| Page 16 | 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
 

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

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.

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:

Ronny Thomas

Honourable Judge
UPC Local Division

Ronny Thomas

Honourable Judge
UPC Local Division

Author:

Edger Brinkman

Honourable Judge, Local Division Hague
UPC

Edger Brinkman

Honourable Judge, Local Division Hague
UPC