| Page 233 | Kisaco Research

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

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.

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.

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.