HOT TOPIC | A Seismic Shift in Australian Pharma Patent Strategy | Fault Lines Emerge in PTEs and Preliminary Injunctions

Recent developments in Australian law and practice concerning Patent Term Extensions (PTEs) and preliminary injunctions (PIs) will shake up the pharmaceutical market.

For originators, generics and biosimilar sponsors alike, long-standing strategies relating to likely loss of exclusivity dates and enforcement/launch strategies are being reimagined following recent developments relating to PTEs and preliminary/interlocutory injunctions (PI).

Formulation Patents & PTE:

• Formulation patents have been routinely extended for up to 5 years for pharma products since the early 2000s.
• Most on-patent pharma products have formulation patents, and most of those are extended.
• The Full Court’s decision in Otsuka in December 2025 confirmed that the patent office practice and a handful of first instance decisions in the Federal Court were wrong, rendering a myriad of formulation patent PTEs invalid.
• If the formulation patent was a barrier to generic/biosimilar launch, then this barrier has now been removed by the Full Court during the extended period.
• The High Court may grant Otsuka’s request for special leave to appeal, but more likely it will not. Even if special leave is granted, it will not be until (at least) the end of 2026 (and perhaps 2027) that the High Court decides the matter.
• In the meantime, extended formulation patents are dead during the (now invalid) PTE.

Preliminary Injunctions:

• No PI was granted between the Roche PI against Sandoz on Rituximab in June 2018 and the Paliperidone PI against Juno (Arrotex) by Janssen granted in December 2025.
• In the interim were rejections by the Court on applications for PI:
  • in 2021: By Biogen against Pharmacor on DMF (PTE likely invalid)
  • in 2025: By Regeneron/Bayer against Sandoz on Aflibercept (on non infringement grounds)
• Since the Juno decision, AZ’s application for PI against Pharmacor succeeded on Dapagliflozin
  
• We also see a trend away from seeking PI. (please do not quote me on this, but feel free to raise it in your note: I think this is due to patentee concerns about exposure to the commonwealth on damages)
• What is clear is that in the right case, PI can be avoided. We would never have said this 5 years ago!

These 2 developments together result in the “perfect storm” which will dramatically change the IP strategies deployed by pharma companies in Australia, and for many INNs, will induce the “loss of exclusivity” date by many years. Pearce IP will explore these issues in a complimentary Masterclass, including practical insights on the evolving litigation landscape and strategic commentary on the prosecution implications for patentees seeking to safeguard and future-proof their portfolios in Australia.

About Pearce IP

Pearce IP is a specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.