The Full Federal Court of Australia decision in Sun Pharma ANZ Pty Ltd v Otsuka Pharmaceutical Co Ltd [2025] FCA 44 has found that only patents directed to active pharmaceutical ingredients (API) per se are eligible for a patent term extension.  This decision overturns earlier decisions of the Federal Court, and a considerable body of practice, allowing patent term extensions for patents directed to pharmaceutical formulations. 

Following this decision, it is expected to be much harder for patentees to obtain a pharmaceutical term extension, especially where the patent relates to a new formulation of a known API.   Similarly a large number of patents have been granted patent term extensions which may now be vulnerable to challenge.  Both patentees and potential challengers should review their strategies in Australia in light of this change. 

There remains a possibility of appeal from the Full Federal Court to the High Court of Australia, with an appeal deadline in early January 2026.  We will keep you updated.  

David Nowak - August 2025