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Bill would force drug firms to match FDA and patent office filings

Placed on the calendarS. 2658Latest action

Sponsor: Margaret Wood Hassan · Senator · NH

AIDecoded by AI · checked against the record
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Official title: Medication Affordability and Patent Integrity Act

119th Congress

Topics: Health care

Introduced:

Read the official bill on Congress.gov

In plain words

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Drug companies would have to certify that FDA and patent office filings match, or face penalties.

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What does this do?

This bill requires drug companies to certify that information given to the FDA about a drug's makeup, testing, and manufacturing matches what they tell the USPTO for patent purposes. Companies would also share relevant technical information between the two agencies. This aims to prevent "patent thicketing," where inconsistent information is used to obtain extra patents extending drug control.

Who does it affect?

Pharmaceutical and biotech companies making brand-name drugs and biologics, and their legal and regulatory teams, are directly affected. Consumers and generic/biosimilar competitors could be indirectly affected.

Why does it matter?

Companies that fail to make required disclosures or certifications could face FDA enforcement penalties. Generic or biosimilar companies sued for patent infringement could use a patent holder's non-disclosure as a legal defense.

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Read the official bill on Congress.gov

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Where does it stand?

  1. IntroducedAug 1, 2025
  2. Senate committee
  3. Senate voteYou are here · Jul 28, 2026
  4. House
  5. The president's desk

Right now: it was placed on the , and the official record shows no floor action on it since. If the House changes it, it goes back to the Senate before reaching the president.

Latest action: — Placed on Senate Legislative Calendar under General Orders. Calendar No. 528.

Data as of October 14, 2026
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