Leveraging FTO Analyses for Strategic Deal Negotiations: Maximizing Value and Mitigating Risks in Life Sciences IP Transactions

November 28, 2023 3:00pm

Donna Meuth
Associate General Counsel IP
Eisai Inc.

Alicia Russo
Partner, Chair of IP Transactional Group
Venable Fitzpatrick LLP

Erica Norey
Senior Counsel, Intellectual Property for Global Business Development & M&A
Sanofi

In today’s competitive landscape, conducting comprehensive freedom-to-operate (FTO) analysis is vital to identify potential patent infringement risks. However, it’s equally important to go beyond mere risk assessment and leverage the results of FTO analysis to inform strategic deal negotiations. During this session, topics of discussion will include:

  • Exploring different types of FTO analysis
    • Competitor-specific, feature-specific, and comprehensive
  • Avoiding the pitfall of searching only the claims without due consideration for the details in the specification
  • The advantages and disadvantages of using patent search software
  • Cost-efficient strategies for conducting an FTO in a crowded space (e.g., CRISPR)
  • Knowing the next steps when the target gets sued close to the closing date
  • Formulating strategies to address potential infringement risks based on claim constructions
    • Assessing the risk of injunctive relief and quantifying that risk
    • The importance of going beyond the identification of weaknesses in the IP by proposing appropriate solutions, e.g., contacting the competitor to purchase or license the patent; designing around the competitors patent; or challenging the competitor patent in a post-grant proceeding
  • What impact will the PTAB reformations proposed by the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act have on the valuation of patents?
  • Discussing how to potentially assess and value the need for a license
    • How to approach negotiations