2023 Kisaco Life Sciences Strategy Summit on IP & Exclusivity

Fish's Moritz Ammelburg, Martina Hufnal, and Brian Coggio will speak at the Life Sciences Strategy Summit on IP & Exclusivity in Munich on October 10 and 11.

Fish is proud to support the Life Sciences Strategy Summit on IP & Exclusivity. This premier life sciences intellectual property event brings together top legal professionals in biopharma for a three-day practical discussion on industry-driven patent strategy, patent prosecution, and market exclusivity. It's the first gathering since the launch of the Unified Patent Court, providing an opportunity to join the leading community of life sciences patent professionals and gain insights into the industry's response to the new court system while engaging in candid discussions with European life sciences IP experts.

Skinny Label/Second Medical Use Case Law and Their Impact Upon Your IP Strategy
Tuesday, October 10, 2023 | 2:30 p.m. UTC +2

Skinny label/second medical use repurposing is an attractive option for life sciences corporations seeking to maximize market exclusivity. This industry-led panel session will explore options for second medical use and skinny label within Europe and the U.S.

Part 1 – Second Medical Use Strategies

  • Discover the different forms of claims that the EPO will accept as valid forms of protection.
  • Determine the “substance or composition" balance in accordance with the EPO Article 54 (5) of the European Patent Convention.
  • Understand the importance of “plausibility" regarding second medical use claims.
  • Assess recent case law and understand its impact upon your second medical use patent strategy.
  • Assess the impact of the UPC upon second medical use claims.
  • Discuss the alignment between patent attorneys and the research and public relations team:
    • How do you prevent your company from making novelty-destroying disclosures before you file your secondary use patent application?

Part 2 – Skinny Label Strategies

  • Understand how these cases can provide types of evidence that can be used to demonstrate induced infringement, both before and after launch:
    • GSK v. Teva (2022)
    • Amarin v. Hikma (2022)
  • Understand when the skinny label adequately carves out the use.


  • Martina Hufnal, Principal, Fish & Richardson
  • Thomas Boehmer, Head of Intellectual Property, Pieris Pharmaceuticals
  • Mike Gilbert, Partner, Marks and Clerk
  • Margaret O'Gara, Head of IP, Nanobiotix

The Bolar Exemption and Safe Harbor: Discover the Latest Regulatory Challenges in Application
Wednesday, October 11, 2023 | 11:30 a.m. UTC +2

The bolar exemption and safe harbor are a core feature of generic entry to market, and they are regulations that condition the patent strategies of the life sciences industry. This panel session will explore these regulations and help you to build an IP strategy that incorporates the latest developments.

Part 1 – Bolar Exemption

  • Discuss the jurisdictional differences across Europe.
  • Understand the regulatory landscape at the European Commission regarding the Bolar Exemption.
  • Discover the divergences within European law and UK law.
  • Understand the interplay between the SPC waiver and the bolar exemption (if any).

Part 2 – Safe Harbor

  • Understand the scope and history of protection afforded by the safe harbor in the U.S.
  • Discover how to take advantage of geographical locations to avoid infringement accusations in the R&D stage of medicinal products.
  • Understand the lessons learned from Amgen v. Hospira (2019), in which the court found that the production of certain batches was not protected, and the jury awarded $70M in damages.


  • Brian Coggio, Of Counsel, Fish & Richardson
  • Ina Burck, Director of Intellectual Property, BioNTech
  • Christoph Rehfuess, Head of IP, SOTIO
  • Bea McDonald, Vice President of Intellectual Property, Vaccitech
  • Takanori Abe, Partner, Abe Law

Clinical Trial Regulation Update and Its Impact Upon a Comprehensive IP Strategy
Wednesday, October 11, 2023 | 2:15 p.m. UTC +2

Clinical trial regulation No. 536/2014 came into force on 31 October 2022 and has direct consequences for the management of life sciences portfolios. This panel session will explore patent protection and how it relates to clinical trial results in Europe and further afield.


  • Moritz Ammelburg, Principal, Fish & Richardson
  • Gemma Campabadal, Director of Patent Law, Johnson and Johnson

To learn more, click here.​