Medication Affordability and Patent Integrity Act

The Medication Affordability and Patent Integrity Act would establish new transparency requirements for pharmaceutical and biological product manufacturers. Under this bill, drug companies would be required to certify that information they submit to the Food and Drug Administration (FDA) is consistent with information they provide to the U.S. Patent and Trademark Office (USPTO), and vice versa. Specifically, manufacturers would need to disclose all information material to patentability, including analytical data, patent characterizations, and prior art information.

The bill aims to address a practice where drug manufacturers strategically withhold information from patent applications that they have submitted to the FDA. By submitting partial information to the patent office while providing complete information to the FDA, companies can potentially extend the period during which a drug is protected from generic competition, delaying lower-cost alternatives. The legislation would also create a new legal defense for generic and biosimilar manufacturers in patent infringement cases if a patent holder fails to comply with these disclosure requirements.