Evolving clinical trial transparency obligations are materially affecting life science patent strategies, both in Europe and internationally, with growing tensions around public disclosures, post-filing amendments and the requirement for more data to demonstrate a plausible clinical effect. Now more than ever, the ability to successfully patent a clinical invention depends on crucial decisions at the interface between IP and regulatory strategy.

This session will discuss the need for coordination between IP and regulatory teams on the publication of clinical data, strategies for safely redacting confidential clinical information relevant to your future patent filings and approaches for aligning your patent filing strategies with timelines around clinical trial disclosures.

- How do different jurisdictions define a novelty destroying act in the context of a clinical trial?
- Where are the boundaries drawn between prior art and novel material in Europe post G1/23?
- How are the EPO approaching plausibility and post published clinical data following G2/21?
- What are you required to disclose in clinical trial publications? What can you safely redact?
- Can retaining confidential information relevant to future patent filings be used as an argument to justify redactions from clinical publications?
- How might transparency and data-sharing reforms under the EU Pharma Package and Biotech Act impact disclosure risk and optimal filing strategy?

The EU Pharma Package has instigated a landmark shift from market-access discretion to increasingly mandated market participation, with new launch and supply obligations raising fundamental questions around legal definitions, liability exposure and antitrust risk for life science companies. As these legislative changes unfold against a global backdrop of U.S. MFN pricing and mounting commercial pressure, legal teams must navigate a complex, evolving intersection between regulatory obligations, market access strategy and wider commercial dynamics.

This session will examine the implications of new EU launch and supply mandates, exploring how these legislative obligations are reshaping decision-making by marketing authorisation (MA) holders regarding launch sequencing and market participation amid global pricing pressures.

- How could enforcement of new launch obligations under the EU Pharma Package interact with European IP strategy and the revised “8+1(+1)(+1) regulatory exclusivity framework”?
- How might Member States interpret and enforce requirements around “adequate” or “sufficient” medicine supply under the new framework?
- What circumstances might constitute an acceptable “exceptional circumstance” justifying delayed launch or non-launch?
- What safeguards will be available to companies seeking to challenge or prevent misuse of launch and supply mandates by national authorities?
- How will new obligations interact with global pricing dynamics, including U.S. MFN policies, to influence where, when and in what geographical order companies choose to launch new products?
- How will new launch and supply obligations interact with competition law frameworks?

Divisional filing strategies have become a crucial and often contentious issue at the intersection between life science IP and antitrust law. As patent offices face growing pressure to alter their stance on divisional practice and competitors increasingly scrutinise filing strategies, companies must navigate a complex, high stakes environment where portfolio decisions can significantly impact market exclusivity timelines, public perception and revenues from blockbuster products.

This session will define the legal boundaries between anti-competitive evergreening and strategic portfolio optimisation, discuss how divisional filing strategies should be aligned with regulatory exclusivity and SPC frameworks, and explore the most effective approaches for generics companies seeking to challenge access blocking divisional patent families.

- Where does the legitimate boundary lie between portfolio optimisation and anti-competitive “evergreening”?
- How should originator companies design divisional strategies in parallel with regulatory exclusivity and SPC frameworks?
- How should generics companies coordinate IP invalidity, regulatory and competition strategies when confronting large divisional families?
- How does the UPC shift the litigation and competition risk profile of divisional portfolios?
- Are we entering a more interventionist phase in EU scrutiny of patent strategy – what signals should companies be monitoring in this space?

Competition law is no longer a standalone legal discipline within the life science sector. As antitrust scrutiny expands across patent practices, litigation settlements, pricing and deal-making, competition risk has become an increasingly important strategic issue, with significant potential implications for how you and your company approach future IP, regulatory and corporate decision-making.

This holistic, industry-led keynote will bring together private practitioners, regulators and in-house counsel to examine the evolving landscape of life science antitrust and discuss how recent developments in this area are reshaping legal strategy across the sector.

- How are interactions between competition authorities, patent offices and healthcare agencies reshaping the legal operating landscape for life science companies?
- How are industry perspectives on M&As, settlements and other life science transactions evolving?
- How are regulators scrutinising IP and regulatory frameworks in abuse of dominance investigations?
- What global trends are emerging in dawn raids, antitrust litigation and financial enforcement mechanisms targeting anti-competitive conduct in the life sciences sector?
- How should legal teams integrate competition risk into broader IP, regulatory and corporate strategy?