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119-s-2658119th CongressWALLET

Medication Affordability and Patent Integrity Act

Sponsored By: Senator Hassan, Margaret Wood [D-NH]

In Committee

Summary

Creates a mandatory cross‑agency disclosure system tying what drug and biologic developers tell the FDA to what they must tell the USPTO. It imposes paired certification duties on sponsors and holders and adds a statutory patent‑infringement defense for failures to comply.

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  • Drug and biologic sponsors and approved product holders must certify to the FDA that their FDA submissions are consistent with what they sent the USPTO and must submit "information material to patentability" to the USPTO. This applies to original applications filed on or after enactment and to certain later supplements and patents.
  • Generic and biosimilar developers and other accused infringers gain a new defense under 35 U.S.C. section 274 that can be raised if a patent owner negligently or intentionally failed to meet the Act’s disclosure duties. The defense excludes parties defined as "covered foreign persons."
  • The USPTO must protect submitted material as trade secret or confidential commercial information but may disclose when needed for public understanding of patent claims and must update its rules to implement these protections.

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Bill Overview

Analyzed Economic Effects

2 provisions identified: 0 benefits, 0 costs, 2 mixed.

New drug patent disclosure duties

If enacted, drug and biologic sponsors would have to certify to the FDA that patent-related information they submit matches what they tell the USPTO. Sponsors would also have to send to the USPTO any information material to patentability that they gave the FDA and certify those USPTO submissions are complete. These duties would apply to original applications filed on or after enactment and to certain later submissions or patents tied to that date. Information sent to the USPTO only because of these duties would stay protected as trade secrets or confidential FDA information, but the USPTO could disclose what is necessary to explain patent claims and must update its procedures.

New enforcement and patent defenses

If enacted, failing to submit the required FDA/USPTO certifications would become a prohibited act the FDA could enforce. In patent lawsuits over applicable patents, a defendant could assert a defense if the patent owner negligently or intentionally failed to make the required FDA or USPTO disclosures. That defense would apply only to patents defined as applicable patents and would not be available to covered foreign persons. If enacted, these changes could alter litigation incentives and affect timing of generic and biosimilar market entry.

Sponsors & CoSponsors

Sponsor

Hassan, Margaret Wood [D-NH]

NH • D

Cosponsors

  • Sen. Hawley, Josh [R-MO]

    MO • R

    Sponsored 8/1/2025

Roll Call Votes

No roll call votes available for this bill.

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