(g)(8) is submitted to the Commis-
sioner of Food and Drugs; and 
(ii) the petition for review shall be 
filed in the court not later than 30 days 
after such order is served on the party seek-
ing review. 
(3) ADDITIONAL ENFORCEMENT AUTHORITY.— 
(A) CIVIL PENALTY.—The Commission may 
commence a civil action to recover a civil pen-
alty in a district court of the United States 
against any NDA or BLA holder or subsequent 
filer that violates this section. 
(B) SPECIAL RULE FOR RECOVERY OF PEN-
ALTY IF CEASE AND DESIST ORDER ISSUED.— 
(i) IN GENERAL.—If the Commission 
has issued a cease and desist order in a pro-
ceeding under section 5 of the Federal Trade 
Commission Act (15 U.S.C. 45) for viola-
tion of this section— 
(I) the Commission may com-
mence a civil action under subpara-
graph (A) to recover a civil penalty 
against any party to such order at any 
time before the expiration of the 1-year 
period beginning on the date on which 
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such order becomes final under section 
5(g) of such Act (15 U.S.C. 45(g)); and 
(II) in such civil action, the find-
ings of the Commission as to the mate-
rial facts in such proceeding shall be 
conclusive, unless— 
(aa) the terms of such order 
expressly provide that the Com-
mission’s findings shall not be 
conclusive; or 
(bb) such order became final 
by reason of section 5(g)(1) of 
such Act (15 U.S.C. 45(g)(1)), in 
which case such findings shall be 
conclusive if supported by evi-
dence. 
(ii) RELATIONSHIP TO PENALTY FOR 
VIOLATION
OF
AN
ORDER.—The penalty 
provided in clause (i) for violation of this 
section is separate from and in addition to 
any penalty that may be incurred for viola-
tion of an order of the Commission under 
section 5(l) of the Federal Trade Commis-
sion Act (15 U.S.C. 45(l)). 
(C) AMOUNT OF PENALTY.— 
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(i) IN
GENERAL.—The amount of a 
civil penalty imposed in a civil action 
under subparagraph (A) on a party to an 
agreement described in subsection (a) shall 
be sufficient to deter violations of this sec-
tion, but in no event greater than— 
(I) if such party is the NDA or 
BLA holder (or, in the case of an 
agreement between two subsequent fil-
ers, the subsequent filer who gave the 
value described in subsection (a)(1)), 
the greater of— 
(aa) 3 times the value re-
ceived by such NDA or BLA hold-
er (or by such subsequent filer) 
that is reasonably attributable to 
the violation of this section; or 
(bb) 3 times the value given 
to the subsequent filer (or to the 
other subsequent filer) reasonably 
attributable to the violation of 
this section; and 
(II) if such party is the subse-
quent filer (or, in the case of an agree-
ment between two subsequent filers, the 
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subsequent filer who received the value 
described in subsection (a)(1)), 3 times 
the value received by such subsequent 
filer that is reasonably attributable to 
the violation of this section. 
(ii) FACTORS FOR CONSIDERATION.— 
In determining such amount, the court shall 
take into account— 
(I) the nature, circumstances, ex-
tent, and gravity of the violation; 
(II) with respect to the violator, 
the degree of culpability, any history of 
violations, the ability to pay, any effect 
on the ability to continue doing busi-
ness, profits earned by the NDA or 
BLA holder (or, in the case of an 
agreement between two subsequent fil-
ers, the subsequent filer who gave the 
value described in subsection (a)(1)), 
compensation received by the subse-
quent filer (or, in the case of an agree-
ment between two subsequent filers, the 
subsequent filer who received the value 
described in subsection (a)(1)), and the 
amount of commerce affected; and 
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(III) other matters that justice re-
quires. 
(D) INJUNCTIONS AND OTHER EQUITABLE 
RELIEF.—In a civil action under subparagraph 
(A), the United States district courts are empow-
ered to grant mandatory injunctions and such 
other and further equitable relief as they deem 
appropriate. 
(4) REMEDIES IN ADDITION.—Remedies provided 
in this subsection are in addition to, and not in lieu 
of, any other remedy provided by Federal law. 
(5) PRESERVATION OF AUTHORITY OF COMMIS-
SION.—Nothing in this section shall be construed to 
affect any authority of the Commission under any 
other provision of law. 
(e) FEDERAL TRADE COMMISSION RULEMAKING.—The 
Commission may, in its discretion, by rule promulgated 
under section 553 of title 5, United States Code, exempt 
from this section certain agreements described in subsection 
(a) if the Commission finds such agreements to be in fur-
therance of market competition and for the benefit of con-
sumers. 
(f) ANTITRUST LAWS.—Nothing in this section shall 
modify, impair, limit, or supersede the applicability of the 
antitrust laws as defined in subsection (a) of the first sec-
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pamtmann on DSKBFK8HB2PROD with BILLS
tion of the Clayton Act (15 U.S.C. 12(a)), and of section 
5 of the Federal Trade Commission Act (15 U.S.C. 45) to 
the extent that such section 5 applies to unfair methods of 
competition. Nothing in this section shall modify, impair, 
limit, or supersede the right of a subsequent filer to assert 
claims or counterclaims against any person, under the anti-
trust laws or other laws relating to unfair competition. 
(g) DEFINITIONS.—In this section: 
(1) AGREEMENT RESOLVING OR SETTLING A COV-
ERED
PATENT
INFRINGEMENT
CLAIM.—The term 
‘‘agreement resolving or settling a covered patent in-
fringement claim’’ means any agreement that— 
(A) resolves or settles a covered patent in-
fringement claim; or 
(B) is contingent upon, provides for a con-
tingent condition for, or is otherwise related to 
the resolution or settlement of a covered patent 
infringement claim. 
(2) 
COMMISSION.—The 
term 
‘‘Commission’’ 
means the Federal Trade Commission. 
(3) COVERED PATENT INFRINGEMENT CLAIM.— 
The term ‘‘covered patent infringement claim’’ means 
an allegation made by the NDA or BLA holder to a 
subsequent filer (or, in the case of an agreement be-
tween two subsequent filers, by one subsequent filer to 
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another), whether or not included in a complaint filed 
with a court of law, that— 
(A) the submission of the application de-
scribed in subparagraph (A) or (B) of paragraph 
(9), or the manufacture, use, offering for sale, 
sale, or importation into the United States of a 
covered product that is the subject of such an ap-
plication— 
(i) in the case of an agreement between 
an NDA or BLA holder and a subsequent 
filer, infringes any patent owned by, or ex-
clusively licensed to, the NDA or BLA hold-
er of the covered product; or 
(ii) in the case of an agreement be-
tween two subsequent filers, infringes any 
patent owned by the subsequent filer; or 
(B) in the case of an agreement between an 
NDA or BLA holder and a subsequent filer, the 
covered product to be manufactured under such 
application uses a covered product as claimed in 
a published patent application. 
(4) COVERED
PRODUCT.—The term ‘‘covered 
product’’ means a drug (as defined in section 201(g) 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321(g))), including a biological product (as 
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under section 351(a) of such Act (42 U.S.C. 
262(a)); or 
(C) the predecessors, subsidiaries, divisions, 
groups, and affiliates controlled by, controlling, 
or under common control with any entity de-
scribed in subparagraph (A) or (B) (such control 
to be presumed by direct or indirect share owner-
ship of 50 percent or greater), as well as the li-
censees, licensors, successors, and assigns of each 
of the entities. 
(6) PATENT.—The term ‘‘patent’’ means a pat-
ent issued by the United States Patent and Trade-
mark Office. 
(7) STATUTORY EXCLUSIVITY.—The term ‘‘statu-
tory exclusivity’’ means those prohibitions on the sub-
mission or approval of drug applications under 
clauses (ii) through (iv) of section 505(c)(3)(E) (5- 
and 3-year exclusivity), clauses (ii) through (iv) of 
section 505(j)(5)(F) (5-year and 3-year exclusivity), 
section 505(j)(5)(B)(iv) (180-day exclusivity), section 
527 (orphan drug exclusivity), section 505A (pedi-
atric exclusivity), or section 505E (qualified infec-
tious disease product exclusivity) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(c)(3)(E), 
355(j)(5)(B)(iv), 355(j)(5)(F), 360cc, 355a, 355f), or 
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prohibitions on the submission or licensing of bio-
logics license applications under section 351(k)(6) 
(interchangeable biological product exclusivity) or sec-
tion 351(k)(7) (biological product reference product 
exclusivity) of the Public Health Service Act (42 
U.S.C. 262(k)(6), (7)). 
(8) SUBSEQUENT FILER.—The term ‘‘subsequent 
filer’’ means— 
(A) in the case of a drug, a party that owns 
or controls an abbreviated new drug application 
submitted pursuant to section 505(j) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)) or a new drug application submitted 
pursuant to section 505(b)(2) of the Federal 
Food, Drug, and Cosmetic Act (21U.S.C. 
355(b)(2)) and filed under section 505(b)(1) of 
such Act (21 U.S.C. 355(b)(1)) or has the exclu-
sive rights to distribute the covered product that 
is the subject of such application; or 
(B) in the case of a biological product, a 
party that owns or controls an application filed 
with the Food and Drug Administration under 
section 351(k) of the Public Health Service Act 
(42 U.S.C. 262(k)) or has the exclusive rights to 
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distribute the biological product that is the sub-
ject of such application. 
(h) EFFECTIVE DATE.—This section applies with re-
spect to agreements described in subsection (a) entered into 
on or after the date of the enactment of this Act. 
SEC. 3. NOTICE AND CERTIFICATION OF AGREEMENTS. 
(a) NOTICE OF ALL AGREEMENTS.—Section 1111(7) 
of the Medicare Prescription Drug, Improvement, and Mod-
ernization Act of 2003 (21 U.S.C. 355 note) is amended 
by inserting ‘‘or the owner of a patent for which a claim 
of infringement could reasonably be asserted against any 
person for making, using, offering to sell, selling, or import-
ing into the United States a biological product that is the 
subject of a biosimilar biological product application’’ be-
fore the period at the end. 
(b) CERTIFICATION OF AGREEMENTS.—Section 1112 
of such Act (21 U.S.C. 355 note) is amended by adding 
at the end the following: 
‘‘(d) CERTIFICATION.—The Chief Executive Officer or 
the company official responsible for negotiating any agree-
ment under subsection (a) or (b) that is required to be filed 
under subsection (c) shall, within 30 days of such filing, 
execute and file with the Assistant Attorney General and 
the Commission a certification as follows: ‘I declare that 
the following is true, correct, and complete to the best of 
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my knowledge: The materials filed with the Federal Trade 
Commission and the Department of Justice under section 
1112 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003, with respect to the agreement 
referenced in this certification— 
‘‘ ‘(1) represent the complete, final, and exclusive 
agreement between the parties; 
‘‘ ‘(2) include any ancillary agreements that are 
contingent upon, provide a contingent condition for, 
were entered into within 30 days of, or are otherwise 
related to, the referenced agreement; and 
‘‘ ‘(3) include written descriptions of any oral 
agreements, representations, commitments, or prom-
ises between the parties that are responsive to sub-
section (a) or (b) of such section 1112 and have not 
been reduced to writing.’.’’. 
SEC. 4. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD. 
Section 505(j)(5)(D)(i)(V) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(V)) is amend-
ed by inserting ‘‘section 2 of the Protecting Consumer Access 
to Generic Drugs Act of 2019 or’’ after ‘‘that the agreement 
has violated’’. 
SEC. 5. COMMISSION LITIGATION AUTHORITY. 
Section 16(a)(2) of the Federal Trade Commission Act 
(15 U.S.C. 56(a)(2)) is amended— 
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(1) in subparagraph (D), by striking ‘‘or’’ after 
the semicolon; 
(2) in subparagraph (E), by inserting ‘‘or’’ after 
the semicolon; and 
(3) by inserting after subparagraph (E) the fol-
lowing: 
‘‘(F) under section 2(d)(3)(A) of the Pro-
tecting Consumer Access to Generic Drugs Act of 
2019;’’. 
SEC. 6. STATUTE OF LIMITATIONS. 
(a) IN GENERAL.—Except as provided in subsection 
(b), the Commission shall commence any administrative 
proceeding or civil action to enforce section 2 of this Act 
not later than 6 years after the date on which the parties 
to the agreement file the Notice of Agreement as provided 
by section 1112(c)(2) and (d) of the Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003 (21 
U.S.C. 355 note). 
(b) CIVIL ACTION AFTER ISSUANCE OF CEASE AND 
DESIST ORDER.—If the Commission has issued a cease and 
desist order under section 5 of the Federal Trade Commis-
sion Act (15 U.S.C. 45) for violation of section 2 of this 
Act and the proceeding for the issuance of such order was 
commenced within the period required by subsection (a) of 
this section, such subsection does not prohibit the commence-
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Union Calendar No. 30 
116TH CONGRESS 
1ST SESSION 
H. R. 1499 
[Report No. 116–52, Part I] 
A BILL 
To prohibit brand name drug manufacturers from 
compensating generic drug manufacturers to 
delay the entry of a generic drug into the mar-
ket, and to prohibit biological product manufac-
turers from compensating biosimilar and inter-
changeable product manufacturers to delay entry 
of biosimilar and interchangeable products, and 
for other purposes. 
MAY 10, 2019 
Reported from the Committee on Energy and Commerce 
with an amendment 
MAY 10, 2019 
Committee on the Judiciary discharged; committed to the 
Committee of the Whole House on the State of the 
Union and ordered to be printed 
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