Kisaco Pharma & Biotech Patent Litigation Summit 2025

Fish & Richardson Principals Rae Crisler, Martina Hufnal, and Douglas McCann will speak at the Kisaco Pharma & Biotech Patent Litigation Summit in Amsterdam on January 21 and 22, 2025.

Fish is proud to support the Pharma & Biotech Patent Litigation Summit. This internationally recognized event will provide attendees with the necessary practical tools to defend patent litigation challenges for pharma and biotech products, while also maximizing litigation strategy to allow for successful intellectual property protection.

Global Review of Preliminary Injunctions: The UPC, National Courts, the USA, and Further Afield
Tuesday, January 21 | 9:55-10:50 a.m. UTC+1

The biggest hammer that a patent holder has is an injunction, meaning that case law, updates, and strategies concerning preliminary injunctions for the healthcare sector are crucial in determining your life science strategy for 2025. This cross-jurisdictional panel will discuss the power of a preliminary injunction and the different nuances occurring across the globe.

• Receive an overview of recent developments in preliminary injunctions across the UPC, European jurisdictions, and the USA.
• Discover significant recent cases and their implications for pharma and biotech patent litigation.
• Understand strategies for obtaining and defending against preliminary injunctions in different jurisdictions.
• Audience Q&A to address specific questions and practical concerns related to preliminary injunctions.

Speakers:

• Martina Hufnal, Principal, Fish & Richardson
• Bolko Ehlgen, Partner, Linklaters
• Carsten Richter, Head of Division IP, Euroimmun
• Ewan Nettleton, Principal IP Counsel, Novartis
• Matthew O'Neill, Director of European IP, Glenmark Pharmaceuticals
• Tim Powell, Partner, Morgan Lewis

Global Biosimilar Molecule Patent Litigation and Launch Review
Wednesday, January 22 | 9:10 a.m. UTC+1

There is a suggestion that a second wave of biosimilars has appeared. This global panel session will review the state of biosimilar litigation in Europe, the USA, and further afield. By looking at individual molecules, this industry-led panel session will assess the state of the biosimilar IP industry.

• Understand the state of biosimilar litigation related to molecules including Eylea, Inflectra, Soliris, and Stelara.
• Discover strategies concerning BPCIA, PIs, and second medical use/skinny labels for biosimilar products.

Speakers:

• Rae Crisler, Principal, Fish & Richardson
• Shohta Ueno, Senior Director – Dispute Resolution, Regeneron
• Frits Gerritzen, Partner, A&O Shearman
• Mike Gilbert, Partner, Marks & Clerk

Bolar Exemption and Safe Harbor Update Across Europe and the USA
Wednesday, January 22 | 10:00 a.m. UTC+1

The Bolar exemption and safe harbor regulations set out the legal provisions allowing generic manufacturers to perform experiments and tests necessary for regulatory approval. This industry-led session will highlight some of the core case law in Europe and the USA and determine your optimal IP strategy.

Part 1: The Bolar Exemption

• Discover the divergences between the Bolar exemptions across Europe and the UPC.
• Understand the interaction between the SPC manufacturing waiver and the Bolar exemption.
• Determine the latest update from the European Commission on the potential for continent-wide harmonization.
• Case Study Highlight: Italian Supreme Court Rules on Bolar Exemption in Boehringer Ingelheim Dispute (2024).

Part 2: Safe Harbor

• Understand the scope and history of protection afforded by safe harbor in the U.S.
• Compare the interpretations and applications of safe harbor regulations between the U.S. and Europe.

Speakers:

• Doug McCann, Principal, Fish & Richardson
• Bart Newland, General Counsel, Atalanta Therapeutics
• Cecile Teles, Head if IP, Zentiva
• Christoph Rehfuess, Head of IP, Sotio
• Marco Stief, Partner, Maiwald
• Ozge Atilgan Karakulak, Partner, Gün + Partners

For more information, or to register, click here.