I 
117TH CONGRESS 
1ST SESSION 
H. R. 153 
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 
JANUARY 4, 2021 
Mr. RUSH (for himself, Mr. CASTEN, Mr. COHEN, Mr. CONNOLLY, Mr. 
DESAULNIER, Mr. NEGUSE, Mr. RUIZ, Ms. UNDERWOOD, and Mr. VAN 
DREW) 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 2021’’. 
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 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 
(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 
that the value described in subsection (a)(1) is compensa-
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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 
subparagraph (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 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.— 
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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 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 
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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 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 
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ultimate parent entity, as defined in 
section 801.1(a)(3) of title 16, Code 
of Federal Regulations, or any suc-
cessor 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 subparagraph (A) or (B) of sub-
section (g)(8) or an approved applica-
tion that is deemed to be a license for 
a biological 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 Com-
missioner 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 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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(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 
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. 
(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 
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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 
(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 
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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 (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 
holder (or by such subsequent 
filer) that is reasonably attrib-
utable to the violation of this sec-
tion; or 
(bb) 3 times the value given 
to the subsequent filer (or to the 
other subsequent filer) reason-
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ably attributable to the violation 
of this section; and 
(II) if such party is the subse-
quent filer (or, in the case of an 
agreement between two subsequent fil-
ers, the subsequent filer who received 
the value described in subsection 
(a)(1)), 3 times the value received by 
such subsequent filer that is reason-
ably 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 (or, in the case of an 
agreement between two subsequent fil-
ers, the subsequent filer who gave the 
value described in subsection (a)(1)), 
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compensation received by the subse-
quent filer (or, in the case of an 
agreement between two subsequent fil-
ers, the subsequent filer who received 
the value described in subsection 
(a)(1)), and the amount of commerce 
affected; and 
(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) FEDERAL TRADE COMMISSION RULEMAKING.— 
The Commission may, in its discretion, by rule promul-
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