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 intellectual property to inhibit competition. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Increasing Prescription 

5 Drug Competition Act’’. 


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1 SEC. 2. PREVENTING THE USE OF PATENTS, TRADE SE2 CRETS, OR OTHER INTELLECTUAL PROPERTY 

3 ON RISK EVALUATION AND MITIGATION 

4 STRATEGIES TO INHIBIT COMPETITION. 

5 Section 505–1 of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 355–1) is amended by adding at the 

7 end the following: 

8 ‘‘(n) ADDITIONAL REQUIREMENTS.— 

9 ‘‘(1) PATENTS CLAIMING REMS.—If an applica10 tion under subsection (b)(2) or (j) of section 505 in11 cludes a certification under subsection (b)(2)(A) or 

12 (j)(2)(A)(vii) of section 505 with respect to a patent 

13 that claims an aspect of the elements to assure safe 

14 use of a risk evaluation and mitigation strategy re15 quirements under subsection (f) for the applicable 

16 listed drug, such certification shall have no effect on 

17 the effective date of the approval of the application, 

18 notwithstanding subparagraphs (B) and (C) of sec19 tion 505(c)(3) and clauses (ii) and (iii) of section 

20 505(j)(5)(B). This paragraph shall apply to all ap21 plications submitted to the Secretary under sub22 section (b)(2) or (j) of section 505 before, on, or 

23 after the date of enactment of the Increasing Pre24 scription Drug Competition Act. 

25 ‘‘(2) DAMAGES.—In the event that the sponsor 

26 of another application under section 505 of this Act 


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1 or section 351 of the Public Health Service Act in2 fringes a patent, trade secret, or any other intellec3 tual property held by the sponsor or holder to com4 ply with risk evaluation and mitigation strategy re5 quirements under this section, the sponsor or holder 

6 of the approved application shall not seek, or claim 

7 entitlement to, any remedy other than damages aris8 ing from the infringement. 

9 ‘‘(3) CLARIFICATIONS.—Nothing in this section 

10 shall be construed as— 

11 ‘‘(A) prohibiting the sponsor or holder of 

12 an approved application from allowing the spon13 sor of another application under section 505 of 

14 this Act or section 351 of the Public Health 

15 Service Act to use the patent, trade secret, or 

16 any other intellectual property other than as de17 scribed in this subsection; 

18 ‘‘(B) preventing a sponsor of an applica19 tion under section 505 of this Act or section 

20 351 of the Public Health Service Act from 

21 using a different, comparable aspect of the ele22 ments to assure safe use as authorized under 

23 this section; 

24 ‘‘(C) in any way negating the applicability 

25 of a risk evaluation and mitigation strategy 


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1 with elements to assure safe use, as otherwise 

2 required under this section; or 

3 ‘‘(D) limiting the application of any provi4 sion of the antitrust laws (as defined in sub5 section (a) of the first section of the Clayton 

6 Act (15 U.S.C. 12(a)).’’. 

Æ 


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