I 

116TH CONGRESS 

1ST SESSION H. R. 3812 

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

of abbreviated new drug applications. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 17, 2019 

Mr. MCKINLEY (for himself and Mr. WELCH) 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 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 Evergreen5 ing and Manipulation that Extends Drug Years Act’’ or 

6 the ‘‘REMEDY Act’’. 

7 SEC. 2. AMENDMENTS TO ANDA APPROVAL PROVISION. 

8 (a) IN GENERAL.—Section 505 of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 355) is amended— 


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1 (1) in subsection (c)(3)(C), by inserting ‘‘in the 

2 case of a certification with respect to a patent that 

3 claims a drug substance (and not in the case of a 

4 certification with respect to a patent that claims a 

5 drug product or method of use for a drug, except 

6 that, in the case of a patent that claims a drug sub7 stance and a drug product or method of use, this 

8 subparagraph shall apply, but only to the extent the 

9 patent claims a drug substance),’’ after ‘‘imme10 diately unless,’’; and 

11 (2) in subsection (j)(5)(B)(iii), by inserting ‘‘in 

12 the case of a certification with respect to a patent 

13 that claims a drug substance (and not in the case 

14 of a certification with respect to a patent that claims 

15 a drug product or method of use for a drug, except 

16 that, in the case of a patent that claims a drug sub17 stance and a drug product or method of use, this 

18 clause shall apply, but only to the extent the patent 

19 claims a drug substance),’’ after ‘‘immediately un20 less,’’. 

21 (b) ORANGE BOOK UPDATES WITH RESPECT TO IN22 VALIDATED PATENTS.— 

23 (1) IN GENERAL.—Section 505(j)(7)(A) of the 

24 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 


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1 355(j)(7)(A)) is amended by adding at the end the 

2 following: 

3 ‘‘(iv) In the case of a listed drug for which the 

4 list under clause (i) includes a patent that claims the 

5 drug or a use for such drug, and where the Under 

6 Secretary of Commerce for Intellectual Property and 

7 Director of the United States Patent and Trade8 mark Office has cancelled any claim of the patent 

9 relating to such drug or such use pursuant to a de10 termination by the Patent Trial and Appeal Board 

11 in an inter partes review conducted under chapter 

12 31 of title 35, United States Code, or a post-grant 

13 review conducted under chapter 32 of that title, and 

14 any such cancellation, if appealed, has been upheld 

15 upon appeal, the holder of the applicable approved 

16 application shall notify the Secretary of such can17 cellation, and the revisions required under clause 

18 (iii) shall include striking the patent from the list 

19 with respect to such drug.’’. 

20 (2) NO EFFECT ON FIRST APPLICANT EXCLU21 SIVITY PERIOD.—Section 505(j)(5)(B)(iv)(I) is 

22 amended by adding at the end the following: ‘‘This 

23 subclause shall apply even if a patent is stricken 

24 from the list under paragraph (7)(A), pursuant to 

25 the second sentence of clause (iii) of such paragraph, 


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1 provided that, at the time that the first applicant 

2 submitted an application under this subsection con3 taining a certification described in paragraph 

4 (2)(A)(vii)(IV), the patent that was the subject of 

5 such certification was included in such list with re6 spect to the listed drug.’’. 

Æ 


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