On 14 May 2024, we reported that Cipla had commenced Federal Court proceedings challenging the patent term extension (PTE) to Novo Nordisk’s liraglutide formulation patent (AU2004290862). Liraglutide is marketed by Novo Nordisk in Australia as Victoza®. Cipla argued that the PTE was invalid on the basis that only patents for active ingredients and not patents for formulations (which included mixtures of active ingredient(s) and excipients) were eligible to be extended under the Australian PTE regime.
On 12 December 2024, the Federal Court delivered a decision rejecting Cipla’s challenge and upholding Novo Nordisk’s PTE, which extends the patent term from 18 November 2024 to 26 August 2025.
Accordingly, subject to any appeal, formulation patents continue to be eligible for PTEs in Australia. Cipla can also no longer achieve its intended Australian liraglutide product launch date of January 2025, as the Federal Court upheld Novo Nordisk’s cross-claim seeking injunctive relief on the basis that it was not in dispute that Cipla’s product would infringe Novo Nordisk’s patent.