The past twelve months have marked a notable inflection point for pharmaceutical patent law in Australia, with appellate courts revisiting foundational questions of patent scope and remedies that will set the direction of originator-generic disputes for years to come.
Several major pharmaceutical patent disputes still before the Court (Pfizer v Samsung (etanercept) and Otsuka v Generic Health (aripiprazole – Government damages)) have moved closer to final resolution, while a number of new cases have also been filed. As the Federal Court’s new practice directions designed to streamline patent litigation now taking effect, we expect to see meaningful procedural efficiencies in how these cases are managed. We hope that bringing these developments together serves as a practical resource for navigating this evolving terrain.
Some of our key articles are summarised and linked below, while the Full Report includes additional articles, updates on key pharmaceutical policy issues, current pharmaceutical patent litigation cases and hot topics. Feel free to download the full report here and reach out to the team for all of your IP legal issues.
Highlights
The High Court of Australia has granted special leave to appeal the Full Federal Court’s decision in Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd [2025] FCAFC 161, a case that may redefine the eligibility of pharmaceutical formulation patents for patent term extensions. The grant of special leave signals that the boundaries of the extension of term regime remain unsettled, with significant implications for the effective patent life of reformulated products.
Lessons from recent interlocutory injunctions in pharmaceutical patent cases
The recent resurgence of interlocutory injunctions in pharmaceutical patent litigation represents a meaningful shift in the risk calculus for generic entrants. After a seven-year hiatus, the Federal Court’s decisions in Janssen Pharmaceutica NV v Juno Pharmaceuticals Pty Ltd [2025] FCA 1538 and AstraZeneca AB v Pharmacor Pty Ltd [2026] FCA 88 demonstrate that injunctive relief remains a live weapon for originators.
PBS price reductions: How far do they reach?
The Newron Pharmaceuticals S.p.A. v Arrotex Pharmaceuticals Pty Ltd [2025] FCA 1321 and [2025] FCA 1437 decisions confirm the relatively low threshold for obtaining preliminary discovery, underscoring its utility as an early strategic tool.
Generic entry: Preliminary discovery in pharmaceutical patent disputes
The Federal Court’s decision in Gilead Sciences Pty Ltd v Minister for Health and Ageing [2026] FCA 232 confirms that statutory price reductions triggered by generic entry on the Pharmaceutical Benefits Scheme can flow through to combination products sharing a common listed component drug, a ruling with substantial potential commercial consequences for originators whose revenue concentration is tied to combination therapies anchored by a single active ingredient approaching loss of exclusivity.
Australia’s new merger control regime: What it means for patent transactions
Australia’s new mandatory merger control regime, which commenced on 1 January 2026 under Part IVA of the Competition and Consumer Act 2010 (Cth), requires ACCC clearance for acquisitions meeting monetary thresholds. Patent transactions are particularly affected, because these transactions are excluded from the “ordinary course of business” exception that applies under the merger control regime. We explore a range of factors that patentees need to be aware of.
Beyond case law, we examine areas of commercial and strategic importance:
- the rapidly evolving field of needle-free vaccine delivery systems, from microarray patches and mucosal vaccines to jet injectors and solid-dose devices, and the cross-disciplinary IP strategies required to protect these innovations
- a summary of ongoing pharmaceutical patent litigation in the Courts
- our policy update covers significant regulatory and legislative developments, including IP Australia’s consultation on the reform of exclusive licensing provisions, and
- key pharmaceutical measures in the 2026-2027 Federal Budget.
We hope this review serves as a practical resource for navigating the evolving terrain of pharmaceutical patent law in Australia.
All of our authors are subject-matter experts in their respective fields, so please feel free to reach out to any of them for further information on the issues raised in these important decisions.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
