Draft Pharmaceutical Patents Review Report released – bad news for research based pharmaceutical in
On 2 April 2013 the Pharmaceutical Patents Review Panel released its draft report for public comment. While the findings and recommendations in the Report are not unexpected, given the make up of the panel and the short time frames provided to the Panel for carrying out its enquiry, the Report will nonetheless be of great concern to the research based pharmaceutical sector. The Report can be found on the Review Website, and in it the Panel members make it clear that they would like to see a reduction in the term of pharmaceutical patent extensions, agreement from pharmaceutical patent owners that they will not enforce their patents in respect of manufacture for export activities, limitations on the contributory infringement provisions which allow patents relating to new therapeutic methods to be enforced, and the introduction of various committees to monitor IP Australia’s activities and the operation of the Pharmaceutical Benefits Scheme. The Panel does not recommend any expansion of the classes of pharmaceutical patents that may be eligible for pharmaceutical patent term extensions, even when the patent owners experience significant regulatory delays in obtaining the necessary approvals to allow them to market those pharmaceutical inventions. All in all, there is not much in it that is attractive to the research based pharmaceutical sector, except perhaps removal of the requirement to file expenditure returns to complete the patent term extension process. It should be understood, however, that this report represents merely an interim report, which will be finalised based upon further public consultation. Once the report is finalised the Government will be able to accept, modify or reject any of the Panel’s recommendations. Given that a federal election is scheduled for 14 September 2013, there is already a full legislative program up to the election and the Government currently holds a slender majority it appears unlikely that any substantial legislative reform could take place within the current Government’s term.
Nonetheless, if you have concerns with regard to any of the draft recommendations we suggest that you engage in the public consultation process by filing a submission in response. The deadline for filing submissions in response to the 224 page report is 30 April 2013. Submissions should be sent to:
PO Box 200
Woden ACT 2606