Interagency Patent Coordination and Improvement Act of 2025
This bill, the Interagency Patent Coordination and Improvement Act of 2025, would create an official interagency unit—the Interagency Task Force on Patents—within the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA). The purpose is to coordinate information sharing and technical assistance related to patents, specifically for human drugs and biological products. It envisions closer collaboration between the USPTO and FDA to improve patent examination, ensure accurate and consistent representations about patent applications and drug/biologic approvals, and to help examiners access relevant information from FDA processes. The bill also sets out confidentiality protections and a framework for how information may be shared, including protections to avoid disclosure of sensitive information and a requirement for notice to sponsors before sharing certain confidential data. In addition to creating the task force, the bill requires a congressionally directed report within four years detailing how FDA information is provided to USPTO, what types of information are most useful to examiners, recommendations for congressional action, and other agencies with which similar coordination could be pursued. It also adds a new statutory subsection tying patent-related decision-making for drugs and biologics to the interagency task force and to a formal memorandum of understanding between the USPTO Director and the FDA Commissioner. Sponsor: Rep. Neguse (Introduced July 21, 2025). Status: Introduced. This is a proposed law and has not yet been enacted.
Key Points
- 1Establishment of the Interagency Task Force on Patents (the task force) to coordinate patent-related activities between the USPTO and the FDA, focusing on human drugs and biological products.
- 2Creation of a binding framework (including a Memorandum of Understanding) and defined membership, with designated personnel from both the USPTO and the FDA who have relevant expertise and decision-making authority.
- 3Authority to share information and provide access to confidential or non-public data, with strict confidentiality protocols, notices to sponsors, and safeguards to prevent inadvertent disclosure of sensitive information.
- 4A formal process for the USPTO to obtain information from the FDA (and for the FDA to provide information to the USPTO) about drug/biologic approvals, labeling updates, and related materials to aid patent examinations, while preserving ministerial FDA functions such as listing patents.
- 5A requirement that the USPTO Director consult the FDA Commissioner in patent decisions involving human drugs and biological products, tying those decisions to the task force’s coordination.
- 6A mandatory four-year post-enactment report to Congress (Senate and House Judiciary Committees) evaluating the frequency and usefulness of FDA-to-PTO information sharing, identifying the most beneficial information types and methods, and recommending congressional actions and potential expansion to other federal agencies.