Bill > S2658

This bill introduces new transparency requirements for drug and biological product manufacturers when interacting with the Food and Drug Administration (FDA) and the United States Patent and Trademark Office (USPTO). Under the Medication Affordability and Patent Integrity Act, drug and biological product application sponsors must now certify that information they submit to the FDA is consistent with information they have provided to the USPTO, and vice versa. Specifically, they must disclose all information material to patentability, including statements about analytical data, patent characterizations, and prior art. The bill applies to both new drug applications and existing applications, with slightly different implementation timelines. Importantly, the legislation also creates a new legal defense against patent infringement: if a patent owner fails to disclose required information, the defendant can use this non-disclosure as a defense in court. The bill aims to increase transparency and prevent potential inconsistencies in patent and drug approval processes by requiring cross-agency information sharing and certification, while maintaining protections for confidential and trade secret information.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/2658/all-info