I 
117TH CONGRESS 
1ST SESSION H. R. 2891 
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 28, 2021 
Mr. NADLER (for himself, Mr. CICILLINE, Mr. BUCK, and Mrs. CAROLYN B. 
MALONEY of New York) introduced the following bill; which was referred 
to the Committee on the Judiciary, 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 committee 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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