II 

118TH CONGRESS 

2D SESSION S. 4878 

To amend the Federal Food, Drug, and Cosmetic Act with respect to approval 

of abbreviated new drug applications. 

IN THE SENATE OF THE UNITED STATES 

JULY 31, 2024 

Mr. DURBIN (for himself and Mr. CASSIDY) 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 with 

respect to approval of abbreviated new drug applications. 

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 ‘‘Reforming 

5 Evergreening and Manipulation that Extends Drug Years 

6 Act’’ or the ‘‘REMEDY Act’’. 

7 SEC. 2. AMENDMENTS TO ANDA APPROVAL PROVISIONS. 

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

9 Act (21 U.S.C. 355) is amended— 


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1 (1) in subsection (c)(2) by adding at the end 

2 the following: ‘‘With respect to a drug approved on 

3 or after the date of enactment of the Reforming 

4 Evergreening and Manipulation that Extends Drug 

5 Years Act, when a holder of an approved application 

6 first files information under this paragraph with re7 spect to one or more patents described in subsection 

8 (b)(1)(A)(viii), the holder shall select one such pat9 ent with respect to which the owner or licensee may 

10 receive the 30-month stay under paragraph (3)(C), 

11 as applicable; for purposes of paragraphs (3)(C) and 

12 (3)(E) and subsections (j)(5)(D)(iii) and 

13 (j)(5)(F)(ii), such patent shall be referred to as the 

14 ‘covered patent’. The selection of such covered pat15 ent may not be changed or amended.’’; 

16 (2) in subsection (c)(3)(C)— 

17 (A) in the matter preceding clause (i)— 

18 (i) by striking ‘‘an action is brought 

19 for infringement’’ and all that follows 

20 through the period at the end of the first 

21 sentence and inserting ‘‘with respect to a 

22 drug approved under this subsection before 

23 the date of enactment of the Reforming 

24 Evergreening and Manipulation that Ex25 tends Drug Years Act, an action is 


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1 brought for infringement of any patent 

2 that is the subject of the certification and 

3 for which information was submitted to the 

4 Secretary under paragraph (2) or sub5 section (b)(1) before the date on which the 

6 application (excluding an amendment or 

7 supplement to the application) was sub8 mitted, or, with respect to a drug approved 

9 under this subsection on or after the date 

10 of enactment of the Reforming 

11 Evergreening and Manipulation that Ex12 tends Drug Years Act, an action is 

13 brought for infringement of the covered 

14 patent (as described in paragraph (2)), be15 fore the date on which the application (ex16 cluding an amendment or supplement to 

17 the application) was submitted.’’; and 

18 (ii) by striking ‘‘an action is brought 

19 before’’ and inserting ‘‘an action with re20 spect to a patent or a covered patent, as 

21 applicable, is brought before’’; and 

22 (B) in clause (i), by striking ‘‘decides that 

23 the patent’’ and inserting ‘‘decides that the pat24 ent or the covered patent, as applicable’’; 


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1 (3) in the second sentence of subsection 

2 (c)(3)(E)(ii), by inserting ‘‘with respect to any pat3 ent that claims a drug that was approved under this 

4 subsection before the date of enactment of the Re5 forming Evergreening and Manipulation that Ex6 tends Drug Years Act, or, with respect to a covered 

7 patent (as described in paragraph (2)) that claims a 

8 drug approved under this subsection on or after the 

9 date of enactment of such Act,’’ after ‘‘action for 

10 patent infringement’’; 

11 (4) in subsection (j)(5)(B)(iii)— 

12 (A) in the matter preceding subclause 

13 (I)— 

14 (i) by striking ‘‘an action is brought 

15 for infringement’’ and all that follows 

16 through the period at the end of the first 

17 sentence and inserting ‘‘with respect to a 

18 drug approved under subsection (c) before 

19 the date of enactment of the Reforming 

20 Evergreening and Manipulation that Ex21 tends Drug Years Act, an action is 

22 brought for infringement of any patent 

23 that is the subject of the certification and 

24 for which information was submitted to the 

25 Secretary under subsection (b)(1) or (c)(2) 


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1 before the date on which the application 

2 (excluding an amendment or supplement to 

3 the application), which the Secretary later 

4 determines to be substantially complete, 

5 was submitted, or, with respect to a drug 

6 approved under subsection (c) on or after 

7 the date of enactment of the Reforming 

8 Evergreening and Manipulation that Ex9 tends Drug Years Act, an action is 

10 brought for infringement of the covered 

11 patent (as described in subsection (c)(2)) 

12 before the date on which the application 

13 (excluding an amendment or supplement to 

14 the application), which the Secretary later 

15 determines to be substantially complete, 

16 was submitted.’’; and 

17 (ii) by striking ‘‘an action is brought 

18 before’’ and inserting ‘‘an action with re19 spect to a patent or a covered patent, as 

20 applicable, is brought before’’; and 

21 (B) in subclause (I), by striking ‘‘decides 

22 that the patent’’ and inserting ‘‘decides that the 

23 patent or covered patent, as applicable,’’; and 

24 (5) in the second sentence of subsection 

25 (j)(5)(F)(ii), by inserting ‘‘with respect to any patVerDate Sep 11 2014 02:27 Aug 29, 2024 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S4878.IS S4878

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1 ent that claims a drug that was approved under sub2 section (c) before the date of enactment of the Re3 forming Evergreening and Manipulation that Ex4 tends Drug Years Act, or, with respect to a covered 

5 patent (as described in subsection (c)(2)) that claims 

6 a drug approved under subsection (c) on or after the 

7 date of enactment of such Act,’’ after ‘‘action for 

8 patent infringement’’. 

Æ 


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