II 

118TH CONGRESS 

1ST SESSION S. 1128 

To establish special rules relating to information provided with respect to 

drug applications concerning method of use patents. 

IN THE SENATE OF THE UNITED STATES 

MARCH 30, 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 establish special rules relating to information provided 

with respect to drug applications concerning method of 

use patents. 

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 ‘‘Ensuring Access to 

5 Generic Medications Act’’. 


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•S 1128 IS

1 SEC. 2. SPECIAL RULES RELATING TO METHOD OF USE 

2 PATENTS. 

3 Section 505 of the Federal Food, Drug, and Cosmetic 

4 Act (21 U.S.C. 355) is amended by adding at the end the 

5 following: 

6 ‘‘(z) CAUSE OF ACTION RELATING TO DRUG USE

7 CODES.— 

8 ‘‘(1) IN GENERAL.—In the case of an applica9 tion under subsection (b)(2) or (j) of this section or 

10 section 351(k) of the Public Health Service Act with 

11 respect to which the applicant seeking approval in12 cludes in the application a statement that a patent 

13 claiming a method of use does not claim a use for 

14 the drug that is the subject of such application, as 

15 described in subsection (b)(2)(B) or (j)(2)(A)(viii), 

16 or in the case of an application under such section 

17 351(k), as otherwise required by the Secretary, the 

18 sponsor of the application under subsection (b)(2) or 

19 (j) or such section 351(k) described in paragraph (2) 

20 may file a civil action in an appropriate district 

21 court of the United States against the holder of the 

22 approved application for the applicable reference 

23 drug or reference product seeking a court order re24 quiring the holder to correct or delete information 

25 relating to a use code submitted by the holder of the 

26 reference drug or reference product with respect to 


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•S 1128 IS

1 such patent claiming a method of use, on the ground 

2 that such use code— 

3 ‘‘(A) does not correspond to a patent that 

4 claims the reference drug or reference product 

5 for which the application was approved; 

6 ‘‘(B) does not correspond to a patent that 

7 claims an approved method of using the ref8 erence drug or reference product; or 

9 ‘‘(C) is overly broad or otherwise inac10 curate or inappropriate. 

11 ‘‘(2) RULE OF CONSTRUCTION.—Nothing in 

12 this subsection shall be construed to affect the appli13 cation of subsection (j)(5)(C)(ii). 

14 ‘‘(3) DEFINITION.—For purposes of paragraph 

15 (1), the term ‘use code’ means the information relat16 ing to a patent claiming a method of using a drug 

17 that is approved under section 505 of this Act or 

18 under section 351 of the Public Health Service Act, 

19 as applicable, based upon information submitted by 

20 the drug sponsor or holder of the approved applica21 tion or licensure pursuant to section 

22 314.53(c)(2)(ii)(P)(3) of title 21, Code of Federal 

23 Regulations (or any successor regulations).’’. 

Æ 


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