IP Overview for Drugs and Biologics

Part 1 – Patents and Related IP Protections and Mechanisms

September 20, 2023 2:45pm

Alissa Lipton
Finnegan, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC)

Patent Protection for Drugs and Biologics

  • Summarizing the patenting process for drugs and biologics
  • Strategies for building patent protection for drugs and biologics
  • Applying for and achieving extension of patent term for time spent in the drug approval process
    • Patent Term Extension (“PTE”)
    • Patent Term Adjustment (“PTA”)
  • Reviewing the 271(e)(1) “safe harbor” provision
  • Distinguishing the patenting process for drugs from that of biologics
  • Identifying the respective roles of the FDA and the PTO in the protection of drugs and biological products