154 
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-
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-
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155 
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 
(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 
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156 
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 
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— 
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157 
(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.— 
(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— 
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158 
(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-
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-
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159 
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)), 
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. 
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160 
(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-
gated 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 furtherance of market competition and for the 
benefit of consumers. 
(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-
tion of the Clayton Act (15 U.S.C. 12(a)), and of section 
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161 
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, 
under the antitrust laws or other laws relating to unfair 
competition. 
(g) 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 (or, in the case of an agree-
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162 
ment between two subsequent filers, by one subse-
quent filer to 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 para-
graph (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 application— 
(i) in the case of an agreement be-
tween an NDA or BLA holder and a sub-
sequent filer, infringes any patent owned 
by, or exclusively licensed to, the NDA or 
BLA holder 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 
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163 
U.S.C. 321(g))), including a biological product (as 
defined in section 351(i) of the Public Health Serv-
ice 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 
(ii) a biologics license application filed 
under section 351(a) of the Public Health 
Service Act (42 U.S.C. 262(a)) with re-
spect 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) any list published under section 
351 of the Public Health Service Act (42 
U.S.C. 262) comprised of patents associ-
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164 
ated with biologics license 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. 
(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 submission 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 (pediatric exclusivity), or section 505E 
(qualified infectious disease product exclusivity) of 
the Federal Food, Drug, and Cosmetic Act (21 
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165 
U.S.C. 355(c)(3)(E), 355(j)(5)(B)(iv), 355(j)(5)(F), 
360cc, 355a, 355f), or prohibitions on the submis-
sion or licensing of biologics license applications 
under section 351(k)(6) (interchangeable biological 
product exclusivity) or section 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 ‘‘subse-
quent filer’’ means— 
(A) in the case of a drug, a party that 
owns or controls an abbreviated new drug appli-
cation submitted pursuant to section 505(j) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)) or a new drug application sub-
mitted pursuant to section 505(b)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.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 exclusive rights to distribute the cov-
ered product that is the subject of such applica-
tion; 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 
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166 
(42 U.S.C. 262(k)) or has the exclusive rights 
to distribute the biological product that is the 
subject 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. 302. 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-
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 
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167 
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-
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. 303. 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 301 of the Lower Costs, 
More Cures Act of 2021 or’’ after ‘‘that the agreement 
has violated’’. 
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168 
SEC. 304. 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 moving the margin 
2 ems to the left and inserting ‘‘or’’ after the semi-
colon; and 
(3) by inserting after subparagraph (E) the fol-
lowing: 
‘‘(F) under section 301(d)(3)(A) of the Lower 
Costs, More Cures Act of 2021;’’. 
SEC. 305. 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 301 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 
Commission Act (15 U.S.C. 45) for violation of section 
301 of this Act and the proceeding for the issuance of 
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169 
such order was commenced within the period required by 
subsection (a) of this section, such subsection does not 
prohibit the commencement, after such period, of a civil 
action under section 301(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. 
Subtitle B—Advancing Education 
on Biosimilars 
SEC. 321. EDUCATION ON BIOLOGICAL PRODUCTS. 
(a) WEBSITE; CONTINUING EDUCATION.—Subpart 1 
of part F of title III of the Public Health Service Act (42 
U.S.C. 262 et seq.) is amended by adding at the end the 
following: 
‘‘SEC. 352A. EDUCATION ON BIOLOGICAL PRODUCTS. 
‘‘(a) INTERNET WEBSITE.— 
‘‘(1) IN GENERAL.—The Secretary shall main-
tain and operate an internet website to provide edu-
cational materials for health care providers, patients, 
and caregivers, regarding the meaning of the terms, 
and the standards for review and licensing of, bio-
logical products, including biosimilar biological prod-
ucts and interchangeable biosimilar biological prod-
ucts. 
‘‘(2) CONTENT.—Educational materials pro-
vided under paragraph (1) may include— 
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‘‘(A) explanations of key statutory and 
regulatory terms, including ‘biosimilar’ and 
‘interchangeable’, and clarification regarding 
the use of interchangeable biosimilar biological 
products; 
‘‘(B) information related to development 
programs for biological products, including bio-
similar biological products and interchangeable 
biosimilar biological products and relevant clin-
ical considerations for prescribers, which may 
include, as appropriate and applicable, informa-
tion related to the comparability of such biologi-
cal products; 
‘‘(C) an explanation of the process for re-
porting adverse events for biological products, 
including biosimilar biological products and 
interchangeable biosimilar biological products; 
and 
‘‘(D) an explanation of the relationship be-
tween biosimilar biological products and inter-
changeable biosimilar biological products li-
censed under section 351(k) and reference 
products (as defined in section 351(i)), includ-
ing the standards for review and licensing of 
each such type of biological product. 
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