Part 1 – Patents and Related IP Protections and Mechanisms

March 13, 2024 3:00pm

Jonathan B. Roses
Wolf, Greenfield & Sacks, P.C.

Patent Protection for Drugs and Biologics

  • Summarizing the patenting process for drugs and biologics
  • Patentability requirements and differing patent strategies 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
  • Patent validity challenges and infringement proceedings for drugs and biologics under the Hatch-Waxman Act and Biologics Price Competition and Innovation Act (BPCIA)