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?

The EU Pharma Package’s controversial expansion of the Bolar exemption has the potential to recalibrate launch timing, litigation leverage and competitive dynamics across the originator-generic divide. The reform directly challenges traditional assumptions about the protective scope of patent rights and the practical meaning of exclusivities in Europe, while inviting direct comparison with the U.S. Hatch-Waxman safe harbor framework.

This session will explore the expanded Bolar exemption and its broad implications across the sector, addressing how national courts are likely to interpret the legislation and how the new provisions compare with established U.S. safe harbor frameworks. Gain an enhanced understanding of how this landmark shift at the interface of IP and regulatory strategy will impact your life science legal work, and receive exclusive advice to help you adjust to the new provisions with confidence.

- What is the scope of the expanded Bolar exemption under the EU Pharma Package, and how does it compare with the U.S. Hatch-Waxman safe harbor?
- Will the expanded provisions actually enable day one generic entry in practice?
- How will expansions to the Bolar exemption play out in the national courts?
- How will incorporating aspects of pricing, public tender and reimbursement into the new provisions interplay with existing IP rules?
- Where do the core risks now lie for innovators, biosimilars and generics? How can they be minimised?
- What are the downstream implications of these legislative changes for patent litigation strategies?

The CMA marks a structural shift in EU life science policy, introducing new definitions, supply obligations, disclosure requirements and procurement mechanisms that will directly impact pricing, manufacturing strategy and governance frameworks. It signals a move from crisis-driven coordination towards a permanent resilience regime, embedding supply security and transparency as enforceable regulatory objectives.

This session will dissect this important new legislative framework, addressing its key aims, uncertainties and implications for your company.

- What will constitute a critical medicine?
- How will the Act work in practice?
- How will the responsibility for its implementation be divided between the Commission and Member States?
- What incentives or other support will companies receive for diversifying their supply chains towards Europe and participating in Strategic Partnerships?
- How will the new public and collaborative procurement initiative influence pricing dynamics?
- How will supply continuity obligations for critical medicines be enforced? Where is the litigation risk, and what is the scope for force majeure?
- What supply chain information will need to be disclosed/reported? What steps will be taken to protect commercially sensitive information?
- How will the Act interplay with the EU HTA Regulations and other legislative frameworks?

The EU Pharma Package replaces the long-standing certainty of fixed-term RDP and market exclusivity with a more complex and ambiguous system of incentives linked to operational and product requirements. By conditioning additional exclusivities, the reform has introduced a significant new layer of uncertainty that will require companies to recalibrate proactively across IP, regulatory and broader corporate functions.

This session will examine the Pharma Package’s changes to RDP and market exclusivity, and discuss the implications of this marked departure from the status quo for legal strategy across the life sciences sector. Hear expert insights into how the new legislation will alter the complex interplay between your IP, regulatory and overall business strategies, and position your company to respond successfully to an era-defining shift in the European regulatory landscape.

- How feasible will it be for companies to meet the criteria for beyond-baseline extensions to regulatory exclusivities on pharmaceuticals?
- What does “unmet medical need” mean in a legal context? How will this be evaluated in practice?
- How are exclusivities and incentives changing for paediatric medicines, priority antimicrobials and orphan medicinal products?
- How feasible are the criteria for SPC extensions under the EU Biotech Act? How will they be assessed?