The Freedom to Operate: Assessing Competitors, Mapping Opportunities, and Mastering the IP Due Diligence Process for New Modalities

March 21, 2023 3:00pm

Todd Spalding
SVP, Deputy General Counsel
Alexion, AstraZeneca Rare Disease

Chuck Sholtz
Vice President, IP
Nutcracker Therapeutics

Brian W. Nolan
Mayer Brown LLP


William B. Raich
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

More companies are investing heavily in the IP rights attempting to cover the revolutionary technologies driving the biopharma revolution, while simultaneously embarking upon equally aggressive licensing programs. Thus, anyone intending to use these new technologies and therapies must be wary of investing without thorough and robust IP due diligence.  As these clashes over IP begin to play out, clever participants are paying close attention and taking stock of the outcomes, as they will inform best practices for the freedom-to-operate analysis the ability to commercialize inventions. Points of discussion will include:

  • Defining the scope of the patent search strategies
  • Identifying and mitigating patent infringement risks prior to commercialization
  • Considering how best to position and properly protect your IP
    • Ensuring the freedom-to-operate via IP inventory and FTO analysis
  • Conducting client competitor patent landscape analyses and preparing the FTO opinion
  • Identifying common missteps to avoid with an FTO analysis specific to new modalities
    • Minimizing future risk of litigation and avoiding unnecessary expenses