Communications about competing therapies play a critical role in life science competition, particularly where companies seek to influence clinical practice and decisions surrounding pricing and reimbursement. However, statements relating to the safety, efficacy or regulatory status of rival products may raise competition concerns where they risk distorting market perceptions.

This session will examine the competition risks associated with product communications in the life science sector, and explore how you can manage the boundaries between legitimate scientific debate and unlawful disparagement when discussing competing medicines.

- Where do competition authorities draw the line between legitimate scientific debate and unlawful disparagement?
- What types of product communications are most likely to attract competition scrutiny?
- How should companies manage the legal risk of product comparisons across departments?
- How might product communications about competing therapies become evidence in competition investigations?
- How does disparagement fit within the broader category of exclusionary conduct in life science competition law?

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?
- Pending CJEU referrals and national court decisions on the SPC manufacturing waiver.
- How might proposed incentives relating to 12-month SPC extensions for innovative biotech medicines and ATMPs under the EU Biotech Act play out in practice?
- What are the latest developments on the proposed unitary SPC system? What are the likely timings? Who will have jurisdiction? How will appeals be handled?

The life sciences sector has seen a marked increase in strategic acquisitions in recent years, as companies seek to replenish innovation pipelines and safeguard future growth against looming patent cliffs and loss of exclusivity. In this context, merger control is becoming a central strategic constraint, with competition authorities responding to heightened deal activity by intensifying their focus on pipeline overlaps, future competition and integration across R&D and manufacturing value chains.

This session will explore recent trends in the life science M&A landscape, before drawing on case studies to examine the latest developments in how competition authorities are scrutinising transactions.

- What are the key trends shaping life science M&A activity today? What are the predominant transaction types, and where is the most significant deal activity occurring globally?
- How are competition authorities currently assessing life science M&As? What types of deals are attracting the most scrutiny?
- What conclusions can be drawn from Illumina/Grail, Novo Holdings/Catalent and other recent cases in terms of how authorities are approaching innovation risk, vertical integration and control over critical capabilities?
- How should companies evaluate antitrust risk when acquiring early-stage or pre-market pipeline assets?
- When does horizontal or vertical integration create meaningful competition risk?
- At what stage in the M&A process should antitrust considerations influence the deal structure, valuation and conditionality, and how are companies adapting in practice?

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?