# 119-s-2658: Medication Affordability and Patent Integrity Act

119-s-2658, Medication Affordability and Patent Integrity Act, is a 119th Congress bill sponsored by Sen. Hassan, Margaret Wood [D-NH] (D-NH); status in_committee; PRIA reads it as touching household money (as of 2026-10-21).

- Canonical: https://policyrisk.com/legislation/119-s-2658
- As of: 2026-10-21
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-s-2658
- Congress: 119
- Title: Medication Affordability and Patent Integrity Act
- Status: in_committee
- Introduced: 2025-08-01
- Sponsor: Sen. Hassan, Margaret Wood [D-NH] (D-NH)
- Cosponsors: 1
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-10-21

## Summary

**Creates a mandatory cross‑agency disclosure system tying what drug and biologic developers tell the FDA to what they must tell the USPTO.** It imposes paired certification duties on sponsors and holders and adds a statutory patent‑infringement defense for failures to comply. - Drug and biologic sponsors and approved product holders must certify to the FDA that their FDA submissions are consistent with what they sent the USPTO and must submit "information material to patentability" to the USPTO. This applies to original applications filed on or after enactment and to certain later supplements and patents. - Generic and biosimilar developers and other accused infringers gain a new defense under 35 U.S.C. section 274 that can be raised if a patent owner negligently or intentionally failed to meet the Act’s disclosure duties. The defense excludes parties defined as "covered foreign persons." - The USPTO must protect submitted material as trade secret or confidential commercial information but may disclose when needed for public understanding of patent claims and must update its rules to implement these protections.

## Cosponsors (1)

- Sen. Hawley, Josh [R-MO] (R-MO), 2025-08-01T00:00:00.000Z

## Provisions PRIA read

- New drug patent disclosure duties: mixed, medium. If enacted, drug and biologic sponsors would have to certify to the FDA that patent-related information they submit matches what they tell the USPTO. Sponsors would also have to send to the USPTO any information material to patentability that they gave the FDA and certify those USPTO submissions ar…
- New enforcement and patent defenses: mixed, medium. If enacted, failing to submit the required FDA/USPTO certifications would become a prohibited act the FDA could enforce. In patent lawsuits over applicable patents, a defendant could assert a defense if the patent owner negligently or intentionally failed to make the required FDA or USPTO disclosur…

## Related bills

- 119-s-1748: Kids Online Safety Act
- 119-s-3990: PrEP Access and Coverage Act of 2026
- 119-s-237: Honoring Our Fallen Heroes Act of 2025
- 119-s-2823: FAMILY Act
- 119-s-4429: Connected Vehicle Security Act of 2026
- 119-s-4927: Rural Hospital Emergency Room Guarantee Act

## Sources
- [119-s-2658 on Congress.gov](https://www.congress.gov/bill/119th-congress/senate-bill/2658)

## Related
- [119-s-1748: Kids Online Safety Act](https://policyrisk.com/legislation/119-s-1748)
- [119-s-3990: PrEP Access and Coverage Act of 2026](https://policyrisk.com/legislation/119-s-3990)
- [119-s-237: Honoring Our Fallen Heroes Act of 2025](https://policyrisk.com/legislation/119-s-237)
- [119-s-2823: FAMILY Act](https://policyrisk.com/legislation/119-s-2823)
- [119-s-4429: Connected Vehicle Security Act of 2026](https://policyrisk.com/legislation/119-s-4429)
- [119-s-4927: Rural Hospital Emergency Room Guarantee Act](https://policyrisk.com/legislation/119-s-4927)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-s-2658 (as of 2026-10-21).