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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:

Draft recommendation

Summary of current provisions

The Australian Government should reform extensions of patent term for pharmaceuticals such that they are calculated based only on the time taken for regulatory approval by the Therapeutic Goods Administration (TGA) over and above 1 year.

An extension of patent term of up to 5 years can be obtained for pharmaceutical patents.  The length of the extension is the length of time between the “date of the patent” (usually the filing date of the Australian patent) and the date of the first regulatory approval granted by the TGA for any pharmaceutical substance per se, or pharmaceutical substance when produced by a process that involves the use of recombinant DNA technology, claimed in the patent, less 5 years (with a maximum extension of 5 years).

 

Regardless of the method of calculating their duration, extensions of term in Australia should only be granted though a tailored system which explicitly allows for manufacture for export in the extension period.

The extension of term applies to all pharmaceutical substances per se, or pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology, claimed in the patent. During the extended term of an Australian patent, the manufacture of a pharmaceutical substance claimed in the patent for export for sale in another country for therapeutic use, would infringe the patent.

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.  

If you have any questions concerning the Productivity Commission’s draft report please contact us.

 

 

Our Expert Project Lead