(B) its directors, officers, employees, 
agents, representatives, successors, and assigns; 
and 
(C) the joint ventures, subsidiaries, part-
nerships, divisions, groups, and affiliates it con-
trols, and the respective directors, officers, em-
ployees, agents, representatives, successors, and 
assigns of each. 
(5) SERIES
OF
COVERED
PETITIONS.—The 
term ‘‘series of covered petitions’’ means any group 
of more than one covered petition. 
(6) SHAM.—The term ‘‘sham’’ means a covered 
petition that is objectively baseless and that at-
tempts to use a governmental process, as opposed to 
the outcome of that process, to interfere with the 
business of a competitor, or a series of covered peti-
tions, that attempts to use a governmental process, 
as opposed to the outcome of that process, to inter-
fere with the business of a competitor. 
(b) VIOLATION.— 
(1) IN
GENERAL.—A person submitting or 
causing the submission of a covered petition or a se-
ries of covered petitions that is a sham shall be lia-
ble for engaging in an unfair method of competition 
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under section 5(a)(1) of the Federal Trade Commis-
sion Act (15 U.S.C. 45(a)(1)). 
(c) CIVIL ACTION.— 
(1) IN GENERAL.—If the Commission has rea-
son to believe that the submission of a covered peti-
tion or a series of covered petitions constitutes a vio-
lation of section 5(a)(1) of the Federal Trade Com-
mission Act (15 U.S.C. 45(a)(1)), the Commission 
may commence a civil action to recover a civil pen-
alty and seek other appropriate relief in a district 
court of the United States against any person that 
submitted or caused to be submitted such covered 
petition or such series of covered petitions, including 
successors or assigns. 
(2) PRESUMPTION.—In a civil action under 
paragraph (1), a covered petition shall be presumed 
to be part of a series of covered petitions that is a 
sham under subsection (b) of this section if the Sec-
retary of Health and Human Services has deter-
mined that the covered petition was submitted with 
the primary purpose of delaying the approval of a 
covered application, was part of a series of covered 
petitions, and has referred such determination to the 
Federal Trade Commission in writing, with a rea-
soned basis for the determination. 
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(3) EXCEPTION.—The presumption in para-
graph (2) shall not apply if the defendant estab-
lishes, by a preponderance of the evidence, that the 
series of covered petitions that includes the covered 
petition referred to the Commission by the Secretary 
of Health and Human Services is not a sham. 
(4) CIVIL PENALTY.—In an action under para-
graph (1), any person that has been found liable for 
a violation of section 5(a)(1) of the Federal Trade 
Commission Act (15 U.S.C. 45(a)(1)) shall be sub-
ject to a civil penalty for each violation of not more 
than the greater of— 
(A) any revenue earned from the sale by 
such person of any drug product, referenced in 
a covered application that was the subject of a 
covered petition or a series of covered petitions 
that is a sham, during the period in which the 
covered petition or series of covered petitions 
was under review by the Secretary of Health 
and Human Services; or 
(B) $50,000 for each calendar day that 
each covered petition that is a sham or that was 
part of a series of covered petitions that is a 
sham was under review by the Secretary of 
Health and Human Services. 
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(5) ANTITRUST LAWS.—Nothing in this section 
shall modify, impair, limit, or supersede the applica-
bility 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 the Federal Trade Com-
mission Act (15 U.S.C. 45) to the extent that it ap-
plies to unfair methods of competition. 
(6) RULE OF CONSTRUCTION.—The civil pen-
alty provided in this subsection is in addition to, and 
not in lieu of, any other remedies provided by Fed-
eral law, including under section 16 of the Clayton 
Act (15 U.S.C. 26) or under section 13(b) of the 
Federal Trade Commission Act (15 U.S.C. 53(b)). 
Nothing in this paragraph shall be construed to af-
fect any authority of the Commission under any 
other provision of law. 
(d) APPLICABILITY.—This section shall apply to any 
covered petition submitted on or after the date of enact-
ment of this Act. 
SEC. 3. SEVERABILITY. 
If any provision of this Act, an amendment made by 
this Act, or the application of such provision or amend-
ment to any person or circumstance is held to be unconsti-
tutional, the remainder of this Act, the amendments made 
by this Act, and the application of the provisions of such 
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Act or amendments to any person or circumstance shall 
not be affected. 
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Union Calendar No. 577 
116TH CONGRESS 
2D SESSION 
H. R. 2374 
[Report No. 116–694] 
A BILL 
To enable the Federal Trade Commission to deter 
filing of sham citizen petitions to cover an at-
tempt to interfere with approval of a competing 
generic drug or biosimilar, to foster competition 
and facilitate the efficient review of petitions 
filed in good faith to raise legitimate public heath 
concerns, and for other purposes. 
DECEMBER 24, 2020 
Committed to the Committee of the Whole House on the 
State of the Union and ordered to be printed 
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