Interagency Patent Coordination and Improvement Act of 2025

The bill would amend title 35 of the United States Code to create the Interagency Task Force on Patents, a formal body composed of employees from both the USPTO and the FDA. The task force would be directed to share information on each agency's review processes, new patent and drug approvals, new technologies, and scientific developments. It would also establish a process requiring the USPTO to request — and the FDA to provide — information useful to patent examiners, including access to drug approval records and communications between FDA and drug sponsors that are not publicly available. Additionally, the task force would require the USPTO to assist the FDA in its ministerial role of listing patents.

The bill would not authorize the USPTO to interfere with or supersede the FDA's patent-listing function, and it would not change that ministerial function. It includes detailed confidentiality protections, requiring protocols to safeguard shared information and providing drug or biological product sponsors 30 days' notice before their information is shared between the two agencies. Within four years of enactment, the USPTO Director would be required to report to Congress on the task force's activities and recommend any further coordination opportunities with other federal agencies.

Patent examiners at the USPTO reviewing applications for human drugs and biological products; the FDA and its staff who would participate in the task force and respond to USPTO information requests; pharmaceutical and biotechnology companies whose drug and biological product application records and labeling information could be shared between the two agencies; and patent applicants whose claimed inventions relate to human drugs or biological products.

Patent examiners currently may lack access to relevant FDA data — such as whether a drug was on sale before a patent's filing date — needed to assess prior art accurately. If enacted, the task force would create a structured channel for that information to flow to USPTO, potentially improving patent quality and reducing disputes over pharmaceutical patents. Drug sponsors would gain a new notice-and-consultation right before their confidential FDA records are shared.

The USPTO Director and FDA Commissioner would first enter into or update a memorandum of understanding to implement the task force. The task force would be staffed by agency appointees with operational, technical, medical, and scientific expertise. It would establish information-sharing protocols, confidentiality safeguards, and a process for USPTO to formally request FDA data for use in patent examinations. Sponsors receive 30 days' notice before their information is shared. USPTO must keep FDA-supplied information separate from pending applications. Four years after enactment, the USPTO Director reports to the Senate and House Judiciary Committees on the task force's effectiveness and offers recommendations for further interagency coordination.