Medication Affordability and Patent Integrity Act | ChamberLight

REPORTED· 119TH CONGRESS

Senate BillS 2658Inflation and pricesDrug safety, medical device, and laboratory regulation

Medication Affordability and Patent Integrity Act

INTRO AUG 1· LAST ACTION JUL 28

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Became Law

WHAT THE BILL DOES

AI-written

This bill matters because it addresses a critical issue impacting medication costs and access: how drug companies manage their patents. Currently, companies can sometimes make different claims about the same patent to the FDA and the USPTO, potentially creating confusion or extending patent protections beyond what's warranted. These extended protections, often called 'patent thickets,' can delay the entry of more affordable generic and biosimilar drugs.

If this bill becomes law, requiring consistent and truthful information sharing between the two agencies could make the patent system more transparent and accurate. This increased clarity might help prevent companies from unfairly delaying generic competition, which could ultimately lead to lower drug prices and improved access to medications for consumers. If it doesn't become law, the existing system, where inconsistencies in patent claims can persist, may continue to contribute to higher drug costs and slower generic market entry.

KEY PROVISIONS

4AI-extracted

PROVISION 01

Drug companies must certify to the FDA that patent-related information they submit to the FDA is consistent with what they've provided to and communicated with the USPTO.

This ensures the FDA has accurate patent information, which is crucial for determining generic drug approval timelines.

PROVISION 02

Drug companies must submit to the USPTO any patent-related information they provided to the FDA and certify that this submission includes all material information and is consistent with their FDA communications.

This aims to prevent companies from making differing patent claims to each agency, clarifying the patent landscape for generics.

PROVISION 03

The United States Patent and Trademark Office (USPTO) must update its regulations to protect trade secrets and confidential information shared under these new disclosure requirements.

This ensures proprietary business information is safeguarded while still promoting transparency in patent claims.

PROVISION 04

These new disclosure and certification rules apply to both new drug applications (NDAs) and biological product applications (BLAs).

This broadens the scope of the consistency requirements to cover a wide range of medications, including complex biologics.

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ACTION TIMELINE

12 EVENTS

JUL 28

Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.

COMMITTEE

JUL 28

Placed on Senate Legislative Calendar under General Orders. Calendar No. 528.

CALENDARS

JUN 17

Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.

COMMITTEE

JUN 17

Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.

COMMITTEE

BILL INFO

TypeSenate Bill

NumberS 2658

Congress119th

StatusReported

IntroducedAug 1, 2025

Last actionJul 28, 2026

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REPORTED· 119TH CONGRESS · HEALTH, EDUCATION, LABOR, AND PENSIONS COMMITTEE · INTRODUCED AUG 1, 2025

Senate BillS 2658Inflation and pricesDrug safety, medical device, and laboratory regulation

Medication Affordability and Patent Integrity Act

INTRODUCED AUG 1, 2025· LAST ACTION JUL 28, 2026

PASSAGE CHANCES

—%

READING

20 min

COSPONSORS

COMPLEXITY

Moderate

Call my reps

LEGISLATIVE PROGRESS

STEP 3 OF 8

Introduced

In Committee

Reported

Passed Senate

Passed House

Conference

To President

Became Law

Introduced
In Committee
Reported
Passed Senate
Passed House
Conference
To President
Became Law

WHAT THE BILL DOES

AI-written

KEY PROVISIONS

AI-extracted

high

Drug companies must certify to the FDA that patent-related information they submit to the FDA is consistent with what they've provided to and communicated with the USPTO.

This ensures the FDA has accurate patent information, which is crucial for determining generic drug approval timelines.

high

This aims to prevent companies from making differing patent claims to each agency, clarifying the patent landscape for generics.

med

The United States Patent and Trademark Office (USPTO) must update its regulations to protect trade secrets and confidential information shared under these new disclosure requirements.

This ensures proprietary business information is safeguarded while still promoting transparency in patent claims.

med

These new disclosure and certification rules apply to both new drug applications (NDAs) and biological product applications (BLAs).

This broadens the scope of the consistency requirements to cover a wide range of medications, including complex biologics.

DEADLINES & DATES

AI-extracted

An AI model extracted this from the bill’s official record and can make mistakes. Check the official text ↗ (opens in new tab)

Date of enactment

Applicable to original drug applications submitted on or after the date of enactment.

Date of enactment and ongoing

For applications submitted before enactment, requirements apply to applicable patents issued on or after the date of enactment, and to submissions/communications made on or after the date of enactment for existing patents.

GLOSSARY

AI-written

Food and Drug Administration (FDA): A federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices, among other things.
United States Patent and Trademark Office (USPTO): A federal agency that issues patents to inventors and registers trademarks for products and services.
Drug application sponsor/holder: The company or entity that submits an application to the FDA for approval of a new drug or biological product, or holds the approval for an already marketed product.
Applicable patent: A patent that covers a drug or biological product, including its formulation, method of use, or manufacturing process, and is owned or licensed by the company seeking or holding FDA approval.
Material to patentability: Information that is important for determining whether an invention can be granted a patent, often defined by USPTO regulations.
New Drug Application (NDA): A formal application submitted to the FDA for approval to market a new drug in the United States.
Biological Product Application (BLA)

ACTION TIMELINE

12 EVENTS

JUL 28

Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.

COMMITTEE

JUL 28

Placed on Senate Legislative Calendar under General Orders. Calendar No. 528.

CALENDARS

JUN 17

Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.

COMMITTEE

JUN 17

Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.

COMMITTEE

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Committee Referrals

Health, Education, Labor, and Pensions CommitteeReferred

Jul 28, 2026

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Medication Affordability and Patent Integrity Act

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WHAT THE BILL DOES

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Medication Affordability and Patent Integrity Act

LEGISLATIVE PROGRESS

WHAT THE BILL DOES

KEY PROVISIONS

DEADLINES & DATES

GLOSSARY

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