IB 
Union Calendar No. 30 
116TH CONGRESS 
1ST SESSION H. R. 1499 
[Report No. 116–52, Part I] 
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 
MAY 10, 2019 
Additional sponsors: Mr. PALLONE, Mr. RUIZ, Mrs. DINGELL, Mrs. CRAIG, 
Ms. ESHOO, Mr. KENNEDY, Ms. MATSUI, Mr. VAN DREW, Ms. CLARKE 
of New York, Mr. KHANNA, Ms. SCHAKOWSKY, Mr. PAPPAS, Mr. COHEN, 
Mr. WELCH, Mr. LARSON of Connecticut, Mr. HASTINGS, Mr. NEGUSE, 
Ms. FINKENAUER, Mr. CASE, Mr. QUIGLEY, Ms. WILD, Mr. LANGEVIN, 
Mr. COOPER, Mr. RASKIN, Mr. DAVID
SCOTT
of Georgia, Ms. 
MUCARSEL-POWELL, Mr. THOMPSON of Mississippi, Ms. STEVENS, Mr. 
CISNEROS, Ms. KELLY
of Illinois, Mr. CASTEN
of Illinois, Ms. 
HOULAHAN, Mr. CARSON of Indiana, Mr. CARBAJAL, Ms. DAVIDS of 
Kansas, Mr. SMITH of Washington, Mr. CONNOLLY, and Ms. UNDER-
WOOD 
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MAY 10, 2019 
Reported from the Committee on Energy and Commerce with an amendment 
[Strike out all after the enacting clause and insert the part printed in italic] 
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 
[For text of introduced bill, see copy of bill as introduced on March 5, 2019] 
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. 
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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 ‘‘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 (or for two subsequent 
filers) 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 (or in the case of such an 
agreement between two subsequent filers, the other 
subsequent filer) anything of value, including a li-
cense; and 
(2) the subsequent filer agrees to limit or forego 
research on, or development, manufacturing, mar-
keting, 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 (g)(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 
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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. 
(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 (or from 
one subsequent filer to another) 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 subpara-
graph (A) or (B) of subsection (g)(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 expenses 
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.— 
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(1) GENERAL
APPLICATION.—The requirements 
of this section apply, according to their terms, to an 
NDA or BLA holder or subsequent filer that is— 
(A) a person, partnership, or corporation 
over which the Commission has authority pursu-
ant to section 5(a)(2) of the Federal Trade Com-
mission Act (15 U.S.C. 45(a)(2)); or 
(B) a person, partnership, or corporation 
over which the Commission would have authority 
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 
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means, and with the same jurisdiction, 
powers, and duties as though all applicable 
terms and provisions of the Federal Trade 
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 Commission 
under section 5 of the Federal Trade Commission 
Act (15 U.S.C. 45) for violation of this section, 
a party to such order may obtain judicial review 
of such order as provided in such section 5, ex-
cept that— 
(i) such review may only be obtained 
in— 
(I) the United States Court of Ap-
peals for the District of Columbia Cir-
cuit; 
(II) the United States Court of 
Appeals for the circuit in which the ul-
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timate parent entity, as defined in sec-
tion 801.1(a)(3) of title 16, Code of 
Federal Regulations, or any successor 
thereto, of the NDA or BLA holder (if 
any such holder is a party to such 
order) is incorporated as of the date 
that the application described in sub-
paragraph (A) or (B) of subsection 
(g)(8) or an approved application that 
is deemed to be a license for a biologi-
cal product under section 351(k) of the 
Public Health Service Act (42 U.S.C. 
262(k)) pursuant to section 7002(e)(4) 
of the Biologics Price Competition and 
Innovation Act of 2009 (Public Law 
111–148; 124 Stat. 817) is submitted 
to the Commissioner of Food and 
Drugs; or 
(III) the United States Court of 
Appeals for the circuit in which the ul-
timate parent entity, as so defined, of 
any subsequent filer that is a party to 
such order is incorporated as of the 
date that the application described in 
subparagraph (A) or (B) of subsection 
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