Increasing Prescription Drug Competition Act

118 S574 IS: Increasing Prescription Drug Competition Act U.S. Senate 2023-03-01 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. II 118th CONGRESS 1st Session S. 574 IN THE SENATE OF THE UNITED STATES March 1, 2023 Ms. Hassan (for herself and Mr. Braun ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act to prevent the use of patents, trade secrets, or other intellectual property to inhibit competition. 1. Short title This Act may be cited as the Increasing Prescription Drug Competition Act . 2. Preventing the use of patents, trade secrets, or other intellectual property on risk evaluation and mitigation strategies to inhibit competition Section 505–1 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1 ) is amended by adding at the end the following: (n) Additional requirements (1) Patents claiming REMS If an application under subsection (b)(2) or (j) of section 505 includes a certification under subsection (b)(2)(A) or (j)(2)(A)(vii) of section 505 with respect to a patent that claims an aspect of the elements to assure safe use of a risk evaluation and mitigation strategy requirements under subsection (f) for the applicable listed drug, such certification shall have no effect on the effective date of the approval of the application, notwithstanding subparagraphs (B) and (C) of section 505(c)(3) and clauses (ii) and (iii) of section 505(j)(5)(B). This paragraph shall apply to all applications submitted to the Secretary under subsection (b)(2) or (j) of section 505 before, on, or after the date of enactment of the Increasing Prescription Drug Competition Act . (2) Damages In the event that the sponsor of another application under section 505 of this Act or section 351 of the Public Health Service Act infringes a patent, trade secret, or any other intellectual property held by the sponsor or holder to comply with risk evaluation and mitigation strategy requirements under this section, the sponsor or holder of the approved application shall not seek, or claim entitlement to, any remedy other than damages arising from the infringement. (3) Clarifications Nothing in this section shall be construed as— (A) prohibiting the sponsor or holder of an approved application from allowing the sponsor of another application under section 505 of this Act or section 351 of the Public Health Service Act to use the patent, trade secret, or any other intellectual property other than as described in this subsection; (B) preventing a sponsor of an application under section 505 of this Act or section 351 of the Public Health Service Act from using a different, comparable aspect of the elements to assure safe use as authorized under this section; (C) in any way negating the applicability of a risk evaluation and mitigation strategy with elements to assure safe use, as otherwise required under this section; or (D) limiting the application of any provision of the antitrust laws (as defined in subsection (a) of the first section of the Clayton Act ( 15 U.S.C. 12(a) ). .