Latest updates to Patent Law in Australia
Federal Court
Sun Pharma ANZ Pty Ltd v Otsuka Pharmaceutical Co Ltd [2025] FCA 44 and Cipla Australia Pty Ltd v Novo Nordisk A/S [2024] FCA 1414
In Sun Pharma ANZ Pty Ltd v Otsuka Pharmaceutical Co Ltd [2025] FCA 44 and Cipla Australia Pty Ltd v Novo Nordisk A/S [2024] FCA 1414 the Federal Court clarified the eligibility criteria for patent term extensions (PTE) and in particular, the scope of the expression “pharmaceutical substance per se”. In both cases it was held that claims to pharmaceutical formulations, which include both active pharmaceutical ingredient and excipients, are considered "pharmaceutical substances per se" and qualify for PTE.
IP Australia
IP Australia released its Cost Recovery Implementation Statement (CRIS) on 2 September 2024, which included fee changes that were to come into effect from 1 October 2024. An important procedural change that accompanied the new fee schedule related to excess claim fees. For patent applications where examination was requested on or after 1 October 2024, excess claim fees for applications with more than 20 claims will initially be calculated and charged upon issuance of the first examination report. Excess claim fees will also be incurred at acceptance (allowance) if the number of claims has increased beyond 20 during examination. Chapter 6 has been updated to reflect the new excess claim fee procedure.
Please click here for a more detailed summary of the latest release.
The Patent Law in Australia online service continues to be an indispensable guide to obtaining, maintaining, enforcing and challenging the validity of patents in Australia. Balancing both the practical nature of IP Australia processes and in-depth analysis of statute and case law, Patent Law in Australia navigates every aspect of the patenting process, with detailed commentary on the law pertaining to each stage and therefore provides relevant and effective advice for patent attorney's, intellectual property lawyers and barristers. The publication launched in 2008 and is published both as an online subscription service and as a book. The third edition of Patent Law in Australia was published in 2018.
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Linda Govenlock is the Head of Allens Patent & Trade Mark Attorneys and has practised as a registered patent attorney in Australia and New Zealand for 25+ years. She specialises in the chemical, industrial and life sciences patent areas, with a particular focus on new drug substances, development of new pharmaceutical formulations, diagnosis and treatment of diseases, securing patent term extension for pharmaceutical patents, industrial and agricultural chemicals, material sciences, and mining processes. She holds a PhD in organic chemistry and a Masters of Industrial Property Law. Linda is a Fellow of the Institute of Patent and Trade Mark Attorneys of Australia and a member of the Intellectual Property Society of Australia and New Zealand.