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 
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 
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(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-
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 (8), 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 
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(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 
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 
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Service Act (42 U.S.C. 262(a)) for a cov-
ered 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-
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. 
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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 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 
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-
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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 
(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. 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 
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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 
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, 
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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. 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 2021 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 2021;’’. 
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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 
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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