Now’s the time for pharmaceutical companies to review their patent portfolio

9 November 2016

Patent term extension case appeal could open opportunities 

With an appeal lodged by the Commissioner of Patents in the AbbVie Biotechnology patent term extension case, now might be a good time for pharmaceutical companies to review their patent portfolios.

Contrary to current practice, an Administrative Appeals Tribunal decision in September (AbbVie Biotechnology Ltd v Commissioner of Patents [2016] AATA 682)  found that a patent term extension may be based on a Swiss-style (second medical use) claim provided that the pharmaceutical substance is produced by a process that involves the use of recombinant DNA technology. The decision also seemingly left open the door to patent term extensions based on method of treatment claims.

AbbVie had gone to the AAT seeking extensions to three patents relating to HUMIRA, which is a pharmaceutical substance produced by a process that involves the use of recombinant DNA technology, each patent claiming treatment of a new indication for HUMIRA. However, the patents did not include a claim to the pharmaceutical substance itself.

While the AAT decided patent term extensions may be granted based on a Swiss-style claim when the pharmaceutical substance is produced using recombinant DNA technology, AbbVie was unable to win a longer patent term extension based on when the new indication for HUMIRA was included on the Australian Register of Therapeutic Goods. The AAT held that the length of the extension of term is to be determined based on the date that the pharmaceutical substance itself was first included on the ARTG, not the date of addition of any new indications.

Given that there is no limit of the number of patent term extensions per pharmaceutical substance, the AAT decision would be expected to result in more patents being granted patent term extensions. 

The Commissioner has appealed the AAT decision.  A hearing and judgement are unlikely until mid-2017.

In view of the AAT decision and the pending appeal, now is an ideal opportunity for pharmaceutical companies to review their patent portfolios to identify patents protecting pharmaceutical substances with Swiss-style and/or method of treatment claims that may be eligible for patent term extension pending the appeal decision.  

If the appeal upholds the AAT decision, pharmaceutical companies that have identified relevant patents will be ready to apply for a patent term extension quickly after the decision issues.

By Malcolm Lyons

Our Expert