Hatch-Waxman Integrity Act of 2019

II 116TH CONGRESS 1ST SESSION S. 344 To amend the Federal Food, Drug, and Cosmetic Act and the Securities Exchange Act of 1934 to prevent the inter partes review process for challenging patents from diminishing competition in the pharmaceutical industry and with respect to drug innovation, and for other purposes. IN THE SENATE OF THE UNITED STATES FEBRUARY 6, 2019 Mr. TILLIS 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 and the Securities Exchange Act of 1934 to prevent the inter partes review process for challenging patents from diminishing competition in the pharmaceutical industry and with respect to drug innovation, and for other pur- poses. 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 ‘‘Hatch-Waxman Integ- 4 rity Act of 2019’’. 5 VerDate Sep 11 2014 21:43 Feb 13, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S344.IS S344 pamtmann on DSKBFK8HB2PROD with BILLS 2 •S 344 IS SEC. 2. PREVENTING THE INTER PARTES REVIEW PROCESS 1 FOR CHALLENGING PATENTS FROM DIMIN- 2 ISHING COMPETITION IN THE PHARMA- 3 CEUTICAL INDUSTRY AND WITH RESPECT TO 4 DRUG INNOVATION. 5 (a) BRAND NAME DRUGS.—Section 505(b)(2) of the 6 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 7 355(b)(2)) is amended— 8 (1) in subparagraph (A)(iv), by striking ‘‘and’’ 9 at the end; 10 (2) in subparagraph (B), by striking the period 11 at the end and inserting ‘‘; and’’; and 12 (3) by adding at the end the following: 13 ‘‘(C) in each certification required under sub- 14 paragraph (A) with respect to a patent, a certifi- 15 cation that— 16 ‘‘(i) neither the applicant nor any party in 17 privity with, related to, or cooperating with the 18 applicant has filed, or will file, a petition to in- 19 stitute an inter partes review or a post-grant 20 review of that patent under chapter 31 or 32, 21 respectively, of title 35, United States Code; 22 and 23 ‘‘(ii) in making the certification required 24 under subparagraph (A), the applicant is not 25 relying in whole or in part on any decision 26 VerDate Sep 11 2014 21:43 Feb 13, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S344.IS S344 pamtmann on DSKBFK8HB2PROD with BILLS 3 •S 344 IS issued by the Patent Trial and Appeal Board in 1 an inter partes review or a post-grant review in- 2 stituted under chapter 31 or 32, respectively, of 3 title 35, United States Code.’’. 4 (b) GENERIC DRUGS.—Section 505(j)(2)(A) of the 5 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 6 355(j)(2)(A)) is amended— 7 (1) in clause (vii)(IV), by striking ‘‘and’’ at the 8 end; 9 (2) in clause (viii), by striking the period at the 10 end and inserting ‘‘; and’’; 11 (3) by inserting after clause (viii), as amended 12 by paragraph (2), the following: 13 ‘‘(ix) in each certification required under 14 clause (vii) with respect to a patent, a certifi- 15 cation that— 16 ‘‘(I) neither the applicant nor any 17 party in privity with, related to, or cooper- 18 ating with the applicant has filed, or will 19 file, a petition to institute an inter partes 20 review or a post-grant review of that pat- 21 ent under chapter 31 or 32, respectively, of 22 title 35, United States Code; and 23 ‘‘(II) in making the certification re- 24 quired under clause (vii), the applicant is 25 VerDate Sep 11 2014 21:43 Feb 13, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S344.IS S344 pamtmann on DSKBFK8HB2PROD with BILLS 4 •S 344 IS not relying in whole or in part on any deci- 1 sion issued by the Patent Trial and Appeal 2 Board in an inter partes review or a post- 3 grant review instituted under chapter 31 4 or 32, respectively, of title 35, United 5 States Code.’’; and 6 (4) in the flush text following clause (ix), as 7 added by paragraph (3), by striking ‘‘(viii)’’ and in- 8 serting ‘‘(ix)’’. 9 (c) BIOSIMILAR DRUGS; EVALUATION BY THE SEC- 10 RETARY.—Section 351(k) of the Public Health Service Act 11 (42 U.S.C. 262(k)) is amended— 12 (1) in paragraph (2)(A)(iii)— 13 (A) by redesignating subclauses (I) and 14 (II) as items (aa) and (bb), respectively, and 15 adjusting the margins accordingly; 16 (B) in the matter preceding item (aa), as 17 so redesignated, by striking ‘‘An application’’ 18 and inserting the following: 19 ‘‘(I) IN GENERAL.—An applica- 20 tion’’; 21 (C) in subclause (I), as so designated— 22 (i) in item (aa), as so redesignated, by 23 striking ‘‘and’’ at the end; 24 VerDate Sep 11 2014 21:43 Feb 13, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S344.IS S344 pamtmann on DSKBFK8HB2PROD with BILLS 5 •S 344 IS (ii) in item (bb), as so redesignated, 1 by striking the period at the end and in- 2 serting ‘‘; and’’; and 3 (iii) by adding at the end the fol- 4 lowing: 5 ‘‘(cc) shall, with respect to a 6 patent described in subclause 7 (II), include a certification that 8 neither the applicant nor any 9 party in privity with, related to, 10 or cooperating with the applicant 11 has filed, or will file, a petition to 12 institute an inter partes review or 13 a post-grant review of the patent 14 under chapter 31 or 32, respec- 15 tively, of title 35, United States 16 Code.’’; and 17 (D) by adding at the end the following: 18 ‘‘(II) PATENT DESCRIBED.—A 19 patent is described in this subclause 20 if— 21 ‘‘(aa) the patent covers the 22 reference product or a method 23 for using the reference product; 24 and 25 VerDate Sep 11 2014 21:43 Feb 13, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S344.IS S344 pamtmann on DSKBFK8HB2PROD with BILLS 6 •S 344 IS ‘‘(bb)(AA) the reference 1 product described in item (aa) is 2 marked under section 287(a) of 3 title 35, United States Code; or 4 ‘‘(BB) there is otherwise 5 public notice regarding the appli- 6 cability of the reference product 7 described in item (aa).’’; and 8 (2) in paragraph (3)— 9 (A) in subparagraph (A)(ii), by striking 10 ‘‘and’’ at the end; 11 (B) in subparagraph (B), by striking the 12 period at the end and inserting ‘‘; and’’; and 13 (C) by adding at the end the following: 14 ‘‘(C) the Secretary determines that the ap- 15 plication fully complies with the requirements 16 under paragraph (2)(A)(iii).’’. 17 SEC. 3. PREVENTING THE MANIPULATIVE AND DECEPTIVE 18 USE OF INTER PARTES REVIEW. 19 Section 10(b) of the Securities Exchange Act of 1934 20 (15 U.S.C. 78j(b)) is amended— 21 (1) by inserting ‘‘(1)’’ after ‘‘(b)’’; and 22 (2) by adding at the end the following: 23 VerDate Sep 11 2014 21:43 Feb 13, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S344.IS S344 pamtmann on DSKBFK8HB2PROD with BILLS 7 •S 344 IS ‘‘(2) For purposes of paragraph (1), a person shall 1 be considered to be using a manipulative or deceptive de- 2 vice if— 3 ‘‘(A) the person, or an affiliate of the person, 4 files a petition to institute an inter partes review 5 under chapter 31 of title 35, United States Code, 6 with respect to a patent; and 7 ‘‘(B) the person, or an affiliate of the person, 8 during the 180-day period beginning on the date 9 that is 90 days before the date on which the person 10 files the petition described in subparagraph (A), en- 11 gages in a short sale of any publicly traded security 12 of the owner of the patent that is the subject of the 13 petition.’’. 14 Æ VerDate Sep 11 2014 21:43 Feb 13, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\S344.IS S344 pamtmann on DSKBFK8HB2PROD with BILLS