High Court grants special leave appeal application in the Otsuka “patent term extension” case
In December 2025, the Full Court of the Australian Federal Court issued their decision in Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd [2025] FCAFC 161 (The Otsuka decision)
It has been widely reported that the Otsuka decision makes patents covering pharmaceutical formulations ineligible for pharmaceutical term extensions (PTEs). More importantly, and as reported in our previous article, the Otsuka decision also potentially prohibits PTEs for patents covering certain first generation active pharmaceutical ingredients (APIs).
The Latest Development
Today (12th March 2026) the High Court granted special leave to Otsuka to appeal the decision and will consider the validity of the Full Court’s findings later this year. This decision will be welcomed by Australian pharmaceutical applicants as well as the Institute of Patent and Trade Mark Attorneys of Australia (IPTA) and Medicines Australia both of whom made submissions to the High Court in support of the special leave application.
We previously reported that IP Australia had suspended consideration of pending PTE applications based on pharmaceutical formulations until the outcome of the special leave application.
What Happens Next?
It remains to be seen whether these PTE applications will be put on hold until a final decision is issued by the High Court, which is expected sometime in 2027. We will, of course, keep you advised of developments.
In the meantime, patent attorneys and their Applicants should remain vigilant during the patent prosecution process to ensure that pharmaceutical patents, when granted, include claims that render them eligible for a patent term extension.
Should you have any questions about patent term extensions, please contact the authors of this article Grant Shoebridge (grant.shoebridge@wrays.com.au) or Bindhu Holavanahalli (Bindhu.holavanahalli@wrays.com.au).