S 2658 119th Congress
Medication Affordability and Patent Integrity Act
A bill to require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office.
Official Title as Introduced Congress.gov
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Bill journey
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Introduction Congress.gov
Introduced
Introduced in the Senate.
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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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Introduced in Senate
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Introduced in Senate
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Committee on Health, Education, Labor, and Pensions. Hearings held.
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Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
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Placed on Senate Legislative Calendar under General Orders. Calendar No. 528.
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Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
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Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
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Reported to Senate
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View the complete bill journey as an accessible table
| Date and time | Record | Official detail | Source |
|---|---|---|---|
| IntroductionIntroduced | Introduced in the Senate. | Congress.gov | |
| Official actionRead twice and referred to the Committee on Health, Education, Labor, and Pensions. | No additional detail supplied.IntroReferral · Senate | Congress.gov | |
| Official actionIntroduced in Senate | No additional detail supplied.IntroReferral · Library of Congress · Code 10000 | Congress.gov | |
| Text versionIntroduced in Senate | A dated text-version record is available. | Congress.gov | |
| Official actionCommittee on Health, Education, Labor, and Pensions. Hearings held. | No additional detail supplied.Committee · Senate | Congress.gov | |
| Official actionCommittee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. | No additional detail supplied.Committee · Senate | Congress.gov | |
| Official actionPlaced on Senate Legislative Calendar under General Orders. Calendar No. 528. | No additional detail supplied.Calendars · Senate | Congress.gov | |
| Official actionCommittee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report. | No additional detail supplied.Committee · Senate | Congress.gov | |
| Official actionCommittee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report. | No additional detail supplied.Committee · Library of Congress · Code 14000 | Congress.gov | |
| Text versionReported to Senate | A dated text-version record is available. | Congress.gov |
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Congressional Research Service
CRS summary
Medication Affordability and Patent Integrity ActThis 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.
Official documents
Text versions
- Reported to SenateJul 28, 2026
- Introduced in SenateAug 1, 2025