the approved application nor the owner of the 
patent seek a preliminary injunction prohibiting 
the applicant from engaging in the commercial 
manufacture or sale (or both) of the drug, the 
approval shall be made effective on the expira-
tion of 60 days after the date on which the no-
tice provided under paragraph (2)(B)(ii) was 
received. 
‘‘(bb) If the action is an action referred to 
in subclause (I)(aa), and such a preliminary in-
junction is sought and the court denies the mo-
tion, the approval shall be made effective on the 
date on which the court denies the injunction. 
‘‘(cc) If neither item (aa) nor (bb) applies, 
and the holding of the court in the decision in 
the action is that the patent is invalid or was 
not infringed, the approval shall be made effec-
tive on the date of the decision of the court. 
‘‘(dd) If neither item (aa) nor (bb) applies, 
and the holding of the court in the decision in 
the action is that the patent was infringed, the 
approval shall be made effective on such date as 
the court orders under section 271(e)(4)(A) of 
title 35, United States Code.’’; and
(2) by inserting before subparagraph (D) (as 
added by section 201(a)(3)) the following subpara-
graph: 
‘‘(C) With respect to a civil action described in sub-
paragraph (B)(iii)(II): 
‘‘(i) Each of the parties shall reasonably cooper-
ate in expediting the action. 
‘‘(ii) If the notice under paragraph (2)(B)(ii) 
contains an address for the receipt of expedited noti-
fication of such an action, the plaintiff shall, on the 
date the complaint is filed in the court, simulta-
neously cause a notification of such action to be de-
livered to such address by the next business day. 
‘‘(iii) An action for a declaratory judgment au-
thorized in such subparagraph may not be brought 
by the applicant until the expiration of 45 days after 
the date the notice provided under paragraph 
(2)(B)(ii) was received, except that if information on 
the patent involved has been published under sub-
section (c)(2) for at least one year after the date on 
which the application under this subsection was filed 
in relation to the listed drug involved, the applicant 
may immediately bring such an action for declara-
tory judgment.
‘‘(iv) Any such action shall be brought in the 
judicial district in which the defendant has its prin-
cipal place of business or a regular and established 
place of business.’’. 
(b) NEW DRUG APPLICATIONS.—Section 505(c)(3) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(c)(3)) is amended by striking subparagraph (C) and 
inserting the following: 
‘‘(C)(i)(I) If the applicant made a certification 
described in subsection (b)(2)(A)(iv) and—
‘‘(aa) no action is brought for infringement 
of a patent that is the subject of the certifi-
cation before the expiration of the 45-day pe-
riod beginning on the date on which the notice 
provided under subsection (b)(3)(B) was re-
ceived; and 
‘‘(bb) the applicant does not bring an ac-
tion for declaratory judgment authorized in 
subclause (II) before the expiration of the 60-
day period beginning on the date on which the 
notice provided under subsection (b)(3)(B) was 
received; 
the approval shall be made effective on the expira-
tion of 60 days after the date on which the notice 
provided under subsection (b)(3)(B) was received,
provided that none of the conditions for refusal of 
approval in subsection (d) apply. 
‘‘(II) With respect to an applicant who made a 
certification described in subsection (b)(2)(A)(iv), if 
an action referred to in item (aa) of subclause (I) 
is brought before the expiration of the period de-
scribed in such item, or if the applicant brings an 
action for declaratory judgment of invalidity or non-
infringement of such patent (which action is hereby 
authorized) before the expiration of the period de-
scribed in item (bb) of such subclause, the approval 
shall, provided none of the conditions for refusal of 
approval in subsection (d) apply, be made effective 
in accordance with the following: 
‘‘(aa) If the action is an action referred to 
in subclause (I)(aa), and neither the holder of 
the approved application nor the owner of the 
patent seek a preliminary injunction prohibiting 
the applicant from engaging in the commercial 
manufacture or sale (or both) of the drug, the 
approval shall be made effective on the expira-
tion of 60 days after the date on which the no-
tice provided under subsection (b)(3)(B) was re-
ceived.
‘‘(bb) If the action is an action referred to 
in subclause (I)(aa), and such a preliminary in-
junction is sought and the court denies the mo-
tion, the approval shall be made effective on the 
date on which the court denies the injunction. 
‘‘(cc) If neither item (aa) nor (bb) applies, 
and the holding of the court in the decision in 
the action is that the patent is invalid or was 
not infringed, the approval shall be made effec-
tive on the date of the decision of the court. 
‘‘(dd) If neither item (aa) nor (bb) applies, 
and the holding of the court in the decision in 
the action is that the patent was infringed, the 
approval shall be made effective on such date as 
the court orders under section 271(e)(4)(A) of 
title 35, United States Code. 
‘‘(ii) With respect to a civil action described in 
clause (i)(II): 
‘‘(I) Each of the parties shall reasonably 
cooperate in expediting the action. 
‘‘(II) If the notice under subsection 
(b)(3)(B) contains an address for the receipt of 
expedited notification of such an action, the 
plaintiff shall, on the date the complaint is filed 
in the court, simultaneously cause a notification
of such action to be delivered to such address 
by the next business day. 
‘‘(III) An action for a declaratory judg-
ment authorized in such clause may not be 
brought by the applicant until the expiration of 
45 days after the date the notice provided 
under subsection (b)(3)(B) was received, except 
that if information on the patent involved has 
been published under paragraph (2) for at least 
one year after the date on which the application 
was filed in relation to the drug involved, the 
applicant may immediately bring such an action 
for declaratory judgment. 
‘‘(IV) Any such action shall be brought in 
the judicial district in which the defendant has 
its principal place of business or a regular and 
established place of business.’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall not apply to an application submitted 
under section 505(b)(1) or 505(j) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) before the date 
of the enactment of this Act.
SEC. 203. ADDITIONAL USES. 
Section 505(j) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)) is amended by adding at the 
end the following paragraph:’’
‘‘(10)(A) A drug for which an application has been 
submitted or approved under this subsection shall not be 
considered ineligible for approval under this subsection or 
misbranded under section 502 on the basis that the label-
ing of the drug omits a use or any other aspect of labeling 
when the omitted use or other aspect is protected by pat-
ent or by exclusivity under clause (iii) or (iv) of paragraph 
(5)(D). 
‘‘(B) Notwithstanding clauses (iii) and (iv) of para-
graph (5)(D), the Secretary may require that the labeling 
of a drug approved under this subsection that omits a use 
or other aspect of labeling as described in subparagraph 
(A) include—
‘‘(i) any statement that the Secretary considers 
necessary for the safe use of the drug, such as ap-
propriate 
contraindications, 
warnings, 
or 
pre-
cautions; and 
‘‘(ii) a statement that, because of marketing ex-
clusivity for a manufacturer, the drug is not labeled 
for the use.’’.
Subtitle B—Notification of Agree-
ments Affecting the Sale or Mar-
keting of Generic Drugs 
SEC. 211. DEFINITIONS. 
In this subtitle: 
(1) 
AGREEMENT.—The 
term 
‘‘agreement’’ 
means an agreement under section 1 of the Sherman 
Act (15 U.S.C. 1) or section 5 of the Federal Trade 
Commission Act (15 U.S.C. 45). 
(2) ANTITRUST
LAWS.—The term ‘‘antitrust 
laws’’ has the same meaning as in section 1 of the 
Clayton Act (15 U.S.C. 12), except that such term 
includes section 5 of the Federal Trade Commission 
Act (15 U.S.C. 45) to the extent that such section 
applies to unfair methods of competition. 
(3) ANDA.—The term ‘‘ANDA’’ means an Ab-
breviated New Drug Application, as defined under 
section 505(j) of the Federal Food, Drug and Cos-
metic Act. 
(4) BRAND NAME DRUG COMPANY.—The term 
‘‘brand name drug company’’ means a person en-
gaged in the manufacture or marketing of a drug 
approved under section 505(b) of the Federal Food, 
Drug and Cosmetic Act.
100
(5) COMMISSION.—The term ‘‘Commission’’ 
means the Federal Trade Commission. 
(6) FDA.—The term ‘‘FDA’’ means the United 
States Food and Drug Administration. 
(7) GENERIC DRUG.—The term ‘‘generic drug’’ 
means a product that is the subject of an ANDA. 
(8) GENERIC
DRUG
APPLICANT.—The term 
‘‘generic drug applicant’’ means a person who has 
filed or received approval for an ANDA under sec-
tion 505(j) of the Federal Food, Drug and Cosmetic 
Act. 
(9) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services. 
SEC. 212. NOTIFICATION OF AGREEMENTS AFFECTING THE 
SALE OR MARKETING OF GENERIC DRUGS. 
A brand name drug company and a generic drug ap-
plicant that enter into an agreement regarding the sale 
or manufacture of a generic drug that the Secretary has 
determined is the therapeutic equivalent of a brand name 
drug that is manufactured or marketed by that brand 
name drug company, or for which the generic drug appli-
cant seeks such a determination of therapeutic equiva-
lence, and which agreement could have the effect of lim-
iting the research, development, manufacture, marketing, 
or selling of a generic drug that has been or could be ap-
101
proved for sale by the FDA pursuant to an ANDA, shall 
file with the Commission and the Secretary the text of 
the agreement, an explanation of the purpose and scope 
of the agreement, and an explanation of whether the 
agreement could delay, restrain, limit, or in any way inter-
fere with the production, manufacture, or sale of the ge-
neric version of the drug in question. 
SEC. 213. FILING DEADLINES. 
Any notice, agreement, or other material required to 
be filed under section 212 shall be filed with the Commis-
sion and the Secretary not later than 10 business days 
after the date the agreement is executed. 
SEC. 214. ENFORCEMENT. 
(a) CIVIL FINE.—Any person, or any officer, direc-
tor, or partner thereof, who fails to comply with any provi-
sion of this subtitle shall be liable for a civil penalty of 
not more than $20,000 for each day during which such 
person is in violation of this subtitle. Such penalty may 
be recovered in a civil action brought by the United States, 
or brought by the Commission in accordance with the pro-
cedures established in section 16(a)(1) of the Federal 
Trade Commission Act (15 U.S.C. 56(a)). 
(b) COMPLIANCE AND EQUITABLE RELIEF.—If any 
person, or any officer, director, partner, agent, or em-
ployee thereof, fails to comply with the notification re-
102
quirement under section 212 of this subtitle, the United 
States district court may order compliance, and may grant 
such other equitable relief as the court in its discretion 
determines necessary or appropriate, upon application of 
the Commission or the Assistant Attorney General. 
SEC. 215. RULEMAKING. 
The Commission, in consultation with the Secretary, 
and with the concurrence of the Assistant Attorney Gen-
eral and by rule in accordance with section 553 of title 
5, United States Code, consistent with the purposes of this 
subtitle—
(1) may require that the notice described in sec-
tion 212 of this subtitle be in such form and contain 
such documentary material and information relevant 
to the agreement as is necessary and appropriate to 
enable the Commission and the Assistant Attorney 
General to determine whether such agreement may 
violate the antitrust laws; 
(2) may define the terms used in this subtitle; 
(3) may exempt classes of persons or agree-
ments from the requirements of this subtitle; and 
(4) may prescribe such other rules as may be 
necessary and appropriate to carry out the purposes 
of this subtitle.
103
SEC. 216. EFFECTIVE DATES. 
This subtitle shall take effect 90 days after the date 
of enactment of this Act.
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