U.S. Congress legislation · 119th Congress
SB2658: Medication Affordability and Patent Integrity Act
Status: In committee, July 28, 2026
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.
What the bill says
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.
From the introduced text, July 28, 2026:
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. SECTION 1. Short title This Act may be cited as the Medication Affordability and Patent Integrity Act . SECTION 2. Disclosure of information (a) In general (1) In general Section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ) is amended by adding at the end the and (ii) (I) submit to the United States Patent and Trademark Office any information material to patentability with respect to such applicable patent that the sponsor or holder submits to the Food and Drug Administration, and any information the Food and Drug Administration provided in response; and (II) certify to the United States Patent and Trademark Office that the submission under subclause (I), to the best knowledge of the sponsor or holder, includes all information material to patentability, and is consistent with the information such sponsor or holder provided to the Food and Drug Administration and any communications such sponsor or holder had with the Food and Drug Administration. (B) The information described in this subparagraph is limited to information that is material to patentability, as defined in regulations promulgated by the United States Patent …
Sponsors
- Margaret Hassan (D, SD-NH) · primary sponsor
- Hawley, Josh (R, SD-MO)
Latest actions
- : Placed on Senate Legislative Calendar under General Orders. Calendar No. 528.
- : Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
- : Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- : Committee on Health, Education, Labor, and Pensions. Hearings held.
- : Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- : Introduced in Senate
Subjects: Inflation and prices, Manufacturing, Drug safety, medical device, and laboratory regulation, Health, Prescription drugs, Intellectual property
Common questions
- What is SB2658?
- SB2658 is a bill in Congress (119th Congress): Medication Affordability and Patent Integrity Act.
- What does SB2658 do?
- In its own words: 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.
- What is the status of SB2658?
- In committee as of July 28, 2026. Latest action: Placed on Senate Legislative Calendar under General Orders. Calendar No. 528. (July 28, 2026).
- Who sponsored SB2658?
- Margaret Hassan (D, SD-NH), with 1 co-sponsor.
- Where is the official record for SB2658?
- On the Congress website: https://www.congress.gov/bill/119th-congress/senate-bill/2658
Source: official Congress record. Tracked by Delilah, AI for legislation across all 50 states and Congress.