Medication Affordability and Patent Integrity Act

This bill requires drug and biological product application sponsors and approved application holders to certify to the Food and Drug Administration (FDA) that certain patent-related information they submit is complete and consistent with what they provided to the United States Patent and Trademark Office (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 noncompliance.

Sec. 2, Disclosure of information: This section amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to require sponsors and holders of approved applications for drugs and biological products to certify to the FDA that information submitted to the FDA about applicable patents is complete and consistent with information provided to the USPTO and any communications with the USPTO. They must also submit to the USPTO any information material to patentability that they submit to the FDA, and any related communications with the FDA, and certify that this information is complete and consistent with what was provided to the FDA. The requirements apply to original applications submitted on or after the bill's enactment, and to amendments or supplements to such applications. For applications submitted before enactment, the requirements apply to applicable patents issued after enactment, and for patents issued before enactment, only to submissions and communications made after enactment. The FDA may not approve an application if the sponsor fails to comply with the certification requirement.

Sec. 2, Enforcement: This section makes failure to comply with the new disclosure requirements a prohibited act under the Federal Food, Drug, and Cosmetic Act, enabling FDA enforcement. It also creates a new defense in patent infringement actions: a person accused of infringing an applicable patent is entitled to a defense if the patent owner or predecessor negligently or intentionally failed to disclose any information required to be disclosed under the new requirements.