Brand and Generic Perspectives on the Latest FDA Initiatives Impacting Pharmaceutical Patents

April 27, 2022 8:15am

Maryll Toufanian
Director, Office of Generic Drug Policy
U.S. FDA

David B. Abramowitz
Partner
Locke Lord LLP

Kurt Karst
Director
Hyman, Phelps & McNamara PC

Christopher Pruitt
Director, Division of Legal and Regulatory Support
Office of Generic Drug Policy

U.S. FDA

John Bennett
Partner
Allen & Overy LLP

  • Understanding the significance of the conversion of certain Orange Book NDAs to BLAs under the BPCIA and how this may influence Hatch-Waxman litigation strategies
    • Teva’s Copaxone citizen’s petition
  • Exploring branded and generic interests in GDUFA and PDUFA renewals
  • Examining new attacks on 180-day exclusivity per the propose Blocking Act
  • Assessing status of FDA activity concerning Hatch-Waxman reform