I 
116TH CONGRESS 
1ST SESSION H. R. 1506 
To amend the Federal Food, Drug, and Cosmetic Act to ensure that valid 
generic drugs may enter the market. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 5, 2019 
Ms. BARRAGA´N introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce, and in addition to the Committee on 
the Judiciary, for a period to be subsequently determined by the Speaker, 
in each case for consideration of such provisions as fall within the juris-
diction of the committee concerned 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
ensure that valid generic drugs may enter the market. 
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 ‘‘Fair And Immediate 
Release of Generic Drugs Act’’ or the ‘‘FAIR Generics 
Act’’. 
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SEC. 2. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS RE-
GARDING FIRST APPLICANT STATUS. 
(a) AMENDMENTS TO FEDERAL FOOD, DRUG, AND 
COSMETIC ACT.— 
(1) IN GENERAL.—Section 505(j)(5)(B) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(5)(B)) is amended— 
(A) in clause (iv)(II)— 
(i) by striking item (bb); and 
(ii) by redesignating items (cc) and 
(dd) as items (bb) and (cc), respectively; 
and 
(B) by adding at the end the following: 
‘‘(v) FIRST APPLICANT DEFINED.—As used in 
this subsection, the term ‘first applicant’ means an 
applicant— 
‘‘(I)(aa) that, on the first day on which a 
substantially complete application containing a 
certification 
described 
in 
paragraph 
(2)(A)(vii)(IV) is submitted for approval of a 
drug, submits a substantially complete applica-
tion that contains and lawfully maintains a cer-
tification described in paragraph (2)(A)(vii)(IV) 
for the drug; and 
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‘‘(bb) that has not entered into a disquali-
fying 
agreement 
described 
under 
clause 
(vii)(II); or 
‘‘(II)(aa) for the drug that is not described 
in subclause (I) and that, with respect to the 
applicant and drug, each requirement described 
in clause (vi) is satisfied; and 
‘‘(bb) that has not entered into a disquali-
fying 
agreement 
described 
under 
clause 
(vii)(II). 
‘‘(vi) REQUIREMENT.—The requirements de-
scribed in this clause are the following: 
‘‘(I) The applicant described in clause 
(v)(II) submitted and lawfully maintains a cer-
tification described in paragraph (2)(A)(vii)(IV) 
or 
a 
statement 
described 
in 
paragraph 
(2)(A)(viii) for each unexpired patent for which 
a first applicant described in clause (v)(I) had 
submitted a certification described in paragraph 
(2)(A)(vii)(IV) on the first day on which a sub-
stantially complete application containing such 
a certification was submitted. 
‘‘(II) With regard to each such unexpired 
patent for which the applicant described in 
clause (v)(II) submitted a certification de-
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scribed in paragraph (2)(A)(vii)(IV), no action 
for patent infringement was brought against 
such applicant within the 45-day period speci-
fied in paragraph (5)(B)(iii); or if an action 
was brought within such time period, such an 
action was withdrawn or dismissed by a court 
(including a district court) without a decision 
that the patent was valid and infringed; or if an 
action was brought within such time period and 
was not withdrawn or so dismissed, such appli-
cant has obtained the decision of a court (in-
cluding a district court) that the patent is in-
valid or not infringed (including any substantive 
determination that there is no cause of action 
for patent infringement or invalidity, and in-
cluding a settlement order or consent decree 
signed and entered by the court stating that the 
patent is invalid or not infringed). 
‘‘(III) If an applicant described in clause 
(v)(I) has begun commercial marketing of such 
drug, the applicant described in clause (v)(II) 
does not begin commercial marketing of such 
drug until the date that is 30 days after the 
date on which the applicant described in clause 
(v)(I) began such commercial marketing.’’. 
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(2) 
CONFORMING
AMENDMENT.—Section 
505(j)(5)(D)(i)(IV) 
of 
such 
Act 
(21 
U.S.C. 
355(j)(5)(D)(i)(IV)) is amended by striking ‘‘The 
first applicant’’ and inserting ‘‘The first applicant, 
as defined in subparagraph (B)(v)(I),’’. 
(b) APPLICABILITY.—The amendments made by sub-
section (a) shall apply only with respect to an application 
filed under section 505(j) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)) to which the amendments 
made by section 1102(a) of the Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003 (Pub-
lic Law 108–173) apply. 
SEC. 3. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS RE-
GARDING AGREEMENTS TO DEFER COMMER-
CIAL MARKETING. 
(a) AMENDMENTS TO FEDERAL FOOD, DRUG, AND 
COSMETIC ACT.— 
(1) LIMITATIONS ON AGREEMENTS TO DEFER 
COMMERCIAL
MARKETING
DATE.—Section 
505(j)(5)(B) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)(5)(B)), as amended by 
section 2, is further amended by adding at the end 
the following: 
‘‘(vii) AGREEMENT
BY
FIRST
APPLICANT
TO 
DEFER
COMMERCIAL
MARKETING; LIMITATION
ON 
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ACCELERATION
OF
DEFERRED
COMMERCIAL
MAR-
KETING DATE.— 
‘‘(I) AGREEMENT TO DEFER APPROVAL OR 
COMMERCIAL
MARKETING
DATE.—An agree-
ment described in this subclause is an agree-
ment between a first applicant and the holder 
of the application for the listed drug or an 
owner of one or more of the patents as to which 
any applicant submitted a certification quali-
fying such applicant for the 180-day exclusivity 
period whereby that applicant agrees, directly 
or indirectly, (aa) not to seek an approval of its 
application that is made effective on the earliest 
possible date under this subparagraph, subpara-
graph (F) of this paragraph, section 505A, or 
section 527, (bb) not to begin the commercial 
marketing of its drug on the earliest possible 
date after receiving an approval of its applica-
tion that is made effective under this subpara-
graph, subparagraph (F) of this paragraph, sec-
tion 505A, or section 527, or (cc) to both items 
(aa) and (bb). 
‘‘(II) AGREEMENT THAT DISQUALIFIES AP-
PLICANT FROM FIRST APPLICANT STATUS.—An 
agreement described in this subclause is an 
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agreement between an applicant and the holder 
of the application for the listed drug or an 
owner of one or more of the patents as to which 
any applicant submitted a certification quali-
fying such applicant for the 180-day exclusivity 
period whereby that applicant agrees, directly 
or indirectly, not to seek an approval of its ap-
plication or not to begin the commercial mar-
keting of its drug until a date that is after the 
expiration of the 180-day exclusivity period 
awarded to another applicant with respect to 
such drug (without regard to whether such 180- 
day exclusivity period is awarded before or after 
the date of the agreement). 
‘‘(viii) LIMITATION ON ACCELERATION.—If an 
agreement described in clause (vii)(I) includes more 
than 1 possible date when an applicant may seek an 
approval of its application or begin the commercial 
marketing of its drug— 
‘‘(I) the applicant may seek an approval of 
its application or begin such commercial mar-
keting on the date that is the earlier of— 
‘‘(aa) the latest date set forth in the 
agreement on which that applicant can re-
ceive an approval that is made effective 
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under this subparagraph, subparagraph 
(F) of this paragraph, section 505A, or 
section 527, or begin the commercial mar-
keting of such drug, without regard to any 
other provision of such agreement pursu-
ant to which the commercial marketing 
could begin on an earlier date; or 
‘‘(bb) 180 days after another first ap-
plicant begins commercial marketing of 
such drug; and 
‘‘(II) the latest date set forth in the agree-
ment on which that applicant can receive an ap-
proval that is made effective under this sub-
paragraph, subparagraph (F) of this paragraph, 
section 505A, or section 527, or begin the com-
mercial marketing of such drug, without regard 
to any other provision of such agreement pursu-
ant to which commercial marketing could begin 
on an earlier date, shall be the date used to de-
termine whether an applicant is disqualified 
from first applicant status pursuant to clause 
(vii)(II).’’. 
(2) NOTIFICATION OF FDA.—Section 505(j) of 
such Act (21 U.S.C. 355(j)) is amended by adding 
at the end the following: 
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‘‘(11)(A) The holder of an abbreviated application 
under this subsection shall submit to the Secretary a noti-
fication that includes— 
‘‘(i)(I) the text of any agreement entered into 
by 
such 
holder 
described 
under 
paragraph 
(5)(B)(vii)(I); or 
‘‘(II) if such an agreement has not been re-
duced to text, a written detailed description of such 
agreement that is sufficient to disclose all the terms 
and conditions of the agreement; and 
‘‘(ii) the text, or a written detailed description 
in the event of an agreement that has not been re-
duced to text, of any other agreements that are con-
tingent upon, provide a contingent condition for, or 
are otherwise related to an agreement described in 
clause (i). 
‘‘(B) The notification described under subparagraph 
(A) shall be submitted not later than 10 business days 
after execution of the agreement described in subpara-
graph (A)(i). Such notification is in addition to any notifi-
cation required under section 1112 of the Medicare Pre-
scription Drug, Improvement, and Modernization Act of 
2003. 
‘‘(C) Any information or documentary material filed 
with the Secretary pursuant to this paragraph shall be ex-
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empt from disclosure under section 552 of title 5, United 
States Code, and no such information or documentary ma-
terial may be made public, except as may be relevant to 
any administrative or judicial action or proceeding. Noth-
ing in this paragraph is intended to prevent disclosure to 
either body of the Congress or to any duly authorized com-
mittee or subcommittee of the Congress.’’. 
(3) PROHIBITED ACTS.—Section 301(e) of such 
Act (21 U.S.C. 331(e)) is amended by striking ‘‘505 
(i) or (k)’’ and inserting ‘‘505 (i), (j)(11), or (k)’’. 
(b) INFRINGEMENT OF PATENT.—Section 271(e) of 
title 35, United States Code, is amended by adding at the 
end the following: 
‘‘(7) The exclusive remedy under this section for an 
infringement of a patent for which the Secretary of Health 
and Human Services has published information pursuant 
to subsection (b)(1) or (c)(2) of section 505 of the Federal 
Food, Drug, and Cosmetic Act shall be an action brought 
under this subsection within the 45-day period described 
in subsection (j)(5)(B)(iii) or (c)(3)(C) of section 505 of 
the Federal Food, Drug, and Cosmetic Act.’’. 
(c) APPLICABILITY.— 
(1) LIMITATIONS
ON
ACCELERATION
OF
DE-
FERRED
COMMERCIAL
MARKETING
DATE.—The 
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amendment made by subsection (a)(1) shall apply 
only with respect to— 
(A) an application filed under section 
505(j) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)) to which the 
amendments made by section 1102(a) of the 
Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (Public Law 108– 
173) apply; and 
(B) an agreement described under section 
505(j)(5)(B)(vii)(I) of the Federal Food, Drug, 
and Cosmetic Act (as added by subsection 
(a)(1)) executed after the date of enactment of 
this Act. 
(2) NOTIFICATION OF FDA.—The amendments 
made by paragraphs (2) and (3) of subsection (a) 
shall apply only with respect to an agreement de-
scribed under section 505(j)(5)(B)(vii)(I) of the 
Federal Food, Drug, and Cosmetic Act (as added by 
subsection (a)(1)) executed after the date of enact-
ment of this Act. 
Æ 
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