Patent term extensions – Australian Federal Court says the Commissioner’s interpretation of the legislation “absurd” and third party ARTG listing dates are not relevant
Written By
Partner
Australia
I am a partner in our Intellectual Property Group, based in Sydney. My experience spans the breadth and depth of IP issues, but my specialty is complex IP litigation and disputes including contentious patent, trade mark, copyright, and confidential information and consumer protection/passing-off matters.
The term of a standard patent in Australia is 20 years, but for “pharmaceutical substances per se” (new and inventive substances), the Patents Act 1990 (Cth) provides a scheme whereby, in certain circumstances, the 20 year term can be extended once for further period of up to 5 years.
The Commissioner of Patents has always taken the position that such applications require consideration of the first ARTG listing of any product that falls within the claims of the relevant patent – even if this product was a third party ARTG listing.
This was the case in Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643, where Ono had sought an extension of term of its patent directed at human monoclonal antibodies to programmed death 1 (PD-1) on the basis of a product marketed by a related entity under the name OPDIVO included on the ARTG on 11 January 2016.
In the scheme of extensions under the Patents Act, generally the later the registration of the relevant reference product on the ARTG, the longer the extension, and hence the preferred use of OPDIVO as the reference product.
A Delegate of the Commissioner held that the application did not meet the statutory requirements because the application should have been made on the basis of KEYTRUDA, a product marketed by a third party competitor, that was included earlier on the ARTG on 16 April 2015.
This decision was the…
