This session examines the legal and structural complexities facing small-to-medium-sized life science companies when pursuing licensing, collaboration, joint venture and M&A agreements with larger, more established players in the market. Participants will examine how life science SMEs can structure transactions strategically to optimise valuation, protect foreground and background IP and retain sufficient governance control to support secondary patent filings and pipeline expansions.

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.

As the U.S. Patent Trial and Appeal Board (PTAB) recalibrates its approach to discretionary denials under Director Squires' leadership, PTAB strategy is becoming harder to predict and more important to get right. This roundtable will examine how the new standards are playing out in practice and what they mean for challengers and patent owners navigating PTAB proceedings.

This session will examine evolving Environmental, Social and Governance (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.

Managing IP ownership transfers following cross-border M&A transactions remains an underestimated challenge for many organisations, with ownership errors creating significant hidden risk across global IP portfolios. This roundtable will explore how to manage multi-jurisdictional portfolio transitions efficiently, covering best practices for reducing risk and ensuring compliance during IP ownership changes. Attendees will discuss the operational and strategic challenges in post-acquisition IP integration, and leave with a clearer picture of how to improve visibility, coordination and efficiency in global IP portfolio transitions. 

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 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?