AUSTRALIA Trends and Developments Contributed by: Ben Miller, Alexandra de Zwart, Fiona Deng and Emma Woelke, Maddocks
Maddocks Lawyers Level 10 33 Alfred Street Circular Quay, Sydney NSW 2000 Australia Tel: +61 292 916 100 Email: info@maddocks.com.au Web: www.maddocks.com.au
Overview The life sciences and pharma IP litigation landscape is rapidly evolving in Australia, propelled by innovation, a dynamic regulatory environment and shifting market forces. Key legal battles – including increased scru ‑ tiny of patent term extensions, important interlocutory injunction decisions and significant biologic/biosimilar disputes – have shaped strategies for market access and patent protection. Recent regulatory changes – including amendments to the Pharmaceutical Benefits Scheme (PBS) and reduced prescription co-payments, along with Thera ‑ peutic Goods Administration (TGA) actions underscor ‑ ing a more proactive approach to enforcement – have also influenced the pharma IP litigation landscape. There has been a noticeable increase in trade mark filings within the life sciences sector, likely driven by brand owners placing greater emphasis on securing robust and more diverse trade mark protection. These developments highlight Australia’s growing role in the international life sciences sector and in strate ‑ gic IP litigation (often as part of a multi-jurisdictional strategy), as policy reforms, commercial opportunities and judicial precedent intersect to set the stage for the
Australia’s innovation performance also strength ‑ ened in 2025. Australia ranked 22nd in the Global Innovation Index, up one place from 2024, reflecting improvements in innovation inputs and outputs and aligning with a sustained uplift in commercialisation activity and patenting quality. Within the World Intel ‑ lectual Property Organization’s (WIPO) global top 100 innovation clusters, Sydney ranked 36 for medical technology (by patent filings) and engineering (by aca ‑ demia), while Melbourne ranked 52 for pharmaceuti ‑ cals (by patent filings) and engineering, highlighting the complementary strengths of Australia’s largest life sciences hubs. The Pharmaceutical Benefits Scheme (PBS) has seen several changes, including expanding access for cer ‑ tain indications and dropping the PBS general co- payment to AUD25 per prescription (from AUD31.60), as part of measures to increase affordability of medi ‑ cines. Interlocutory Injunctions – the Balance of Convenience Starts to Favour Biosimilars: Regeneron v Sandoz In June 2025, Regeneron and Bayer sued Sandoz in the Federal Court, seeking injunctive relief to prevent the launch of Australia’s first biosimilar competitors to aflibercept (EYLEA). However, in a decision handed down on 3 September 2025, Justice Rofe declined to grant an interlocutory injunction ( Regeneron Phar- maceuticals, Inc v Sandoz Pty Ltd [2025] FCA 1067). Until recently, the Federal Court had been inclined to grant interlocutory injunctions to preserve the status quo on the basis that generic/biosimilar entry would
sector’s future direction. The Australian Market
The Australian life sciences sector continues on an upward trajectory, employing approximately 350,000 people across 3,000 organisations, underscoring the sector’s growing economic footprint.
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