Agenda - Pharma & Biotech | Kisaco Research
Agenda Days: 
  • Day Zero (UPC Litigation Forum): Monday, 19 Jan, 2026
    09:00am - 10:00am
    Registration
    10:00am - 10:10am
    Chair’s Introduction to the UPC Litigation Forum
    10:10am - 11:00am

    Claim Construction at the UPC: A Review of EPO, National and UPC Case Law

    Claim Construction at the UPC: A Review of EPO, National and UPC Case Law This session examines the UPC’s evolving approach to claim interpretation, highlighting key decisions that clarify how claims are construed in comparison with EPO and national practices. It will explore recent landmark rulings and ongoing developments shaping patent litigation strategies.


    • Review the UPC Court of Appeal decision NanoString Technologies v. 10xGenomics, which clarified the standard for interpreting patent claims based on Article 69 EPC and its Protocol, affecting both infringement and validity assessments.
    • Examine the ongoing question of whether the file wrapper should be considered in claim construction, which awaits a final decision by the UPC Court of Appeal.
    • Analyse the decision of G1/24 and its impact upon claims raised at national courts, the EPO and the UPC.

    Speaker(s): 
    Session Type: 
    Panel
    11:00am - 11:45am

    The Development of the Doctrine of Equivalents Case Law: Comparing the UPC with National Jurisdictions

    This session examines how the UPC’s evolving case law on equivalence compares with national practices in jurisdictions such as the UK, Germany, and Brazil. With recent UPC decisions applying the four-prong test to life sciences disputes, panellists will assess whether the doctrine is delivering legal certainty while ensuring fair protection for patentees.

    • Analyse how recent UPC rulings apply the doctrine of equivalents and compare with approaches in the UK, Germany, and Brazil.
    • Are the four key UPC questions workable in practice, especially in the life sciences context?
    • Evaluate the balance between legal certainty for third parties and fair protection for patent holders under the UPC system.

    Speaker(s): 

    Author:

    Viviane Kunisawa

    Partner
    Daniel Law

    Viviane Kunisawa

    Partner
    Daniel Law
    Session Type: 
    Panel
    11:45am - 12:15pm
    Networking Break
    12:15pm - 13:15pm

    UPC Judges Panel Session: Understanding the Case Law and Operations Behind the Decision Makers at the Court

    Join an exclusive panel featuring esteemed judges from the UPC, whose decisions are shaping the future of patent litigation across Europe. This prestigious session offers a rar opportunity to gain invaluable insights into the judicial mindset and decision-making processes at one of the most important new patent courts globally. Don’t miss this chance to engage with the very authorities defining the UPC’s jurisprudence and influencing litigation strategies across industries.

    Speaker(s): 

    Author:

    Emmanuel Gougé

    Honourable Judge
    UPC Court of Appeal

    Emmanuel Gougé

    Honourable Judge
    UPC Court of Appeal

    Author:

    Kai Harmänd

    Honourable Judge
    UPC Court of First Instance

    Kai Harmänd

    Honourable Judge
    UPC Court of First Instance

    Author:

    Peter Blok

    Honourable Judge
    UPC Court of Appeal

    Peter Blok

    Honourable Judge
    UPC Court of Appeal

    Author:

    Ronny Thomas

    Honourable Judge
    UPC Local Division

    Ronny Thomas

    Honourable Judge
    UPC Local Division
    Session Type: 
    General Session (Presentation)
    13:15pm - 14:15pm
    Networking Lunch
    14:15pm - 15:00pm

    The UPC and Injunctions: Is the Court Shaping up to be Pro-Patentee?

    With the UPC issuing an increasing number of rulings, its developing case law on injunctions is critical for shaping enforcement strategies. For IP counsel and litigators, understanding how and when the UPC is willing to grant or deny injunctions - whether preliminary or permanent - is essential for advising clients, managing litigation risk, and crafting effective pan-European strategies.


    • Review Grundfos v. Canned Motor Pump (Düsseldorf LD), where the court issued a permanent injunction despite ongoing licensing talks and clarified that lack of inventive step must be explicitly argued - not merely referenced via prior art.
    • Analyse Boehringer v. Zentiva (Lisbon LD), in which the court denied provisional measures due to lack of proof of imminent infringement, offering key insights into evidentiary thresholds at the UPC.
    • Understand the Milan LD’s approach to litigation costs in Ericsson v. Digital River and Oerlikon v. Bhagat, highlighting how procedural context and case complexity affect fee shifting.
    • Discuss how this growing body of UPC injunction case law is influencing strategic decision-making across industries and jurisdictions.

    Speaker(s): 

    Author:

    Ewan Nettleton

    Principal IP Counsel- Oncology Litigation
    Novartis

    Ewan Nettleton

    Principal IP Counsel- Oncology Litigation
    Novartis

    Author:

    Tobias Wuttke

    Partner
    Bardehle Pagenberg

    Tobias Wuttke

    Partner
    Bardehle Pagenberg
    Session Type: 
    General Session (Presentation)
    15:00pm - 15:45pm

    UPC Case Law Review: A Discussion of the Trends and Changes Taking Place at Europe’s Newest Patent Court

    As the UPC continues to take shape through early rulings, procedural clarifications, and appeals, legal teams across Europe are watching closely to understand how this new venue is redefining enforcement strategy. This session offers a practical review of the key decisions to date, considers procedural and jurisdictional trends, and examines the strategic calculus of litigating in the UPC versus national courts.


    • Review recent UPC case law and appeals to understand emerging judicial approaches and procedural norms:
    - Edwards Lifesciences v Meril (2025)
    - Mul-T-Lock v IMC Créations (2025)
    - Abbott Diabetes Care v Sibio Technology (2025)
    • Examine strategic decision-making: when and why companies are choosing the UPC over national courts. Compare early UPC developments to UK patent litigation to identify points of convergence and divergence.

    Session Type: 
    Panel
    15:45pm - 16:00pm
    Networking Break
    16:00pm - 16:45pm
    Interactive Workshop Session
    16:45pm - 17:00pm

    UPC In-House Strategy Session: Settlements, Prosecution and Cost Savings

    The UPC is not just a litigation forum, it is also proving to be a strategic lever for in-house counsel seeking faster resolutions, stronger negotiating positions, and cost-effective enforcement. This session will examine how companies are recalibrating their patent prosecution and litigation strategies to take advantage of the UPC’s tight timelines, wide territorial scope, and growing body of case law on injunctions and costs.


    • Explore how the mere filing of UPC cases - such as Ocado’s triple-action move against Autostore - can accelerate settlements in long-running, multi-jurisdictional disputes.
    • Understand how the UPC’s efficiency and Europe-wide reach heighten pressure on implementers, making the threat of an injunction a powerful driver of licensing outcomes.
    • Examine how the UPC’s approach to proportionate injunctions and litigation cost allocation (e.g., Milan LD rulings) are influencing early settlement calculus and portfolio management.
    • Discuss how in-house teams are adapting prosecution strategies - such as timing of unitary effect requests - to align with their risk tolerance and enforcement goals.

    Session Type: 
    Panel
    17:00pm - 17:45pm

    The Reach of the UPC: Long-Arm Jurisdiction and Strategic Considerations for Non-Member States

    As the UPC becomes more active, questions are emerging around its jurisdictional reach - particularly regarding its influence on companies and enforcement strategies in non-UPC countries like the UK and Spain. This session explores how far UPC decisions can stretch, and what it means for rights holders and litigants operating beyond its formal borders.


    • Examine the potential extraterritorial effect of UPC decisions on non-participating states.
    • Hear perspectives from UK, Spanish, and international counsel on the limits and risks of UPC long-arm jurisdiction.
    • Explore defensive and offensive strategies for companies based in or targeting non-UPC jurisdictions.

    Session Type: 
    Panel
    17:45pm
    Chair Closing Comments
    17:55pm
    Icebreaker Drinks Reception
  • Day One | Main Event : Tuesday, 20 Jan, 2026
    08:00am - 09:00am
    Registration
    09:00am - 09:10am
    Chairs’ Opening Remarks: Introduction to Patent Litigation Europe
    09:10am - 10:00am

    Cross-Border Pharmaceutical Patent Litigation Cases and the Effect Upon Your IP Strategy

    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.

    Speaker(s): 

    Author:

    Daniel Lim

    Partner
    Kirkland & Ellis

    Daniel Lim

    Partner
    Kirkland & Ellis

    Author:

    George Moore

    Assistant General Counsel
    Viatris

    George Moore

    Assistant General Counsel
    Viatris

    Author:

    Laila Beynon

    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. 

    Laila Beynon

    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. 

    Author:

    Raquel Frisardi

    Senior Corporate Counsel
    Novo Nordisk

    Raquel Frisardi

    Senior Corporate Counsel
    Novo Nordisk

    Author:

    Rob Rodrigues

    Partner
    RNA law

    Rob Rodrigues

    Partner
    RNA law
    Session Type: 
    Panel
    10:00am - 10:45am

    Second Medical Use Strategies and Case Law Across the UK, UPC and Rest of the World

    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.

    Speaker(s): 

    Author:

    Axel Berger

    Partner
    Bardehle

    Axel Berger

    Partner
    Bardehle

    Author:

    James Horgan

    Chief IP Counsel- Policy & Litigation
    MSD

    James Horgan

    Chief IP Counsel- Policy & Litigation
    MSD

    Author:

    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.

    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.

    Session Type: 
    Panel
    10:45am - 11:15am
    Networking Break
    11:15am - 12:00pm

    Plausibility, Litigation and the Comparative Landscapes in the UK and the Rest of the World

    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.

    Speaker(s): 

    Author:

    Corinna Sundermann

    Senior Vice President Intellectual Property
    Fresenius Kabi

    Corinna Sundermann

    Senior Vice President Intellectual Property
    Fresenius Kabi

    Author:

    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.

    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.

    Author:

    Jin Ooi

    Partner
    Kirkland & Ellis

    Jin Ooi

    Partner
    Kirkland & Ellis
    Session Type: 
    Panel
    12:00pm - 12:45pm

    Judges Roundtable: Understanding Decisions and Perspectives from National and UPC Courts

    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.

    Speaker(s): 

    Author:

    Ronny Thomas

    Honourable Judge
    UPC Local Division

    Ronny Thomas

    Honourable Judge
    UPC Local Division
    Session Type: 
    Workshop
    12:45pm - 13:45pm
    Networking Lunch
    13:45pm - 14:30pm

    Bolar Exemptions and Safe Harbor – Navigating Litigation and Legislative Changes

    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.

    Speaker(s): 

    Author:

    Christoph Rehfuess

    Head of IP
    Sotio

    Christoph Rehfuess

    Head of IP
    Sotio
    Session Type: 
    Panel
    14:30pm - 15:15pm

    Biologics and Biosimilar Litigation Review in Europe, the USA and Asia

    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.

    Speaker(s): 

    Author:

    James Holtom

    Partner
    McCarthy Tetrault

    James Holtom

    Partner
    McCarthy Tetrault
    Session Type: 
    Panel
    15:15pm - 15:45pm
    Networking Break
    15:45pm - 17:25pm
    Connect 26 - Roundtable Discussions

    Netherlands

    Understanding the Doctrine of Equivalents in the Netherlands.

    Session Type: 
    Breakout

    UK

    The Use of the Arrow Declaration as a Patent Litigation Tool.

    Session Type: 
    Breakout

    France

    Saisie Contrefaçon- a New Tool in the UPC Armoury. 

    Session Type: 
    Breakout

    Germany

    The Power of German National Courts in light of the UPC.

    Session Type: 
    Breakout

    Europe

    EPO Board of Appeals Review and the Effect on Litigation Strategy. 

    Session Type: 
    General Session (Presentation)

    Europe (2)

    The Interaction Between the EPO, UPC and National Courts for a Comprehensive Patent Strategy.

    Session Type: 
    Breakout

    Europe (3)

    Clinical Trial Regulatory Changes and the Intersection with your IP Strategy. 

    Session Type: 
    Breakout

    Global

    Regulatory Exclusivity Protection Calculations. 

    Session Type: 
    Breakout

    China

    Understanding the New PTE in China.

    Session Type: 
    Breakout

    India

    Case Law Review Across India. 

    Session Type: 
    Panel

    USA

    Navigating AI in U.S. IP Litigation. 

    Session Type: 
    Breakout

    USA (2)

    Hatch Waxman Litigation Review in the USA.

    Session Type: 
    Breakout

    UPC

    The Long Arm Reach of the UPC.

    Session Type: 
    Breakout

    Latin America

    Patent Litigation Case Law Review. 

    Session Type: 
    Panel
    17:25pm
    Chair Ends Day 1
    17:55pm
    Networking Drinks Reception
  • Day Two | Main Event : Wednesday, 21 Jan, 2026
    08:00 - 09:00
    Registration
    09:00am - 09:10am
    Chair’s Recap of Day 1 and Introduction to Day 2
    09:10am - 10:00am

    Preliminary Injunction Review for the Life Science Sector

    Injunctions can be decisive in life sciences patent litigation, particularly in fast-moving markets. This session delivers a strategic overview of recent developments in preliminary injunctions across the UPC, Europe, and the United States, helping patent holders and challengers alike prepare for high-stakes enforcement in 2025. With a cross-border perspective, expert speakers will unpack emerging trends, legal thresholds, and jurisdictional contrasts shaping the availability and strength of injunctive relief.

    • Explore the latest PI case law from the UPC, key EU countries, and the USA and how it impacts pharma and biotech strategies.
    • Understand practical approaches for securing or resisting injunctions in different jurisdictions, including timing, evidence, and risk assessment.
    • Gain actionable insights on how PI outcomes are influencing broader litigation and market entry planning in the life sciences.

    Speaker(s): 

    Author:

    Kristin Cooklin

    Group Head IP Counsel
    Recordati

    Kristin Cooklin

    Group Head IP Counsel
    Recordati

    Author:

    Michal Porubsky

    Senior Litigation Counsel
    Novo Nordisk

    Michal Porubsky

    Senior Litigation Counsel
    Novo Nordisk

    Author:

    Richard Roberts

    Partner
    Potter Clarkson

    Richard Roberts

    Partner
    Potter Clarkson
    Session Type: 
    Panel
    10:00am - 10:45am

    Competition Law Review from the Life Science Sector: A Review of Recent Court Decisions

    As patent enforcement strategies face growing scrutiny, competition law is increasingly influencing how life science companies manage exclusivity and market access. This session will unpack recent court and authority decisions across Europe, Switzerland, and the United States, spotlighting how regulators are drawing the line between legitimate IP enforcement and anti-competitive conduct. From divisional strategy concerns in the Copaxone case to the exoneration of Novartis by COMCO, attendees will gain a nuanced understanding of evolving antitrust standards and how to adapt their own IP strategy accordingly.


    • Analyse the implications of the Copaxone divisional strategy case and what it signals about future antitrust enforcement in the context of IP gaming.
    • Understand why COMCO cleared the Cosentyx® patent portfolio case and what it reveals about balancing freedom to operate and competition law.
    • Explore the intersection of U.S. antitrust enforcement with FDA listing practices delistings, ANDA exclusivity, and the shifting impact of FTC and Federal Circuit decisions.
    • Examine how China’s recent implementation of ANDA litigation and patent linkage modeled on the U.S. Hatch-Waxman system - is impacting exclusivity, competition, and antitrust scrutiny in both jurisdictions.

    Speaker(s): 

    Author:

    Julia Pike

    Global Head of IP
    Sandoz

    Since March 2020, Julia has been the Global Head of IP for Sandoz. In her previous roles with Sandoz, she has had a leading role in the first wave of US biosimilars litigation, including the first litigations on critical aspects of the governing legislation (the Biologics Price Competition and Innovation Act or BPCIA), culminating in the landmark US Supreme Court decision, Sandoz v Amgen.

     

    Since leaving private practice at Corrs Chambers Westgarth, Julia has been in-house counsel for many years including at Mayne Pharma and Hospira Inc before joining Sandoz in 2008. While there, she has taken on roles in European public affairs and led Sandoz’s global IP litigation function as Global Head of IP Litigation. Through those roles, she has maintained a keen interest in IP strategy and litigation worldwide, including cases arising under the Hatch-Waxman and BPCIA legislation in the US, PM(NOC) regulations in Canada and litigation arising from patent linkage systems around the world. 

    Julia Pike

    Global Head of IP
    Sandoz

    Since March 2020, Julia has been the Global Head of IP for Sandoz. In her previous roles with Sandoz, she has had a leading role in the first wave of US biosimilars litigation, including the first litigations on critical aspects of the governing legislation (the Biologics Price Competition and Innovation Act or BPCIA), culminating in the landmark US Supreme Court decision, Sandoz v Amgen.

     

    Since leaving private practice at Corrs Chambers Westgarth, Julia has been in-house counsel for many years including at Mayne Pharma and Hospira Inc before joining Sandoz in 2008. While there, she has taken on roles in European public affairs and led Sandoz’s global IP litigation function as Global Head of IP Litigation. Through those roles, she has maintained a keen interest in IP strategy and litigation worldwide, including cases arising under the Hatch-Waxman and BPCIA legislation in the US, PM(NOC) regulations in Canada and litigation arising from patent linkage systems around the world. 

    Author:

    Philippe Bessiere

    Global Head of Patents
    Pierre Fabre Group

    Philippe Bessiere

    Global Head of Patents
    Pierre Fabre Group
    Session Type: 
    Panel
    10:45am - 11:15am
    Networking Break
    11:15am - 12:00pm

    UPC Strategy Session: Discussing the Effect of Europe’s Newest Patent Court Upon the Life Science Sector

    The UPC was met with caution by the life science sector. Nevertheless, new data from its first two years shows a changing reality - pharmaceutical and chemistry-related litigation is not only present, it’s gaining momentum. This session will offer a deep dive into the UPC’s evolving role in high-stakes life science patent disputes, helping you prepare an informed strategy for 2025 and beyond.


    • Understand the latest UPC litigation statistics and what they reveal about pharma and chemistry sector adoption.
    • Discover why Milan and Munich are emerging as key venues for life science disputes and what it means for your forum selection.
    • Learn how English-language dominance is shaping litigation strategy for multinational teams.
    • Analyse how early UPC case law is influencing industry confidence and what your business risks by staying on the sidelines.
    • Hear how to coordinate UPC proceedings with EPO oppositions to build an integrated and effective litigation approach.

    Speaker(s): 

    Author:

    James Robertson

    Head of Global IP
    BioMérieux

    James Robertson

    Head of Global IP
    BioMérieux

    Author:

    Siddharth Kusumakar

    Partner
    Powell Gilbert

    Siddharth Kusumakar

    Partner
    Powell Gilbert
    Session Type: 
    Panel
    12:00pm - 12:45pm

    To Settle or Not to Settle? Decisions and Strategies for Life Science In-House Counsels

    With the introduction of the UPC and shifting dynamics in global patent enforcement, life science companies face renewed questions about when to settle, when to litigate, and how to choose the right forum. This candid, cross-sector panel of in-house counsel and litigators will explore how dispute resolution strategy is evolving across the industry.


    • Discover how in-house teams weigh the risks and rewards of litigation versus settlement in a post-UPC world.
    • Determine whether certain sectors - such as biotech, generics, or medtech - are more inclined to settle and why.
    • Discuss practical insights on how to structure licensing negotiations or parallel proceedings to support favourable outcomes.

    Speaker(s): 

    Author:

    Shohta Ueno

    Assistant General Counsel - Dispute Resolution
    Regeneron

    Shohta Ueno

    Assistant General Counsel - Dispute Resolution
    Regeneron
    Session Type: 
    Panel
    12:45pm - 13:45pm
    Networking Lunch
    13:45pm - 14:30pm

    SPC & PTE Litigation Review for the Life Sciences Sector

    Supplementary Protection Certificates remain a critical and complex aspect of pharmaceutical patent strategy. This session offers a comprehensive review of recent landmark rulings and evolving practices across Europe, providing life sciences patent holders with key insights to refine their SPC approaches in 2025.


    • Explore pivotal cases such as Teva/MSD and Halozyme, and their impact on Articles 3(a), 3(c), and 1(b) concerning combination products and active ingredient interpretation.
    • Understand how recent UK decisions, including Merck v Comptroller (2025), reflect divergence from broader European SPC practice, and examine emerging trends in antibody SPCs and unitary SPC legal status.
    • Examine the expanded SPC Manufacturing Waiver regime since 2022, including conflicting rulings from Belgium, Germany, and the Netherlands on storage, export, and notification requirements.
    • Gain practical guidance on managing waiver-related risks, protecting exclusivity, and navigating cross-jurisdictional challenges in SPC enforcement and litigation.

    Speaker(s): 

    Author:

    Karin Pramberger

    Head of IP
    Polpharma Group

    Karin has been Intellectual Property Director at the Polpharma Group since April 2018. She is responsible for all patent and trade mark related activities. Prior to joining the Polpharma Group, Karin was Head of IP of Medichem, Spain, and worked in various positions within the patent department of Teva, Barr and Pliva.  She spent 7 years in a law firm in Vienna, Austria, where she became European and Austrian patent and trade mark attorney. She studied Biotechnology in Vienna, Austria, and at the Ecole Nationale Supérieure de Chemie de Paris, France. In 2017 she graduated with an LLB from the University of London. Since 2005 she has been a tutor at CEIPI, University of Strasbourg, for the pre-exam and the C-part of the European Qualifying Exam. 

    Karin Pramberger

    Head of IP
    Polpharma Group

    Karin has been Intellectual Property Director at the Polpharma Group since April 2018. She is responsible for all patent and trade mark related activities. Prior to joining the Polpharma Group, Karin was Head of IP of Medichem, Spain, and worked in various positions within the patent department of Teva, Barr and Pliva.  She spent 7 years in a law firm in Vienna, Austria, where she became European and Austrian patent and trade mark attorney. She studied Biotechnology in Vienna, Austria, and at the Ecole Nationale Supérieure de Chemie de Paris, France. In 2017 she graduated with an LLB from the University of London. Since 2005 she has been a tutor at CEIPI, University of Strasbourg, for the pre-exam and the C-part of the European Qualifying Exam. 

    Author:

    Sebastian Moore

    Partner
    HSF Kramer

    Sebastian Moore

    Partner
    HSF Kramer
    Session Type: 
    Panel
    14:30pm - 15:45pm

    Regulatory Changes for the Life Science Sector- How Should You Prepare Your Life Science Litigation Strategy?

    The EU pharmaceutical package is set to reshape the European life sciences landscape, introducing significant reforms around data exclusivity, compulsory licences, and SPCs. With ongoing negotiations and key provisions still under debate, this reform presents both opportunities and uncertainties for patent enforcement and market strategy. Join leading experts to understand the implications of these regulatory changes and how in house counsel can adapt their litigation strategies accordingly.


    • Review proposed changes to data exclusivity periods and their impact on generic market access and innovation incentives.
    • Examine the introduction of compulsory licences in emergency situations and the potential risks and benefits for patent holders.
    • Explore the push for a centralised unitary SPC system across Europe and what this means for patent protection harmonisation.
    • Discuss how these reforms might influence competition, supply security, and environmental requirements in the pharmaceutical sector.

    Speaker(s): 

    Author:

    Adrian Spillmann

    Director of Intellectual Property
    Valneva

    Adrian Spillmann

    Director of Intellectual Property
    Valneva
    Session Type: 
    Panel
    15:45pm
    Chair Closing Comments
    15:50pm
    Conference End
Event Reference: 
The Pharma & Biotech Patent Litigation Summit, Europe