S. 2658 · 119th Congress
Medication Affordability and Patent Integrity Act
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HassanSponsor1 cosponsor · 1 R
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
This bill requires applicants seeking approval of a drug or licensure of a biological product to submit certain information about relevant patents to both the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO).
What it does: CRS summary · Reported to Senate · Jul 28, 2026
Medication Affordability and Patent Integrity Act
This bill requires applicants seeking approval of a drug or licensure of a biological product to submit certain information about relevant patents to both the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO).
Specifically, the bill requires applicants to make certifications and disclosures related to each applicable patent on a proposed drug or biological product. An applicable patent is a patent or patent application held or sought by the applicant for the drug or biological product (including a formulation or composition, method of use, or method of manufacturing).
For each applicable patent, an applicant must submit to the USPTO any information material to patentability that the applicant submitted to the FDA and any information provided by the FDA in response. The applicant must certify that this submission is complete and consistent with the information the applicant provided to the FDA.
Further, for each applicable patent, an applicant must certify that certain information submitted to the FDA is consistent with information the applicant provided to the USPTO. This is specific to statements or characterizations that are material to patentability and related to (1) an applicable patent (including a statement or characterization of relevant publicly known information), or (2) analytical data included in a new drug or biological product application.
The bill establishes a defense to a patent infringement action if the owner of an applicable patent negligently or intentionally failed to make the disclosures required by these provisions.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Medication Affordability and Patent Integrity Act
Latest action (Jul 28, 2026): Placed on Senate Legislative Calendar under General Orders. Calendar No. 528.
Policy area: Health · Origin: Senate · Introduced: Aug 1, 2025
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.