Durbin, Tillis Introduce Legislation To Improve Coordination Between USPTO and FDA On Pharma Patents
The Interagency Patent Coordination and Improvement Act would establish a task force between agencies to share information, foster good governance in activities related to prescription drug patents
WASHINGTON – U.S. Senate Democratic Whip Dick Durbin (D-IL), Ranking Member of the Senate Judiciary Committee, and U.S. Senator Thom Tillis (R-NC), along with U.S. Senators Chuck Grassley (R-IA), Chairman of the Senate Judiciary Committee, Chris Coons (D-DE), and Peter Welch (D-VT) today introduced bipartisan legislation, the Interagency Patent Coordination and Improvement Act, which would establish a task force between the United States Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) to improve communication and coordination in implementing each agency’s activities related to pharmaceutical patents. Currently, there is limited collaboration between USPTO and FDA, despite both agencies playing a role related to patents and competition involving prescription drugs. Numerous concerns have been raised about gamesmanship, abuses, or lack of clarity that can harm prescription drug affordability by limiting generic competition. This legislation was passed by the Senate Judiciary Committee in the 118th Congress by voice vote.
“Establishing clear avenues for collaboration between USPTO and FDA is essential for both agencies to oversee patent laws that protect innovation and promote competition,” said Durbin. “By incentivizing coordination through the Interagency Patent Coordination and Improvement Act, we can address gamesmanship and abuses with pharmaceutical patents that keep prescription drug prices too high for American patients.”
“Enhancing coordination between the USPTO and FDA will ensure that patent examiners have the necessary information to make well-informed decisions regarding patentability,” said Tillis.“This bill is a straightforward, commonsense measure that strengthens the patent system, improves patent quality, and reduces unnecessary bureaucracy.”
Given the shared interaction and overlapping jurisdiction between USPTO and FDA, this legislation promotes efficiency and good governance by fostering communication between the two agencies, while respecting their distinct purviews. Specifically, the task force created by this legislation would: enhance information sharing on each agency’s processes, standards, and methods; improve dialogue on new technologies and scientific trends; enable confidential reciprocal access to information, if requested and only as needed, related to prior art; ensure accurate representations by companies between the two agencies; and ensure accuracy of patent listings. This enhanced coordination will help bolster innovation while preventing inappropriate tactics to delay access to affordable generic medications.
This bipartisan legislation is endorsed by AARP and Patients For Affordable Drugs Now.
“AARP, which advocates for the more than 100 million Americans age 50 and over, is pleased to endorse the Interagency Patent Coordination and Improvement Act of 2025,” said Bill Sweeney, AARP’s Senior Vice President of Government Affairs. “We value Senators Durbin and Tillis’s bipartisan efforts to increase transparency and access to affordable prescription drugs and look forward to continuing to work with them on these and other measures to lower drug prices for all Americans.”
“This bill improves coordination between the Patent and Trademark Office (PTO) and the Food and Drug Administration (FDA) to close loopholes that brand-name drug corporations exploit to block competition – helping to stop patent abuse before it starts. Boosting competition is one of the most powerful tools we have to lower drug prices for Americans of all ages, in every state, who are struggling to afford the medications they need. Patients For Affordable Drugs Now is proud to support this legislation,” said Merith Basey, Executive Director of Patients for Affordable Drugs Now.
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