On 5 March 2026, Pearce IP hosted a Masterclass on changes that mean market entry dynamics for generic and biosimilar launches in Australia have dramatically shifted. Two elements are responsible for this shift: PTEs and PIs.
On-Demand Pearce IP Webinars
Do Recent Developments in PTEs & PIs Create New Strategic Opportunities to Disrupt the Pharma Market?
The market entry dynamics for generic and biosimilar launches in Australia have dramatically shifted. Two elements are responsible for this shift:
➡️ PTE: The Courts have ‘reined in’ the patent term extension regime, with the Full Court confirming in December 2025 that formulation patents are inextensible;
➡️ PI: Originator sponsors are less inclined to seek interlocutory/preliminary injunction (PI) against generic/biosimilar market entrants. Following a series of PI rejections between June 2018 and December 2025, 2 PIs were granted in December 2025 and February 2026.
Recent developments in law and practice relating to PTE & PI create new opportunities for pharma litigants to ‘play’ with creative strategies. But what are these opportunities? What are the trends?
In this masterclass, you will learn from leading Pearce IP pharma patent litigators Naomi Pearce and Helen Macpherson and patent prosecutor Mat Lucas:
✅ What are these changes in law/practice?
✅ What do they mean for pharmaceutical/biopharmaceutical market entrants in Australia?
✅ What new market entry opportunities exist for generic/biosimilar applicants?
Chaired by dual AU/NZ registered IP litigator Paul Johns.
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