I 
116TH CONGRESS 
1ST SESSION H. R. 2375 
To prohibit prescription drug companies from compensating other prescription 
drug companies to delay the entry of a generic drug, biosimilar biological 
product, or interchangeable biological product into the market. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 29, 2019 
Mr. NADLER (for himself, Mr. COLLINS of Georgia, and Mr. CICILLINE) intro-
duced the following bill; which was referred to the Committee on the Ju-
diciary, and in addition to the Committee on Energy and Commerce, 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 com-
mittee concerned 
A BILL 
To prohibit prescription drug companies from compensating 
other prescription drug companies to delay the entry 
of a generic drug, biosimilar biological product, or inter-
changeable biological product into the market. 
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 ‘‘Preserve Access to Af-
fordable Generics and Biosimilars Act’’. 
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SEC. 2. DECLARATION OF PURPOSES. 
The purposes of this Act are— 
(1) to enhance competition in the pharma-
ceutical market by stopping anticompetitive agree-
ments between manufacturers of brand name and 
generic drug products or biosimilar biological prod-
ucts, or among manufacturers of generic drug prod-
ucts or biosimilar biological products, that limit, 
delay, or otherwise prevent competition from generic 
drugs and biosimilar biological products; and 
(2) to support the purpose and intent of anti-
trust law by prohibiting anticompetitive practices in 
the pharmaceutical industry that harm consumers. 
SEC. 3. UNLAWFUL COMPENSATION FOR DELAY. 
(a) IN GENERAL.—The Federal Trade Commission 
Act (15 U.S.C. 44 et seq.) is amended by inserting after 
section 26 (15 U.S.C. 57c–2) the following: 
‘‘SEC. 27. PRESERVING ACCESS TO AFFORDABLE GENERICS 
AND BIOSIMILARS. 
‘‘(a) IN GENERAL.— 
‘‘(1) ENFORCEMENT PROCEEDING.—The Com-
mission may initiate a proceeding to enforce the pro-
visions of this section against the parties to any 
agreement resolving or settling, on a final or interim 
basis, a patent claim, in connection with the sale of 
a drug product or biological product. 
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‘‘(2) PRESUMPTION AND VIOLATION.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), in such a proceeding, an agreement 
shall be presumed to have anticompetitive ef-
fects and shall be a violation of this section if— 
‘‘(i) an ANDA filer or a biosimilar bi-
ological product application filer receives 
anything of value, including an exclusive li-
cense; and 
‘‘(ii) the ANDA filer or biosimilar bio-
logical product application filer agrees to 
limit or forgo research, development, man-
ufacturing, marketing, or sales of the 
ANDA product or biosimilar biological 
product, as applicable, for any period of 
time. 
‘‘(B) 
EXCEPTION.—Subparagraph 
(A) 
shall not apply if the parties to such agreement 
demonstrate by clear and convincing evidence 
that— 
‘‘(i) the value described in subpara-
graph (A)(i) is compensation solely for 
other goods or services that the ANDA 
filer or biosimilar biological product appli-
cation filer has promised to provide; or 
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‘‘(ii) the procompetitive benefits of the 
agreement outweigh the anticompetitive ef-
fects of the agreement. 
‘‘(b) LIMITATIONS.—In determining whether the set-
tling parties have met their burden under subsection 
(a)(2)(B), the fact finder shall not presume— 
‘‘(1) that entry would not have occurred until 
the expiration of the relevant patent or statutory ex-
clusivity; or 
‘‘(2) that the agreement’s provision for entry of 
the ANDA product or biosimilar biological product 
prior to the expiration of the relevant patent or stat-
utory exclusivity means that the agreement is pro-
competitive. 
‘‘(c) EXCLUSIONS.—Nothing in this section shall pro-
hibit a resolution or settlement of a patent infringement 
claim in which the consideration that the ANDA filer or 
biosimilar biological product application filer receives as 
part of the resolution or settlement includes only one or 
more of the following: 
‘‘(1) The right to market and secure final regu-
latory approval for the ANDA product or biosimilar 
biological product at a date, whether certain or con-
tingent, in the United States prior to the expiration 
of— 
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‘‘(A) any patent that is the basis for the 
patent infringement claim; or 
‘‘(B) any patent right or other statutory 
exclusivity that would prevent the marketing of 
such ANDA product or biosimilar biological 
product. 
‘‘(2) A payment for reasonable litigation ex-
penses not to exceed— 
‘‘(A) for calendar year 2019, $7,500,000; 
and 
‘‘(B) for calendar year 2020 and each cal-
endar year thereafter, the amount determined 
for the preceding calendar year adjusted to re-
flect the percentage increase (if any) in the 
Producer Price Index for Legal Services pub-
lished by the Bureau of Labor Statistics of the 
Department of Labor for the then most recent 
12-month period ending December 31. 
‘‘(3) A covenant not to sue on any claim that 
the ANDA product or biosimilar biological product 
infringes a United States patent. 
‘‘(d) ENFORCEMENT.— 
‘‘(1) ENFORCEMENT.—A violation of this sec-
tion shall be treated as an unfair method of competi-
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tion under section 5(a)(1) of the Federal Trade 
Commission Act (15 U.S.C. 45(a)(1)). 
‘‘(2) JUDICIAL REVIEW.— 
‘‘(A) IN GENERAL.—Any party that is sub-
ject to a final order of the Commission, issued 
in an administrative adjudicative proceeding 
under the authority of subsection (a)(1), may, 
within 30 days of the issuance of such order, 
petition for review of such order in— 
‘‘(i) the United States Court of Ap-
peals for the District of Columbia Circuit; 
‘‘(ii) the United States Court of Ap-
peals 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 successor thereto, of 
the NDA holder or biological product li-
cense holder is incorporated as of the date 
that the NDA or biological product license 
application, as applicable, is filed with the 
Commissioner of Food and Drugs; or 
‘‘(iii) the United States Court of Ap-
peals for the circuit in which the ultimate 
parent entity of the ANDA filer or bio-
similar biological product application filer 
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is incorporated as of the date that the 
ANDA or biosimilar biological product ap-
plication is filed with the Commissioner of 
Food and Drugs. 
‘‘(B) TREATMENT
OF
FINDINGS.—In a 
proceeding for judicial review of a final order of 
the Commission, the findings of the Commis-
sion as to the facts, if supported by evidence, 
shall be conclusive. 
‘‘(e) 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 section of the Clayton Act (15 U.S.C. 12(a)), and 
of section 5 of this Act to the extent that section 5 applies 
to unfair methods of competition. Nothing in this section 
shall modify, impair, limit, or supersede the right of an 
ANDA filer or biosimilar biological product application 
filer to assert claims or counterclaims against any person, 
under the antitrust laws or other laws relating to unfair 
competition. 
‘‘(f) PENALTIES.— 
‘‘(1) FORFEITURE.—Each party that violates or 
assists in the violation of this section shall forfeit 
and pay to the United States a civil penalty suffi-
cient to deter violations of this section, but in no 
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event greater than 3 times the value received by the 
party that is reasonably attributable to the violation 
of this section. If no such value has been received by 
the NDA holder, biological product license holder, 
the ANDA filer, or biosimilar biological product ap-
plication filer the penalty to the NDA holder, bio-
logical product license holder, the ANDA filer, or 
biosimilar biological product application filer shall be 
sufficient to deter violations, but in no event greater 
than 3 times the value given to an ANDA filer or 
biosimilar biological product application filer reason-
ably attributable to the violation of this section. 
Such penalty shall accrue to the United States and 
may be recovered in a civil action brought by the 
Commission, in its own name by any of its attorneys 
designated by it for such purpose, in a district court 
of the United States against any party that violates 
this section. In such actions, the United States dis-
trict courts are empowered to grant mandatory in-
junctions and such other and further equitable relief 
as they deem appropriate. 
‘‘(2) CEASE AND DESIST.— 
‘‘(A) IN GENERAL.—If the Commission has 
issued a cease and desist order with respect to 
a party in an administrative adjudicative pro-
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ceeding under the authority of subsection 
(a)(1), an action brought pursuant to para-
graph (1) may be commenced against such 
party at any time before the expiration of 1 
year after such order becomes final pursuant to 
section 5(g). 
‘‘(B) EXCEPTION.—In an action under 
subparagraph (A), the findings of the Commis-
sion as to the material facts in the administra-
tive adjudicative proceeding with respect to the 
violation of this section by a party shall be con-
clusive unless— 
‘‘(i) the terms of such cease and de-
sist order expressly provide that the Com-
mission’s findings shall not be conclusive; 
or 
‘‘(ii) the order became final by reason 
of section 5(g)(1), in which case such find-
ing shall be conclusive if supported by evi-
dence. 
‘‘(3) CIVIL
PENALTY.—In determining the 
amount of the civil penalty described in this section, 
the court shall take into account— 
‘‘(A) the nature, circumstances, extent, 
and gravity of the violation; 
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‘‘(B) with respect to the violator, the de-
gree of culpability, any history of violations, the 
ability to pay, any effect on the ability to con-
tinue doing business, profits earned by the 
NDA holder, biological product license holder, 
the ANDA filer, or biosimilar biological product 
application filer, compensation received by the 
ANDA filer or biosimilar biological product ap-
plication filer, and the amount of commerce af-
fected; and 
‘‘(C) other matters that justice requires. 
‘‘(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. Nothing in this paragraph shall be construed to 
affect any authority of the Commission under any 
other provision of law. 
‘‘(g) DEFINITIONS.—In this section: 
‘‘(1) 
AGREEMENT.—The 
term 
‘agreement’ 
means anything that would constitute an agreement 
under section 1 of the Sherman Act (15 U.S.C. 1) 
or section 5 of this Act. 
‘‘(2) AGREEMENT RESOLVING OR SETTLING A 
PATENT INFRINGEMENT CLAIM.—The term ‘agree-
ment resolving or settling a patent infringement 
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claim’ includes any agreement that is entered into 
within 30 days of the resolution or the settlement of 
the claim, or any other agreement that is contingent 
upon, provides a contingent condition for, or is oth-
erwise related to the resolution or settlement of the 
claim. 
‘‘(3) ANDA.—The term ‘ANDA’ means an ab-
breviated new drug application filed under section 
505(j) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(j)) or a new drug application filed 
under section 505(b)(2) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(b)(2)). 
‘‘(4) ANDA FILER.—The term ‘ANDA filer’ 
means a party that owns or controls an ANDA filed 
with the Food and Drug Administration or has the 
exclusive rights under such ANDA to distribute the 
ANDA product. 
‘‘(5) ANDA 
PRODUCT.—The term ‘ANDA 
product’ means the product to be manufactured 
under the ANDA that is the subject of the patent 
infringement claim. 
‘‘(6) BIOLOGICAL
PRODUCT.—The term ‘bio-
logical product’ has the meaning given such term in 
section 351(i)(1) of the Public Health Service Act 
(42 U.S.C. 262(i)(1)). 
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‘‘(7) BIOLOGICAL PRODUCT LICENSE APPLICA-
TION.—The term ‘biological product license applica-
tion’ means an application under section 351(a) of 
the Public Health Service Act (42 U.S.C. 262(a)). 
‘‘(8) BIOLOGICAL
PRODUCT
LICENSE
HOLD-
ER.—The term ‘biological product license holder’ 
means— 
‘‘(A) the holder of an approved biological 
product license application for a biological prod-
uct; 
‘‘(B) a person owning or controlling en-
forcement of any patents that claim the biologi-
cal product that is the subject of such approved 
application; or 
‘‘(C) the predecessors, subsidiaries, divi-
sions, groups, and affiliates controlled by, con-
trolling, or under common control with any of 
the entities described in subparagraphs (A) and 
(B) (such control to be presumed by direct or 
indirect share ownership of 50 percent or great-
er), as well as the licensees, licensors, succes-
sors, and assigns of each of the entities. 
‘‘(9) BIOSIMILAR BIOLOGICAL PRODUCT.—The 
term ‘biosimilar biological product’ means the prod-
uct to be manufactured under the biosimilar biologi-
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cal product application that is the subject of the pat-
ent infringement claim. 
‘‘(10) BIOSIMILAR BIOLOGICAL PRODUCT APPLI-
CATION.—The term ‘biosimilar biological product ap-
plication’ means an application under section 351(k) 
of the Public Health Service Act (42 U.S.C. 262(k)) 
for licensure of a biological product as biosimilar to, 
or interchangeable with, a reference product. 
‘‘(11) BIOSIMILAR BIOLOGICAL PRODUCT APPLI-
CATION
FILER.—The term ‘biosimilar biological 
product application filer’ means a party that owns or 
controls a biosimilar biological product application 
filed with the Food and Drug Administration or has 
the exclusive rights under such application to dis-
tribute the biosimilar biological product. 
‘‘(12) DRUG PRODUCT.—The term ‘drug prod-
uct’ has the meaning given such term in section 
314.3(b) of title 21, Code of Federal Regulations (or 
any successor regulation). 
‘‘(13) MARKET.—The term ‘market’ means the 
promote, offer for sale, sell, or distribute a drug 
product. 
‘‘(14) NDA.—The term ‘NDA’ means a new 
drug application filed under section 505(b) of the 
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Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(b)). 
‘‘(15) NDA HOLDER.—The term ‘NDA holder’ 
means— 
‘‘(A) the holder of an approved NDA appli-
cation for a drug product; 
‘‘(B) a person owning or controlling en-
forcement of the patent listed in the Approved 
Drug Products With Therapeutic Equivalence 
Evaluations (commonly known as the ‘FDA Or-
ange Book’) in connection with the NDA; or 
‘‘(C) the predecessors, subsidiaries, divi-
sions, groups, and affiliates controlled by, con-
trolling, or under common control with any of 
the entities described in subparagraphs (A) and 
(B) (such control to be presumed by direct or 
indirect share ownership of 50 percent or great-
er), as well as the licensees, licensors, succes-
sors, and assigns of each of the entities. 
‘‘(16) PARTY.—The term ‘party’ means any 
person, partnership, corporation, or other legal enti-
ty. 
‘‘(17) 
PATENT
INFRINGEMENT.—The 
term 
‘patent infringement’ means infringement of any 
patent or of any filed patent application, including 
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any extension, reissue, renewal, division, continu-
ation, continuation in part, reexamination, patent 
term restoration, patents of addition, and extensions 
thereof. 
‘‘(18) PATENT
INFRINGEMENT
CLAIM.—The 
term ‘patent infringement claim’ means any allega-
tion made to an ANDA filer or biosimilar biological 
product application filer, whether or not included in 
a complaint filed with a court of law, that its ANDA 
or ANDA product, or biological product license ap-
plication or biological product, may infringe any pat-
ent held by, or exclusively licensed to, the NDA 
holder or biological product license holder, biological 
product license holder, the ANDA filer, or biosimilar 
biological product application filer of the drug prod-
uct or biological product, as applicable. 
‘‘(19) STATUTORY
EXCLUSIVITY.—The term 
‘statutory exclusivity’ means those prohibitions on 
the approval of drug applications under clauses (ii) 
through (iv) of section 505(c)(3)(E) (5- and 3-year 
data exclusivity), section 527 (orphan drug exclu-
sivity), or section 505A (pediatric exclusivity) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(c)(3)(E), 360cc, 355a), or on the licensing of 
biological 
product 
applications 
under 
section 
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351(k)(7) (12-year exclusivity) or paragraph (2) or 
(3) of section 351(m) (pediatric exclusivity) of the 
Public Health Service Act (42 U.S.C. 262) or under 
section 527 of the Federal Food, Drug, and Cos-
metic Act (orphan drug exclusivity).’’. 
(b) EFFECTIVE DATE.—Section 27 of the Federal 
Trade Commission Act, as added by this section, shall 
apply to all agreements described in section 27(a)(1) of 
that Act entered into on or after the date of enactment 
of this Act. 
SEC. 4. 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 the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (21 U.S.C. 355 note) is 
amended by adding at the end the following: 
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‘‘(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), within 30 days after such 
filing, shall 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 subtitle B of title XI of the Medi-
care Prescription Drug, Improvement, 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, 
or are otherwise related to, the referenced agree-
ment; 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.’.’’. 
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