119-S-2658 Journalist Public Summary

Public Summary: S. 2658 — Medication Affordability and Patent Integrity Act

1. 1) Headline Summary: A bipartisan proposal to make drug companies give FDA and the U.S. Patent and Trademark Office the same, patent‑relevant information—and certify it’s consistent—to prevent patent games that can delay cheaper generics and biosimilars. (hassan.senate.gov)

2) What It Does: The bill amends the Food, Drug, and Cosmetic Act and the Public Health Service Act so that, when seeking approval or maintaining approval, brand‑name and biologic manufacturers must (a) certify to FDA that key information is consistent with what they told the USPTO, and (b) submit to the USPTO any information “material to patentability” that they send to FDA (and vice‑versa responses). It also makes failure to provide the required FDA certifications a prohibited act under federal drug law and creates a new defense in patent lawsuits if a patent owner negligently or intentionally withholds required information. (congress.gov)

3) Why It Matters: Backers say better FDA–USPTO coordination would reduce “evergreening” and other tactics that can extend monopolies and delay lower‑cost competition; they argue this could help bring down prices when generics or biosimilars enter. Critics counter that the bill would force disclosure of sensitive development data and add burdens that could slow innovation. (hassan.senate.gov)

• Sen. Maggie Hassan (D‑NH) and Sen. Josh Hawley (R‑MO) — sponsors; they frame the bill as closing oversight gaps that let companies make inconsistent statements to FDA and USPTO to block competition. (hassan.senate.gov)
• Patient and consumer groups — a 2024 sign‑on letter (supporting the same policy framework) from organizations such as the American Diabetes Association, National Multiple Sclerosis Society, Patients Rising, and others urged HELP leaders to advance the bill’s core provisions. (aafa.org)
• Drug‑pricing reform advocates — analyses like I‑MAK’s describe the bill’s approach as targeting patent abuses that can keep prices high. (i-mak.org)

4) Who’s Against It:

• Council for Innovation Promotion (C4IP) — warns the bill could expose trade secrets and undermine IP by compelling disclosure of confidential FDA materials to the USPTO. (c4ip.org)
• We Work For Health — an industry‑aligned coalition urging the Senate HELP Committee to reject the bill, citing risks to innovation. (weworkforhealth.org)
• Commentary in legal/industry press — argues the proposal may politicize the patent system and raise costs. (news.bloomberglaw.com)

5) What’s Next: As of March 20, 2026, Congress.gov shows S. 2658 has been introduced and referred to the Senate Health, Education, Labor, and Pensions (HELP) Committee (last listed action: August 1, 2025). The next step would be a HELP Committee markup and vote before any potential Senate floor action. (congress.gov)

6) Tone: This is a neutral, plain‑English explainer to help a typical voter understand the stakes without legal or technical jargon.