Medication Affordability and Patent Integrity Act

This bill requires drug and biological product sponsors and application holders to certify to the FDA that information they submit about applicable patents is complete and consistent with what they provided to the USPTO, and to submit to the USPTO any information material to patentability that they submit to the FDA, along with related communications, and certify its completeness and consistency. It also creates enforcement mechanisms for non-compliance.

Sec. 2, Disclosure of information: For drug applications under the Federal Food, Drug, and Cosmetic Act, sponsors or holders must certify to the FDA that information on applicable patents is complete and consistent with USPTO submissions and communications, and submit to the USPTO any information material to patentability that they submit to the FDA, along with related communications, and certify its completeness and consistency. The same requirements apply to biological product applications under the Public Health Service Act. The FDA may not approve an application if the sponsor fails to comply with these certification requirements. These requirements apply to original applications submitted on or after the bill's enactment, and to patents issued on or after that date for earlier applications.

Sec. 3, Enforcement: Failure to comply with the new disclosure requirements is a prohibited act under the Federal Food, Drug, and Cosmetic Act. In patent infringement actions, a person may assert a defense if the patent owner or predecessor negligently or intentionally failed to disclose required information.