The FDA and Patent Office React to Biden’s Call to Action on DrugPatents

Sidley partners Sona De and Steven J. Horowitz, assisted by managing associate Amana Abdulwakeel, published an article in the New York Law Journal titled “The FDA and Patent Office React to Biden’s Call to Action on Drug Patents.” The article discusses President Biden’s July 2021 Executive Order that directed the U.S. Food and Drug Administration and the U.S. Patent and Trademark Office to collaborate and identify ways to increase competition within the pharmaceutical industry. It goes on to describe the agencies’ response to that Order in the form of proposed initiatives to change how patents that protect drugs are examined. It also surveys public comments by trade groups representing sectors of the pharmaceutical industry – both on the innovator and the generic/biosimilar side – on those initiatives and what to expect next.

"Reprinted with permission from the March 27, 2023 issue of New York Law Journal.© 2023 ALM Media Properties, LLC. Further duplication without permission is prohibited. All rights reserved."