I 
112TH CONGRESS 
2D SESSION 
H. R. 3995 
To prohibit brand name drug companies from compensating generic drug 
companies to delay the entry of a generic drug into the market, and 
for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 9, 2012 
Mr. RUSH (for himself and Mr. WAXMAN) introduced the following bill; which 
was referred to the Committee on Energy and Commerce, and in addition 
to the Committee on the Judiciary, for a period to be subsequently deter-
mined by the Speaker, in each case for consideration of such provisions 
as fall within the jurisdiction of the committee concerned 
A BILL 
To prohibit brand name drug companies from compensating 
generic drug companies to delay the entry of a generic 
drug into the market, and for other purposes. 
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 ‘‘Protecting Consumer 
Access to Generic Drugs Act of 2012’’. 
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SEC. 2. UNFAIR AND DECEPTIVE ACTS AND PRACTICES RE-
LATED TO NEW DRUG APPLICATIONS. 
(a) CONDUCT PROHIBITED.—It shall be unlawful for 
any person to directly or indirectly be a party to any 
agreement resolving or settling a patent infringement 
claim in which— 
(1) an ANDA filer receives anything of value; 
and 
(2) the ANDA filer agrees not to research, de-
velop, manufacture, market, or sell, for any period 
of time, the drug that is to be manufactured under 
the ANDA involved and is the subject of the patent 
infringement claim. 
(b) 
EXCEPTIONS.—Notwithstanding 
subsection 
(a)(1), subsection (a) does not prohibit a resolution or set-
tlement of a patent infringement claim in which the value 
received by the ANDA filer includes no more than— 
(1) the right to market the drug that is to be 
manufactured under the ANDA involved and is the 
subject of the patent infringement claim, before the 
expiration of— 
(A) the patent that is the basis for the pat-
ent infringement claim; or 
(B) any other statutory exclusivity that 
would prevent the marketing of such drug; and 
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(2) the waiver of a patent infringement claim 
for damages based on prior marketing of such drug. 
(c) ENFORCEMENT.—A violation of subsection (a) 
shall be treated as an unfair and deceptive act or practice 
and an unfair method of competition in or affecting inter-
state commerce prohibited under section 5 of the Federal 
Trade Commission Act (15 U.S.C. 45). The Federal Trade 
Commission shall enforce this Act in the same manner, 
by the same means, and with the same jurisdiction as 
though all applicable terms and provisions of the Federal 
Trade Commission Act were incorporated into and made 
a part of this Act. 
(d) DEFINITIONS.—In this section: 
(1) 
AGREEMENT.—The 
term 
‘‘agreement’’ 
means anything that would constitute an agreement 
for purposes of section 5 of the Federal Trade Com-
mission Act (15 U.S.C. 45). 
(2) AGREEMENT RESOLVING OR SETTLING.— 
The term ‘‘agreement resolving or settling’’, in ref-
erence to a patent infringement claim, includes any 
agreement that is contingent upon, provides a con-
tingent condition for, or is otherwise related to the 
resolution or settlement of the claim. 
(3) ANDA.—The term ‘‘ANDA’’ means an ab-
breviated new drug application for the approval of a 
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new drug under section 505(j) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)). 
(4) ANDA FILER.—The term ‘‘ANDA filer’’ 
means a party that has filed an ANDA with the 
Food and Drug Administration. 
(5) PATENT INFRINGEMENT.—The term ‘‘pat-
ent infringement’’ means infringement of any patent 
or of any filed patent application, extension, 
reissuance, renewal, division, continuation, continu-
ation in part, reexamination, patent term restora-
tion, patent of addition, or extension thereof. 
(6) PATENT INFRINGEMENT CLAIM.—The term 
‘‘patent infringement claim’’ means any allegation 
made to an ANDA filer, whether or not included in 
a complaint filed with a court of law, that its ANDA 
or drug to be manufactured under such ANDA may 
infringe any patent. 
SEC. 3. FTC RULEMAKING. 
The Federal Trade Commission may, by rule promul-
gated under section 553 of title 5, United States Code, 
exempt certain agreements described in section 2 if the 
Commission finds such agreements to be in furtherance 
of market competition and for the benefit of consumers. 
Consistent with the authority of the Commission, such 
rules may include interpretive rules and general state-
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ments of policy with respect to the practices prohibited 
under section 2. 
SEC. 4. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD 
UNDER THE FFDCA. 
Section 505(j)(5)(D)(i) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)) is amended 
in subclause (V) by inserting ‘‘section 2 of the Protecting 
Consumer Access to Generic Drugs Act of 2012 or’’ after 
‘‘that the agreement has violated’’. 
SEC. 5. NOTICE AND CERTIFICATION OF AGREEMENTS. 
(a) 
NOTICE
OF
ALL
AGREEMENTS.—Section 
1112(c)(2) of the Medicare Prescription Drug, Improve-
ment, and Modernization Act of 2003 (21 U.S.C. 3155 
note) is amended by— 
(1) striking ‘‘the Commission the’’ and insert-
ing ‘‘the Commission (1) the’’; and 
(2) inserting before the period at the end the 
following: ‘‘; and (2) a description of the subject 
matter of any other agreement the parties enter into 
within 30 days of an entering into an agreement 
covered by subsection (a) or (b)’’. 
(b) CERTIFICATION OF AGREEMENTS.—Section 1112 
of such Act is amended by adding at the end the following: 
‘‘(d) CERTIFICATION.—The Chief Executive Officer 
or the company official responsible for negotiating any 
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agreement required to be filed under subsection (a), (b), 
or (c) shall execute and file with the Assistant Attorney 
General and the Commission a certification as follows: ‘I 
declare under penalty of perjury that the following is true 
and correct: The materials filed with the Federal Trade 
Commission and the Department of Justice under section 
1112 of subtitle B of title XI of the Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003, with 
respect to the agreement referenced in this certification: 
(1) represent the complete, final, and exclusive 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 agreement; 
and (3) include written descriptions of any oral agree-
ments, representations, commitments, or promises be-
tween the parties that are responsive to subsection (a) or 
(b) of such section 1112 and have not been reduced to 
writing.’.’’. 
Æ 
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