Event

Life Sciences Strategy Summit on IP & Exclusivity

Hosts

Fish’s Chad Shear, Brian Coggio, and Jon Singer will present at the Life Sciences Strategy Summit on IP & Exclusivity on October 11 and 12 in Munich, Germany.

Fish is proud to support the Life Sciences Strategy Summit on IP & Exclusivity. This premier IP and regulatory event will gather industry-leading pharma, biotech, and medical device IP counsel to tackle the latest industry questions surrounding patent prosecution, litigation, and regulatory challenges.

“Skinny” Label Second Medical Use Disputes
Tuesday, October 11, 2022 | 4:00 p.m. CET

  • Explore updates related to Teva vs GlaxoSmithKline:
    • Discover how this affects the ability of generics to use “skinny” labelling
    • What are the consequences for inducement of infringement?
  • Examine practical uses for second medical use within Europe.
  • Discuss practical and pre-emptive strategies that innovator companies can employ in the U.S. and Europe.

Speaker:

  • Chad Shear, Principal, Fish & Richardson

Examine Practical Approaches to Achieve Maximal Exclusivity
Wednesday, October 12, 2022 | 9:10 a.m. CET

This exclusive cross-industry panel has been set up to understand perspectives from the pharmaceutical and biotechnology industries on how to maximize exclusivity for large and small molecule produces, including patent and regulatory strategies, as well as research and marketing strategies. During early stages of product development, industries are required to devise a competitive strategy. This practical panel will examine the latest industry developments and discuss their impacts and consequences on the product market. This panel will explore:

  • Data exclusivity in Europe:
    • Understand how and when a product can use EU data regulations (Article14(11) of regulation (EC) No 726/2004) to create a commercially successful product portfolio.
    • What are the present views of the EMA?
  • Market exclusivity in Europe:
    • Analyze the most successful applications of market exclusivity.
  • Exclusivity in the U.S.:
    • Understand the different forms of exclusivity within the U.S. and how this can be used to maximize a product portfolio:
      • New chemical entity exclusivity
      • Orphan drug exclusivity
      • Pediatric and antibiotic exclusivities
      • Biologics license exclusivities
    • Understand the different regulatory exclusivities for small vs. large molecules

Speakers:

  • Brian Coggio, Of Counsel, Fish & Richardson
  • Georgia Gavriilidou, Associate General Counsel, Amgen
  • Toni Santamaria, Vice President Intellectual Property, Adalvo

An Analysis of Damages Awarded in Patent Infringement Cases Across Europe and the U.S.
Wednesday, October 12, 2022 | | 2:30 p.m. CET

  • Assess the jurisdictional differences; how are different calculations worked out?
  • Discover how the UPC will approach damages and compensation claims.
  • Vectura v. GlaxoSmithKline LLC
    • What are the implications of this $90 million damage case?
    • How does this ruling clarify the U.S. requirement for apportionment and what are the practical lessons to be learned?
    • Assess how the entire market value of a product can impact the method for calculating damages.

Speaker:

  • Jon Singer, Principal, Fish & Richardson

To learn more, click here.