‘‘(3) Clause (ii), (iii), or (iv) of section 
505(j)(5)(F). 
‘‘(4) Section 505A. 
‘‘(5) Section 505E. 
‘‘(6) Section 527. 
‘‘(7) Section 351(k)(7) of the Public Health 
Service Act. 
‘‘(8) Any other provision of this Act that pro-
vides for market exclusivity (or extension of market 
exclusivity) with respect to a drug. 
‘‘(c) VIOLATIONS.— 
‘‘(1) IN
GENERAL.—A violation described in 
this subsection is a violation of a law described in 
paragraph (2), enforced by a Federal or State gov-
ernmental entity that results in— 
‘‘(A) a criminal conviction of a person de-
scribed in subsection (a); 
‘‘(B) a civil judgment against a person de-
scribed in subsection (a); or 
‘‘(C) a settlement agreement in which a 
person described in subsection (a) admits to 
fault. 
‘‘(2) LAWS DESCRIBED.—The laws described in 
this paragraph are the following: 
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‘‘(A) The provisions of this Act that pro-
hibit— 
‘‘(i) the adulteration or misbranding 
of a drug; 
‘‘(ii) the making of false statements to 
the Secretary or committing fraud; or 
‘‘(iii) the illegal marketing of a drug. 
‘‘(B) Section 3729 of title 31, United 
States Code. 
‘‘(C) Section 286 or 287 of title 18, United 
States Code. 
‘‘(D) The Medicare and Medicaid Patient 
Protection and Program Act of 1987 (com-
monly known as the ‘Antikickback Statute’). 
‘‘(E) Section 1927 of the Social Security 
Act. 
‘‘(F) A State law against fraud comparable 
to a law described in subparagraphs (A) 
through (E). 
‘‘(d) DATE
OF EXCLUSIVITY TERMINATION.—The 
date on which the exclusivity shall be terminated as de-
scribed in subsection (a) is the date on which, as applica-
ble— 
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‘‘(1) a final judgment is entered relating to a 
violation described in subparagraph (A) or (B) of 
subsection (c)(1); or 
‘‘(2)(A) a settlement agreement described in 
subsection (c)(1)(C) is approved by a court order 
that is or becomes final and nonappealable; or 
‘‘(B) if there is no court order approving a set-
tlement agreement described in subsection (c)(1)(C), 
a court order dismissing the applicable case, issued 
after the settlement agreement, is or becomes final 
and nonappealable. 
‘‘(e) REPORTING OF INFORMATION.— 
‘‘(1) IN GENERAL.—A person described in sub-
section (a) that commits a violation described in 
subsection (c)(1) shall report such violation to the 
Secretary no later than 30 days after the date 
that— 
‘‘(A) a final judgment is entered relating 
to a violation described in subparagraph (A) or 
(B) of subsection (c)(1); or 
‘‘(B)(i) a settlement agreement described 
in subsection (c)(1)(C) is approved by a court 
order that is or becomes final and nonappeal-
able; or 
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100 
‘‘(ii) if there is no court order approving a 
settlement agreement described in subsection 
(c)(1)(C), a court order dismissing the applica-
ble case, issued after the settlement agreement, 
is or becomes final and nonappealable. 
‘‘(2) CIVIL PENALTY.—A person who fails to re-
port a violation as required under paragraph (1) 
shall be subject to a civil penalty in the amount of 
$200,000 for each day the failure to report con-
tinues, beginning with the day after the date on 
which such report is due as described in paragraph 
(1).’’. 
(b) FTC.—There are authorized to be appropriated 
to the Federal Trade Commission such sums as may be 
necessary for the purpose of carrying out activities related 
to addressing criminal activity and anticompetitive prac-
tices by pharmaceutical companies. 
TITLE IV—CHOICE AND 
COMPETITION 
SEC. 
401. 
PRESERVING 
ACCESS 
TO 
AFFORDABLE 
GENERICS. 
(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: 
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101 
‘‘SEC. 
27. 
PRESERVING 
ACCESS 
TO 
AFFORDABLE 
GENERICS. 
‘‘(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 infringement claim, in connection 
with the sale of a drug product. 
‘‘(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 be a violation of this section if— 
‘‘(i) an ANDA filer receives anything 
of value, including an exclusive license; and 
‘‘(ii) the ANDA filer agrees to limit or 
forego research, development, manufac-
turing, marketing, or sales of the ANDA 
product 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 
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102 
other goods or services that the ANDA 
filer has promised to provide; or 
‘‘(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 prior to the expiration of the rel-
evant patent or statutory exclusivity means that the 
agreement is procompetitive. 
‘‘(c) EXCLUSIONS.—Nothing in this section shall pro-
hibit a resolution or settlement of a patent infringement 
claim in which the consideration granted by the NDA 
holder to the ANDA filer as part of the resolution or set-
tlement includes only one or more of the following: 
‘‘(1) The right to market the ANDA product in 
the United States prior to the expiration of— 
‘‘(A) any patent that is the basis for the 
patent infringement claim; or 
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