In connection with the Executive Order on Competition in the American Economy (EO 14036), FDA and the U.S. Patent and Trademark Office (USPTO) are engaged in a robust set of initiatives aimed at protecting and promoting U.S. innovation while advancing marketplace competition that can lower drug prices for all Americans.
As part of these efforts, FDA and USPTO exchanged letters outlining ways the two agencies can collaborate and work within our respective authorities to further address the need for an appropriate balance between innovation and patient access to needed medicines. The letters discuss specific initiatives FDA and USPTO are exploring to ensure that the U.S. patent system properly and adequately protects innovation and is not used to unjustifiably delay getting generic, biosimilar, and more affordable versions of pharmaceuticals into the hands of Americans who need them.
- Federal Register Notice: Joint USPTO-FDA Collaboration Initiatives
- Joint Blog by Kathi Vidal, Under Secretary of Commerce for Intellectual Property and Director of the USPTO, and Robert M. Califf, FDA Commissioner
- FDA Letter to USPTO
- USPTO Letter to FDA