Medication Affordability and Patent Integrity Act

The Medication Affordability and Patent Integrity Act would require drug sponsors and holders of approved drug and biological product applications to disclose certain patent-related information to two agencies: the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO). Specifically, sponsors would certify that information submitted to the USPTO is consistent with what they provided to FDA and with any FDA communications, and they would also submit information material to patentability (such as data supporting FDA approval and statements about prior art) to the USPTO. The bill applies these requirements to new applications filed after enactment (with transitional rules for pre-enactment filings) and would extend to biological products as well. It also creates new enforcement and litigation provisions aimed at ensuring compliance, including a new non-disclosure defense to patent infringement if the patent owner failed to disclose required information, and it preserves trade-secret protections for the disclosed material. In short, the bill strengthens cross-agency information sharing between FDA and USPTO around patent-related disclosures, ties patentability information to the FDA approval process, and introduces legal consequences for non-compliance intended to curb questionable patent practices and promote transparency.