S. 2658119th CongressPlaced on the calendarLatest action Jul 28, 2026Decoded by AI · checked against the record
Official title: Medication Affordability and Patent Integrity Act
Introduced:
Read the official bill on Congress.govThe plain-language version leads. The official text is always the reference.
Drug companies would have to certify that FDA and patent office filings match, or face penalties.
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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.
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.
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.
AI-drafted summary. Verify it against the official text before you act on it. Read the official bill on Congress.gov
Right now: it was placed on the Senate floor calendar, 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.