| Page 230 | Kisaco Research

Author:

Dan McGrath

Partner
Marks & Clerk

Dan is an experienced patent litigator who advises clients on a wide range of intellectual property issues. He has considerable experience in biopharmaceutical patent and supplementary protection certificate litigation and has represented clients in some of the most complex technical disputes tried in the English courts. Dan also has significant expertise in litigation before the Unified Patent Court and is currently instructed on several high-profile patent disputes. Dan sits on the BioIndustry Association's IP Advisory Committee and its SPC sub-committee.

 

In the UK, Dan has advised clients in actions in the High Court and Court of Appeal. Dan regularly manages multi-jurisdictional disputes, co-ordinating and working with litigation teams globally. He has been involved in hearings at the Unified Patent Court, European Patent Office, District Court in The Hague and in North America.

 

With a keen interest in scientific innovation, Dan is readily able to master highly technical issues and has a strong grasp of the technical and commercial landscape in which his clients operate

Dan McGrath

Partner
Marks & Clerk

Dan is an experienced patent litigator who advises clients on a wide range of intellectual property issues. He has considerable experience in biopharmaceutical patent and supplementary protection certificate litigation and has represented clients in some of the most complex technical disputes tried in the English courts. Dan also has significant expertise in litigation before the Unified Patent Court and is currently instructed on several high-profile patent disputes. Dan sits on the BioIndustry Association's IP Advisory Committee and its SPC sub-committee.

 

In the UK, Dan has advised clients in actions in the High Court and Court of Appeal. Dan regularly manages multi-jurisdictional disputes, co-ordinating and working with litigation teams globally. He has been involved in hearings at the Unified Patent Court, European Patent Office, District Court in The Hague and in North America.

 

With a keen interest in scientific innovation, Dan is readily able to master highly technical issues and has a strong grasp of the technical and commercial landscape in which his clients operate

Author:

James Horgan

Chief IP Counsel, International Litigation & Policy
MSD

James Horgan

Chief IP Counsel, International Litigation & Policy
MSD
 

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 Kariuki

CEO & Co-founder
Fastagger

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.

Author:

Frank Landolt

Chief Counsel, IP & Legal
Confo Therapeutics

Frank Landolt is Chief Counsel, Intellectual Property and Legal at Confo Therapeutics, a privately held biopharmaceutical start-up based in Ghent, Belgium specializing in GPCR-targeted therapeutics.

After studying chemistry and law at the University of Leiden in the Netherlands, Frank worked for almost ten years on pharmaceutical and biotechological patents and licensing in private practice in the Netherlands, where his clients included major pharmaceutical companies as well as some of the top biotech firms and research institutions in the Netherlands. 

Prior to joining Confo in 2018, Frank worked for fifteen years in Ablynx N.V. (now a wholly owned Sanofi company), where he was a member of the management team and headed an integrated IP and legal group of four lawyers and five patent professionals. At Ablynx, Frank was involved in negotiating Ablynx’s strategic partnerships and licensing deals with AbbVie, Boehringer-Ingelheim, MSD, Merck-Serono, Novartis, Novo Nordisk, Sanofi and Wyeth. 

From 2000 to 2004, Frank was director of IP and legal counsel at Devgen N.V. (now part of Syngenta), another Ghent-based biotechnology company, where he was involved in negotiating Devgen’s strategic collaborations with Sumitomo, Monsanto and DuPont Pioneer.

Frank is a Dutch and European patent attorney, and also holds a degree in business law from the University of Antwerp. He is a member of the Dutch association of patent attorneys (where he is a tutor for the professional qualification course), EPI and LES Benelux (where he is involved in the LES Licensing Course). He is a regular speaker on a range of topics relating to IP and licensing in the (bio)pharmaceutical sector. Frank was named as one of Managing IP’s ‘Corporate IP stars’ for four years in a row (2015-2018).

Frank Landolt

Chief Counsel, IP & Legal
Confo Therapeutics

Frank Landolt is Chief Counsel, Intellectual Property and Legal at Confo Therapeutics, a privately held biopharmaceutical start-up based in Ghent, Belgium specializing in GPCR-targeted therapeutics.

After studying chemistry and law at the University of Leiden in the Netherlands, Frank worked for almost ten years on pharmaceutical and biotechological patents and licensing in private practice in the Netherlands, where his clients included major pharmaceutical companies as well as some of the top biotech firms and research institutions in the Netherlands. 

Prior to joining Confo in 2018, Frank worked for fifteen years in Ablynx N.V. (now a wholly owned Sanofi company), where he was a member of the management team and headed an integrated IP and legal group of four lawyers and five patent professionals. At Ablynx, Frank was involved in negotiating Ablynx’s strategic partnerships and licensing deals with AbbVie, Boehringer-Ingelheim, MSD, Merck-Serono, Novartis, Novo Nordisk, Sanofi and Wyeth. 

From 2000 to 2004, Frank was director of IP and legal counsel at Devgen N.V. (now part of Syngenta), another Ghent-based biotechnology company, where he was involved in negotiating Devgen’s strategic collaborations with Sumitomo, Monsanto and DuPont Pioneer.

Frank is a Dutch and European patent attorney, and also holds a degree in business law from the University of Antwerp. He is a member of the Dutch association of patent attorneys (where he is a tutor for the professional qualification course), EPI and LES Benelux (where he is involved in the LES Licensing Course). He is a regular speaker on a range of topics relating to IP and licensing in the (bio)pharmaceutical sector. Frank was named as one of Managing IP’s ‘Corporate IP stars’ for four years in a row (2015-2018).

Author:

Peter van Schijndel

Partner
Hoyng Rokh Monegier

Peter van Schijndel

Partner
Hoyng Rokh Monegier

Author:

Gemma Barrett

Partner
A&O Shearman

Gemma is an experienced and trusted advisor for some of the world’s leading life sciences and chemical companies. Her background in biochemistry means she specialises in complex technical disputes in the life sciences sector.  She has more than fifteen years’ experience advising clients in patent litigation matters before the English Courts including securing preliminary injunctions. She is also experienced in advising on global cross-border litigation, and coordinating worldwide litigation, working closely with multi-disciplinary teams in the defence and enforcement of patent portfolios. She has developed innovative and successful strategies, often combining patent and regulatory law, to assist pharmaceutical companies in the enforcement of their rights.

Gemma Barrett

Partner
A&O Shearman

Gemma is an experienced and trusted advisor for some of the world’s leading life sciences and chemical companies. Her background in biochemistry means she specialises in complex technical disputes in the life sciences sector.  She has more than fifteen years’ experience advising clients in patent litigation matters before the English Courts including securing preliminary injunctions. She is also experienced in advising on global cross-border litigation, and coordinating worldwide litigation, working closely with multi-disciplinary teams in the defence and enforcement of patent portfolios. She has developed innovative and successful strategies, often combining patent and regulatory law, to assist pharmaceutical companies in the enforcement of their rights.

Author:

Selma Ünlü

Senior Partner
NSN Law

Selma Ünlü

Senior Partner
NSN Law

Author:

James Holtom

Partner
McCarthy Tetrault

James Holtom

Partner
McCarthy Tetrault

Author:

Gwilym J.O. Attwell

Principal
Fish & Richardson

Gwilym J.O. Attwell

Principal
Fish & Richardson

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.

Author:

Christoph Rehfuess

Head of IP
SOTIO Biotech

Christoph Rehfuess

Head of IP
SOTIO Biotech

Author:

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.

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.

Author:

Eleanor Root

Partner
Bird & Bird

Eleanor Root

Partner
Bird & Bird

Author:

Maria Balestriero

Of Counsel
Portolano Cavallo

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.

Author:

Colin Birss

Chancellor
High Court of England and Wales

Sir Colin Birss was sworn in as Chancellor of the High Court in November 2025. He was called to the English Bar in 1990 and practiced in intellectual property law, taking silk in 2008.  In 2010 Colin Birss went on the bench, first as judge of the Patents County Court (now IPEC) and then, in 2013, to the High Court.  In 2019 became Judge in Charge of the Patents Court. Colin was sworn in as a Lord Justice of the Court of Appeal in 2021 and took up a senior leadership role as the Deputy Head of Civil Justice until November 2025.

Colin Birss

Chancellor
High Court of England and Wales

Sir Colin Birss was sworn in as Chancellor of the High Court in November 2025. He was called to the English Bar in 1990 and practiced in intellectual property law, taking silk in 2008.  In 2010 Colin Birss went on the bench, first as judge of the Patents County Court (now IPEC) and then, in 2013, to the High Court.  In 2019 became Judge in Charge of the Patents Court. Colin was sworn in as a Lord Justice of the Court of Appeal in 2021 and took up a senior leadership role as the Deputy Head of Civil Justice until November 2025.

Author:

Paul Inman

Partner
Gowling WLG

With a first degree in Molecular Biology and Biochemistry and more than 30 years' experience of litigating intellectual property disputes, Paul Inman draws on his deep sector insight to advise a wide variety of clients across many jurisdictions. While experienced across a range of industries, Paul specialises in the life sciences sector and has worked with clients ranging from multi-national businesses, pharma and medical device companies, to research bodies, chemical companies and small start-ups.

His work has included acting on high-profile pharmaceutical and biotech patent infringement and revocation actions in the UK Patents Court, and more recently on UPC actions. In addition, Paul's interest and expertise in the life sciences sector has seen him advise on regulatory work concerning European pharmaceutical bodies. He is also experienced in acting for a wide range of patent and design proprietors.

 

Whether "success" is measured by getting the right court order at the end of the dispute or evaluating and reaching the right commercial settlement between the parties beforehand, a thorough and balanced assessment on each case is critical. The ultimate aim for Paul is to provide his clients with well-rounded advice and guidance to ensure the best possible outcome.

Paul's background in molecular biology and biochemistry means he can take on highly complex pharmaceutical or biotechnological inventions, as easily as less technical (but equally important) mechanical patents and designs.

Successfully guiding clients through the maze of litigation is where Paul's strength lies, having now been involved over 30 years in the field of litigation with his cases leading to more than 60 reported judgments, ranging from the tribunals of the UK Patent Office (UKIPO) up to the UK Supreme Court (formerly the House of Lords), European Patent Office (EPO) and European Court of Justice (CJ EU).

 

As well as litigating in the English courts, Paul has co-ordinated and advised on IP and regulatory litigation matters across the globe, as far afield as the US, South Africa, Malaysia, the Philippines, Australia and New Zealand, and closer to home in the UPC, Scotland, Ireland, France, Germany, Holland, Denmark, Sweden. Norway, Belgium, Spain, Portugal, Italy and Greece.

Paul is ranked as a leading individual in Chambers UK for both Patent Litigation and Life Sciences. He is also recognised in the 'IAM Patent 1000' global rankings and in the 'Best Lawyers®' UK 2025 guide.

Paul Inman

Partner
Gowling WLG

With a first degree in Molecular Biology and Biochemistry and more than 30 years' experience of litigating intellectual property disputes, Paul Inman draws on his deep sector insight to advise a wide variety of clients across many jurisdictions. While experienced across a range of industries, Paul specialises in the life sciences sector and has worked with clients ranging from multi-national businesses, pharma and medical device companies, to research bodies, chemical companies and small start-ups.

His work has included acting on high-profile pharmaceutical and biotech patent infringement and revocation actions in the UK Patents Court, and more recently on UPC actions. In addition, Paul's interest and expertise in the life sciences sector has seen him advise on regulatory work concerning European pharmaceutical bodies. He is also experienced in acting for a wide range of patent and design proprietors.

 

Whether "success" is measured by getting the right court order at the end of the dispute or evaluating and reaching the right commercial settlement between the parties beforehand, a thorough and balanced assessment on each case is critical. The ultimate aim for Paul is to provide his clients with well-rounded advice and guidance to ensure the best possible outcome.

Paul's background in molecular biology and biochemistry means he can take on highly complex pharmaceutical or biotechnological inventions, as easily as less technical (but equally important) mechanical patents and designs.

Successfully guiding clients through the maze of litigation is where Paul's strength lies, having now been involved over 30 years in the field of litigation with his cases leading to more than 60 reported judgments, ranging from the tribunals of the UK Patent Office (UKIPO) up to the UK Supreme Court (formerly the House of Lords), European Patent Office (EPO) and European Court of Justice (CJ EU).

 

As well as litigating in the English courts, Paul has co-ordinated and advised on IP and regulatory litigation matters across the globe, as far afield as the US, South Africa, Malaysia, the Philippines, Australia and New Zealand, and closer to home in the UPC, Scotland, Ireland, France, Germany, Holland, Denmark, Sweden. Norway, Belgium, Spain, Portugal, Italy and Greece.

Paul is ranked as a leading individual in Chambers UK for both Patent Litigation and Life Sciences. He is also recognised in the 'IAM Patent 1000' global rankings and in the 'Best Lawyers®' UK 2025 guide.

Author:

Andras Kupecz

Honourable Judge
UPC Munich Central Division

Andras Kupecz

Honourable Judge
UPC Munich Central Division

Author:

Kai Harmänd

Honourable Judge
UPC Court of First Instance

Kai Harmänd

Honourable Judge
UPC Court of First Instance

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

Founding Partner
Licks Attorneys

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

Founding Partner
Licks Attorneys

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, International Litigation & Policy
MSD

James Horgan

Chief IP Counsel, International Litigation & Policy
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 A. ("Kassie") Helm, co-chair of the global intellectual property practice and head of the IP litigation group, is a first-chair lead counsel who represents top innovator pharmaceutical and biotechnology companies in patent litigation and patent-adjacent litigation matters. Dr. Helm leverages her doctorate in neuroscience and legal acumen to develop and execute winning positions for life sciences companies in high-stakes patent litigation, including district court litigation, Federal Circuit and other circuit court appeals, and before the Patent Trial and Appeal Board (PTAB). She represents life sciences companies as both plaintiff and defendant in patent infringement actions and as both petitioner and patent owner at the PTAB. Patent-adjacent matters are an increasingly significant part of her practice, including complex commercial disputes in federal and state courts involving IP assets, breach of contract claims, equitable claims and defenses, as well as antitrust litigation involving pharmaceutical assets, and in arbitrating licensing disputes with joint ventures and drug development collaborations. She also regularly plays a leading role in coordinated European/U.S. proceedings. Fluent in French, Dr. Helm is frequently involved in patent disputes with multijurisdictional aspects, including international arbitrations and post-issuance patent proceedings worldwide. Dr. Helm and her team have also been successful in utilizing large-scale U.S. discovery mechanisms under 28 USC § 1782 to assist with foreign patent proceedings. 

In 2025, Dr. Helm was ranked by Chambers USA for Intellectual Property: Patents in New York. Her clients praised her for her “outstanding knowledge of the industry and the implications of a case in both the short and long term,” describing her as “super pragmatic in her advice,” “very creative, an out-of-the-box thinker [who] knows a lot about our business,” and “excellent at strategy development and believes personally in the case, assembling teams that are equally as good.” She was named among Managing Intellectual Property’s Top 250 Women in IP for the third consecutive year, as well as named a 2025 patent “IP STAR” by the same publication. She was also recognized as a leading Intellectual Property lawyer by The Best Lawyers in America 2025. In 2024, Dr. Helm was named a leading practitioner by Who’s Who Legal: Thought Leaders USA, listed as a Recommended Individual for Patent Litigation in Who’s Who Legal: Life Sciences, and named a Future Star by Benchmark Litigation. Dr. Helm was also shortlisted for 2024 Litigator of the Year – New York by the Managing IP Americas Awards. She is routinely listed as a Life Sciences Star by LMG Life Sciences and was shortlisted in the LMG Life Sciences Americas Awards for Litigator of the Year – NY in both 2023 and 2024. 

She has been recognized by numerous publications for her expertise, including routinely by IAM Patent 1000 for New York Litigation. In 2025, IAM stated that Dr. Helm is “Recognized by peers as a formidable trial attorney” and that she “collects accolades for her unparalleled expertise in patent law for pharmaceutical and biotechnology companies,” with one client noting, “Kassie is a superb strategist. She is knowledgeable, well prepared and singularly focused on achieving the best outcome for clientele. She is appropriately aggressive and out-of-the-box in her thinking.” In 2024, she was described by IAM as “a smart choice for pharmaceutical and medical research clients,” as well as “a seasoned trial attorney familiar with a variety of arenas, including the PTAB and the district court of Delaware.” In 2023, IAM described Dr. Helm as someone who “excels in biologics litigation and is a go-to for some of the industry’s major players to handle their most important disputes.” Previously, in 2022, she was noted by IAM as the “fulcrum” around which Dechert’s Patent Litigation group turns, “who marshals the ensemble’s resources very effectively and gets difficult jobs done for her clients.” In 2021, she was praised by the same publication for being “gifted at handling global lawsuits” and in “cases with concurrent patent office proceedings” and “An absolute dynamo who makes significant contributions both to the Dechert practice and to the wider IP community, she never fails to impress. 

In 2023, Dr. Helm was the sole female named a Global Elite Thought Leader for Patent Litigation, individuals who receive the highest number of nominations from peers, corporate counsel and other market sources, across North America by Who’s Who Legal: Life Sciences. She was highlighted for her ability to “assess and define a global strategy and suggest winning tactics.” Dr. Helm was highly commended by the Financial Times North America Innovative Lawyers Awards 2023 in the “Innovation in Healthcare & Life Sciences” category for her work on behalf of Eli Lilly & Co. in a transatlantic patent dispute with Novartis. She is routinely listed for Patent Litigation expertise in Life Sciences by The Legal 500 US (2021-2025) and was previously named a Global Leader in 2021 in life sciences patent litigation by Who’s Who Legal. In 2020, she was named an Intellectual Property Trailblazer by the National Law Journal, awarded “Best in Patents” in the U.S. by Euromoney’s Women in Business Law Awards, named a leading female lawyer who breaks barriers in Profiles in Diversity Journal’s Women Worth Watching in STEM Awards, and recognized as a Top Intellectual Property Litigator in New York by Super Lawyers. 

Dr. Helm’s patent litigation trial successes were profiled as contributing matters to Dechert’s recognition as a Law360 Life Sciences Practice Group of the Year in each of 2022 and 2020, and she was previously named the 2019 winner of the "U.S. Rising Star – Intellectual Property" award from LMG Life Sciences. 

Dr. Helm is an active participant in the IP community and an authoritative, sought-after speaker and writer on IP topics in the U.S. and Europe. She has authored over 100 articles, book chapters and commentary on legal and scientific topics, including as a former columnist for Law.com and the ALM media group. She is a current legal columnist on IP issues for Thomson Reuters/Westlaw. 

Dr. Helm is committed to advancing women in the profession as a founder of the New York chapter of ChIPs (Chiefs of Intellectual Property), a global nonprofit organization with thousands of members dedicated to advancing and connecting women in law, technology and regulatory policy. She is also a founder of the Lead Counsel Summit (LCS), a force for advancing female lead trial counsel. She has had several leadership roles on Federal Circuit Bar Association committees, Law360’s Life Sciences Editorial Board, and other bar association leadership positions. In 2021, Dr. Helm was individually recognized as a winner of Dechert’s Samuel E. Klein Pro Bono Awards, for her work on behalf of military veterans before the U.S. Court of Appeals for the Federal Circuit. In 2025, Dr. Helm was appointed as Co-Chair of the Patent Litigation Committee of the American Bar Association Section of Intellectual Property Law (ABA-IPL) and in 2024, was a signatory member of ABA-IPL’s Task Force on Improving the Durability and Reliability of the Patent Rights. Dr. Helm is also a Fellow of the Litigation Counsel of America, The Trial Lawyer Honorary Society, and a member of the Trial Law Institute and Diversity Law Institute. 

Katherine Helm

Partner
Dechert

Katherine A. ("Kassie") Helm, co-chair of the global intellectual property practice and head of the IP litigation group, is a first-chair lead counsel who represents top innovator pharmaceutical and biotechnology companies in patent litigation and patent-adjacent litigation matters. Dr. Helm leverages her doctorate in neuroscience and legal acumen to develop and execute winning positions for life sciences companies in high-stakes patent litigation, including district court litigation, Federal Circuit and other circuit court appeals, and before the Patent Trial and Appeal Board (PTAB). She represents life sciences companies as both plaintiff and defendant in patent infringement actions and as both petitioner and patent owner at the PTAB. Patent-adjacent matters are an increasingly significant part of her practice, including complex commercial disputes in federal and state courts involving IP assets, breach of contract claims, equitable claims and defenses, as well as antitrust litigation involving pharmaceutical assets, and in arbitrating licensing disputes with joint ventures and drug development collaborations. She also regularly plays a leading role in coordinated European/U.S. proceedings. Fluent in French, Dr. Helm is frequently involved in patent disputes with multijurisdictional aspects, including international arbitrations and post-issuance patent proceedings worldwide. Dr. Helm and her team have also been successful in utilizing large-scale U.S. discovery mechanisms under 28 USC § 1782 to assist with foreign patent proceedings. 

In 2025, Dr. Helm was ranked by Chambers USA for Intellectual Property: Patents in New York. Her clients praised her for her “outstanding knowledge of the industry and the implications of a case in both the short and long term,” describing her as “super pragmatic in her advice,” “very creative, an out-of-the-box thinker [who] knows a lot about our business,” and “excellent at strategy development and believes personally in the case, assembling teams that are equally as good.” She was named among Managing Intellectual Property’s Top 250 Women in IP for the third consecutive year, as well as named a 2025 patent “IP STAR” by the same publication. She was also recognized as a leading Intellectual Property lawyer by The Best Lawyers in America 2025. In 2024, Dr. Helm was named a leading practitioner by Who’s Who Legal: Thought Leaders USA, listed as a Recommended Individual for Patent Litigation in Who’s Who Legal: Life Sciences, and named a Future Star by Benchmark Litigation. Dr. Helm was also shortlisted for 2024 Litigator of the Year – New York by the Managing IP Americas Awards. She is routinely listed as a Life Sciences Star by LMG Life Sciences and was shortlisted in the LMG Life Sciences Americas Awards for Litigator of the Year – NY in both 2023 and 2024. 

She has been recognized by numerous publications for her expertise, including routinely by IAM Patent 1000 for New York Litigation. In 2025, IAM stated that Dr. Helm is “Recognized by peers as a formidable trial attorney” and that she “collects accolades for her unparalleled expertise in patent law for pharmaceutical and biotechnology companies,” with one client noting, “Kassie is a superb strategist. She is knowledgeable, well prepared and singularly focused on achieving the best outcome for clientele. She is appropriately aggressive and out-of-the-box in her thinking.” In 2024, she was described by IAM as “a smart choice for pharmaceutical and medical research clients,” as well as “a seasoned trial attorney familiar with a variety of arenas, including the PTAB and the district court of Delaware.” In 2023, IAM described Dr. Helm as someone who “excels in biologics litigation and is a go-to for some of the industry’s major players to handle their most important disputes.” Previously, in 2022, she was noted by IAM as the “fulcrum” around which Dechert’s Patent Litigation group turns, “who marshals the ensemble’s resources very effectively and gets difficult jobs done for her clients.” In 2021, she was praised by the same publication for being “gifted at handling global lawsuits” and in “cases with concurrent patent office proceedings” and “An absolute dynamo who makes significant contributions both to the Dechert practice and to the wider IP community, she never fails to impress. 

In 2023, Dr. Helm was the sole female named a Global Elite Thought Leader for Patent Litigation, individuals who receive the highest number of nominations from peers, corporate counsel and other market sources, across North America by Who’s Who Legal: Life Sciences. She was highlighted for her ability to “assess and define a global strategy and suggest winning tactics.” Dr. Helm was highly commended by the Financial Times North America Innovative Lawyers Awards 2023 in the “Innovation in Healthcare & Life Sciences” category for her work on behalf of Eli Lilly & Co. in a transatlantic patent dispute with Novartis. She is routinely listed for Patent Litigation expertise in Life Sciences by The Legal 500 US (2021-2025) and was previously named a Global Leader in 2021 in life sciences patent litigation by Who’s Who Legal. In 2020, she was named an Intellectual Property Trailblazer by the National Law Journal, awarded “Best in Patents” in the U.S. by Euromoney’s Women in Business Law Awards, named a leading female lawyer who breaks barriers in Profiles in Diversity Journal’s Women Worth Watching in STEM Awards, and recognized as a Top Intellectual Property Litigator in New York by Super Lawyers. 

Dr. Helm’s patent litigation trial successes were profiled as contributing matters to Dechert’s recognition as a Law360 Life Sciences Practice Group of the Year in each of 2022 and 2020, and she was previously named the 2019 winner of the "U.S. Rising Star – Intellectual Property" award from LMG Life Sciences. 

Dr. Helm is an active participant in the IP community and an authoritative, sought-after speaker and writer on IP topics in the U.S. and Europe. She has authored over 100 articles, book chapters and commentary on legal and scientific topics, including as a former columnist for Law.com and the ALM media group. She is a current legal columnist on IP issues for Thomson Reuters/Westlaw. 

Dr. Helm is committed to advancing women in the profession as a founder of the New York chapter of ChIPs (Chiefs of Intellectual Property), a global nonprofit organization with thousands of members dedicated to advancing and connecting women in law, technology and regulatory policy. She is also a founder of the Lead Counsel Summit (LCS), a force for advancing female lead trial counsel. She has had several leadership roles on Federal Circuit Bar Association committees, Law360’s Life Sciences Editorial Board, and other bar association leadership positions. In 2021, Dr. Helm was individually recognized as a winner of Dechert’s Samuel E. Klein Pro Bono Awards, for her work on behalf of military veterans before the U.S. Court of Appeals for the Federal Circuit. In 2025, Dr. Helm was appointed as Co-Chair of the Patent Litigation Committee of the American Bar Association Section of Intellectual Property Law (ABA-IPL) and in 2024, was a signatory member of ABA-IPL’s Task Force on Improving the Durability and Reliability of the Patent Rights. Dr. Helm is also a Fellow of the Litigation Counsel of America, The Trial Lawyer Honorary Society, and a member of the Trial Law Institute and Diversity Law Institute. 

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