Interagency Patent Coordination and Improvement Act of 2025
Sponsored By: Representative Neguse, Joe [D-CO-2]
Introduced
Summary
Creates an interagency task force to let the USPTO and FDA share technical and regulatory information about human drugs and biological products to improve patent examination. It would set rules for sharing FDA approvals, labeling updates, indications, and certain nonpublic communications while protecting confidentiality and preserving each agency's ministerial roles.
Show full summary
- Patent examiners and patent applicants would gain access to FDA-provided data and certain nonpublic FDA communications on approvals, label changes, and indications to better assess prior art and on-sale issues.
- Drug sponsors and manufacturers would get at least 30 days' notice before the FDA shares confidential information and the bill requires safeguards, separation from pending patent applications, and remedies for unauthorized disclosure.
- The USPTO Director and FDA Commissioner would coordinate the task force via a memorandum of understanding and must report to the House and Senate Judiciary Committees within 4 years on how information sharing worked and what changes are recommended.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
New drug patent task force
If enacted, the government would set up a joint task force for drug and biologic patents. The USPTO Director and FDA Commissioner would run it and pick members. They would sign or update a memorandum of understanding to guide how it works. When making patent decisions on drugs or biologics, the USPTO Director would consult the FDA through this task force. It would start upon enactment.
Patent info sharing with safeguards
If enacted, the task force would hold regular meetings and training to share how the USPTO and FDA review cases. The USPTO Director could ask the FDA for specific information to help examiners, only as needed for patent work. Confidential records could be shared with safeguards. Drug or biologic sponsors would get at least 30 days’ notice and a 30‑day consultation before sharing. The USPTO would keep shared material separate from pending patent applications.
Sponsors & CoSponsors
Sponsor
Neguse, Joe [D-CO-2]
CO • D
Cosponsors
There are no cosponsors for this bill.
Roll Call Votes
No roll call votes available for this bill.
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