Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act

To amend title 35, United States Code, to clarify and improve the process for subsection (k) applicants to resolve patent infringement claims for biological products (commonly known as the patent dance 1. Short title This Act may be cited as the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act 2. Title 35 amendments (a) In general Section 271(e) of title 35, United States Code, is amended— (1) in paragraph (2)(C), in the flush text following clause (ii), by adding at the end the following: With respect to a submission described in clause (ii), the act of infringement shall extend to any patent that claims the biological product, a method of using the biological product, or a method or product used to manufacture the biological product. (2) by adding at the end the following: (7) (A) Subject to subparagraphs (C), (D), and (E), if the sponsor of an approved application for a reference product, as defined in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) reference product sponsor subsection (k) applicant (B) The patents described in this subparagraph are patents that satisfy each of the following requirements: (i) Patents that claim the biological product that is the subject of an application under section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) (ii) Patents that are included on the list of patents described in section 351(l)(3)(A) of the Public Health Service Act ( 42 U.S.C. 262(l)(3)(A) (iii) Patents that— (I) have an actual filing date of more than 4 years after the date on which the reference product is approved; or (II) include a claim to a method in a manufacturing process that is not used by the reference product sponsor. (C) The court in which an action described in subparagraph (A) is brought may increase the number of patents limited under that subparagraph— (i) if the request to increase that number is made without undue delay; and (ii) (I) if the interest of justice so requires; or (II) for good cause shown, which— (aa) shall be established if the subsection (k) applicant fails to provide information required under section 351(k)(2)(A) of the Public Health Service Act ( 42 U.S.C. 262(k)(2)(A) (bb) may be established— (AA) if there is a material change to the biological product (or process with respect to the biological product) of the subsection (k) applicant that is the subject of the application; (BB) if, with respect to a patent on the supplemental list described in section 351(l)(7)(A) of Public Health Service Act ( 42 U.S.C. 262(l)(7)(A) (CC) for another reason that shows good cause, as determined appropriate by the court. (D) In determining whether good cause has been shown for the purposes of subparagraph (C)(ii)(II), a court may consider whether the reference product sponsor has provided a reasonable description of the identity and relevance of any information beyond the subsection (k) application that the court believes is necessary to enable the court to form a belief with respect to whether a claim of infringement under this section could reasonably be asserted. (E) The limitation imposed under subparagraph (A)— (i) shall apply only if the subsection (k) applicant completes all actions required under paragraphs (2)(A), (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of section 351(l) of the Public Health Service Act ( 42 U.S.C. 262(l) (ii) shall not apply with respect to any patent that claims, with respect to a biological product, a method for using that product in therapy, diagnosis, or prophylaxis, such as an indication or method of treatment or other condition of use. . (b) Applicability The amendments made by subsection (a) shall apply with respect to an application submitted under section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k)

Summary: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act This bill limits in certain instances the number of patents that the manufacturer of a biologic drug can assert in a lawsuit against a company seeking to sell a biosimilar version of that drug. (A biologic drug is produced through natural processes or isolated from natural sources. A biosimilar version is substantially similar to the original biologic, which is the reference product, and is often marketed as a less expensive alternative.) The bill's provisions apply to an existing framework that gives the biosimilar manufacturer an abbreviated path to Food and Drug Administration approval to sell the biosimilar. Specifically, if the biosimilar manufacturer completes certain actions under the framework, such as sharing certain information about its product with the reference product manufacturer, the bill limits the number of certain patents that the reference product manufacturer may assert in a lawsuit, such as patents that were filed more than four years after the reference product received market approval. The limit shall not apply to patents claiming certain methods for using the biologic drug. The court in which the infringement lawsuit is filed may increase the limit if justice so requires or if there is good cause for the increase.