Part 1 – Patents, Trademarks and Other IP Protections and Mechanisms

September 18, 2014 1:45pm


Jill K. MacAlpine, Ph.D.
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Washington, DC)

Donna M. Meuth
Associate General Counsel, Intellectual Property
Eisai Inc. (Andover, MA)

Patent Protection for Drugs and Biologics

  • Summarizing the patenting process for drugs and biologics
  • Strategies for building patent protection drugs and biologics
  • Seeking extension of patent term for time spent in the drug approval process (Patent Term Extension, Supplemental Protection Certificates), and/or time spent obtaining a patent at the United States Patent Office (Patent Term Adjustment)
  • 271(e)(1) “safe harbor”
  • Identifying the respective roles of the FDA and the PTO in the patenting of drugs and biological products

Trademarks, Trade Names, and Trade Dress

  • The art and science of selecting a brand name for a proposed drug product
  • Understanding the respective 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
  • Appreciating the use of trade dress as a means of IP protection for drug products