Australian Patent Term Extensions Narrowed: Full Federal Court Rules Formulation Claims Ineligible
In Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd [2025] FCAFC 161[1], the Full Federal Court has confirmed that Australian patent term extensions (PTE) apply only to patents claiming an active pharmaceutical ingredient (API) per se. Formulation claims no longer qualify. This overturns earlier authorities and reshapes exclusivity strategies for originators. Background: Australian …
>> Read more