As competition authorities intensify scrutiny of patent settlements in the life sciences sector, so called “pay-for-delay” agreements remain firmly in the enforcement spotlight. For litigators and legal teams navigating complex disputes, the challenge is no longer simply whether to settle, but how to structure agreements that balance commercial objectives against evolving antitrust expectations.

This focused industry briefing will provide a practical overview of how pay-for-delay risk is shaping settlement strategy in the life sciences sector, drawing on recent enforcement trends and real-world considerations across the U.S. and Europe. Attendees will gain clear, actionable insight into how to identify risk and structure defensible agreements that withstand scrutiny while preserving commercial outcomes.

- How are competition authorities in the U.S. and Europe currently assessing pay-for-delay agreements? Where are the key divergences?
- What value transfers are most likely to attract antitrust scrutiny in settlement agreements?
- How are evolving antitrust enforcement trends influencing whether, when and on what terms companies choose to settle life science disputes?
- What practical steps can legal teams take to structure settlements that withstand competition scrutiny while achieving commercial objectives?
- How should companies assess whether a proposed settlement could be perceived as restricting competition or delaying market entry?

Supplementary Protection Certificates remain at the heart of pharmaceutical and biotechnology patent lifecycle strategies. Recent CJEU referrals, together with divergent decisions emerging from national courts, have raised crucial questions about key provisions of the SPC Regulation and how they are interpreted across European jurisdictions. The outcomes of these important cases hold significant strategic implications for the future pursuit, enforcement and opposition of SPC protection across the life science industry.

This session will review the past year’s most significant SPC-related decisions from the CJEU and national courts, bringing together private practitioners, senior in house counsel and representatives from European patent offices to explore their implications for future SPC practice. In addition, the discussion will consider how ongoing SPC-related policy developments, including draft measures under the EU Biotech Act and the proposed introduction of a unitary SPC system, may further reshape the strategic use of SPC protection within the broader European exclusivity framework.

- CJEU Referral C-456/24 (Halozyme): what qualifies as an “active ingredient” under Article 1(b)?
- CJEU referral C-15/26 (Boehringer Ingelheim v GPTO) concerning ciclesonide: can a later veterinary MA qualify as “the first authorisation to place a product on the market as a medicinal product” where an earlier human MA already exists for the same active ingredient? How strict is Article 3 (d) on this point?
- Conflicting European national case law concerning lisdexamfetamine and the recent CJEU referral C 794/25 (Stada v Takeda): what constitutes the “product” in a pro-drug scenario?

Heightened merger scrutiny in the life sciences sector is reshaping how transactions are structured, evaluated and defended, as authorities intensify their focus on pipeline overlaps across R&D and manufacturing value chains.

This session will examine current trends in life science M&A, novel approaches to assessing horizontal and vertical concentration and the core implications of antitrust M&A risk for your overall transaction strategy and design.

- How are competition authorities currently assessing life science M&As? What types of deals are attracting the most scrutiny?
- How should companies evaluate antitrust risk when acquiring early-stage or pipeline assets that are not yet on the market? - When does vertical/horizontal integration create meaningful competition risk?
- When during an M&A process should antitrust considerations influence the deal structure, valuation and conditionality?

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?