REMEDY Act

II 116TH CONGRESS 1ST SESSION S. 1209 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 APRIL 11, 2019 Mr. CASSIDY (for himself and Mr. DURBIN) introduced the following bill; which was read twice and referred to the Committee on Health, Edu- cation, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Reforming 4 Evergreening and Manipulation that Extends Drug Years 5 Act’’ or the ‘‘REMEDY Act’’. 6 SEC. 2. AMENDMENTS TO ANDA APPROVAL PROVISION. 7 (a) IN GENERAL.—Section 505 of the Federal Food, 8 Drug, and Cosmetic Act (21 U.S.C. 355) is amended— 9 VerDate Sep 11 2014 03:14 Apr 23, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1209.IS S1209 kjohnson on DSK79L0C42 with BILLS 2 •S 1209 IS (1) in subsection (c)(3)(C), by inserting ‘‘in the 1 case of a certification with respect to a patent that 2 claims a drug substance (and not in the case of a 3 certification with respect to a patent that claims a 4 drug product or method of use for a drug, except 5 that, in the case of a patent that claims a drug sub- 6 stance and a drug product or method of use, this 7 subparagraph shall apply, but only to the extent the 8 patent claims a drug substance),’’ after ‘‘imme- 9 diately unless,’’; and 10 (2) in subsection (j)(5)(B)(iii), by inserting ‘‘in 11 the case of a certification with respect to a patent 12 that claims a drug substance (and not in the case 13 of a certification with respect to a patent that claims 14 a drug product or method of use for a drug, except 15 that, in the case of a patent that claims a drug sub- 16 stance and a drug product or method of use, this 17 clause shall apply, but only to the extent the patent 18 claims a drug substance),’’ after ‘‘immediately un- 19 less,’’. 20 (b) ORANGE BOOK UPDATES WITH RESPECT TO IN- 21 VALIDATED PATENTS.— 22 (1) IN GENERAL.—Section 505(j)(7)(A) of the 23 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 24 VerDate Sep 11 2014 03:14 Apr 23, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1209.IS S1209 kjohnson on DSK79L0C42 with BILLS 3 •S 1209 IS 355(j)(7)(A)) is amended by adding at the end the 1 following: 2 ‘‘(iv) In the case of a listed drug for which the 3 list under clause (i) includes a patent that claims the 4 drug or a use for such drug, and where the Under 5 Secretary of Commerce for Intellectual Property and 6 Director of the United States Patent and Trade- 7 mark Office has cancelled any claim of the patent 8 relating to such drug or such use pursuant to a de- 9 termination by the Patent Trial and Appeal Board 10 in an inter partes review conducted under chapter 11 31 of title 35, United States Code, or a post-grant 12 review conducted under chapter 32 of that title, and 13 any such cancellation, if appealed, has been upheld 14 upon appeal, the holder of the applicable approved 15 application shall notify the Secretary of such can- 16 cellation, and the revisions required under clause 17 (iii) shall include striking the patent from the list 18 with respect to such drug.’’. 19 (2) NO EFFECT ON FIRST APPLICANT EXCLU- 20 SIVITY PERIOD.—Section 505(j)(5)(B)(iv)(I) is 21 amended by adding at the end the following: ‘‘This 22 subclause shall apply even if a patent is stricken 23 from the list under paragraph (7)(A), pursuant to 24 the second sentence of clause (iii) of such paragraph, 25 VerDate Sep 11 2014 03:14 Apr 23, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1209.IS S1209 kjohnson on DSK79L0C42 with BILLS 4 •S 1209 IS provided that, at the time that the first applicant 1 submitted an application under this subsection con- 2 taining a certification described in paragraph 3 (2)(A)(vii)(IV), the patent that was the subject of 4 such certification was included in such list with re- 5 spect to the listed drug.’’. 6 Æ VerDate Sep 11 2014 03:14 Apr 23, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\S1209.IS S1209 kjohnson on DSK79L0C42 with BILLS