Intellectual Property


FDA and Patents? FDA’s Letter to the USPTO and Possible Next Steps | New York State Bar Association Annual Conference

January 28, 2022 • Webinar

Starts: 12:10 PM (EST)
Ends: 1:00 PM (EST)

President Biden’s Executive Order 14036 (“Order”) aimed at “Promoting Competition in the American Economy” directed the Acting Commissioner (Janet Woodcock, M.D.) of the U.S. Food and Drug Administration (FDA) to take an unprecedented position on patents and related laws that may he been misused to inhibit or delay generic drugs and biosimilar products. In that letter, Dr. Woodcock addressed concerns of continuation patents creating patent thickets with no new inventive value and various evergreening or product hopping situations, where such continuation patents are granted post-approval to extent to follow-on products with little value except to delay generic and biosimilar approvals. The FDA asked the U.S. Patent and Trademark Office (USPTO) to provide feedback on whether post grant proceedings have helped to reduce such patent thickets. Finally, the FDA offered to work with the USPTO as the USPTO examined new patents to help the USPTO uncover relevant prior art and other regulatory considerations to patentability. This panel will look at the recommendations in the FDA’s letter to the USPTO and offer input whether one or more the FDA’s recommendations can be implemented and what the pros/cons would be for such actions to be taken.
Crowell & Moring Participant(s):
Terry Rea
Partner – Washington, D.C.
Phone: +1.202.624.2620
Email: trea@crowell.com
For more information, please visit these areas: