I 
116TH CONGRESS 
1ST SESSION H. R. 1499 
To prohibit brand name drug manufacturers from compensating generic drug 
manufacturers to delay the entry of a generic drug into the market, 
and to prohibit biological product manufacturers from compensating bio-
similar and interchangeable product manufacturers to delay entry of 
biosimilar and interchangeable products, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 5, 2019 
Mr. RUSH introduced the following bill; which was referred to the Committee 
on Energy and Commerce, and in addition to the Committee on the Judi-
ciary, 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 prohibit brand name drug manufacturers from compen-
sating generic drug manufacturers to delay the entry 
of a generic drug into the market, and to prohibit bio-
logical product manufacturers from compensating bio-
similar and interchangeable product manufacturers to 
delay entry of biosimilar and interchangeable products, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Protecting Consumer 
Access to Generic Drugs Act of 2019’’. 
SEC. 2. UNLAWFUL AGREEMENTS. 
(a) AGREEMENTS PROHIBITED.—Subject to sub-
sections (b) and (c), it shall be unlawful for an NDA or 
BLA holder and a subsequent filer to enter into, or carry 
out, an agreement resolving or settling a covered patent 
infringement claim on a final or interim basis if under 
such agreement— 
(1) a subsequent filer directly or indirectly re-
ceives from such holder anything of value, including 
an exclusive license; and 
(2) the subsequent filer agrees to limit or fore-
go research on, or development, manufacturing, 
marketing, or sales, for any period of time, of the 
covered product that is the subject of the application 
described in subparagraph (A) or (B) of subsection 
(f)(8). 
(b) EXCLUSION.—It shall not be unlawful under sub-
section (a) if a party to an agreement described in such 
subsection demonstrates by clear and convincing evidence 
that the value described in subsection (a)(1) is compensa-
tion solely for other goods or services that the subsequent 
filer has promised to provide. 
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(c) LIMITATION.—Nothing in this section shall pro-
hibit an agreement resolving or settling a covered patent 
infringement claim in which the consideration granted by 
the NDA or BLA holder to the subsequent filer as part 
of the resolution or settlement includes only one or more 
of the following: 
(1) The right to market the covered product 
that is the subject of the application described in 
subparagraph (A) or (B) of subsection (f)(8) in the 
United States before the expiration of— 
(A) any patent that is the basis of the cov-
ered patent infringement claim; or 
(B) any patent right or other statutory ex-
clusivity that would prevent the marketing of 
such covered product. 
(2) A payment for reasonable litigation ex-
penses not to exceed $7,500,000 in the aggregate. 
(3) A covenant not to sue on any claim that 
such covered product infringes a patent. 
(d) ENFORCEMENT BY FEDERAL TRADE COMMIS-
SION.— 
(1) GENERAL APPLICATION.—The requirements 
of this section apply, according to their terms, to an 
NDA or BLA holder or subsequent filer that is— 
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(A) a person, partnership, or corporation 
over which the Commission has authority pur-
suant to section 5(a)(2) of the Federal Trade 
Commission Act (15 U.S.C. 45(a)(2)); or 
(B) a person, partnership, or corporation 
over which the Commission would have author-
ity pursuant to such section but for the fact 
that such person, partnership, or corporation is 
not organized to carry on business for its own 
profit or that of its members. 
(2) UNFAIR OR DECEPTIVE ACTS OR PRACTICES 
ENFORCEMENT AUTHORITY.— 
(A) IN GENERAL.—A violation of this sec-
tion shall be treated as an unfair or deceptive 
act or practice in violation of section 5(a)(1) of 
the Federal Trade Commission Act (15 U.S.C. 
45(a)(1)). 
(B) POWERS OF COMMISSION.—Except as 
provided in subparagraph (C) and paragraphs 
(1)(B) and (3)— 
(i) the Commission shall enforce this 
section in the same manner, by the same 
means, and with the same jurisdiction, 
powers, and duties as though all applicable 
terms and provisions of the Federal Trade 
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Commission Act (15 U.S.C. 41 et seq.) 
were incorporated into and made a part of 
this section; and 
(ii) any NDA or BLA holder or subse-
quent filer that violates this section shall 
be subject to the penalties and entitled to 
the privileges and immunities provided in 
the Federal Trade Commission Act. 
(C) JUDICIAL REVIEW.—In the case of a 
cease and desist order issued by the Commis-
sion under section 5 of the Federal Trade Com-
mission Act (15 U.S.C. 45) for violation of this 
section, a party to such order may obtain judi-
cial review of such order as provided in such 
section 5, except that— 
(i) such review may only be obtained 
in— 
(I) the United States Court of 
Appeals for the District of Columbia 
Circuit; 
(II) the United States Court of 
Appeals 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 suc-
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cessor thereto, of the NDA or BLA 
holder is incorporated as of the date 
that the application described in sub-
paragraph (A) or (B) of subsection 
(f)(8) is submitted to the Commis-
sioner of Food and Drugs; or 
(III) the United States Court of 
Appeals for the circuit in which the 
ultimate parent entity, as so defined, 
of the subsequent filer is incorporated 
as of the date that the application de-
scribed in subparagraph (A) or (B) of 
subsection (f)(8) is submitted to the 
Commissioner 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 
seeking review. 
(3) ADDITIONAL ENFORCEMENT AUTHORITY.— 
(A) CIVIL
PENALTY.—The Commission 
may commence a civil action to recover a civil 
penalty in a district court of the United States 
against any NDA or BLA holder or subsequent 
filer that violates this section. 
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(B) SPECIAL
RULE
FOR
RECOVERY
OF 
PENALTY
IF
CEASE
AND
DESIST
ORDER 
ISSUED.— 
(i) IN GENERAL.—If the Commission 
has issued a cease and desist order in a 
proceeding under section 5 of the Federal 
Trade Commission Act (15 U.S.C. 45) for 
violation 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 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 ma-
terial 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 
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(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.— 
(i) IN GENERAL.—The amount of a 
civil penalty imposed in a civil action under 
subparagraph (A) on a party to an agree-
ment described in subsection (a) shall be 
sufficient to deter violations of this section, 
but in no event greater than— 
(I) if such party is the NDA or 
BLA holder, the greater of— 
(aa) 3 times the value re-
ceived by such NDA or BLA 
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holder that is reasonably attrib-
utable to the violation of this sec-
tion; or 
(bb) 3 times the value given 
to the subsequent filer reasonably 
attributable to the violation of 
this section; and 
(II) if such party is the subse-
quent filer, 3 times the value received 
by such subsequent filer that is rea-
sonably 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 
business, profits earned by the NDA 
or BLA holder, compensation received 
by the subsequent filer, and the 
amount of commerce affected; and 
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(III) other matters that justice 
requires. 
(D) INJUNCTIONS AND OTHER EQUITABLE 
RELIEF.—In a civil action under subparagraph 
(A), the United States district courts are em-
powered to grant mandatory injunctions and 
such other and further equitable relief as they 
deem appropriate. 
(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. 
(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) 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-
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, im-
pair, limit, or supersede the right of a subsequent filer 
to assert claims or counterclaims against any person, 
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under the antitrust laws or other laws relating to unfair 
competition. 
(f) DEFINITIONS.—In this section: 
(1) AGREEMENT
RESOLVING
OR
SETTLING
A 
COVERED
PATENT
INFRINGEMENT
CLAIM.—The 
term ‘‘agreement resolving or settling a covered pat-
ent infringement 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 hold-
er to a subsequent filer, whether or not included in 
a complaint filed with a court of law, that— 
(A) the submission of the application de-
scribed in clause (i) or (ii) of paragraph (5)(A), 
or the manufacture, use, offering for sale, sale, 
or importation into the United States of a cov-
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ered product that is the subject of such an ap-
plication, infringes any patent owned by, or ex-
clusively licensed to, the NDA or BLA holder of 
the covered product; or 
(B) the covered product to be manufac-
tured under such application uses a covered 
product as claimed in a published patent appli-
cation. 
(4) COVERED
PRODUCT.—The term ‘‘covered 
product’’ means— 
(A) a new drug (as defined in section 
201(p) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321(p))); or 
(B) a biological product (as defined in sec-
tion 351(i) of the Public Health Service Act (42 
U.S.C. 262(i))). 
(5) NDA OR BLA HOLDER.—The term ‘‘NDA 
or BLA holder’’ means— 
(A) the holder of— 
(i) an approved new drug application 
filed under section 505(b)(1) of the Fed-
eral Food, Drug, and Cosmetic Act (21 
U.S.C. 355(b)(1)) for a covered product; 
or 
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(ii) an application approved under sec-
tion 351(a) of the Public Health Service 
Act (42 U.S.C. 262(a)) with respect to a 
biological product; 
(B) a person owning or controlling enforce-
ment of the patent on— 
(i) the list published under section 
505(j)(7) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(7)) in con-
nection with the application described in 
subparagraph (A)(i); or 
(ii) the equivalent list published under 
section 351 of the Public Health Service 
Act (42 U.S.C. 262) comprised of patents 
associated with applications filed under 
section 351(a) of such Act (42 U.S.C. 
262(a)); or 
(C) the predecessors, subsidiaries, divi-
sions, groups, and affiliates controlled by, con-
trolling, or under common control with any en-
tity described in subparagraph (A) or (B) (such 
control to be presumed by direct or indirect 
share ownership of 50 percent or greater), as 
well as the licensees, licensors, successors, and 
assigns of each of the entities. 
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(6) PATENT.—The term ‘‘patent’’ means a pat-
ent issued by the United States Patent and Trade-
mark Office. 
(7) 
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 505(j)(5)(B)(iv) (180-day 
exclusivity), section 527 (orphan drug exclusivity), 
section 505A (pediatric exclusivity), or section 505E 
(qualified infectious disease product exclusivity) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(c)(3)(E), 355(j)(5)(B)(iv), 360cc, 355a, 
355f), or section 351(k)(6) (interchangeable biologi-
cal product exclusivity) or section 351(k)(7) (biologi-
cal product reference product exclusivity) of the 
Public Health Service Act (42 U.S.C. 262(k)(6), 
(7)). 
(8) SUBSEQUENT
FILER.—The term ‘‘subse-
quent filer’’ means— 
(A) in the case of a drug, a party that 
owns or controls an abbreviated new drug appli-
cation 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 
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section 505(b)(2) of such Act (21 U.S.C. 
355(b)(2)) or has the exclusive rights to dis-
tribute 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 distribute the biological product that is the 
subject of such application. 
(g) EFFECTIVE DATE.—This section shall apply to 
all agreements described in subsection (a) entered into 
after June 17, 2013, except that a civil penalty may only 
be obtained under subsection (d)(3)(A) with respect to 
such an agreement entered into on or after the date of 
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 
Modernization 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, sell-
ing, or importing into the United States a biological prod-
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uct that is the subject of a biosimilar biological product 
application’’ before 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 
agreement 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 my knowledge: The materials filed with the Federal 
Trade Commission and the Department of Justice under 
section 1112 of the Medicare Prescription Drug, Improve-
ment, and Modernization Act of 2003, with respect to the 
agreement referenced in this certification— 
‘‘ ‘(1) represent the complete, final, and exclu-
sive 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-
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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 amended by inserting ‘‘section 2 of the Protecting Con-
sumer 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— 
(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 
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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 
Commission 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 sub-
section (a) of this section, such subsection does not pro-
hibit the commencement, after such period, of a civil ac-
tion under section 2(d)(3)(A) against a party to such 
order or a civil action under subsection (l) of such section 
5 for violation of such order. 
Æ 
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