Expanding Access to Low-Cost Generics Act of 2019

II 116TH CONGRESS 1ST SESSION S. 3092 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes. IN THE SENATE OF THE UNITED STATES DECEMBER 18, 2019 Ms. SMITH (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 with respect to the 180-day exclusivity period, and for other purposes. 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 ‘‘Expanding Access to 4 Low-Cost Generics Act of 2019’’. 5 SEC. 2. 180-DAY EXCLUSIVITY PERIOD. 6 (a) IN GENERAL.—Section 505(j)(5)(B)(iv) of the 7 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 8 355(j)(5)(B)(iv)) is amended— 9 VerDate Sep 11 2014 22:46 Dec 21, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3092.IS S3092 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 3092 IS (1) in subclause (I), by striking ‘‘effective on 1 the date that is 180 days after’’ and all that follows 2 through the period at the end and inserting the fol- 3 lowing: ‘‘effective— 4 ‘‘(aa) except as provided in item (bb), 5 on the date that is 180 days after the date 6 of the first commercial marketing of the 7 drug (including the commercial marketing 8 of the listed drug) by any first applicant; 9 or 10 ‘‘(bb) if, in an infringement action 11 brought in a district court solely against 12 the applicant for the application described 13 in this subclause (or any affiliate of the 14 applicant), or an action in a district court 15 for a declaratory judgment brought by that 16 applicant, with respect to each patent to 17 which a first applicant had submitted and 18 lawfully maintained a certification under 19 paragraph (2)(A)(vii)(IV), the district 20 court decides that each patent is invalid or 21 not infringed (including any substantive 22 determination that there is no cause of ac- 23 tion for patent infringement or invalidity), 24 and the applicant for the application de- 25 VerDate Sep 11 2014 22:46 Dec 21, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3092.IS S3092 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 3092 IS scribed in this subclause meets the require- 1 ments under subclause (III), immediately 2 upon the district court entering such deci- 3 sion for such applicant.’’; and 4 (2) by adding at the end the following: 5 ‘‘(III) APPLICANT REQUIREMENTS.—The 6 requirements under this subclause are that the 7 applicant for the application described in sub- 8 clause (I)— 9 ‘‘(aa) does not stay the action de- 10 scribed in item (bb) of such subclause; 11 ‘‘(bb) does not agree to be bound by 12 a judgment as to another applicant; and 13 ‘‘(cc) does not request joinder under 14 section 42.122 of title 37, Code of Federal 15 Regulations (or any corresponding similar 16 regulation or ruling), for any petition that 17 the applicant may have filed with respect 18 to the application.’’. 19 (b) APPLICABILITY.—The amendments made by sub- 20 section (a) shall apply only with respect to an application 21 filed under section 505(j) of the Federal Food, Drug, and 22 Cosmetic Act (21 U.S.C. 355(j)) after the date of enact- 23 ment of this Act that identifies a listed drug for which 24 VerDate Sep 11 2014 22:46 Dec 21, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3092.IS S3092 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 3092 IS no certification under paragraph (2)(A)(vii)(IV) of such 1 section was made before such date of enactment. 2 Æ VerDate Sep 11 2014 22:46 Dec 21, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\S3092.IS S3092 pamtmann on DSKBC07HB2PROD with BILLS