Medication Affordability and Patent Integrity Act

This legislation aims to enhance transparency and consistency in information sharing between drug manufacturers, the Food and Drug Administration (FDA), and the United States Patent and Trademark Office (USPTO). It amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to require sponsors of drug and biological product applications, or holders of approved applications, to make specific disclosures. Manufacturers must certify to the FDA that information submitted to the FDA regarding an applicable patent is consistent with what they provided to the USPTO. Concurrently, they must submit to the USPTO any information material to patentability that was shared with the FDA, along with any FDA responses, and certify that this submission is complete and consistent with FDA communications. Information material to patentability includes analytical data from chemistry, manufacturing, and controls sections, as well as statements or characterizations related to the patent or prior art. An "applicable patent" covers patents claiming the drug or biological product, including those for formulation, method of use, or manufacturing, and related patent applications. The bill applies to new applications and, for existing applications, to patents issued or submissions/communications made after the enactment date. To ensure protection, the USPTO is directed to update its regulations to safeguard trade secret or confidential information submitted under these new requirements. Non-compliance with these disclosure and certification mandates constitutes a prohibited act enforceable by the FDA . Furthermore, the bill establishes a new defense against patent infringement actions, allowing an alleged infringer to claim a defense if the patent owner negligently or intentionally failed to provide the required information to the FDA or USPTO.