth hundreds of millions of dollars to a patentee. Accordingly, this recommendation sent shock waves through the pharmaceutical industry and the Government’s response to the Final Report was awaited with much anticipation. However, following lodgement of the Final Report (which was not published), the Government was silent with regard to the Pharmaceutical Patents Review until 11 February 2014, when the Minister for Industry, Ian Macfarlane, responded to a Question in Writing and stated the following:

“The Government has no plans to release the final report at this stage. The Government is not considering the recommendations made by the panel in the draft report. The Pharmaceutical Patents Review panel delivered its final report to the previous government in May 2013, which did not release the report. As the Pharmaceutical Patents Review was commissioned by the previous government and conducted by an independent panel, the government is not obliged to release the report”.

Following lodgement of the Final Report, a Federal election resulted in a change of Government and it would appear that the new Government is in no hurry to revisit the Pharmaceutical Patents Review. As such, PTEs will be available in Australia for the foreseeable future.