The Productivity Commission has issued a draft report on Intellectual Property Arrangements in Australia for public consultation and input. Amongst numerous other recommendations, the 601 page draft report recommends changes to the patent laws in Australia concerning extensions of patent term for pharmaceutical patents.

The Productivity Commission has issued a draft report on Intellectual Property Arrangements in Australia for public consultation and input. Amongst numerous other recommendations, the 601 page draft report recommends changes to the patent laws in Australia concerning extensions of patent term for pharmaceutical patents. If implemented, these recommendations would, in many circumstances, result in shorter extensions of term and the patentee having more limited rights during the extended term than under the current laws in Australia.

The Productivity Commission’s draft report is the latest review of the intellectual property system in Australia. As the Productivity Commission noted in its draft report, there have been a number of reviews of aspects of the intellectual property system in Australia over recent years. This draft report is unusual, however, because it seeks to take a more holistic perspective in order to identify ways that the IP system as a whole could be improved rather than focussing on a specific area of IP.

Patent term extensions

The recommendations concerning patent term extensions for pharmaceutical patents include:

Click here to view table.

Data exclusivity

The draft report also considered the period of data exclusivity for confidential data concerning a new active ingredient provided to the TGA in support of an application for regulatory approval of a pharmaceutical product.  The draft report recommends that there be no extension of the current 5 year data exclusivity period for new chemical entities and biologics. The draft report further recommends that, in the context of international negotiations, the Australian Government should work with other nations towards a system of eventual publication of clinical trial data in exchange for statutory data protection.

Other recommendations concerning patents

Other significant recommendations in the draft report include:

  1. Raising the standard for inventive step to a level similar to that applied by the European Patent Office;
  2. Abolishing the innovation patent system in Australia;
  3. Excluding business methods and software from patentable subject matter.

Click here for a copy of the report.

The draft report has been prepared for public consultation and input. The Productivity Commission has invited submissions in relation to the draft report.  The deadline for filing any submissions is 3 June 2016.  The final report is expected to be provided to the Australian Government in August 2016.

It is important to note that the recommendations in the draft report are merely draft recommendations. Further, even if the draft recommendations are retained in the final report, there have been numerous reports on the patent and IP systems in Australia in recent years and not all recommendations have been implemented.