S. 1041 — Affordable Prescriptions for Patients Act

This section amends the patent infringement safe harbor for biological products (35 U.S.C. 271(e)) by (1) expanding the scope of infringement, with respect to certain submissions under the biologics license pathway, to include any patent claiming the biological product, a method of using the product, or a method or product used to manufacture the product; and (2) limiting a reference product sponsor to asserting no more than 20 qualifying patents against an applicant seeking biosimilar approval under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)), no more than 10 of which may have issued after the date specified in section 351(l)(7)(A) of such Act (i.e., the supplemental patent list deadline). Qualifying patents must claim the biosimilar product (or its use), or a manufacturing method or product; be included on the patent lists under section 351(l)(3)(A) or (7); and either have an actual filing date more than four years after reference product approval or claim a manufacturing process method not used by the reference sponsor. Courts may increase the patent limit for good cause (e.g., biosimilar applicant's failure to provide required information, material product changes, or patent issuance delays) or in the interest of justice, provided the request is timely; the limit applies only if the applicant completes specified steps in the BPCIA patent resolution process (i.e., the "patent dance") and excludes patents claiming therapeutic, diagnostic, or prophylactic methods of use. The amendments apply to section 351(k) applications submitted on or after enactment.