| Page 55 | Kisaco Research

Author:

Camille Pecnard

Partner
Lavoix

Camille Pecnard

Partner
Lavoix

Author:

Aude Veinante

European Patent Attorney
Lavoix

Aude assists her clients in defining their patent strategy. Aude drafts new patent applications and monitors grant procedures in France and abroad. Her work also includes conducting patentability, validity and freedom to operate studies as well as forming consultations relative to supplementary protection certificates (SPCs).

Aude performs audits in the pharmaceutical and life science fields and advises her clients in case of patent disputes.

Aude is a member of the AIPPI (International Association for the Protection of Intellectual Property) and the GRAPI (Groupe Rhône-Alpes pour la protection de la Propriété Intellectuelle [Rhône-Alpes Group for the Protection of Intellectual Property]). She is also a lecturer at the Bordeaux National School of Biomolecule Technology.

Aude Veinante

European Patent Attorney
Lavoix

Aude assists her clients in defining their patent strategy. Aude drafts new patent applications and monitors grant procedures in France and abroad. Her work also includes conducting patentability, validity and freedom to operate studies as well as forming consultations relative to supplementary protection certificates (SPCs).

Aude performs audits in the pharmaceutical and life science fields and advises her clients in case of patent disputes.

Aude is a member of the AIPPI (International Association for the Protection of Intellectual Property) and the GRAPI (Groupe Rhône-Alpes pour la protection de la Propriété Intellectuelle [Rhône-Alpes Group for the Protection of Intellectual Property]). She is also a lecturer at the Bordeaux National School of Biomolecule Technology.

Author:

Pierre-Emmanuel Meynard

Partner
Lavoix

Pierre-Emmanuel Meynard

Partner
Lavoix

Author:

Dan McGrath

Managing Associate
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

Managing Associate
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

 

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:

James Holtom

Partner
McCarthy Tetrault

James Holtom

Partner
McCarthy Tetrault

Author:

Peter van Schijndel

Partner
Hoyng Rokh Monegier

Peter van Schijndel

Partner
Hoyng Rokh Monegier

Author:

Selma Ünlü

Senior Partner
NSN Law

Selma Ünlü

Senior Partner
NSN Law

Author:

Martina Hufnal

Principal
Fish & Richardson

Martina Hufnal

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

Christoph Rehfuess

Head of IP
Sotio

Author:

Andreas Robinson

Senior Counsel Intellectual Property & Litigation
Amgen

Andreas Robinson

Senior Counsel Intellectual Property & Litigation
Amgen

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:

Edger Brinkman

Honourable Judge, Local Division Hague
UPC

Edger Brinkman

Honourable Judge, Local Division Hague
UPC

Author:

Lord Justice Birss

Honourable Judge
Court of Appeal of England and Wales

Lord Justice Birss

Honourable Judge
Court of Appeal of England and Wales

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:

Ronny Thomas

Honourable Judge
UPC Local Division

Ronny Thomas

Honourable Judge
UPC Local Division

The EPO’s decision in G2/21 was meant to bring clarity, but questions around plausibility standards remain unsettled. This panel will assess how national courts and the EPO are applying the doctrine and the implications for life sciences patents.


• Compare approaches to plausibility in the UK, Netherlands, and EPO post-G2/21.
• How are national courts diverging from or aligning with the EPO's reasoning?
• Explore how plausibility has been tested in key cases including Apixaban and Dapagliflozi.
• Understand the vulnerability of life sciences patents under current plausibility thresholds and discuss the risks of invalidation, and how should companies adapt?
• Discuss the comparative written description and enablement standards in the USA and the latest case law which may affect your global litigation strategy.

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

Author:

Eva Ehlich

Partner
Maiwald

Eva Ehlich

Partner
Maiwald

Second medical use patents remain a cornerstone of value creation in the life sciences industry, but enforcement continues to be fragmented. This panel will compare recent decisions and enforcement strategies across the UK, UPC and key global jurisdictions.


• Examine the new UPC plausibility and infringement test and how it applies in practice?
• Review the significance of the first UPC decision at the Dusseldorf Local Division (2025).
- What does it mean for assessing knowledge, intent, and infringement risk?
• Discuss the comparison with the USA and the recent wave of Skinny Label litigation.
• Understand the landscape of prior disclosure (G1/23) and its impact on the patentability of second medical use patents, as well as formulations, crystal forms and polymorphs.

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:

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. 

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

Author:

Katherine Helm

Partner
Dechert

Katherine Helm

Partner
Dechert