103 
‘‘(B) any patent right or other statutory 
exclusivity that would prevent the marketing of 
such drug. 
‘‘(2) A payment for reasonable litigation ex-
penses not to exceed $7,500,000. 
‘‘(3) A covenant not to sue on any claim that 
the ANDA product infringes a United States patent. 
‘‘(d) ENFORCEMENT.— 
‘‘(1) ENFORCEMENT.—A violation of this sec-
tion shall be treated as a violation of section 5. 
‘‘(2) JUDICIAL REVIEW.— 
‘‘(A) IN GENERAL.—Any party that is sub-
ject to a final order of the Commission, issued 
in an administrative adjudicative proceeding 
under the authority of subsection (a)(1), may, 
within 30 days of the issuance of such order, 
petition for review of such order in— 
‘‘(i) the United States Court of Ap-
peals for the District of Columbia Circuit; 
‘‘(ii) the United States Court of Ap-
peals for the circuit in which the ultimate 
parent entity, as defined in section 
801.1(a)(3) of title 16, Code of Federal 
Regulations, or any successor thereto, of 
the NDA holder is incorporated as of the 
VerDate Sep 11 2014 
02:21 Apr 01, 2017
Jkt 069200
PO 00000
Frm 00103
Fmt 6652
Sfmt 6201
E:\BILLS\H1776.IH
H1776
SSpencer on DSK4SPTVN1PROD with BILLS
104 
date that the NDA is filed with the Com-
missioner of Food and Drugs; or 
‘‘(iii) the United States Court of Ap-
peals for the circuit in which the ultimate 
parent entity of the ANDA filer is incor-
porated as of the date that the ANDA is 
filed with the Commissioner of Food and 
Drugs. 
‘‘(B) TREATMENT
OF
FINDINGS.—In a 
proceeding for judicial review of a final order of 
the Commission, the findings of the Commis-
sion as to the facts, if supported by evidence, 
shall be conclusive. 
‘‘(e) ANTITRUST LAWS.—Nothing in this section 
shall be construed to modify, impair, or supersede the ap-
plicability of the antitrust laws as defined in subsection 
(a) of the first section of the Clayton Act (15 U.S.C. 
12(a)), and of section 5 of this Act to the extent that sec-
tion 5 applies to unfair methods of competition. Nothing 
in this section shall modify, impair, limit, or supersede the 
right of an ANDA filer to assert claims or counterclaims 
against any person, under the antitrust laws or other laws 
relating to unfair competition. 
‘‘(f) PENALTIES.— 
VerDate Sep 11 2014 
02:21 Apr 01, 2017
Jkt 069200
PO 00000
Frm 00104
Fmt 6652
Sfmt 6201
E:\BILLS\H1776.IH
H1776
SSpencer on DSK4SPTVN1PROD with BILLS
105 
‘‘(1) FORFEITURE.—Each party that violates or 
assists in the violation of this section shall forfeit 
and pay to the United States a civil penalty suffi-
cient to deter violations of this section, but in no 
event greater than 3 times the value received by the 
party that is reasonably attributable to the violation 
of this section. If no such value has been received by 
the NDA holder, the penalty to the NDA holder 
shall be sufficient to deter violations, but in no event 
greater than 3 times the value given to the ANDA 
filer reasonably attributable to the violation of this 
section. Such penalty shall accrue to the United 
States and may be recovered in a civil action 
brought by the Commission, in its own name by any 
of its attorneys designated by it for such purpose, in 
a district court of the United States against any 
party that violates this section. In such actions, the 
United States district courts are empowered to grant 
mandatory injunctions and such other and further 
equitable relief as they deem appropriate. 
‘‘(2) CEASE AND DESIST.— 
‘‘(A) IN GENERAL.—If the Commission has 
issued a cease and desist order with respect to 
a party in an administrative adjudicative pro-
ceeding under the authority of subsection 
VerDate Sep 11 2014 
02:21 Apr 01, 2017
Jkt 069200
PO 00000
Frm 00105
Fmt 6652
Sfmt 6201
E:\BILLS\H1776.IH
H1776
SSpencer on DSK4SPTVN1PROD with BILLS
106 
(a)(1), an action brought pursuant to para-
graph (1) may be commenced against such 
party at any time before the expiration of 1 
year after such order becomes final pursuant to 
section 5(g). 
‘‘(B) EXCEPTION.—In an action under 
subparagraph (A), the findings of the Commis-
sion as to the material facts in the administra-
tive adjudicative proceeding with respect to the 
violation of this section by a party shall be con-
clusive unless— 
‘‘(i) the terms of such cease and de-
sist order expressly provide that the Com-
mission’s findings shall not be conclusive; 
or 
‘‘(ii) the order became final by reason 
of section 5(g)(1), in which case such find-
ing shall be conclusive if supported by evi-
dence. 
‘‘(3) CIVIL
PENALTY.—In determining the 
amount of the civil penalty described in this section, 
the court shall take into account— 
‘‘(A) the nature, circumstances, extent, 
and gravity of the violation; 
VerDate Sep 11 2014 
02:21 Apr 01, 2017
Jkt 069200
PO 00000
Frm 00106
Fmt 6652
Sfmt 6201
E:\BILLS\H1776.IH
H1776
SSpencer on DSK4SPTVN1PROD with BILLS
107 
‘‘(B) with respect to the violator, the de-
gree of culpability, any history of violations, the 
ability to pay, any effect on the ability to con-
tinue doing business, profits earned by the 
NDA holder, compensation received by the 
ANDA filer, and the amount of commerce af-
fected; and 
‘‘(C) other matters that justice requires. 
‘‘(4) REMEDIES IN ADDITION.—Remedies pro-
vided in this subsection are in addition to, and not 
in lieu of, any other remedy provided by Federal 
law. Nothing in this paragraph shall be construed to 
affect any authority of the Commission under any 
other provision of law. 
‘‘(g) DEFINITIONS.—In this section: 
‘‘(1) 
AGREEMENT.—The 
term 
‘agreement’ 
means anything that would constitute an agreement 
under section 1 of the Sherman Act (15 U.S.C. 1) 
or section 5 of this Act. 
‘‘(2) AGREEMENT RESOLVING OR SETTLING A 
PATENT INFRINGEMENT CLAIM.—The term ‘agree-
ment resolving or settling a patent infringement 
claim’ includes any agreement that is entered into 
within 30 days of the resolution or the settlement of 
the claim, or any other agreement that is contingent 
VerDate Sep 11 2014 
02:21 Apr 01, 2017
Jkt 069200
PO 00000
Frm 00107
Fmt 6652
Sfmt 6201
E:\BILLS\H1776.IH
H1776
SSpencer on DSK4SPTVN1PROD with BILLS
108 
upon, provides a contingent condition for, or is oth-
erwise related to the resolution or settlement of the 
claim. 
‘‘(3) ANDA.—The term ‘ANDA’ means an ab-
breviated new drug application filed under section 
505(j) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(j)) or a new drug application filed 
under section 505(b)(2) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(b)(2)). 
‘‘(4) ANDA FILER.—The term ‘ANDA filer’ 
means a party that owns or controls an ANDA filed 
with the Commission of Food and Drugs or has the 
exclusive rights under such ANDA to distribute the 
ANDA product. 
‘‘(5) ANDA 
PRODUCT.—The term ‘ANDA 
product’ means the product to be manufactured 
under the ANDA that is the subject of the patent 
infringement claim. 
‘‘(6) DRUG PRODUCT.—The term ‘drug prod-
uct’ has the meaning given such term in section 
314.3(b) of title 21, Code of Federal Regulations (or 
any successor regulation). 
‘‘(7) NDA.—The term ‘NDA’ means a new 
drug application filed under section 505(b) of the 
VerDate Sep 11 2014 
02:21 Apr 01, 2017
Jkt 069200
PO 00000
Frm 00108
Fmt 6652
Sfmt 6201
E:\BILLS\H1776.IH
H1776
SSpencer on DSK4SPTVN1PROD with BILLS
109 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(b)). 
‘‘(8) NDA HOLDER.—The term ‘NDA holder’ 
means— 
‘‘(A) the holder of an approved NDA appli-
cation for a drug product; 
‘‘(B) a person owning or controlling en-
forcement of the patent listed in the Approved 
Drug Products With Therapeutic Equivalence 
Evaluations (commonly known as the ‘FDA Or-
ange Book’) in connection with the NDA; or 
‘‘(C) the predecessors, subsidiaries, divi-
sions, groups, and affiliates controlled by, con-
trolling, or under common control with any of 
the entities described in subparagraphs (A) and 
(B) (such control to be presumed by direct or 
indirect share ownership of 50 percent or great-
er), as well as the licensees, licensors, succes-
sors, and assigns of each of the entities. 
‘‘(9) PARTY.—The term ‘party’ means any per-
son, partnership, corporation, or other legal entity. 
‘‘(10) 
PATENT
INFRINGEMENT.—The 
term 
‘patent infringement’ means infringement of any 
patent or of any filed patent application, extension, 
reissue, renewal, division, continuation, continuation 
VerDate Sep 11 2014 
02:21 Apr 01, 2017
Jkt 069200
PO 00000
Frm 00109
Fmt 6652
Sfmt 6201
E:\BILLS\H1776.IH
H1776
SSpencer on DSK4SPTVN1PROD with BILLS
110 
in part, reexamination, patent term restoration, pat-
ents of addition, and extensions thereof. 
‘‘(11) PATENT
INFRINGEMENT
CLAIM.—The 
term ‘patent infringement claim’ means any allega-
tion made to an ANDA filer, whether or not in-
cluded in a complaint filed with a court of law, that 
its ANDA or ANDA product may infringe any pat-
ent held by, or exclusively licensed to, the NDA 
holder of the drug product. 
‘‘(12) STATUTORY
EXCLUSIVITY.—The term 
‘statutory exclusivity’ means those prohibitions on 
the approval of drug applications under clauses (ii) 
through (iv) of section 505(c)(3)(E) (5- and 3-year 
data exclusivity), section 527 (orphan drug exclu-
sivity), or section 505A (pediatric exclusivity) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(c)(3)(E), 360cc, 355a).’’. 
(b) EFFECTIVE DATE.—Section 27 of the Federal 
Trade Commission Act, as added by this section, shall 
apply to all agreements described in section 27(a)(1) of 
that Act entered into after June 17, 2013. Section 27(f) 
of the Federal Trade Commission Act, as added by this 
section, shall apply to agreements entered into on or after 
the date of enactment of this Act. 
VerDate Sep 11 2014 
02:21 Apr 01, 2017
Jkt 069200
PO 00000
Frm 00110
Fmt 6652
Sfmt 6201
E:\BILLS\H1776.IH
H1776
SSpencer on DSK4SPTVN1PROD with BILLS
111 
SEC. 402. 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 
VerDate Sep 11 2014 
02:21 Apr 01, 2017
Jkt 069200
PO 00000
Frm 00111
Fmt 6652
Sfmt 6201
E:\BILLS\H1776.IH
H1776
SSpencer on DSK4SPTVN1PROD with BILLS
112 
‘‘(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-
VerDate Sep 11 2014 
02:21 Apr 01, 2017
Jkt 069200
PO 00000
Frm 00112
Fmt 6652
Sfmt 6201
E:\BILLS\H1776.IH
H1776
SSpencer on DSK4SPTVN1PROD with BILLS
113 
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.’’. 
VerDate Sep 11 2014 
02:21 Apr 01, 2017
Jkt 069200
PO 00000
Frm 00113
Fmt 6652
Sfmt 6201
E:\BILLS\H1776.IH
H1776
SSpencer on DSK4SPTVN1PROD with BILLS
114 
(2) 
CONFORMING
AMENDMENT.—Section 
505(j)(5)(D)(i)(IV) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(IV)) is 
amended by striking ‘‘The first applicant’’ and in-
serting ‘‘The first applicant, as defined in subpara-
graph (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. 403. 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 402, is further amended by adding at the 
end the following: 
VerDate Sep 11 2014 
02:21 Apr 01, 2017
Jkt 069200
PO 00000
Frm 00114
Fmt 6652
Sfmt 6201
E:\BILLS\H1776.IH
H1776
SSpencer on DSK4SPTVN1PROD with BILLS
115 
‘‘(vii) AGREEMENT
BY
FIRST
APPLICANT
TO 
DEFER
COMMERCIAL
MARKETING; LIMITATION
ON 
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). 
VerDate Sep 11 2014 
02:21 Apr 01, 2017
Jkt 069200
PO 00000
Frm 00115
Fmt 6652
Sfmt 6201
E:\BILLS\H1776.IH
H1776
SSpencer on DSK4SPTVN1PROD with BILLS
116 
‘‘(II) AGREEMENT THAT DISQUALIFIES AP-
PLICANT FROM FIRST APPLICANT STATUS.—An 
agreement described in this subclause is an 
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— 
VerDate Sep 11 2014 
02:21 Apr 01, 2017
Jkt 069200
PO 00000
Frm 00116
Fmt 6652
Sfmt 6201
E:\BILLS\H1776.IH
H1776
SSpencer on DSK4SPTVN1PROD with BILLS
117 
‘‘(aa) the latest date set forth in the 
agreement on which that applicant can re-
ceive an approval that is made effective 
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).’’. 
VerDate Sep 11 2014 
02:21 Apr 01, 2017
Jkt 069200
PO 00000
Frm 00117
Fmt 6652
Sfmt 6201
E:\BILLS\H1776.IH
H1776
SSpencer on DSK4SPTVN1PROD with BILLS
118 
(2) NOTIFICATION OF FDA.—Section 505(j) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)) is amended by adding at the end the 
following: 
‘‘(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-
VerDate Sep 11 2014 
02:21 Apr 01, 2017
Jkt 069200
PO 00000
Frm 00118
Fmt 6652
Sfmt 6201
E:\BILLS\H1776.IH
H1776
SSpencer on DSK4SPTVN1PROD with BILLS
119 
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-
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 the 
Federal Food, Drug, and Cosmetic 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 
VerDate Sep 11 2014 
02:21 Apr 01, 2017
Jkt 069200
PO 00000
Frm 00119
Fmt 6652
Sfmt 6201
E:\BILLS\H1776.IH
H1776
SSpencer on DSK4SPTVN1PROD with BILLS
120 
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 
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 
VerDate Sep 11 2014 
02:21 Apr 01, 2017
Jkt 069200
PO 00000
Frm 00120
Fmt 6652
Sfmt 6201
E:\BILLS\H1776.IH
H1776
SSpencer on DSK4SPTVN1PROD with BILLS