Hatch-Waxman Integrity Act of 2019
This bill establishes certain limits on the filing of patent validity challenges with the Patent Trial and Appeal Board, particularly with respect to inter partes review.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 990 Introduced in House (IH)]
<DOC>
116th CONGRESS
1st Session
H. R. 990
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
February 6, 2019
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Hatch-Waxman Integrity Act of
2019''.
SEC. 2. PREVENTING THE INTER PARTES REVIEW PROCESS FOR CHALLENGING
PATENTS FROM DIMINISHING COMPETITION IN THE
PHARMACEUTICAL 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 subparagraph (A)
with respect to a patent, a certification 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
institute inter partes review 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 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 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 certification 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 institute inter partes review 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 required
under clause (vii), the applicant is not
relying in whole or in part on any decision
issued by the Patent Trial and Appeal Board in
an inter partes review or post-grant review
under chapter 31 or 32, respectively, of title
35, United States Code.''; and
(4) in the flush text following clause (ix), as added by
paragraph (3), by striking ``(viii)'' and inserting ``(ix)''.
(c) Biosimilar Drugs; Evaluation by the Secretary.--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 inserting
``; and''; and
(iii) by adding at the end the following:
``(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, respectively,
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 marked under section 287(a)
of title 35, United States
Code; or
``(BB) there is otherwise
public notice regarding the
applicability 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 application
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 device if--
``(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), engages in a short sale of any publicly
traded security of the owner of the patent that is the subject
of the petition.''.
<all>
Introduced in House
Introduced in House
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.
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.
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