Medication Affordability and Patent Integrity Act

S 2780, the Medication Affordability and Patent Integrity Act, requires drug and biologic manufacturers to certify to both the FDA and U.S. Patent and Trademark Office (USPTO) that patent information submitted to the FDA matches what was provided to the USPTO. This applies to sponsors of new drug applications (under FD&C Act §505) and biological product licenses (under PHS Act §351), directly affecting pharmaceutical companies seeking FDA approval. The key mechanism mandates that manufacturers submit patent-related information to the USPTO when sharing it with the FDA and certify its consistency between agencies. If manufacturers fail to disclose required patent information, the FDA may deny approval, and generic manufacturers can use this non-disclosure as a defense in patent infringement lawsuits. The bill aims to improve transparency in drug patent processes without directly altering drug pricing or approval standards.