Bill · S. 2658· Senate(119-S-2658)
Medication Affordability and Patent Integrity Act
- Introduced
- 8/1/2025
- Last activity
- 7/28/2026 — Placed on Senate Legislative Calendar under General Orders. Calendar No. 528.
- Sponsored by
- Maggie Hassan
- Cosponsors
- - 0 - 1
- Introduced
- On Calendar
What this bill would do
The Medication Affordability and Patent Integrity Act requires drug and biological product application sponsors to provide specific information to both the FDA and the USPTO. Sponsors must certify that the information they provide to the FDA is consistent with what they have shared with the USPTO regarding patentability. Additionally, they must submit material information to the USPTO and certify its completeness and consistency with FDA communications. This bill establishes an enforcement mechanism through the FDA for these required certifications. It also creates a legal defense against patent infringement actions if a patent owner fails to disclose required information.
Yes· 3 of 4
Does this make health care easier to get in general?+3
By increasing patent transparency and providing a non-disclosure defense, the bill aims to improve medication affordability.
Would households on low incomes be better off under this?+3
The bill's focus on patent integrity and transparency is intended to enhance medication affordability.
Would middle-income households be better off under this?+3
The bill's focus on patent integrity and transparency is intended to enhance medication affordability.
The opposite
Would business owners be better off under this?-4
The bill increases the regulatory and compliance burden on drug and biological product sponsors.
Does this make it easier to run a small business?-2
The bill imposes new, rigorous certification and disclosure requirements on drug and biological product sponsors.
Who it would affect, and how
Potential Positive Impacts for People
-
Legal Defense against Infringement: A person can now use a non-disclosure defense in patent infringement actions if the patent owner negligently or intentionally fails to disclose required information (Section 2.c.2.A).
-
Transparency of Patent Claims: The protections for trade secrets and confidential information do not apply to information that the USPTO determines is necessary for the public to understand the scope of patent claims granted (Section 2.a.1.E.i).
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Information Consistency: Sponsors must certify that information submitted to the FDA is consistent with communications provided to the USPTO, and vice versa (Section 2.a.1.A.i and Section 2.a.1.A.ii).
Potential Negative Impacts for People
-
Increased Compliance Requirements: Sponsors of drug and biological product applications are now required to submit specific material information to the USPTO and provide various certifications to both the FDA and the USPTO (Section 2.a.1.A and Section 2.b.i).
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Restriction of Legal Defense: The defense against patent infringement actions is not available to a person if they are a covered foreign person as defined in the Defense Production Act of 1950 (Section 2.c.2.A).
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Healthcare
- Improves Healthcare Access+3
- Demographic And Interest Groups
- Good For Low Income Households+3Good For Middle Class Households+3Good For Business Owners-4
- Economy And Finance
- Improves Small Business Support-2
- Governance And Ideology
- Improves Due Process+2
- 7/28/2026
- Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
- Placed on Senate Legislative Calendar under General Orders. Calendar No. 528.
- 6/17/2026
- Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- 3/19/2026
- Committee on Health, Education, Labor, and Pensions. Hearings held.
- 8/1/2025
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 1 Cosponsor added.
- Introduced in Senate
Josh HawleyRepublican · Missouri