United States 118th Congress Status: In Committee Bipartisan · 1 D · 1 R cosponsors

S 574 — Increasing Prescription Drug Competition Act

Last action — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

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  1. ✓
    Introduced
  2. 2
    In Committee
  3. 3
    Passed Senate
  4. 4
    Passed House
  5. 5
    To Executive
  6. 6
    Enacted

This bill died with 118th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

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.

Bill Text

How this bill changes current law

3 changes Share ↗

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

This bill adds provisions to prevent the use of patents and intellectual property related to risk evaluation and mitigation strategies from inhibiting competition in drug approvals.

  • 21 U.S.C. 355-1

    (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.

    This provision clarifies that patents related to risk evaluation and mitigation strategies do not affect the approval timeline of drug applications.

  • 21 U.S.C. 355-1

    (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.

    This clause limits the remedies available to a sponsor of an approved application in case of infringement of patents or intellectual property related to risk evaluation and mitigation strategies.

  • 21 U.S.C. 355-1

    (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)).

    This part clarifies the implications and limitations regarding the use of patents and intellectual property in the context of risk evaluation and mitigation strategies.

Action History

  1. Introduced in Senate

  2. Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Sponsors

Sponsorship breakdown

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1 sponsors · 1 co-sponsors · 545 not signed on

Sponsors (1)

Co-sponsors (1)

Not signed on (545)

545 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

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Subjects

healthcare health-insurance
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Frequently asked questions

What does S 574 do?
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.
Who sponsors S 574?
S 574 is sponsored by Hassan, Margaret Wood (Democratic) and Braun, Mike (Republican).
What is the current status of S 574?
This bill died with 118th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track S 574?
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