IP Overview for Drugs and Biologics: Hatch-Waxman, BPCIA, Trademarks, and More

PART 1: Patents and Related IP Protections and Mechanisms

March 22, 2023 3:00pm

Chad Landmon
Axinn, Veltrop & Harkrider LLP
(Hartford, CT)

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


  • Overview of selecting a brand name for a proposed drug product
  • Roles of the USPTO and FDA in the drug naming process
  • Identifying the PTO and FDA clearances necessary for trade name/trademark approval on your product
  • How does the branding process work for your product