Kisaco European Summit on Pharma and Biotech Patent Litigation


Fish’s Jon Singer, Martina Tyreus Hufnal, and Brian Coggio will speak at the European Summit on Pharma and Biotech Patent Litigation on January 24 and 25.

Fish is proud to support the European Summit on Pharma and Biotech Patent Litigation, an internationally recognized summit that gathers leading counsels in pharma, biotech, and medical device IP to tackle industry questions surrounding the latest regulatory changes, case-law updates, and patent litigation challenges.

Discover the Latest Second Medical Use Patent Strategy in Europe and Determine the Future Application of Skinny Labels in the U.S.
Tuesday, January 24 | 10:50 a.m. UTC +1

The European second medical use application and the U.S. skinny label method continue to be of growing importance in the commercial protection of small molecule and biological products. This panel will provide a need-to-know update on second medical use and skinny label litigation strategies.

  • Discover practical strategies for second medical use and skinny label product protection in the U.S. and Europe.
  • Understand the interplay between plausibility, sufficiency, and inventive step with second medical use cases.
  • Learn how innovator companies can set out preemptive strategies regarding second medical uses.
  • Understand the consequences (if any) of the GSK v. Teva (2022) case:
    • The ability for a generic company to “carve out” patented uses from its label.
    • The potential increase in “carve-out” skinny label litigation in the U.S.
    • How have courts interpreted the decision?


  • Jon Singer, Principal, Fish & Richardson
  • Ewan Nettleton, Principal IP Counsel Oncology Litigation, Novartis
  • Toni Santamaria, Vice President of Intellectual Property, Adalvo

Transatlantic Patent Litigation Strategy Update on the Doctrine of Equivalents: Validity, Predictability, and the Prior Art
Tuesday, January 24 | 11:35 a.m. UTC +1

The jurisdictional adoption of a doctrine of equivalents is an important stage in maintaining more patentee-friendly courts when it comes to infringement cases. It is a fundamental method of protecting innovative products from entering the market that differ immaterially to the original.

Part 1 – Europe

  • Understand the changes in the landscape and the different court systems across Europe.
  • Determine how the UPC will formulate its approach to the doctrine of equivalents:
    • To what extent can file wrapper estoppel limit the extent of protection?
    • How does this relate to claim construction in general?
  • Clarify the process of applying the doctrine of equivalents:
    • Understand issues related to validity, predictability, and the prior art.
    • Is it possible to gain an injunction in case of an equivalent infringement?
    • Understand the precedent set for UK courts in the case Actavis UK v. Eli Lilly (2017).

Part 2 – USA

  • Understand the insubstantial differences test to determine whether the allegedly infringing product or process is substantially different from what has been patented.
  • Consider the intricacies of the “function/way/result” test and learn how this relates to infringement.


  • Martina Tyreus Hufnal, Principal, Fish & Richardson
  • Craig Svoboda, Global Head of Intellectual Property, Alvotech
  • Dean Thomas, Global Head of IP and Associate General Counsel, Ichnos Sciences

Breakfast Briefing: Research Innovation: Finding Safe Harbour in Europe and the U.S.: Update on Case Law for Research and Bolar Exemptions
Wednesday, January 25 | 8:00 a.m. UTC +1

Attend this breakfast briefing to understand the jurisdictional nuances and investigate recent case law. Research and Bolar exemptions are an important way that generic companies in Europe and the U.S. can facilitate their drug manufacturing. However, this area lacks clarity, particularly because there is a lack of harmonization in regulations across the globe.

  • Learn what it means to violate the research exemption in Europe.
  • Discover how the exemption is treated differently in key jurisdictions such as the Netherlands, Germany, France, and the UK.
  • Consider what kind of research activities are considered exempt under the Hatch-Waxman Act.


To learn more, click here.