Increasing Prescription Drug Competition Act

Bill: 118-s-574
Sponsor: full_name: Sen. Hassan, Margaret Wood [D-NH]
Introduced: 2023-03-01
Policy area: Health
Subjects: Civil actions and liability

Drug safety, medical device, and laboratory regulation

Prescription drugs
Latest action: action_date: 2023-03-01
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2023-03-01
action_desc: Introduced in Senate
text: <p><b>Increasing Prescription Drug Competition Act</b></p> <p>This bill provides that certifications in generic drug applications of certain patents involved in Risk Evaluation and Mitigation Strategy (REMS) programs have no effect upon the drug's approval. (The Food and Drug Administration sometimes requires a REMS program for certain drugs with safety risks, which may include restrictions on a drug's distribution through elements to ensure safe use (ETASU), such as special requirements for pharmacies that dispense the drug.)</p> <p>Specifically, certifications in generic drug applications with respect to patents that involve an ETASU for REMS requirements have no effect on the effective date of the drug's approval, notwithstanding any other provisions that allow for a stay of approval pending litigation outcomes (i.e., 30-month stay). </p> <p>The bill also specifies that in a civil action alleging patent infringement with respect to REMS requirements, the sponsor of the approved brand-name drug may only seek damages from (rather than an injunction against) the generic drug applicant.</p>

tv_txt: 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) ). .