Agenda
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Day 1 — Main Conference
May 19, 2026
Registration and Breakfast
The Rise of Cross-Border Patent Enforcement: Redesigning European Patent Litigation Strategy Post-BSH v Electrolux
Dawid SierzantPartnerSDP (Poland)
Wouter PorsPartnerWindt Le Grand Leeuwnburgh (the Netherlands)
Dr. Florian SchweyerJudge7th Civil Chamber, Munich Regional Court
Rais AmilsPartnerGómez-Acebo & Pombo (Spain)
The CJEU’s decision in BSH Hausgeräte v Electrolux (CJEU, C-339/22)(“BSH”) may fundamentally reshape the jurisdictional landscape for patent enforcement, as it’s granted the UPC “long-arm” jurisdiction. This session examines the BSH decision, how it is being operationalized and interpreted by subsequent decisions, and what it means for future life sciences patent litigation strategy before national courts and the UPC.
Topics of discussion include:
- Reframing forum selection following BSH, including the consolidation of multi-state infringement claims
- Assessing early national court applications of BSH and where courts are drawing jurisdictional limits (e.g., Regeneron/Bayer vs Formycon, Onesta v BMW)
- Integrating national and UPC proceedings in parallel cross-border strategies
- Anticipating validity and procedural defenses in multi-jurisdiction infringement actions
- Translating BSH into enforcement playbooks for patentees and alleged infringers
Running and Defending Preliminary Injunctions at the UPC and Beyond: Reconciling Diverging Standards and Making Strategic Choices for Life Sciences
Dr. Moritz SchroederPartnerBird & Bird (Germany)
Matthieu Denne, Ph.D.Founding Partner | UPC RepresentativeDhenne Avocats (France)
Justyna RasiewiczPartnerRasiewicz & Associates (Poland)
Ruud van der VeldenPartner | Head of Amsterdam IPHogan Lovells (the Netherlands)
Although the UPC offers a unified forum for patent enforcement, preliminary injunction practice diverges, not only within the UPC, but also in comparison to national courts. Early case law reveals distinct approaches, each creating materially different outcomes depending on where relief is sought. This session examines how preliminary injunctions are being granted at the UPC and beyond, and provides strategies for navigating these differences.
Topics of discussion include:
- Comparing urgency and proportionality standards across national courts, UPC Local Divisions and the UPC Court of Appeal decision that overturned the PI in NanoString v 10x Genomics
- Evaluating evidentiary thresholds for validity and infringement in UPC PI proceedings
- Understanding the role of ex parte injunctions, where available and where effectively excluded
- Strategizing around timing, knowledge, and delay in light of strict urgency requirements
- Responding quickly to PIs while also positioning the PI within broader UPC and EU litigation strategy, including parallel actions on the merits
Morning Networking Break
The Doctrine of Equivalence: Balancing the UPCs First Approach Against Contrasting UK and German Decisions
Penny GilbertPartnerPowell Gilbert LLP
Oscar LammePartner | UPC RepresentativeSimmons & Simmons LLP (the Netherlands)
Dr. Tobias WuttkePartnerBARDEHLE PAGENBERG (Germany)
Eduardo HallakFounding PartnerLicks Attorneys (Brazil)
The doctrine of equivalence (DoE) in life sciences has long been applied differently by national courts across Europe, creating legal uncertainty and, at times, contrasting outcomes, as illustrated by recent Regeneron patent litigation in the UK and Germany. Against this backdrop, the UPC has articulated its test for DoE. This session examines how equivalence is currently being assessed across Europe, what the UPC’s decision does and does not resolve, and how patentees and alleged infringers in the life sciences should navigate this evolving landscape.
Topics of discussion include:
- Examining the UPC’s first articulation of the doctrine of equivalents in Plant-e v. Arkyne (Bioo), and subsequently in Washtower v BEGA (appeal heard in January 2026)
- Assessing the Hague Local Division’s four-question framework
- Understanding how fairness to patentees, legal certainty for third parties, and novelty over the prior art are being balanced in UPC equivalence analyses
- Analysing how the DoE is applied in key European jurisdictions, including the UK’s Actavis test, Germany’s function- and effect-based approach, and variations across other EU member states
- Comparing the contrasting outcomes on DoE in the Regeneron litigations in the UK and Germany, and what these decisions reveal about national thresholds for finding equivalence
- Evaluating the emerging role of prosecution history and file wrapper estoppel in UPC infringement and equivalence determinations
- Identifying strategic implications for claim drafting, prosecution amendments, and enforcement planning in a multi-jurisdictional European context
Networking Luncheon
European Patent Prosecution Deep Dive
Part I — Claim Interpretation, Description Conflicts, and the Next Chapter in Life Sciences after G 1/24 and G 1/25
Ida GjessingPartnerGjessing (Norway)
Lucy SamuelsDirectorGill Jennings & Every LLP (UK)
The Enlarged Board of Appeal’s decision in G 1/24 was widely seen as a step toward harmonizing claim interpretation across Europe, but subsequent Board of Appeal and UPC decisions have shown that “consulting” the description can lead to very different outcomes in practice. Against this backdrop, the EBA’s pending decision in G 1/25 on description amendments promises to have far-reaching implications for drafting, prosecution, validity, and enforcement strategy. This session distils the emerging jurisprudence and explores what these developments mean for legal certainty and patent litigation strategy in Europe.
- Distilling the core principles emerging from post-G 1/24 EPO case law on when the description may inform, but not override, clear claim language.
- Contrasting EPO and UPC approaches to description definitions and the “patent as its own lexicon”
- Exploring the differing treatment of definitions versus embodiments in the description and their impact on claim scope, validity, and infringement outcomes.
- Assessing how broadening and narrowing interpretations driven by the description can affect novelty, inventive step, and enforcement positions across forums.
- Considering whether G 1/24 may heighten the significance of claim–description inconsistencies in the context of G 1/25.
- Anticipating the practical consequences of the pending G 1/25 referral on description amendments, including drafting choices, opposition strategy, and future litigation risk.
Afternoon Refreshment and Networking Break
Lionel Vial, Ph.D.Founding Partner | UPC RepresentativeCabinet Vial (France)
Markus RieckPartnerFuchs Patentanwälte Partnerschaft mbB (Germany)
Patrick PurcellSenior Patent ExaminerUK Intellectual Property Office
Dr. Tobias FischerVice President of IPHeidelberg Pharma AG (Germany)
Richard GillardPartnerElkington + Fife LLP (UK)
Recent decisions from the EPO, the EBA and other national patent offices and courts influence core aspects of European patent prosecution, from plausibility and post-filed evidence, prior art, procedure, and clinical-stage inventions. Taken together, these rulings offer a snapshot of how patent offices and courts are responding to increasingly complex pharmaceutical and biotech innovation. This session reviews consequential decisions and distills what they mean in practice for filing strategy, portfolio management, and patent defence in Europe.
Topics of discussion include:
- Synthesizing how recent EPO and EBA decisions have recalibrated novelty, inventive step, sufficiency, and procedural rights in Europe (e.g., G2/21, G1/23, G2/24)
- Assessing the evolving role of post-published evidence in supporting or undermining plausibility and technical effect for clinical-stage inventions.
- Evaluating how commercial disclosures, clinical trial protocols, and marketed products are treated as prior art, particularly for complex pharma and biotech products.
- Examining other developments affecting oppositions, appeals, and the strategic risks they create for both patentees and alleged infringers.
- Translating these trends into practical guidance for drafting, timing of filings, and enforcement planning in the life sciences sector.
Dr. Rose Hughes, PhD, EPAEuropean Patent AttorneyEvolve IP
Dr. Graham LewisPartner | UPC RepresentativeJ A Kemp LLP (UK)
Mercedes Meyer, PhDPartnerBanner Witcoff (USA)
This session addresses the continually evolving landscape of antibody patenting in Europe and the U.S., incorporating crucial case law developments into effective prosecution strategies. Session leaders will dissect recent influential decisions and explore their implications for drafting and litigating antibody patents in different jurisdictions.
Topics of discussion will include:
- Adopting effective strategies for claiming antibodies, considering different patent office interpretations and how to draft claims that secure protection across jurisdictions
- Comparing the EU and US approaches to sufficiency and inventive step
- Examining how recent EPO decisions influence the acceptability of claims where a combination of antigen plus function is used to define an antibody
- Understanding the prosecution takeaways for broad claims from the US perspective, including the takeaways from the U.S. Supreme Court’s decision, which deemed claims of two Amgen patents invalid due to insufficient enablement for a genus of antibodies
- Understanding the nuances of epitope-based claims, functional antibody claims, combination therapies, and defining cell therapy products
Networking Cocktail
Conference Adjourns to Day Two
Day 2 — Main Conference
May 20, 2026
Registration and Breakfast
Regulatory Exclusivities and IP After the EU Pharma Package: Key Takeaways for Industry and Litigators
Sergio NapolitanoGeneral Counsel & Director of External RelationsMedicines for Europe (Belgium)
Michael SwitaDirector of IPEFPIA (Belgium)
David CarlingPartnerPotter Clarkson (UK)
With reduced and conditional regulatory protections, expanded Bolar exemptions, new launch and supply obligations, and a re-engineered orphan framework, the EU Pharma Package alters how exclusivity, enforcement, and market entry will interact across the product lifecycle. This session examines the most recent agreed framework through a patent and litigation lens, exploring how innovator and competitor strategies must evolve as regulatory protection become more closely intertwined with pricing, supply, and launch decisions across Member States.
Topics of discussion include:
- Reframing patent and SPC portfolio strategies to complement shortened and conditional regulatory protection periods
- Anticipating new litigation pressure points created by expanded Bolar activities, tender participation, and early market signaling
- Managing orphan and multi-indication portfolios under reduced predictability and constrained exclusivity extensions
- Integrating launch and supply obligations into patent enforcement, forum selection, and risk-allocation decisions across the EU
Morning Networking and Refreshment Break
Competition Law and Patent Strategy in Life Sciences: Dominance, Deal Scrutiny, and the Boundaries of Legitimate Competition
Rieke KaupCase HandlerDG Comp, European Commission
Dr. Cláudia TrabucoFormer Global Head of Competition LawGilead Sciences (Portugal)
Kurt HaegmanPartnerBaker & McKenzie (Belgium)
EU competition authorities and courts are taking a more expansive and coordinated look at how patent strategies are deployed in the life sciences sector. Recent developments, including the European Commission’s enforcement activity, the CJEU’s October 2025 judgment in the Teva and Cephalon Modafinil appeal, and decisions addressing disparagement and market definition, highlight increasing antitrust risk at key points in the product lifecycle. This session examines where EU law now draws the line between legitimate patent enforcement and conduct that may be viewed as restricting competition, and how companies can structure IP strategies accordingly.
Topics of discussion include:
- Reviewing recent enforcement trends affecting pharmaceutical patent strategy, including abuse of dominance and disparagement
- Evaluating portfolio management practices such as divisional filings and litigation sequencing through an antitrust lens
- Understanding disparagement risk following the Commission’s analysis in Teva (Copaxone) and related EU and national decisions
- Developing practical guardrails for IP strategy, including internal documentation, communications, and cross-functional coordination between legal, regulatory, and commercial teams
Supplementary Protection Certificates in Transition: Unpacking Key Case Law for Strategic SPC Planning
Dr. Fergal BradyPatent ExaminerIntellectual Property Office of Ireland
Dr. Martijn de LangePatent ExaminerNetherlands Patent Office
Elodie FerratyPatent ExaminerINPI (French Patent Office)
Dr. Stefanie VukovicPatent ExaminerDPMA (German Patent Office)
Rowena DinhamGroup Head, Patent ExaminationUK Intellectual Property Office
Jiri SlavikVice President, IPAdalvo (Czech Republic)
The EU SPC framework is undergoing significant revision, shaped by the proposed regulatory reform, evolving CJEU and national case law, and the operational realities of the SPC manufacturing waiver. Together, these developments are redefining how SPCs are planned, prosecuted, monitored, and defended across the product lifecycle.
Topics of discussion include:
- Navigating the proposed unitary SPC and recast SPC Regulation, including how centralized examination and grant may reshape SPC filing and portfolio strategies
- Evaluating the strategic coexistence of unitary and national SPCs, including when parallel protection may remain desirable despite harmonization efforts
- Distilling strategic lessons from recent CJEU and national decisions on Articles 3(a), 3(b), and 3(d), including implications for combination products, antibodies, and new medical indications
- Reassessing SPC eligibility and drafting strategies post-Royalty Pharma, Santen, and related case law developments
- Examining the use of the SPC manufacturing waiver through recent cases,
- E.g., notice requirements, timing, and emerging disputes over compliance
Networking Luncheon
Skinny Labels as a Safe Harbour? Second Medical Use Patents and Evolving Infringement Liability in Europe and the US
Dr. Kai RütingPartner | UPC RepresentativeVossius & Partner (Germany)
Daniela Gill-Carey, PhDSenior Director | IP Litigation Lead, EMEAAstellas Pharma Europe Ltd (UK)
Irene CasalprimIP DirectorAdalvo (Spain)
Amanda K. Murphy, Ph.DPartnerFinnegan (UK and US)
Recent jurisprudence at the UPC and national courts have shifted the infringement analysis of second medical use patents toward a holistic assessment of how products are positioned, supplied, and used in the market, placing increased weight on commercial conduct and knowledge of prescribing practices. Equally, the United States Supreme Court recently granted certiorari to hear the longstanding skinny labelling dispute between Amarin Pharma and generic drugmaker Hikma. This session examines how these developments are reshaping liability risk and litigation strategy for second medical use claims, and what this means in practice for patent holders and generic and biosimilar companies.
Topics of discussion include:
- Reviewing the UPCs emerging infringement framework for second medical use from the Sanofi cabazitaxel case, and the Sanofi/Regeneron v Amgen PCSK9 inhibitor cases
- Analyzing the arguments and earlier court decisions of the US Hikman/Amarin skinny labelling case
- Unpacking what anticipated outcomes of the Supreme Court decision could mean for generic and biosimilar defenses
- Comparing UPC evidentiary expectations with US, German and other European standards on cross-label use, market conduct, and exploitation of circumstances
- Reframing infringement analysis for second medical use claims beyond manifest preparation and formal label carve-outs
- Preparing litigation strategies around proof of use, knowledge, and preventive measures in second medical use disputes
Afternoon Break
Demystifying US Invalidity and Infringement: The Need-to-Know Playbook for Coordinating US Patent Disputes with European Strategy
Katherine A. (“Kassie”) HelmPartnerDechert LLP (US)
Ellen Broug, Ph.DEuropean Patent Attorney | UPC RepresentativePlasseraud (the Netherlands)
Sanya SukduangPartnerNorton Rose Fulbright (US)
U.S. post-grant proceedings at the PTAB, and infringement trials through federal district courts, and especially, parallel proceedings, remain a high-impact feature of global patent strategy, yet recent procedural changes and US case law have altered how and when these tools can be used. This session will equip EU patent attorneys and lawyers with the latest knowledge needed to confidently compare and prepare for US patent litigation or invalidity proceedings.
Topics of discussion include:
- Explaining recent procedural and institutional changes under USPTO Director John Squires, including new institution review practices and proposed rule amendments
- Recapping the core features of inter-partes review (IPR) and post-grant review (PGR) including scope, timing, and estoppel and how they differ from EPO opposition
- Coordinating PTAB proceedings with EPO oppositions to manage cost, risk, and parallel outcomes for coordinated global strategy
- Unpacking key differences in US and EU infringement litigation, e.g., disclosure obligations, jury trials, focus on damages
- Demystifying parallel PTAB and US district court actions, including notice obligations, timing considerations, evidence and coordination challenges
- Integrating U.S. post-grant and district court risk and opportunity into global filing, prosecution, and portfolio-management strategies for companies active in both the EU and U.S.
Camille Terfve, PhDPartner, Patent AttorneyMewburn Ellis LLP (UK)
Francesca BlythePartnerSidley Austin LLP (UK)
Michelle AyoraSenior Data Protection LawyerMyData-TRUST (Belgium)
Artificial intelligence is transforming drug discovery, clinical development, and commercialization, often at an unprecedented pace. Governments and regulatory agencies in the US, EU, and China are rapidly developing frameworks that balance innovation with patient safety, data governance, and ethical principles.
This session will explore how the rapidly evolving and fragmented regulatory landscape around AI in pharma and biotech impacts IP, privacy, and compliance.
It will focus on how these intersecting regimes create both legal risk and potential litigation exposure.
The discussion then shifts to how companies can move from regulatory complexity to practical, cross-jurisdictional compliance strategies.
Topics of discussion include:
- Interpreting recent AI regulatory frameworks in the US, EU, and China: where AI regulation stands today in key markets, what high-level updates have emerged over the past year, and what new laws and policies are on the horizon.
- Multiregional collaboration and its practical implications.
- E.g., the EMA and FDA’s joint AI guidance for medicine development (January 2026), as well as ASEAN’s Guidance on AI Governance and Ethics.
- Navigating AI transparency, trade secrets, and patent protection.
- Understanding privacy fundamentals in AI: Navigating global regulatory diversity.
- Evaluating key ethical and governance considerations, including bias mitigation, transparency, explainability, and patient safety in AI-driven processes.
- Comparing global approaches to the cross-regulatory landscape, highlighting similarities, divergences, and lessons for multinational strategy.
- Bridging regulatory divergence: Global strategies across AI, IP, and Privacy.