CIPLA AUSTRALIA PTY LTD

Australian Court Rules Formulation Patents Ineligible for Patent Term Extensions in Landmark Otsuka Decision

- The Full Court of the Federal Court of Australia ruled that only patents claiming active pharmaceutical ingredients are eligible for patent term extensions, not pharmaceutical formulations. - The decision in Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd invalidates existing patent term extensions for formulation patents, creating "zombie PTEs" vulnerable to challenge. - Pharmaceutical companies must urgently review their patent portfolios as the ruling affects loss of exclusivity dates and may accelerate generic drug market entry across Australia.