Interagency Patent Coordination and Improvement Act of 2025
Sponsored By: Senator Durbin, Richard J. [D-IL]
In Committee
Summary
Stronger USPTO–FDA coordination on patents for human drugs and biological products. This bill would create an Interagency Task Force on Patents to share technical and approval information, set a formal process for USPTO requests to the Food and Drug Administration, and have the USPTO assist the FDA with patent listings.
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- Patent examiners would get access to FDA materials relevant to drug and biologic approvals, including product applications, labeling updates, and select nonpublic communications when appropriate to improve examination of prior art and on‑sale issues.
- Establishes a statutory Task Force with members from both agencies, a required memorandum of understanding, routine meetings, training, and a required report to the Judiciary Committees within four years on how often FDA information is used and what methods are most useful.
- Drug and biologic sponsors would get confidentiality safeguards that mirror FDA protections, a notice and 30‑day consultation period before nonpublic information is shared, and procedures for remedies after any inadvertent disclosure.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
New patent task force for drugmakers
This bill would create a new USPTO–FDA Interagency Task Force for patents on human drugs and biologics. The Director and the FDA Commissioner would enter or update a memorandum of understanding and the USPTO Director would consult the FDA through the task force when handling these patents. The task force would let the USPTO request FDA records and limited access needed for patent exams, while keeping FDA-level confidentiality rules. Drug sponsors would get 30 days' notice before confidential FDA information is shared, and the USPTO must report to Congress within 4 years on how FDA data was used.
Sponsors & CoSponsors
Sponsor
Durbin, Richard J. [D-IL]
IL • D
Cosponsors
Sen. Tillis, Thomas [R-NC]
NC • R
Sponsored 3/24/2025
Sen. Grassley, Chuck [R-IA]
IA • R
Sponsored 3/24/2025
Sen. Coons, Christopher A. [D-DE]
DE • D
Sponsored 3/24/2025
Sen. Welch, Peter [D-VT]
VT • D
Sponsored 3/24/2025
Roll Call Votes
No roll call votes available for this bill.
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