S. 2658 · On the floor · Health
Medication Affordability and Patent Integrity Act
Sponsor: Margaret Wood Hassan (D-NH)
What it does
- Requires drug and biological product applicants to disclose to the Food and Drug Administration and U.S. Patent and Trademark Office any information material to patent patentability submitted in support of regulatory approval.
- Mandates applicants certify that patent-related disclosures submitted to the Patent and Trademark Office are complete and consistent with information provided to the Food and Drug Administration.
- Establishes a patent infringement defense if the patent owner negligently or intentionally failed to make required disclosures about drug or biological product patents.
Official summary
Medication Affordability and Patent Integrity Act This bill requires applicants seeking approval of a drug or licensure of a biological product to submit certain information about relevant patents to both the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO). Specifically, the bill requires applicants to make certifications and disclosures related to each applicable patent on a proposed drug or biological product. An applicable patent is a patent or patent application held or sought by the applicant for the drug or biological product (including a formulation or composition, method of use, or method of manufacturing). For each applicable patent, an applicant must submit to the USPTO any information material to patentability that the applicant submitted to the FDA and any information provided by the FDA in response. The applicant must certify that this submission is complete and consistent with the information the applicant provided to the FDA. Further, for each applicable patent, an applicant must certify that certain information submitted to the FDA is consistent with information the applicant provided to the USPTO. This is specific to statements…
Latest action
Jul 28, 2026: Placed on Senate Legislative Calendar under General Orders. Calendar No. 528.
Committee: Senate Health, Education, Labor, and Pensions