Title: Increasing Prescription Drug Competition Act
Policy area: Health

Summary:
Increasing Prescription Drug Competition Act
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.)
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).
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.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4918 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  2d Session
                                S. 4918

 To amend the Federal Food, Drug, and Cosmetic Act to prohibit the use 
 of patents, trade secrets, or other intellectual property to inhibit 
                              competition.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 22, 2022

 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 prohibit the use 
 of patents, trade secrets, or other intellectual property to inhibit 
                              competition.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Increasing Prescription Drug 
Competition Act''.

SEC. 2. PROHIBITING 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) Agreement not to seek 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)).''.
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