H.R. 4570 — Interagency Patent Coordination and Improvement Act of 2025

This section states four congressional findings concerning the relevance of information from other federal agencies to United States Patent and Trademark Office (USPTO) patent examinations, including (1) the potential implications of such information for USPTO patent decisions, (2) the need for accuracy and consistency in information submitted by applicants to the USPTO and other agencies, (3) research indicating benefits to examiners from accessing such information for prior art assessments, and (4) encouragement for the USPTO Director to collaborate with other agencies.

This section directs the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office to submit a report to the Senate and House Judiciary Committees not later than four years after enactment that contains (1) a description of the frequency with which the Food and Drug Administration provides information to the Patent and Trademark Office through the Interagency Task Force on Patents (established under new 35 U.S.C. §14) or related processes, and the frequency with which that information is used in patent examinations; (2) an identification of the most useful methods and types of such information for patent examiners; (3) recommendations for congressional changes to the Task Force's mandate, funding, or operations; and (4) an identification of other federal agencies for potential similar coordination.

This section establishes an Interagency Task Force on Patents (task force) between the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) to coordinate communication, evaluation, and implementation of activities regarding patents for human drugs and biological products. (As background, USPTO patent examiners assess novelty and non-obviousness of inventions—including whether they were on sale before the effective filing date under 35 U.S.C. §102(a)(1)—while FDA approves such products and maintains related approval, labeling, and sponsor communication records; thus, the task force facilitates USPTO examiners' access to relevant FDA information as prior art.) It requires (1) the USPTO Director to consult with the FDA Commissioner through the task force on patent-related decisions and actions for such products; (2) a memorandum of understanding between the agencies to implement task force duties; (3) task force membership of expert employees from both agencies; and (4) task force activities including sharing processes and approval information, establishing reciprocal information requests (e.g., FDA data on approvals and non-public sponsor communications for examiners, USPTO assistance on FDA patent listings), and consultation on post-rejection patent matters. It further specifies confidentiality protocols for shared information—including 30-day notice to product sponsors—and a rule of construction preserving FDA's ministerial patent-listing role without affecting infringement litigation positions.