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?

In the modern era of AI-driven in silico approaches for target selection and lead compound identification, companies must navigate nuanced and unresolved patentability issues, centred on inventorship, disclosure, novelty and non-obviousness. In parallel, regulatory agencies are scrutinising AI algorithms, data provenance and transparency within MA dossiers. To combat this, companies must tightly align their IP and regulatory strategies to secure defensible IP and exclusivity positions for their AI-assisted inventions.

This session will address the key unanswered questions surrounding AI patentability and examine the strategies available to you for securing comprehensive patent protection and straightforward regulatory approval for your latest AI-assisted inventions.

- Should you disclose the use of AI in generating a lead compound on a patent application?
- What are the potential consequences of not disclosing AI use for downstream litigation?
- How are patent offices evaluating key issues around inventorship, disclosure, novelty and non-obviousness for AI-assisted inventions?
- How are regulatory authorities handling AI use during drug discovery processes?
- How should patent drafting strategies for AI-assisted invention be shaped to align with downstream regulatory requirements?
- To what extent should human decision-making be documented during the AI-assisted drug discovery process?
- How and to what extent should IP and Regulatory leads brief R&D teams on their use of AI?

Armed conflict, pricing interventions, the weaponisation of tariffs and intensifying policy competition between major jurisdictions are rapidly reshaping the global operating environment for life science organisations. As geopolitical tensions rise, companies must ensure that international relations are appropriately factored into their approaches to cross-border transactions, global market planning and long-term legal decision-making.

This cross-practice keynote will examine how geopolitical developments are reshaping legal strategy across the life sciences sector, and what this means for how you and your company should approach international investment and global deal-making.

- How are geopolitical tensions and policy interventions, including U.S. MFN pricing and the BIOSECURE Act, reshaping the legal and commercial risks life science companies must manage across global markets?
- How are life science legal teams adapting global strategy in response to increasing government intervention in drug pricing, trade policy and supply chains?
- How are geopolitical risks influencing how companies structure and execute cross-border life science transactions, including M&A, partnership and licensing agreements?
- How should legal teams balance geopolitical risk with commercial opportunity when pursuing international investment and strategic partnerships?

The EU Pharma Package is poised to reshape the commercial landscape for life science companies operating in Europe, with far-reaching implications for pricing, reimbursement negotiations and market access strategy across Member States. Reforms to exclusivity incentives and measures designed to accelerate generic entry could significantly influence pricing dynamics and the way companies approach reimbursement discussions across the region.

This session will explore how the EU Pharma Package could reshape pricing and reimbursement (P&R) dynamics across the EU, and what these changes may mean for your company’s strategic decisions around launch planning, portfolio prioritisation and long-term participation in the European life science market.

- How could changes to exclusivity incentives and earlier generic entry under the EU Pharma Package affect pricing dynamics across Member States?
- What implications might the reforms have for national P&R negotiations, including tender systems and reference pricing mechanisms?
- How might companies need to adapt their market access strategy and launch planning in response to increased pricing pressure?
- Could the reforms alter how companies prioritise product portfolios and decide whether and when to launch medicines in the European market?