S.2658

Medication Affordability and Patent Integrity Act requires drug application sponsors to disclose certain information to the FDA and USPTO.

The Medication Affordability and Patent Integrity Act mandates that sponsors of drug applications and holders of approved applications must submit specific information to both the Food and Drug Administration (FDA) and the United States Patent and Trademark Office (USPTO). This includes any material information related to patentability, such as analytical data, statements, or characterizations of prior art. The bill also establishes a defense against patent infringement actions if the patent owner failed to disclose required information.