This session examines the legal and governance challenges that arise when life sciences companies engage in joint advocacy through trade associations, industry coalitions and collective policy initiatives. Participants will examine how companies can structure regulatory engagement and industry collaboration to support effective advocacy while implementing appropriate safeguards to prevent anti-competitive coordination.

The growth of online pharmacy platforms and sustained parallel trade across the EU has intensified pressure on pharmaceutical trademark rights, particularly where medicines are repackaged and relabelled for distribution across borders. This roundtable will explore the practical strategies companies are deploying to monitor digital marketplaces, challenge unlawful repackaging and coordinate cross-border enforcement while remaining aligned with EU principles on exhaustion and competition law.

This session will examine evolving ESG obligations affecting the life sciences sector, including the revised Urban Waste Water Treatment Directive and its potential cost-allocation consequences for pharmaceutical manufacturers. Participants will explore the new European ESG legislation and discuss how environmental liability exposure, supply chain transparency requirements and new reporting standards are reshaping risk management frameworks and long-term operational planning across the industry.

Ongoing amendments and transitional extensions are continuing to reshape the practical implementation of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) across the EU. This session will outline the latest updates to these legislations and explore the persisting uncertainties and challenges for legal teams managing medical device and IVD portfolios.

The EU Biotech Act introduces both political ambition and significant legal uncertainty, with key questions remaining around its scope and implementation. This roundtable will examine the practical challenges, transitional ambiguity and strategic opportunities arising from the new legislation and assess how biotech companies can leverage the Act to reposition their competitive footprint in Europe.

U.S. product liability continues to represent a material litigation risk for life sciences companies, with multidistrict litigation and escalating jury awards intensifying exposure. This roundtable will examine how pharmaceutical and medical device manufacturers are structuring their defence strategy in this space and mitigating against financial reputational damage.

The recent, high-profile Munich Regional Court I decision on aflibercept has brought renewed focus to the application of the Doctrine of Equivalents in pharmaceutical patent disputes. The court’s reasoning has significant implications for the scope of protection available to originators and the freedom-to-operate assessments undertaken by biosimilar entrants in crowded, high-value markets. This session will examine the aflibercept decision, its interaction with established German and European equivalence case law and its potential consequences for generic launch and future pan-European injunction proceedings.

This roundtable will examine the legal and strategic implications of the EU SPC manufacturing waiver, focusing on its “safe harbour” role in enabling export and day-one EU market entry while reshaping originator exclusivity planning in the final phase of IP protection. Participants will assess notification requirements, stockpiling constraints and enforcement exposure, considering how originators and generics are adapting to core challenges and shifting strategies in response to new legislation and case law.

As scrutiny of inventive step and sufficiency intensifies in Europe under evolving EPO and UPC practice, originators face growing pressure to substantiate broad antibody claims with a credible technical contribution and sufficient data at the point of filing. This pressure is further reinforced post-Amgen v. Sanofi (2023) in the U.S., where the enablement doctrine has tightened the boundaries for broad antibody claims.

This session will examine the core IP challenges in the antibody and biologics space, placing recent high profile European and U.S. case law in the context of practical strategies you can deploy to secure broad and robust protection for biological molecules.

Are broad functional antibody claims in the U.S. still defensible post-Amgen v. Sanofi (2023)?
- What impact has the landmark UPC Court of Appeal decision in Amgen v. Sanofi & Regeneron (Nov 2025) had on antibody claims in Europe?
- How is inventive step for antibodies being assessed currently by major patent offices, including USPTO, EPO, JPO and CNIPA?
- Is the presumption of obviousness of antibody inventions at the EPO justified? - How does the notion of “routine methods” impact antibody patentability?
- How much data do you need in a patent application to demonstrate inventiveness?
- Is there a middle ground between broad, functionally defined claims and narrowly-defined sequence claims?
- How can you curate an antibody development and IP strategy that is adaptable to a changing prior art and reference antibody landscape?

Once viewed as a defensive, compliance-driven function, regulatory engagement is increasingly being integrated into broader corporate strategies for long-term product protection. In the context of MFN initiatives and intensifying commercial pressures, regulatory tools are becoming an important strategic lever for shaping market entry and influencing pricing dynamics, bringing regulatory activity into closer alignment with IP, competition and commercial decision-making.

Using FDA citizen petitions as a case study, this session will examine how often underutilised regulatory mechanisms can be deployed to influence market access and shape competitive positioning, and explore how these engagement tools intersect with IP strategy and antitrust risk.

- How are companies using regulatory tools, such as FDA citizen petitions, to complement IP strategy and support long-term product protection?
- To what extent can regulatory mechanisms be deployed to influence generic market entry without crossing the line into anti-competitive conduct?
- How does the timing and sequencing of regulatory interventions dictate competitive outcomes and antitrust exposure, particularly in the context of generic and biosimilar entry?
- How do regulatory strategies that influence competitive entry translate into pricing dynamics and broader market access outcomes?
- How are regulators, courts and competition authorities assessing and responding to the use of regulatory tools, such as citizen petitions?