Understanding the Doctrine of Equivalents in the Netherlands.
Mutembei Kariuki
CEO & Co-founder
Fastagger
Mutembei Kariuki is CEO and co-founder of Fastagger, building a pioneering Embodied AI runtime that powers autonomous intelligence on edge devices, from smartphones in the field to robots in extreme environments. He has led global innovation and technology initiatives in edge AI, robotics, and frontier technologies, driving real-time decision-making and scalable AI deployments. Mutembei holds degrees in Economics and Information Systems and trained at the MIT Bootcamp for Launching AI Startups (Tokyo, 2019).
This session provides an in-depth analysis of recent high-profile biologics and biosimilar patent disputes across Europe, the USA, and Asia, including landmark cases involving Xtandi, Soliris, and antibody exclusivity challenges. Attendees will explore how evolving case law, patent claim constructions, and regulatory developments are shaping exclusivity periods, enforcement strategies, and market entry pathways. The session will also address comparative litigation trends, strategic patent considerations, and the complexities of navigating both branded vs branded and biosimilar patent conflicts globally.
• Examine key European rulings on Xtandi and Soliris patents, including patent validity challenges and injunction decisions.
• Analyse evolving antibody patent standards post-G2/21, Amgen vs Sanofi, and their impact on inventive step and exclusivity in the US and Europe.
• Explore strategic insights on BPCIA litigation timing, branded vs branded biologics disputes, and regulatory pathways for biosimilar market entry.
James Holtom
Partner
McCarthy Tetrault
Peter van Schijndel
Partner
Hoyng Rokh Monegier
Selma Ünlü
Senior Partner
NSN Law
This session will examine the impact of recent case law and forthcoming legislative reforms on Bolar exemptions and safe harbor provisions in the US and Europe. Experts will discuss how evolving legal frameworks affect patent enforcement strategies, particularly concerning timing for preliminary injunctions and defining “imminent infringement.” Key cases and jurisdictional nuances will be analysed to help patentees and generics understand the shifting landscape.
• Review recent US case law on the § 271(e)(1) research exemption and its enforcement implications.
• Analyse anticipated changes to the European Medicines Directive broadening the Bolar exemption and their effects on patent litigation.
• Discuss jurisdictional differences in preliminary injunction trigger points and the challenges posed by the UPC’s holistic approach to imminent infringement.
Christoph Rehfuess
Head of IP
Sotio
Andreas Robinson
Senior Counsel Intellectual Property & Litigation
Amgen
Cecile Teles
Head of IP
Zentiva
Cecile is Head Patent Attorney at Zentiva. She has over a decade of experience in the pharmaceutical industry.
Cecile is uniquely experienced and knowledgeable in the pharma space as she has experience in-house at an elite innovator company (Sanofi), biologics (Merck Serono), and extensive generic experience she gained as Zentiva.
Cecile is an enthusiastic manager of her team and was a key member of the IP team in leading the transformation of Zentiva into an independent and competitive generic company after divestment from Sanofi.
Cecile is a qualified European Patent Attorney. She also holds a certificate from CEIPI in patent litigation and most recently completed her diploma as a Master of Laws in France.
Eleanor Root
Partner
Bird & Bird
Maria Balestriero
Of Counsel
Portolano Cavallo
Gain firsthand insight into how judges across Europe are approaching pharmaceutical and biotech patent litigation in both national and UPC forums. This session offers a rare opportunity to hear from the bench on key trends, procedural developments, and how judicial thinking is evolving post-UPC launch. Attendees will come away with a deeper appreciation for the considerations shaping decisions in complex cross-border disputes.
Edger Brinkman
Honourable Judge, Local Division Hague
UPC
Lord Justice Birss
Honourable Judge
Court of Appeal of England and Wales
Paul Inman
Partner
Gowling
With more than 25 years' experience of litigating intellectual property (IP) disputes both within the UK and internationally, Paul Inman works with companies ranging from small start-ups to major multi-national corporations. He specialises in the life sciences sector, which includes acting on high-profile pharmaceutical patent infringement cases in the UK Patents Court.
Paul provides life science businesses with commercial advice from an international outlook. His specialist experience ideally places him to provide this expertise and client care, with the ultimate aim of delivering well-rounded advice and guidance to ensure the best possible outcome.
As well as litigating in the English courts, he has co-ordinated and advised on IP and regulatory litigation matters across the globe; from all over Europe and the US, to as far afield as Asia, South Africa, Australia and New Zealand.
Successfully guiding clients through the maze of litigation is where Paul's strength lies, having now been involved over 25 years of litigation in cases leading to more than 40 reported judgments. These range from the tribunals of the UK Patent Office up to the House of Lords, European Patent Office and European Court of Justice.
Paul also has a degree in Molecular Biology and Biochemistry and during his professional career has established an outstanding reputation in the market. He is distinguished in the 2023 edition of IAM Patent 1000: The World's Leading Patent Professionals, ranked individually for both IP law and life sciences law in the peer review publication 'Best Lawyers® in the UK' and recognised in several categories within Chambers & Partners UK 2023.
Ronny Thomas
Honourable Judge
UPC Local Division
The EPO’s decision in G2/21 was meant to bring clarity, but questions around plausibility standards remain unsettled. This panel will assess how national courts and the EPO are applying the doctrine and the implications for life sciences patents.
• Compare approaches to plausibility in the UK, Netherlands, and EPO post-G2/21.
• How are national courts diverging from or aligning with the EPO's reasoning?
• Explore how plausibility has been tested in key cases including Apixaban and Dapagliflozi.
• Understand the vulnerability of life sciences patents under current plausibility thresholds and discuss the risks of invalidation, and how should companies adapt?
• Discuss the comparative written description and enablement standards in the USA and the latest case law which may affect your global litigation strategy.
Corinna Sundermann
Senior Vice President Intellectual Property
Fresenius Kabi
Guido Pontremoli
Vice President Global IP
Chiesi
Currently employed as global Head of the IP department-Patent at Chiesi Farmaceutici SpA, managing and coaching a team of experienced patent attorneys, patent searchers and administrators, working on the protection, enforcement, litigation and/or opposition of the Chiesi IP, aligned with business decisions.
Before joining Chiesi, I worked in IP groups of big pharma companies (GSK Vaccine, and Bracco Imaging) as senior patent attorney responsible for all the IP aspects concerning some key R&D projects. I also had experience as patent counsel in private practices, dealing with pharma, chemical and bio entities.
Graduated in chemistry from the Univ of Milan, with a PhD in medicinal chemistry and a post-doc experience in USA, I am qualified EPA and chartered Italian patent attorney.
Jin Ooi
Partner
Kirkland & Ellis
Eva Ehlich
Partner
Maiwald
Second medical use patents remain a cornerstone of value creation in the life sciences industry, but enforcement continues to be fragmented. This panel will compare recent decisions and enforcement strategies across the UK, UPC and key global jurisdictions.
• Examine the new UPC plausibility and infringement test and how it applies in practice?
• Review the significance of the first UPC decision at the Dusseldorf Local Division (2025).
- What does it mean for assessing knowledge, intent, and infringement risk?
• Discuss the comparison with the USA and the recent wave of Skinny Label litigation.
• Understand the landscape of prior disclosure (G1/23) and its impact on the patentability of second medical use patents, as well as formulations, crystal forms and polymorphs.
Axel Berger
Partner
Bardehle
James Horgan
Chief IP Counsel- Policy & Litigation
MSD
Toni Santamaria
Vice President Intellectual Property
Adalvo
Toni has been leading the Intellectual Property team at Adalvo since 2021. He has more than 20 years of experience in different pharmaceutical companies where he has been involved in developing and implementing complex patent and data exclusivity litigation strategies for several generics and added value products, including leading parallel litigation cases in multiple European countries. He also has experience in patent and trademark prosecution.
Toni qualified as European Patent Attorney in 2010 and holds a PhD in Organic Chemistry.
Fiona Bor
VP - Intellectual Property
Bicycle Therapeutics
Rutger Kleemans
Partner
Freshfields
Cross-border litigation poses unique challenges and opportunities for the pharmaceutical and biotech industries. This panel will explore the complexities of managing patent litigation across multiple jurisdictions, strategies for harmonizing legal approaches, and the impact of international regulatory environments.
• Review the major cross-border case law and discuss the resulting IP effects from decisions such as: Tecfidera, Apixaban, Rivaroxaban, Glucose monitoring device cases, Paxlovid and Jardiance.
• Discuss common challenges faced in cross-border patent litigation, including jurisdictional issues, differing legal standards, and enforcement of judgments.
• Understand strategies for harmonising litigation approaches and minimising conflicting decisions.
Daniel Lim
Partner
Kirkland & Ellis
Elisabeth Haselhorst
IP Litigation Counsel
Bayer
Laila Beynon
Director – Dispute Resolution
Regeneron
Laila Beynon is Director, Dispute Resolution at Regeneron, responsible for the strategic co-ordination of ex-US patent litigation. She has a PhD in Biochemistry/Molecular Biology, 10 years’ private practice experience in life sciences patent litigation at Herbert Smith Freehills LLP, and prior to her role at Regeneron headed up the Patent Litigation team at BAT.
Raquel Frisardi
Senior Corporate Counsel
Novo Nordisk
Rob Rodrigues
Partner
RNA law
Katherine Helm
Partner
Dechert
Roundtable discussions are back! Led by an expert(s) within a jurisdiction, you can discover, question and gain solutions to your most pressing challenges in patent litigation strategy. Jurisdictions that will be covered include:
Netherlands
Understanding the Doctrine of Equivalents in the Netherlands
UK
The Use of the Arrow Declaration as a Patent Litigation Tool
France
Saisie Contrefaçon- a New Tool in the UPC Armoury
Germany
The Power of German National Courts in light of the UPC
Europe
EPO Board of Appeals Review and the Effect on Litigation Strategy
Europe
The Interaction Between the EPO, UPC and National Courts for a Comprehensive Patent Strategy Europe Clinical Trial Regulatory Changes and the Intersection with your IP Strategy
Global
Regulatory Exclusivity Protection Calculations
China
Understanding the New PTE in China
India
Case Law Review Across India
USA
Navigating AI in U.S. IP Litigation Lauren Baker, Partner, Barnes & Thornburg John Cox Partner, Barnes & Thornburg
USA
Hatch Waxman Litigation Review in the USA
UPC
The Long Arm Reach of the UPC
Latin America
Patent Litigation Case Law Review
