Protecting Innovation and Unleashing Market Opportunities: Best Practices and Strategic Insights for Validity and Scope Analyses

November 28, 2023 2:00pm

Lawrence Cogswell, Ph.D.
Hamilton, Brook, Smith & Reynolds P.C.

Len S. Smith
Transformative Legal

Adam Poulin-Kerstien
Vice President, Intellectual Property
Mersana Therapeutics

Henry Gu
SVP, Head of Intellectual Property
Zentalis Pharmaceuticals

The validity and scope analysis in IP due diligence for life sciences transactions serves as a crucial tool to protect investments, safeguard competitive advantage, assess market opportunities, and ultimately – the results may be used to enhance deal negotiations. Conversely, an insufficient validity and scope analysis can have severe consequences because if important aspects are missed or overlooked, gaps or weaknesses in the IP could be exploited by competitors or result in legal challenges, potentially leading to financial losses, disputes, or even the loss of exclusivity. Therefore, a comprehensive and meticulous validity and scope analysis is essential.

Topics of discussion will include:

  • Discovering the newest practices for comprehensive scope and validity analyses
    • Unpacking recent and relevant legislation and caselaw on patentability: the Supreme Court’s Amgen v Sanofi case on written description; the proposed Patent Eligibility Restoration Act of 2023, and more
    • Unpacking recent caselaw on non-obviousness and novelty
  • Understanding how the scope of the IP assists in evaluating the market opportunities
  • The importance of going beyond the identification of weaknesses in the IP by proposing appropriate solutions, e.g., a reissue application, secondary patents, or a terminal disclaimer
    • Evaluating whether a license is needed/how to arrive at the royalty
    • Accounting for this in the negotiations and the ultimate agreement
  • Considering estoppel, inequitable conduct and forum shopping and distilling the impact on deal negotiations
    • 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?