149 
‘‘(vii) Other laboratory and x-ray serv-
ices. 
‘‘(viii) Renal dialysis. 
‘‘(B) OTHER
EXCLUSIONS.—Such term 
also does not include any such drug or product 
for which a National Drug Code number is not 
required by the Food and Drug Administration 
or a drug or biological used for a medical indi-
cation which is not a medically accepted indica-
tion. 
‘‘(C) STATE OPTION.—At the option of a 
State, such term may include any drug, biologi-
cal product, or insulin for which the State is 
the primary payer under this title or a dem-
onstration project concerning this title, and that 
is provided on an outpatient basis as part of, or 
as incident to and in the same setting as, de-
scribed in clause (iv) or (v) of subparagraph (A) 
and for which payment is made as part of pay-
ment for such services. 
‘‘(D) NO EFFECT ON BEST PRICE.—Any 
drug, biological product, or insulin excluded 
from the definition of such term as a result of 
this paragraph shall be treated as a covered 
outpatient drug for purposes of determining the 
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pamtmann on DSKBC07HB2PROD with BILLS
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best price (as defined in subsection (c)(1)(C)) 
for such drug, biological product, or insulin.’’. 
(b) EFFECTIVE
DATE; IMPLEMENTATION
GUID-
ANCE.— 
(1) IN
GENERAL.—The amendment made by 
subsection (a) shall take effect on the date that is 
1 year after the date of enactment of this Act. 
(2) IMPLEMENTATION
AND
GUIDANCE.—Not 
later than 1 year after the date of enactment of this 
Act, the Secretary of Health and Human Services 
shall issue guidance and relevant informational bul-
letins for States, manufacturers (as defined in sec-
tion 1927(k)(5) of the Social Security Act (42 
U.S.C. 1396r–8(k)(5))), and other relevant stake-
holders, including health care providers, regarding 
implementation of the amendment made by sub-
section (a). 
TITLE III—FOOD AND DRUG 
ADMINISTRATION 
Subtitle A—Pay-for-Delay 
SEC. 301. UNLAWFUL AGREEMENTS. 
(a) AGREEMENTS PROHIBITED.—Subject to sub-
sections (b) and (c), it shall be unlawful for an NDA or 
BLA holder and a subsequent filer (or for two subsequent 
filers) to enter into, or carry out, an agreement resolving 
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151 
or settling a covered patent infringement claim on a final 
or interim basis if under such agreement— 
(1) a subsequent filer directly or indirectly re-
ceives from such holder (or in the case of such an 
agreement between two subsequent filers, the other 
subsequent filer) anything of value, including a li-
cense; and 
(2) the subsequent filer agrees to limit or fore-
go research on, or development, manufacturing, 
marketing, or sales, for any period of time, of the 
covered product that is the subject of the application 
described in subparagraph (A) or (B) of subsection 
(g)(8). 
(b) EXCLUSION.—It shall not be unlawful under sub-
section (a) if a party to an agreement described in such 
subsection demonstrates by clear and convincing evidence 
that the value described in subsection (a)(1) is compensa-
tion solely for other goods or services that the subsequent 
filer has promised to provide. 
(c) LIMITATION.—Nothing in this section shall pro-
hibit an agreement resolving or settling a covered patent 
infringement claim in which the consideration granted by 
the NDA or BLA holder to the subsequent filer (or from 
one subsequent filer to another) as part of the resolution 
or settlement includes only one or more of the following: 
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(1) The right to market the covered product 
that is the subject of the application described in 
subparagraph (A) or (B) of subsection (g)(8) in the 
United States before the expiration of— 
(A) any patent that is the basis of the cov-
ered patent infringement claim; or 
(B) any patent right or other statutory ex-
clusivity that would prevent the marketing of 
such covered product. 
(2) A payment for reasonable litigation ex-
penses not to exceed $7,500,000 in the aggregate. 
(3) A covenant not to sue on any claim that 
such covered product infringes a patent. 
(d) ENFORCEMENT BY FEDERAL TRADE COMMIS-
SION.— 
(1) GENERAL APPLICATION.—The requirements 
of this section apply, according to their terms, to an 
NDA or BLA holder or subsequent filer that is— 
(A) a person, partnership, or corporation 
over which the Commission has authority pur-
suant to section 5(a)(2) of the Federal Trade 
Commission Act (15 U.S.C. 45(a)(2)); or 
(B) a person, partnership, or corporation 
over which the Commission would have author-
ity pursuant to such section but for the fact 
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that such person, partnership, or corporation is 
not organized to carry on business for its own 
profit or that of its members. 
(2) UNFAIR OR DECEPTIVE ACTS OR PRACTICES 
ENFORCEMENT AUTHORITY.— 
(A) IN GENERAL.—A violation of this sec-
tion shall be treated as an unfair or deceptive 
act or practice in violation of section 5(a)(1) of 
the Federal Trade Commission Act (15 U.S.C. 
45(a)(1)). 
(B) POWERS OF COMMISSION.—Except as 
provided in subparagraph (C) and paragraphs 
(1)(B) and (3)— 
(i) the Commission shall enforce this 
section in the same manner, by the same 
means, and with the same jurisdiction, 
powers, and duties as though all applicable 
terms and provisions of the Federal Trade 
Commission Act (15 U.S.C. 41 et seq.) 
were incorporated into and made a part of 
this section; and 
(ii) any NDA or BLA holder or subse-
quent filer that violates this section shall 
be subject to the penalties and entitled to 
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