I 

115TH CONGRESS 

2D SESSION H. R. 7251 

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 HOUSE OF REPRESENTATIVES 

DECEMBER 11, 2018 

Mr. FLORES introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on 

Financial Services, for a period to be subsequently determined by the 

Speaker, in each case for consideration of such provisions as fall within 

the jurisdiction of the committee concerned 

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 purposes. 

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 ‘‘Hatch-Waxman Integ5 rity Act of 2018’’. 


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1 SEC. 2. PREVENTING THE INTER PARTES REVIEW PROCESS 

2 FOR CHALLENGING PATENTS FROM DIMIN3 ISHING COMPETITION IN THE PHARMA4 CEUTICAL INDUSTRY AND WITH RESPECT TO 

5 DRUG INNOVATION. 

6 (a) BRAND NAME DRUGS.—Section 505(b)(2) of the 

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

8 355(b)(2)) is amended— 

9 (1) in subparagraph (A)(iv), by striking ‘‘and’’ 

10 at the end; 

11 (2) in subparagraph (B), by striking the period 

12 at the end and inserting ‘‘; and’’; and 

13 (3) by adding at the end the following: 

14 ‘‘(C) in each certification required under sub15 paragraph (A) with respect to a patent, a certifi16 cation that— 

17 ‘‘(i) neither the applicant nor any party in 

18 privity with, related to, or cooperating with the 

19 applicant has filed, or will file, a petition to in20 stitute inter partes review or post-grant review 

21 of that patent under chapter 31 or 32, respec22 tively, of title 35, United States Code; 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 issued by the Patent Trial and Appeal Board in 


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1 an inter partes review or post-grant review 

2 under chapter 31 or 32, respectively, of title 35, 

3 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 certifi15 cation that— 

16 ‘‘(I) neither the applicant nor any 

17 party in privity with, related to, or cooper18 ating with the applicant has filed, or will 

19 file, a petition to institute inter partes re20 view or post-grant review of that patent 

21 under chapter 31 or 32, respectively, of 

22 title 35, United States Code; and 

23 ‘‘(II) in making the certification re24 quired under clause (vii), the applicant is 

25 not relying in whole or in part on any deciVerDate Sep 11 2014 23:05 Dec 13, 2018 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H7251.IH H7251

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1 sion issued by the Patent Trial and Appeal 

2 Board in an inter partes review or post3 grant review under chapter 31 or 32, re4 spectively, of title 35, United States 

5 Code.’’; and 

6 (4) in the flush text following clause (ix), as 

7 added by paragraph (3), by striking ‘‘(viii)’’ and in8 serting ‘‘(ix)’’. 

9 (c) BIOSIMILAR DRUGS; EVALUATION BY THE SEC10 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 application’’; 

20 (C) in subclause (I), as so designated— 

21 (i) in item (aa), as so redesignated, by 

22 striking ‘‘and’’ at the end; 

23 (ii) in item (bb), as so redesignated, 

24 by striking the period at the end and in25 serting ‘‘; and’’; and 


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1 (iii) by adding at the end the fol2 lowing: 

3 ‘‘(cc) shall, with respect to a 

4 patent described in subclause 

5 (II), include a certification that 

6 neither the applicant nor any 

7 party in privity with, related to, 

8 or cooperating with the applicant 

9 has filed, or will file, a petition to 

10 institute inter partes review or 

11 post-grant review of the patent 

12 under chapter 31 or 32, respec13 tively, of title 35, United States 

14 Code.’’; and 

15 (D) by adding at the end the following: 

16 ‘‘(II) PATENT DESCRIBED.—A 

17 patent is described in this subclause 

18 if— 

19 ‘‘(aa) the patent covers the 

20 reference product or a method 

21 for using the reference product; 

22 and 

23 ‘‘(bb)(AA) the reference 

24 product described in item (aa) is 


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1 marked under section 287(a) of 

2 title 35, United States Code; or 

3 ‘‘(BB) there is otherwise 

4 public notice regarding the appli5 cability of the reference product 

6 described in item (aa).’’; and 

7 (2) in paragraph (3)— 

8 (A) in subparagraph (A)(ii), by striking 

9 ‘‘and’’ at the end; 

10 (B) in subparagraph (B), by striking the 

11 period at the end and inserting ‘‘; and’’; and 

12 (C) by adding at the end the following: 

13 ‘‘(C) the Secretary determines that the ap14 plication fully complies with the requirements 

15 under paragraph (2)(A)(iii).’’. 

16 SEC. 3. PREVENTING THE MANIPULATIVE AND DECEPTIVE 

17 USE OF INTER PARTES REVIEW. 

18 Section 10(b) of the Securities Exchange Act of 1934 

19 (15 U.S.C. 78j(b)) is amended— 

20 (1) by inserting ‘‘(1)’’ after ‘‘(b)’’; and 

21 (2) by adding at the end the following: 

22 ‘‘(2) For purposes of paragraph (1), a person shall 

23 be considered to be using a manipulative or deceptive de24 vice if— 


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1 ‘‘(A) the person, or an affiliate of the person, 

2 files a petition to institute an inter partes review 

3 under chapter 31 of title 35, United States Code, 

4 with respect to a patent; and 

5 ‘‘(B) the person, or an affiliate of the person, 

6 during the 180-day period beginning on the date 

7 that is 90 days before the date on which the person 

8 files the petition described in subparagraph (A), en9 gages in a short sale of any publicly traded security 

10 of the owner of the patent that is the subject of the 

11 petition.’’. 

Æ 


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