What This Bill Does
This bill amends federal drug law to prevent companies from using patents, trade secrets, and other intellectual property to block competition in prescription drugs. The bill specifically addresses patents related to risk evaluation and mitigation strategies, which are safety requirements the government puts on certain medications.
Who It Affects
Drug companies that make brand-name medications and companies that want to make generic versions (cheaper copies) of those medications.
Key Provisions
• Patents about safety requirements for a drug cannot delay approval of a competing generic drug application (Sec. 2(n)(1))
• If a generic drug maker infringes on a patent while following required safety procedures, the original drug company can only seek money damages (financial compensation), not other legal remedies like stopping the generic drug from being sold (Sec. 2(n)(2))
• The rule applies to all drug applications submitted before, on, or after the law passes (Sec. 2(n)(1))
• Generic drug makers can use different but comparable safety approaches than the original drug's patented method (Sec. 2(n)(3)(B))
• This law does not change existing antitrust laws, which prevent unfair competition practices (Sec. 2(n)(3)(D))
What Changes
If this becomes law, patents about drug safety procedures will no longer be able to delay approval of generic medications. Companies will be limited to collecting money damages if a patent is broken during the safety approval process.
Important Definitions
• Risk evaluation and mitigation strategy: safety requirements and monitoring procedures that the government requires for certain high-risk medications
• Intellectual property: legal ownership of inventions, trade secrets, and other proprietary information
Effective Date
Not specified in bill text
II
118TH CONGRESS
1ST SESSION
S. 574
To amend the Federal Food, Drug, and Cosmetic Act to prevent the use
of patents, trade secrets, or other intellectual property to inhibit competition.
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 intel-
lectual property to inhibit competition.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE.
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This Act may be cited as the ‘‘Increasing Prescription
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Drug Competition Act’’.
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•S 574 IS
SEC. 2. PREVENTING THE USE OF PATENTS, TRADE SE-
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CRETS, OR OTHER INTELLECTUAL PROPERTY
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ON
RISK
EVALUATION
AND
MITIGATION
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STRATEGIES TO INHIBIT COMPETITION.
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Section 505–1 of the Federal Food, Drug, and Cos-
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metic Act (21 U.S.C. 355–1) is amended by adding at the
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end the following:
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‘‘(n) ADDITIONAL REQUIREMENTS.—
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‘‘(1) PATENTS CLAIMING REMS.—If an applica-
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tion under subsection (b)(2) or (j) of section 505 in-
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cludes a certification under subsection (b)(2)(A) or
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(j)(2)(A)(vii) of section 505 with respect to a patent
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that claims an aspect of the elements to assure safe
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use of a risk evaluation and mitigation strategy re-
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quirements under subsection (f) for the applicable
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listed drug, such certification shall have no effect on
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the effective date of the approval of the application,
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notwithstanding subparagraphs (B) and (C) of sec-
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tion 505(c)(3) and clauses (ii) and (iii) of section
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505(j)(5)(B). This paragraph shall apply to all ap-
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plications submitted to the Secretary under sub-
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section (b)(2) or (j) of section 505 before, on, or
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after the date of enactment of the Increasing Pre-
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scription Drug Competition Act.
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‘‘(2) DAMAGES.—In the event that the sponsor
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of another application under section 505 of this Act
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•S 574 IS
or section 351 of the Public Health Service Act in-
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fringes a patent, trade secret, or any other intellec-
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tual property held by the sponsor or holder to com-
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ply with risk evaluation and mitigation strategy re-
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quirements under this section, the sponsor or holder
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of the approved application shall not seek, or claim
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entitlement to, any remedy other than damages aris-
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ing from the infringement.
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‘‘(3) CLARIFICATIONS.—Nothing in this section
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shall be construed as—
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‘‘(A) prohibiting the sponsor or holder of
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an approved application from allowing the spon-
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sor of another application under section 505 of
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this Act or section 351 of the Public Health
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Service Act to use the patent, trade secret, or
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any other intellectual property other than as de-
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scribed in this subsection;
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‘‘(B) preventing a sponsor of an applica-
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tion under section 505 of this Act or section
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351 of the Public Health Service Act from
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using a different, comparable aspect of the ele-
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ments to assure safe use as authorized under
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this section;
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‘‘(C) in any way negating the applicability
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of a risk evaluation and mitigation strategy
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•S 574 IS
with elements to assure safe use, as otherwise
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required under this section; or
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‘‘(D) limiting the application of any provi-
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sion of the antitrust laws (as defined in sub-
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section (a) of the first section of the Clayton
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Act (15 U.S.C. 12(a)).’’.
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Æ
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