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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.

Author:

Eduardo Hallak

Partner
Licks Attorney

Eduardo Hallak is one of the founding partners at Licks Attorneys and one of our leaders at the Sao Paulo office. For more than a decade, he has been working as a litigator before state and federal courts in Brazil in several complex disputes and leading cases involving Patent law, competition, and regulatory compliance, most of them pursuing the interests of clients in the area of life sciences. He also has extensive practice in trademark litigation as well as technology transfer contracts, working together with multinational clients to establish strong brand protection and licensing programs in the country. Mr. Hallak also currently teaches IP litigation in the Post-Graduation course at the prestigious Pontifical Catholic University of Rio de Janeiro (PUCRJ), has taught Civil Procedure at the at the Brazilian Association of IP Agents (ABAPI), and is often invited to lecture on procedural and strategic aspects of IP litigation, in addition to being a member of the Special Commission on Mediation of the Rio de Janeiro Chapter of the Brazilian Bar Association (OABRJ) and the Enforcement Committee of INTA.

Eduardo Hallak

Partner
Licks Attorney

Eduardo Hallak is one of the founding partners at Licks Attorneys and one of our leaders at the Sao Paulo office. For more than a decade, he has been working as a litigator before state and federal courts in Brazil in several complex disputes and leading cases involving Patent law, competition, and regulatory compliance, most of them pursuing the interests of clients in the area of life sciences. He also has extensive practice in trademark litigation as well as technology transfer contracts, working together with multinational clients to establish strong brand protection and licensing programs in the country. Mr. Hallak also currently teaches IP litigation in the Post-Graduation course at the prestigious Pontifical Catholic University of Rio de Janeiro (PUCRJ), has taught Civil Procedure at the at the Brazilian Association of IP Agents (ABAPI), and is often invited to lecture on procedural and strategic aspects of IP litigation, in addition to being a member of the Special Commission on Mediation of the Rio de Janeiro Chapter of the Brazilian Bar Association (OABRJ) and the Enforcement Committee of INTA.

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

Author:

Özge Atılgan Karakulak

Partner
Gün + Partners

Özge Atılgan Karakulak

Partner
Gün + Partners

Author:

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. 

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. 

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.

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.

Author:

Fiona Bor

VP - Intellectual Property
Bicycle Therapeutics

Fiona Bor

VP - Intellectual Property
Bicycle Therapeutics

Author:

Laura Whiting

Partner
Freshfields

Laura Whiting

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.

Author:

Daniel Lim

Partner
Kirkland & Ellis

Daniel Lim

Partner
Kirkland & Ellis

Author:

Elisabeth Haselhorst

IP Litigation Counsel
Bayer

Elisabeth Haselhorst

IP Litigation Counsel
Bayer

Author:

Raquel Frisardi

Associate Corporate Counsel
Novo Nordisk

Raquel Frisardi

Associate Corporate Counsel
Novo Nordisk

Author:

Rob Rodrigues

Partner
RNA law

Rob Rodrigues

Partner
RNA law

Author:

Katherine Helm

Partner
Dechert

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

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.

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.

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.

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.