Understanding the Impact of New Developments at FDA on the IP Due Diligence Review Process

November 15, 2019 9:15am

Kurt R. Karst
Director
Hyman, Phelps & McNamara PC (Washington, DC)

Michael K. Stern
Of Counsel
Covington & Burling LLP (Washington, DC)

This session aims to answer the following questions:
  • Which RNA therapeutics are likely to qualify for 12-year exclusivity?
  • What does Braeburn v. FDA mean for the scope of 3-year exclusivity?
  • How will FDA assess whether gene or cell therapies are the “same drug” for orphan drug purposes?