S. 2658 — Medication Affordability and Patent Integrity Act

This section amends the new drug application (NDA) requirements in Section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the biologics license application (BLA) requirements in Section 351(a)(2) of the Public Health Service Act to require sponsors or holders, with respect to applicable patents (i.e., patents or applications claiming the drug or biologic, including formulations, methods of use, or manufacturing methods, that are issued, assigned, or licensed to the sponsor or holder), to (1) certify to the Food and Drug Administration (FDA) that material-to-patentability information (e.g., chemistry, manufacturing, and controls analytical data statements, prior art characterizations) submitted to FDA is consistent with information provided to the United States Patent and Trademark Office (USPTO) and related communications; and (2) submit such FDA information and communications to USPTO, certifying to USPTO that the submission is complete and consistent with FDA submissions and communications. It further requires these certifications to be included in NDA content-of-application requirements and directs USPTO to protect submitted FDA information as confidential, as if held by FDA. (Thus, the changes apply to original NDAs or BLAs submitted on or after enactment and, for prior submissions, to applicable patents issued on or after enactment or to post-enactment submissions and communications.)