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 Com-
mittee 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 pur-
poses. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Hatch-Waxman Integ-
rity Act of 2018’’. 
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SEC. 2. PREVENTING THE INTER PARTES REVIEW PROCESS 
FOR CHALLENGING PATENTS FROM DIMIN-
ISHING 
COMPETITION 
IN 
THE 
PHARMA-
CEUTICAL INDUSTRY AND WITH RESPECT TO 
DRUG INNOVATION. 
(a) BRAND NAME DRUGS.—Section 505(b)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(b)(2)) is amended— 
(1) in subparagraph (A)(iv), by striking ‘‘and’’ 
at the end; 
(2) in subparagraph (B), by striking the period 
at the end and inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(C) in each certification required under sub-
paragraph (A) with respect to a patent, a certifi-
cation that— 
‘‘(i) neither the applicant nor any party in 
privity with, related to, or cooperating with the 
applicant has filed, or will file, a petition to in-
stitute inter partes review or post-grant review 
of that patent under chapter 31 or 32, respec-
tively, of title 35, United States Code; and 
‘‘(ii) in making the certification required 
under subparagraph (A), the applicant is not 
relying in whole or in part on any decision 
issued by the Patent Trial and Appeal Board in 
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an inter partes review or post-grant review 
under chapter 31 or 32, respectively, of title 35, 
United States Code.’’. 
(b) GENERIC DRUGS.—Section 505(j)(2)(A) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(2)(A)) is amended— 
(1) in clause (vii)(IV), by striking ‘‘and’’ at the 
end; 
(2) in clause (viii), by striking the period at the 
end and inserting ‘‘; and’’; 
(3) by inserting after clause (viii), as amended 
by paragraph (2), the following: 
‘‘(ix) in each certification required under 
clause (vii) with respect to a patent, a certifi-
cation that— 
‘‘(I) neither the applicant nor any 
party in privity with, related to, or cooper-
ating with the applicant has filed, or will 
file, a petition to institute inter partes re-
view or post-grant review of that patent 
under chapter 31 or 32, respectively, of 
title 35, United States Code; and 
‘‘(II) in making the certification re-
quired under clause (vii), the applicant is 
not relying in whole or in part on any deci-
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sion issued by the Patent Trial and Appeal 
Board in an inter partes review or post- 
grant review under chapter 31 or 32, re-
spectively, of title 35, United States 
Code.’’; and 
(4) in the flush text following clause (ix), as 
added by paragraph (3), by striking ‘‘(viii)’’ and in-
serting ‘‘(ix)’’. 
(c) BIOSIMILAR DRUGS; EVALUATION BY THE SEC-
RETARY.—Section 351(k) of the Public Health Service Act 
(42 U.S.C. 262(k)) is amended— 
(1) in paragraph (2)(A)(iii)— 
(A) by redesignating subclauses (I) and 
(II) as items (aa) and (bb), respectively, and 
adjusting the margins accordingly; 
(B) in the matter preceding item (aa), as 
so redesignated, by striking ‘‘An application’’ 
and inserting the following: 
‘‘(I) IN GENERAL.—An application’’; 
(C) in subclause (I), as so designated— 
(i) in item (aa), as so redesignated, by 
striking ‘‘and’’ at the end; 
(ii) in item (bb), as so redesignated, 
by striking the period at the end and in-
serting ‘‘; and’’; and 
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(iii) by adding at the end the fol-
lowing: 
‘‘(cc) shall, with respect to a 
patent described in subclause 
(II), include a certification that 
neither the applicant nor any 
party in privity with, related to, 
or cooperating with the applicant 
has filed, or will file, a petition to 
institute inter partes review or 
post-grant review of the patent 
under chapter 31 or 32, respec-
tively, of title 35, United States 
Code.’’; and 
(D) by adding at the end the following: 
‘‘(II) PATENT
DESCRIBED.—A 
patent is described in this subclause 
if— 
‘‘(aa) the patent covers the 
reference product or a method 
for using the reference product; 
and 
‘‘(bb)(AA) 
the 
reference 
product described in item (aa) is 
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marked under section 287(a) of 
title 35, United States Code; or 
‘‘(BB) there is otherwise 
public notice regarding the appli-
cability of the reference product 
described in item (aa).’’; and 
(2) in paragraph (3)— 
(A) in subparagraph (A)(ii), by striking 
‘‘and’’ at the end; 
(B) in subparagraph (B), by striking the 
period at the end and inserting ‘‘; and’’; and 
(C) by adding at the end the following: 
‘‘(C) the Secretary determines that the ap-
plication fully complies with the requirements 
under paragraph (2)(A)(iii).’’. 
SEC. 3. PREVENTING THE MANIPULATIVE AND DECEPTIVE 
USE OF INTER PARTES REVIEW. 
Section 10(b) of the Securities Exchange Act of 1934 
(15 U.S.C. 78j(b)) is amended— 
(1) by inserting ‘‘(1)’’ after ‘‘(b)’’; and 
(2) by adding at the end the following: 
‘‘(2) For purposes of paragraph (1), a person shall 
be considered to be using a manipulative or deceptive de-
vice if— 
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‘‘(A) the person, or an affiliate of the person, 
files a petition to institute an inter partes review 
under chapter 31 of title 35, United States Code, 
with respect to a patent; and 
‘‘(B) the person, or an affiliate of the person, 
during the 180-day period beginning on the date 
that is 90 days before the date on which the person 
files the petition described in subparagraph (A), en-
gages in a short sale of any publicly traded security 
of the owner of the patent that is the subject of the 
petition.’’. 
Æ 
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