Grassley, Durbin, Colleagues Introduce Legislation to Improve Coordination between Patent Office and FDA

WASHINGTON – Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa) joined Ranking Member Dick Durbin (D-Ill.), along with Committee members Thom Tillis (R-N.C.), Peter Welch (D-Vt.) and Chris Coons (D-Del.), to introduce the Interagency Patent Coordination and Improvement Act. The bipartisan legislation 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.

“When government agencies fail to coordinate effectively, taxpayers pay the price. These agencies would benefit from increased communication and better cooperation. Our legislation will encourage that collaboration, helping taxpayers in turn by increasing competition and cutting red tape,” Grassley said.

“Establishing clear avenues for collaboration between USPTO and FDA is essential for both agencies to oversee patent laws that protect innovation and promote competition,” Durbin said. “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,” Tillis said. “This bill is a straightforward, commonsense measure that strengthens the patent system, improves patent quality and reduces unnecessary bureaucracy.”

Numerous concerns have been raised about gamesmanship, abuses or lack of clarity that can harm prescription drug affordability by limiting generic competition. However, USPTO and FDA’s collaboration is limited, despite both agencies playing a role related to patents and competition involving prescription drugs.

Specifically, the task force created by the Interagency Patent Coordination and Improvement Act would:

1. Enhance information sharing on each agency’s processes, standards and methods;
2. Improve dialogue on new technologies and scientific trends;
3. Enable confidential reciprocal access to information, if requested and only as needed, related to prior art;
4. Ensure accurate representations by companies between the two agencies; and
5. Ensure accuracy of patent listings

The bill promotes efficiency and good governance by fostering communication between the two agencies, while respecting their distinct purviews. This enhanced coordination will help bolster innovation while preventing inappropriate tactics to delay access to affordable generic medications. The Senate Judiciary Committee passed this legislation in the 118th Congress by voice vote.

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