Welcome to Spruson & Ferguson's review of the most notable developments in Australian pharmaceutical patent law in the past year.
The year has seen a series of landmark decisions from the High Court, the Full Court and the Federal Court, each reshaping the legal landscape for originators and generics. The Courts have addressed critical issues ranging from damages claims by the Commonwealth, patent term extensions (PTEs), the requirements of inventive step as well as sufficiency and support.
Some of our key articles are linked below, while the Full Report includes updates on key pharmaceutical policy issues, a brief on current pharmaceutical patent litigation cases and hot topics, including for clinical trials and training AI with patient data. Feel free to download the full report here and reach out to the team for all of your IP legal issues.
Highlighted articles
Five key lessons from the High Court's decision in the Commonwealth damages case
In Commonwealth of Australia v Sanofi [2024] FCA 47, the High Court delivered its long-awaited decision concerning the Commonwealth's attempts to recover $325 million in damages from Sanofi for increased costs to Australia's Pharmaceutical Benefits Scheme arising from an interlocutory injunction preventing generic launch, based on a patent ultimately found to be invalid. Whilst the Commonwealth failed in its attempt, the judgment provides important lessons that are expected to strengthen the prospects of success for both the Commonwealth and generics in similar cases in the future.
Sandoz ascertains obviousness finding against Bayer's Australian Xarelto patent
In the context of Sandoz AG v Bayer Intellectual Property GmbH [2024] FCAFA 135, we step through the seesawing judgments that led to the final outcome in this case in Sandoz's favour and discuss the implications for both patentees and generics contesting inventive step with respect to pharmaceutical patents.
Novartis patent term extension held to be invalid – Federal Court decision
We review recent developments in relation to PTEs. The most recent decision of Novartis AG v Pharmacor Pty Limited (No.3) [2004] FCA 1307 highlights an increasing trend of challenging patents during an extended term based on the 'first regulatory approval'. We discuss how the Court's decision in this case underscores the complexities of patent claim construction and its implications for pharmaceutical companies seeking to extend the term of their patent protection. We also discuss the need for pharmaceutical companies to carefully develop their PTE strategies with a view to potential litigation.
Sanofi v Amgen dispute update
The case of Sanofi v Amgen Inc. (No. 3) [2025] FCA 387 highlights the different thresholds for sufficiency and support under the "old" vs the current Patents Act.
Read the report
We hope this review serves as a practical resource for navigating the evolving terrain of pharmaceutical patent law in Australia. Please do not hesitate to contact any of our authors, all subject-matter experts in their respective fields, for further information on the issues raised in these important decisions.
For more information about our legal services, head to our IP Law page and take a look at our Patents services here.
Katrina Crooks, Head of Spruson
& Ferguson Lawyers