Legislation6 days ago
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To authorize implementation grants to community-based nonprofits to operate one-stop reentry centers.
HR8548Rep. Kamlager-Dove, Sydney [D-CA-37] (D-CA)
introduced
S2658119th CongressWALLET
Medication Affordability and Patent Integrity Act
Sponsored By: Senator Sen. Hassan, Margaret Wood [D-NH]
In Committee
Summary
Cross-agency patent disclosure and certification for drugs and biologicals. The bill would require sponsors to make sure the patentability information they give to the U.S. Patent and Trademark Office matches what they give the Food and Drug Administration.
Show full summary
- Sponsors and approval holders would have to submit to USPTO any information that is "material to patentability" and certify to both agencies that submissions and communications are complete and consistent. The material is limited to items like analytical data in the chemistry, manufacturing, and controls sections and statements about patents or prior art, and it covers patents that claim the drug, formulation, composition, method of use, or the manufacturing method.
- USPTO would be required to update procedures to keep those submissions protected as trade secret or confidential. FDA’s enforcement framework would be adjusted so the agency can enforce the new certification duties.
- The bill would add a new non-disclosure defense in federal patent law so accused infringers can raise a defense when a patent owner negligently or intentionally failed to provide the required information.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 0 benefits, 0 costs, 2 mixed.
New FDA enforcement and patent defense
This bill would make failing to submit the new certification to FDA a prohibited act FDA can enforce. It would also create a defense in patent lawsuits when a patent owner negligently or intentionally failed to disclose required information. The defense would apply only to patents covered by the bill and would take effect on enactment.
New patent disclosure rules for drugmakers
This bill would require drug and biologic sponsors to certify to FDA that patent-related information they give FDA matches what they gave USPTO. Sponsors would also need to send USPTO any FDA submissions that are material to patentability. USPTO would have to protect information sent only to meet these rules as trade secrets or confidential like FDA does. The new duties would apply to original applications filed on or after enactment, with limited phase-in for older applications and patents issued after enactment.
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Sponsors & CoSponsors
Sponsor
Sen. Hassan, Margaret Wood [D-NH]
NH • D
Cosponsors
Josh Hawley
MO • R
Sponsored 8/1/2025
Roll Call Votes
No roll call votes available for this bill.
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