I 
118TH CONGRESS 
1ST SESSION H. R. 4692 
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 HOUSE OF REPRESENTATIVES 
JULY 17, 2023 
Ms. SLOTKIN introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
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-
tives 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’’. 
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SEC. 2. PREVENTING THE USE OF PATENTS, TRADE SE-
CRETS, OR OTHER INTELLECTUAL PROPERTY 
ON 
RISK 
EVALUATION 
AND 
MITIGATION 
STRATEGIES TO INHIBIT COMPETITION. 
Section 505–1 of the Federal Food, Drug, and Cos-
metic 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 applica-
tion under subsection (b)(2) or (j) of section 505 in-
cludes 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 re-
quirements 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 sec-
tion 505(c)(3) and clauses (ii) and (iii) of section 
505(j)(5)(B). 
‘‘(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 in-
fringes a patent, trade secret, or any other intellec-
tual property held by the sponsor or holder to com-
ply with risk evaluation and mitigation strategy re-
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quirements under this section, the sponsor or holder 
of the approved application shall not seek, or claim 
entitlement to, any remedy other than damages aris-
ing 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 spon-
sor 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 de-
scribed in this subsection; 
‘‘(B) preventing a sponsor of an applica-
tion under section 505 of this Act or section 
351 of the Public Health Service Act from 
using a different, comparable aspect of the ele-
ments 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 provi-
sion of the antitrust laws (as defined in sub-
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