The appeal will consider the Full Federal Court’s ruling that pharmaceutical formulations do not qualify as a “pharmaceutical substance per se” under the Patents Act 1990 and therefore cannot support a patent term extension (PTE) – a decision that departed from earlier authorities and raised significant questions about the scope of Australia’s PTE regime.
Special leave is granted in only a small number of cases each year, and it has been some time since the High Court has agreed to hear a patent appeal, making this a notable development for Australian patent law and for the pharmaceutical sector.
The hearing date has not yet been set but based on typical High Court timelines, the appeal is likely to be heard later in 2026 after the filing of appeal books and written submissions. In the meantime, IP Australia has indicated that it will continue to pause examination or decision-making for certain PTE matters that may be affected by the issues raised in Otsuka, while allowing other applications to proceed.
We will continue to monitor developments in the appeal and provide further updates as the matter progresses.
If you would like to discuss how these developments may affect your Australian patent portfolio or PTE strategy, please contact our team.
