In response, IP Australia has indicated that it has resumed processing pharmaceutical patent term extension (PTE) applications and related matters that it considers are not affected by the issues raised in Otsuka. However, it will continue to pause examination and/or decision-making for applications which it considers relate to pharmaceutical formulations that may be affected by the decision, pending the outcome of the High Court special leave process.
IP Australia has confirmed that PTE applications will not be refused solely due to missed response deadlines where processing remains paused, and extensions of time will be available where appropriate.
In addition, IP Australia has updated the Examiner’s Manual to reflect the Full Court’s decision in Otsuka, stating that a “pharmaceutical substance” is limited to the active pharmaceutical ingredient and does not include formulations or compositions comprising excipients or carriers. It also clarifies that a “mixture or compound of substances” refers to a mixture or compound of active pharmaceutical ingredients, rather than formulations or compositions of APIs with excipients and/or carriers.
Given the evolving legal position, applicants may wish to review their broader Australian PTE strategy, particularly where claims are directed to pharmaceutical formulations or related technologies.
We will continue to monitor developments and provide further updates as the position evolves. Please contact our team if you would like to discuss how these developments may affect your portfolio or future filing strategy.
[1] Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd [2025] FCAFC 161
