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(A) in subparagraph (B)—
(i) by striking ‘‘under the following’’ 
and inserting ‘‘by applying the following to 
each certification made under paragraph 
(2)(A)(vii)’’; and 
(ii) in clause (iii)—
(I) in the first sentence, by strik-
ing ‘‘unless’’ and all that follows and 
inserting ‘‘unless, before the expira-
tion of 45 days after the date on 
which the notice described in para-
graph (2)(B) is received, an action is 
brought for infringement of the patent 
that is the subject of the certification 
and for which information was sub-
mitted to the Secretary under sub-
section (b)(1) or (c)(2) before the date 
on which the application (excluding an 
amendment or supplement to the ap-
plication), which the Secretary later 
determines to be substantially com-
plete, was submitted.’’; and 
(II) in the second sentence—
(aa) by striking subclause 
(I) and inserting the following:
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‘‘(I) if before the expiration of such period 
the district court decides that the patent is in-
valid or not infringed (including any substantive 
determination that there is no cause of action 
for patent infringement or invalidity), the ap-
proval shall be made effective on—
‘‘(aa) the date on which the court en-
ters judgment reflecting the decision; or 
‘‘(bb) the date of a settlement order 
or consent decree signed and entered by 
the court stating that the patent that is 
the subject of the certification is invalid or 
not infringed;’’; 
(bb) by striking subclause 
(II) and inserting the following: 
‘‘(II) if before the expiration of such period 
the district court decides that the patent has 
been infringed—
‘‘(aa) if the judgment of the district 
court is appealed, the approval shall be 
made effective on—
‘‘(AA) the date on which the 
court of appeals decides that the pat-
ent is invalid or not infringed (includ-
ing any substantive determination
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that there is no cause of action for 
patent infringement or invalidity); or 
‘‘(BB) the date of a settlement 
order or consent decree signed and 
entered by the court of appeals stat-
ing that the patent that is the subject 
of the certification is invalid or not in-
fringed; or 
‘‘(bb) if the judgment of the district 
court is not appealed or is affirmed, the 
approval shall be made effective on the 
date specified by the district court in a 
court order under section 271(e)(4)(A) of 
title 35, United States Code;’’; 
(cc) in subclause (III), by 
striking ‘‘on the date of such 
court decision.’’ and inserting ‘‘as 
provided in subclause (I); or’’; 
(dd) by inserting after sub-
clause (III) the following: 
‘‘(IV) if before the expiration of such pe-
riod the court grants a preliminary injunction 
prohibiting the applicant from engaging in the 
commercial manufacture or sale of the drug 
until the court decides the issues of patent va-
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lidity and infringement and if the court decides 
that such patent has been infringed, the ap-
proval shall be made effective as provided in 
subclause (II).’’; and 
(ee) in the matter after and 
below subclause (IV) (as added 
by item (dd)), by striking ‘‘Until 
the expiration’’ and all that fol-
lows; 
(B) by redesignating subparagraphs (C) 
and (D) as subparagraphs (E) and (F), respec-
tively; and 
(C) by inserting after subparagraph (B) 
the following: 
‘‘(C) CIVIL
ACTION
TO
OBTAIN
PATENT 
CERTAINTY.—
‘‘(i) DECLARATORY
JUDGMENT
AB-
SENT INFRINGEMENT ACTION.—
‘‘(I) IN
GENERAL.—No action 
may be brought under section 2201 of 
title 28, United States Code, by an 
applicant under paragraph (2) for a 
declaratory judgment with respect to 
a patent which is the subject of the 
certification referred to in subpara-
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graph (B)(iii) unless the forty-five day 
period referred to in such subpara-
graph has expired, and unless, if the 
notice 
provided 
under 
paragraph 
(2)(B) relates to noninfringement, the 
notice was accompanied by a docu-
ment described in subclause (II). Any 
such action shall be brought in the ju-
dicial district where the defendant has 
its principal place of business or a 
regular and established place of busi-
ness. 
‘‘(II) RIGHT
OF
CONFIDENTIAL 
ACCESS
TO
APPLICATION.—For pur-
poses of subclause (I), the document 
described in this subclause is a docu-
ment providing a right of confidential 
access to the application of the appli-
cant under paragraph (2) for the pur-
pose of determining whether an action 
referred to in subparagraph (B)(iii) 
should be brought. The document pro-
viding the right of confidential access 
shall contain such restrictions as to 
persons entitled to access, and on the
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use and disposition of any information 
accessed, as would apply had a protec-
tive order been entered for the pur-
pose of protecting trade secrets and 
other confidential business informa-
tion. Any person provided a right of 
confidential access shall review the ap-
plication for the sole and limited pur-
pose of evaluating possible infringe-
ment of the patent that is the subject 
of the certification under paragraph 
(2)(A)(vii)(IV) and for no other pur-
pose, and may not disclose informa-
tion of no relevance to any issue of 
patent infringement to any person 
other than a person provided a right 
of confidential access. Further, the 
application may be redacted by the 
applicant to remove any information 
of no relevance to any issue of patent 
infringement. 
‘‘(ii) COUNTERCLAIM
TO
INFRINGE-
MENT ACTION.—
‘‘(I) IN GENERAL.—If an owner 
of the patent or the holder of the ap-
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proved application under subsection 
(b) for the drug that is claimed by the 
patent or a use of which is claimed by 
the patent brings a patent infringe-
ment action against the applicant, the 
applicant may assert a counterclaim 
seeking an order requiring the holder 
to correct or delete the patent infor-
mation submitted by the holder under 
subsection (b) or (c) on the ground 
that the patent does not claim ei-
ther—
‘‘(aa) the drug for which the 
application was approved; or 
‘‘(bb) an approved method 
of using the drug. 
‘‘(II) NO
INDEPENDENT
CAUSE 
OF ACTION.—Subclause (I) does not 
authorize the assertion of a claim de-
scribed in subclause (I) in any civil 
action or proceeding other than a 
counterclaim described in subclause 
(I). 
‘‘(iii) NO
DAMAGES.—An applicant 
shall not be entitled to damages in a civil
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action under subparagraph (i) or a coun-
terclaim under subparagraph (ii).’’. 
(b) APPLICATIONS GENERALLY.—Section 505 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
is amended—
(1) in subsection (b)—
(A) by striking paragraph (3) and insert-
ing the following: 
‘‘(3) NOTICE OF OPINION THAT PATENT IS INVALID 
OR WILL NOT BE INFRINGED.—
‘‘(A) AGREEMENT TO GIVE NOTICE.—An appli-
cant that makes a certification described in para-
graph (2)(A)(iv) shall include in the application a 
statement that the applicant will give notice as re-
quired by this paragraph. 
‘‘(B) TIMING OF NOTICE.—An applicant that 
makes a certification described in paragraph 
(2)(A)(iv) shall give notice as required under this 
paragraph—
‘‘(i) if the certification is in the applica-
tion, not later than 20 days after the date of 
the postmark on the notice with which the Sec-
retary informs the applicant that the applica-
tion has been filed; or
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‘‘(ii) if the certification is in an amend-
ment or supplement to the application, at the 
time at which the applicant submits the amend-
ment or supplement, regardless of whether the 
applicant has already given notice with respect 
to another such certification contained in the 
application or in an amendment or supplement 
to the application. 
‘‘(C) RECIPIENTS
OF
NOTICE.—An applicant 
required under this paragraph to give notice shall 
give notice to—
‘‘(i) each owner of the patent that is the 
subject of the certification (or a representative 
of the owner designated to receive such a no-
tice); and 
‘‘(ii) the holder of the approved application 
under this subsection for the drug that is 
claimed by the patent or a use of which is 
claimed by the patent (or a representative of 
the holder designated to receive such a notice). 
‘‘(D) CONTENTS
OF
NOTICE.—A notice re-
quired under this paragraph shall—
‘‘(i) state that an application that contains 
data from bioavailability or bioequivalence stud-
ies has been submitted under this subsection for
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the drug with respect to which the certification 
is made to obtain approval to engage in the 
commercial manufacture, use, or sale of the 
drug before the expiration of the patent re-
ferred to in the certification; and 
‘‘(ii) include a detailed statement of the 
factual and legal basis of the opinion of the ap-
plicant that the patent is invalid or will not be 
infringed.’’; and 
(B)(i) by redesignating paragraph (4) as 
paragraph (5); and 
(ii) by inserting after paragraph (3) the 
following paragraph: 
‘‘(4)(A) An applicant may not amend or supplement 
an application referred to in paragraph (2) to seek ap-
proval of a drug that is a different drug than the drug 
identified in the application as submitted to the Secretary. 
‘‘(B) With respect to the drug for which such an ap-
plication is submitted, nothing in this subsection or sub-
section (c)(3) prohibits an applicant from amending or 
supplementing the application to seek approval of a dif-
ferent strength.’’; and 
(2) in subsection (c)(3)—
(A) in the first sentence, by striking 
‘‘under the following’’ and inserting ‘‘by apply-
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ing the following to each certification made 
under subsection (b)(2)(A)(iv)’’; 
(B) in subparagraph (C)—
(i) in the first sentence, by striking 
‘‘unless’’ and all that follows and inserting 
‘‘unless, before the expiration of 45 days 
after the date on which the notice de-
scribed in subsection (b)(3) is received, an 
action is brought for infringement of the 
patent that is the subject of the certifi-
cation and for which information was sub-
mitted to the Secretary under paragraph 
(2) or subsection (b)(1) before the date on 
which the application (excluding an amend-
ment or supplement to the application) was 
submitted.’’; 
(ii) in the second sentence—
(I) 
by 
striking 
‘‘paragraph 
(3)(B)’’ and inserting ‘‘subsection 
(b)(3)’’; 
(II) by striking clause (i) and in-
serting the following: 
‘‘(i) if before the expiration of such period 
the district court decides that the patent is in-
valid or not infringed (including any substantive
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determination that there is no cause of action 
for patent infringement or invalidity), the ap-
proval shall be made effective on—
‘‘(I) the date on which the court en-
ters judgment reflecting the decision; or 
‘‘(II) the date of a settlement order or 
consent decree signed and entered by the 
court stating that the patent that is the 
subject of the certification is invalid or not 
infringed;’’; 
(III) by striking clause (ii) and 
inserting the following: 
‘‘(ii) if before the expiration of such period 
the district court decides that the patent has 
been infringed—
‘‘(I) if the judgment of the district 
court is appealed, the approval shall be 
made effective on—
‘‘(aa) the date on which the court 
of appeals decides that the patent is 
invalid or not infringed (including any 
substantive determination that there 
is no cause of action for patent in-
fringement or invalidity); or
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‘‘(bb) the date of a settlement 
order or consent decree signed and 
entered by the court of appeals stat-
ing that the patent that is the subject 
of the certification is invalid or not in-
fringed; or 
‘‘(II) if the judgment of the district 
court is not appealed or is affirmed, the 
approval shall be made effective on the 
date specified by the district court in a 
court order under section 271(e)(4)(A) of 
title 35, United States Code;’’; 
(IV) in clause (iii), by striking 
‘‘on the date of such court decision.’’ 
and inserting ‘‘as provided in clause 
(i); or’’; 
(V) by inserting after clause (iii), 
the following: 
‘‘(iv) if before the expiration of such period 
the court grants a preliminary injunction pro-
hibiting the applicant from engaging in the 
commercial manufacture or sale of the drug 
until the court decides the issues of patent va-
lidity and infringement and if the court decides 
that such patent has been infringed, the ap-
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proval shall be made effective as provided in 
clause (ii).’’; and 
(VI) in the matter after and 
below clause (iv) (as added by sub-
clause (V)), by striking ‘‘Until the ex-
piration’’ and all that follows; and 
(iii) in the third sentence, by striking 
‘‘paragraph (3)(B)’’ and inserting ‘‘sub-
section (b)(3)’’; 
(C) by redesignating subparagraph (D) as 
subparagraph (E); and 
(D) by inserting after subparagraph (C) 
the following: 
‘‘(D) CIVIL
ACTION
TO
OBTAIN
PATENT 
CERTAINTY.—
‘‘(i) DECLARATORY
JUDGMENT
AB-
SENT INFRINGEMENT ACTION.—
‘‘(I) IN
GENERAL.—No action 
may be brought under section 2201 of 
title 28, United States Code, by an 
applicant referred to in subsection 
(b)(2) for a declaratory judgment with 
respect to a patent which is the sub-
ject of the certification referred to in 
subparagraph (C) unless the forty-five
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day period referred to in such sub-
paragraph has expired, and unless, if 
the notice the applicant provided 
under subsection (b)(3) relates to 
noninfringement, the notice was ac-
companied by a document described in 
subclause (II). Any such action shall 
be brought in the judicial district 
where the defendant has its principal 
place of business or a regular and es-
tablished place of business. 
‘‘(II) RIGHT
OF
CONFIDENTIAL 
ACCESS
TO
APPLICATION.—For pur-
poses of subclause (I), the document 
described in this subclause is a docu-
ment providing a right of confidential 
access to the application of the appli-
cant referred to in subsection (b)(2) 
for the purpose of determining wheth-
er an action referred to in subpara-
graph (C) should be brought. The 
document providing the right of con-
fidential access shall contain such re-
strictions as to persons entitled to ac-
cess, and on the use and disposition of
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any information accessed, as would 
apply had a protective order been en-
tered for the purpose of protecting 
trade secrets and other confidential 
business information. Any person pro-
vided a right of confidential access 
shall review the application for the 
sole and limited purpose of evaluating 
possible infringement of the patent 
that is the subject of the certification 
under subsection (b)(2)(A)(iv) and for 
no other purpose, and may not dis-
close information of no relevance to 
any issue of patent infringement to 
any person other than a person pro-
vided a right of confidential access. 
Further, the application may be re-
dacted by the applicant to remove any 
information of no relevance to any 
issue of patent infringement. 
‘‘(ii) COUNTERCLAIM
TO
INFRINGE-
MENT ACTION.—
‘‘(I) IN GENERAL.—If an owner 
of the patent or the holder of the ap-
proved application under subsection
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(b) for the drug that is claimed by the 
patent or a use of which is claimed by 
the patent brings a patent infringe-
ment action against the applicant, the 
applicant may assert a counterclaim 
seeking an order requiring the holder 
to correct or delete the patent infor-
mation submitted by the holder under 
subsection (b) or this subsection on 
the ground that the patent does not 
claim either—
‘‘(aa) the drug for which the 
application was approved; or 
‘‘(bb) an approved method 
of using the drug. 
‘‘(II) NO
INDEPENDENT
CAUSE 
OF ACTION.—Subclause (I) does not 
authorize the assertion of a claim de-
scribed in subclause (I) in any civil 
action or proceeding other than a 
counterclaim described in subclause 
(I). 
‘‘(iii) NO
DAMAGES.—An applicant 
shall not be entitled to damages in a civil
661
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action under clause (i) or a counterclaim 
under clause (ii).’’. 
(c) APPLICABILITY.—
(1) IN GENERAL.—Except as provided in para-
graphs (2) and (3), the amendments made by sub-
sections (a), (b), and (c) apply to any proceeding 
under section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) that is pending on or 
after the date of enactment of this Act regardless of 
the date on which the proceeding was commenced or 
is commenced. 
(2) NOTICE OF OPINION THAT PATENT IS IN-
VALID OR WILL NOT BE INFRINGED.—The amend-
ments made by subsections (a)(1) and (b)(1) apply 
with respect to any certification under subsection 
(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355) after the date of enactment of this Act 
in an application filed under subsection (b)(2) or (j) 
of that section or in an amendment or supplement 
to an application filed under subsection (b)(2) or (j) 
of that section. 
(3) EFFECTIVE
DATE
OF
APPROVAL.—The 
amendments made by subsections (a)(2)(A)(ii)(I) 
and (b)(2)(B)(i) apply with respect to any patent in-
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formation submitted under subsection (b)(1) or 
(c)(2) of section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) made after the date 
of enactment of this Act. 
SEC. 1102. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD. 
(a) IN GENERAL.—Section 505(j)(5) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) (as 
amended by section 1101) is amended—
(1) in subparagraph (B), by striking clause (iv) 
and inserting the following: 
‘‘(iv) 180-DAY EXCLUSIVITY PERIOD.—
‘‘(I) DEFINITIONS.—In this paragraph: 
‘‘(aa) 
180-DAY
EXCLUSIVITY
PE-
RIOD.—The term ‘180-day exclusivity pe-
riod’ means the 180-day period ending on 
the day before the date on which an appli-
cation submitted by an applicant other 
than a first applicant could become effec-
tive under this clause. 
‘‘(bb) FIRST APPLICANT.—As used in 
this subsection, the term ‘first applicant’ 
means an applicant that, on the first day 
on which a substantially complete applica-
tion containing a certification described in 
paragraph (2)(A)(vii)(IV) is submitted for
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approval of a drug, submits a substantially 
complete application containing a certifi-
cation 
described 
in 
paragraph 
(2)(A)(vii)(IV) for the drug. 
‘‘(cc) SUBSTANTIALLY COMPLETE AP-
PLICATION.—As used in this subsection, 
the term ‘substantially complete applica-
tion’ means an application under this sub-
section that on its face is sufficiently com-
plete to permit a substantive review and 
contains all the information required by 
paragraph (2)(A). 
‘‘(dd) TENTATIVE APPROVAL.—
‘‘(AA) IN GENERAL.—The term 
‘tentative approval’ means notification 
to an applicant by the Secretary that 
an application under this subsection 
meets the requirements of paragraph 
(2)(A), but cannot receive effective 
approval because the application does 
not meet the requirements of this sub-
paragraph, there is a period of exclu-
sivity for the listed drug under sub-
paragraph (E) or section 505A, or
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there is a 7-year period of exclusivity 
for the listed drug under section 527. 
‘‘(BB) 
LIMITATION.—A 
drug 
that is granted tentative approval by 
the Secretary is not an approved drug 
and shall not have an effective ap-
proval until the Secretary issues an 
approval after any necessary addi-
tional review of the application. 
‘‘(II) EFFECTIVENESS OF APPLICATION.—
Subject to subparagraph (D), if the application 
contains a certification described in paragraph 
(2)(A)(vii)(IV) and is for a drug for which a 
first applicant has submitted an application 
containing such a certification, the application 
shall be made effective on the date that is 180 
days after the date of the first commercial mar-
keting of the drug (including the commercial 
marketing of the listed drug) by any first appli-
cant.’’; and 
(2) by inserting after subparagraph (C) the fol-
lowing: 
‘‘(D) FORFEITURE
OF
180-DAY
EXCLU-
SIVITY PERIOD.—
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‘‘(i) DEFINITION
OF
FORFEITURE 
EVENT.—In this subparagraph, the term 
‘forfeiture event’, with respect to an appli-
cation under this subsection, means the oc-
currence of any of the following: 
‘‘(I) FAILURE TO MARKET.—The 
first applicant fails to market the 
drug by the later of—
‘‘(aa) the earlier of the date 
that is— 
‘‘(AA) 75 days after the 
date on which the approval 
of the application of the first 
applicant is made effective 
under subparagraph (B)(iii); 
or 
‘‘(BB) 30 months after 
the date of submission of 
the application of the first 
applicant; or 
‘‘(bb) with respect to the 
first applicant or any other appli-
cant (which other applicant has 
received tentative approval), the 
date that is 75 days after the
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date as of which, as to each of 
the patents with respect to which 
the first applicant submitted a 
certification qualifying the first 
applicant for the 180-day exclu-
sivity period under subparagraph 
(B)(iv), at least 1 of the fol-
lowing has occurred: 
‘‘(AA) In an infringe-
ment action brought against 
that applicant with respect 
to the patent or in a declar-
atory 
judgment 
action 
brought by that applicant 
with respect to the patent, a 
court enters a final decision 
from which no appeal (other 
than a petition to the Su-
preme Court for a writ of 
certiorari) has been or can 
be taken that the patent is 
invalid or not infringed. 
‘‘(BB) In an infringe-
ment action or a declaratory 
judgment action described in
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HR 1 RDS 
subitem (AA), a court signs 
a settlement order or con-
sent decree that enters a 
final judgment that includes 
a finding that the patent is 
invalid or not infringed. 
‘‘(CC) The patent ex-
pires. 
‘‘(DD) The patent is 
withdrawn by the holder of 
the 
application 
approved 
under subsection (b). 
‘‘(II) WITHDRAWAL OF APPLICA-
TION.—The first applicant withdraws 
the application or the Secretary con-
siders the application to have been 
withdrawn as a result of a determina-
tion by the Secretary that the applica-
tion does not meet the requirements 
for approval under paragraph (4). 
‘‘(III) AMENDMENT OF CERTIFI-
CATION.—The first applicant amends 
or withdraws the certification for all 
of the patents with respect to which 
that applicant submitted a certifi-
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cation qualifying the applicant for the 
180-day exclusivity period. 
‘‘(IV) FAILURE TO OBTAIN TEN-
TATIVE
APPROVAL.—The first appli-
cant fails to obtain tentative approval 
of the application within 30 months 
after the date on which the applica-
tion is filed, unless the failure is 
caused by a change in or a review of 
the requirements for approval of the 
application imposed after the date on 
which the application is filed. 
‘‘(V) 
AGREEMENT
WITH
AN-
OTHER APPLICANT, THE LISTED DRUG 
APPLICATION HOLDER, OR A PATENT 
OWNER.—The first applicant enters 
into an agreement with another appli-
cant under this subsection for the 
drug, the holder of the application for 
the listed drug, or an owner of the 
patent that is the subject of the cer-
tification 
under 
paragraph 
(2)(A)(vii)(IV), the Federal Trade 
Commission or the Attorney General 
files a complaint, and there is a final
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decision of the Federal Trade Com-
mission or the court with regard to 
the complaint from which no appeal 
(other than a petition to the Supreme 
Court for a writ of certiorari) has 
been or can be taken that the agree-
ment has violated the antitrust laws 
(as defined in section 1 of the Clayton 
Act (15 U.S.C. 12), except that the 
term includes section 5 of the Federal 
Trade Commission Act (15 U.S.C. 45) 
to the extent that that section applies 
to unfair methods of competition). 
‘‘(VI) EXPIRATION OF ALL PAT-
ENTS.—All of the patents as to which 
the applicant submitted a certification 
qualifying it for the 180-day exclu-
sivity period have expired. 
‘‘(ii) FORFEITURE.—The 180-day ex-
clusivity period described in subparagraph 
(B)(iv) shall be forfeited by a first appli-
cant if a forfeiture event occurs with re-
spect to that first applicant.
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‘‘(iii) SUBSEQUENT
APPLICANT.—If 
all first applicants forfeit the 180-day ex-
clusivity period under clause (ii)—
‘‘(I) approval of any application 
containing a certification described in 
paragraph (2)(A)(vii)(IV) shall be 
made effective in accordance with sub-
paragraph (B)(iii); and 
‘‘(II) no applicant shall be eligi-
ble for a 180-day exclusivity period.’’. 
(b) EFFECTIVE DATE.—
(1) IN GENERAL.—Except as provided in para-
graph (2), the amendment made by subsection (a) 
shall be effective only with respect to an application 
filed under section 505(j) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)) after the 
date of enactment of this Act for a listed drug for 
which 
no 
certification 
under 
section 
505(j)(2)(A)(vii)(IV) of that Act was made before 
the date of enactment of this Act. 
(2) COLLUSIVE AGREEMENTS.—If a forfeiture 
event described in section 505(j)(5)(D)(i)(V) of that 
Act occurs in the case of an applicant, the applicant 
shall forfeit the 180-day period under section 
505(j)(5)(B)(iv) of that Act without regard to when
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the 
first 
certification 
under 
section 
505(j)(2)(A)(vii)(IV) of that Act for the listed drug 
was made. 
(3) DECISION OF A COURT WHEN THE 180-DAY 
EXCLUSIVITY PERIOD HAS NOT BEEN TRIGGERED.—
With respect to an application filed before, on, or 
after the date of enactment of this Act for a listed 
drug for which a certification under section 
505(j)(2)(A)(vii)(IV) of that Act was made before 
the date of enactment of this Act and for which nei-
ther of the events described in subclause (I) or (II) 
of section 505(j)(5)(B)(iv) of that Act (as in effect 
on the day before the date of enactment of this Act) 
has occurred on or before the date of enactment of 
this Act, the term ‘‘decision of a court’’ as used in 
clause (iv) of section 505(j)(5)(B) of that Act means 
a final decision of a court from which no appeal 
(other than a petition to the Supreme Court for a 
writ of certiorari) has been or can be taken. 
SEC. 1103. BIOAVAILABILITY AND BIOEQUIVALENCE. 
(a) IN GENERAL.—Section 505(j)(8) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(8)) is 
amended—
(1) by striking subparagraph (A) and inserting 
the following:
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‘‘(A)(i) The term ‘bioavailability’ means the 
rate and extent to which the active ingredient or 
therapeutic ingredient is absorbed from a drug and 
becomes available at the site of drug action. 
‘‘(ii) For a drug that is not intended to be ab-
sorbed into the bloodstream, the Secretary may as-
sess bioavailability by scientifically valid measure-
ments intended to reflect the rate and extent to 
which the active ingredient or therapeutic ingredient 
becomes available at the site of drug action.’’; and 
(2) by adding at the end the following: 
‘‘(C) For a drug that is not intended to be ab-
sorbed into the bloodstream, the Secretary may es-
tablish alternative, scientifically valid methods to 
show bioequivalence if the alternative methods are 
expected to detect a significant difference between 
the drug and the listed drug in safety and thera-
peutic effect.’’. 
(b) EFFECT
OF
AMENDMENT.—The amendment 
made by subsection (a) does not alter the standards for 
approval of drugs under section 505(j) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)). 
SEC. 1104. CONFORMING AMENDMENTS. 
Section 505A of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355a) is amended—
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(1) in subsections (b)(1)(A)(i) and (c)(1)(A)(i), 
by striking ‘‘(j)(5)(D)(ii)’’ each place it appears and 
inserting ‘‘(j)(5)(F)(ii)’’; 
(2) 
in 
subsections 
(b)(1)(A)(ii) 
and 
(c)(1)(A)(ii), by striking ‘‘(j)(5)(D)’’ each place it 
appears and inserting ‘‘(j)(5)(F)’’; and 
(3) in subsections (e) and (l), by striking 
‘‘505(j)(5)(D)’’ each place it appears and inserting 
‘‘505(j)(5)(F)’’. 
Subtitle B—Federal Trade 
Commission Review 
SEC. 1111. DEFINITIONS. 
In this subtitle: 
(1) ANDA.—The term ‘‘ANDA’’ means an ab-
breviated drug application, as defined under section 
201(aa) of the Federal Food, Drug, and Cosmetic 
Act. 
(2) BRAND
NAME
DRUG.—The term ‘‘brand 
name drug’’ means a drug for which an application 
is approved under section 505(c) of the Federal 
Food, Drug, and Cosmetic Act, including an applica-
tion referred to in section 505(b)(2) of such Act. 
(3) BRAND NAME DRUG COMPANY.—The term 
‘‘brand name drug company’’ means the party that 
holds the approved application referred to in para-
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graph (2) for a brand name drug that is a listed 
drug in an ANDA, or a party that is the owner of 
a patent for which information is submitted for such 
drug under subsection (b) or (c) of section 505 of 
the Federal Food, Drug, and Cosmetic Act. 
(4) COMMISSION.—The term ‘‘Commission’’ 
means the Federal Trade Commission. 
(5) GENERIC DRUG.—The term ‘‘generic drug’’ 
means a drug for which an application under section 
505(j) of the Federal Food, Drug, and Cosmetic Act 
is approved. 
(6) 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. 
(7) LISTED
DRUG.—The term ‘‘listed drug’’ 
means a brand name drug that is listed under sec-
tion 505(j)(7) of the Federal Food, Drug, and Cos-
metic Act. 
SEC. 1112. NOTIFICATION OF AGREEMENTS. 
(a) AGREEMENT WITH BRAND NAME DRUG COM-
PANY.—
(1) REQUIREMENT.—A generic drug applicant 
that has submitted an ANDA containing a certifi-
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cation under section 505(j)(2)(A)(vii)(IV) of the 
Federal Food, Drug, and Cosmetic Act and a brand 
name drug company that enter into an agreement 
described in paragraph (2) shall each file the agree-
ment in accordance with subsection (c). The agree-
ment shall be filed prior to the date of the first com-
mercial marketing of the generic drug that is the 
subject of the ANDA. 
(2) SUBJECT
MATTER
OF
AGREEMENT.—An 
agreement described in this paragraph between a ge-
neric drug applicant and a brand name drug com-
pany is an agreement regarding—
(A) the manufacture, marketing or sale of 
the brand name drug that is the listed drug in 
the ANDA involved; 
(B) the manufacture, marketing, or sale of 
the generic drug for which the ANDA was sub-
mitted; or 
(C) the 180-day period referred to in sec-
tion 505(j)(5)(B)(iv) of the Federal Food, 
Drug, and Cosmetic Act as it applies to such 
ANDA or to any other ANDA based on the 
same brand name drug. 
(b) AGREEMENT WITH ANOTHER GENERIC DRUG 
APPLICANT.—
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(1) REQUIREMENT.—A generic drug applicant 
that has submitted an ANDA containing a certifi-
cation under section 505(j)(2)(A)(vii)(IV) of the 
Federal Food, Drug, and Cosmetic Act with respect 
to a listed drug and another generic drug applicant 
that has submitted an ANDA containing such a cer-
tification for the same listed drug shall each file the 
agreement in accordance with subsection (c). The 
agreement shall be filed prior to the date of the first 
commercial marketing of either of the generic drugs 
for which such ANDAs were submitted. 
(2) SUBJECT
MATTER
OF
AGREEMENT.—An 
agreement described in this paragraph between two 
generic drug applicants is an agreement regarding 
the 
180-day 
period 
referred 
to 
in 
section 
505(j)(5)(B)(iv) of the Federal Food, Drug, and 
Cosmetic Act as it applies to the ANDAs with which 
the agreement is concerned. 
(c) FILING.—
(1) AGREEMENT.—The parties that are re-
quired in subsection (a) or (b) to file an agreement 
in accordance with this subsection shall file with the 
Commission the text of any such agreement, except 
that such parties are not required to file an agree-
ment that solely concerns—
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(A) purchase orders for raw material sup-
plies; 
(B) equipment and facility contracts; 
(C) employment or consulting contracts; or 
(D) packaging and labeling contracts. 
(2) OTHER
AGREEMENTS.—The parties that 
are required in subsection (a) or (b) to file an agree-
ment in accordance with this subsection shall file 
with the Commission the text of any agreements be-
tween the parties that are not described in such sub-
sections and are contingent upon, provide a contin-
gent condition for, or are otherwise related to an 
agreement that is required in subsection (a) or (b) 
to be filed in accordance with this subsection. 
(3) DESCRIPTION.—In the event that any 
agreement required in subsection (a) or (b) to be 
filed in accordance with this subsection has not been 
reduced to text, each of the parties involved shall file 
written descriptions of such agreement that are suf-
ficient to disclose all the terms and conditions of the 
agreement. 
SEC. 1113. FILING DEADLINES. 
Any filing required under section 1112 shall be filed 
with the Commission not later than 10 business days after 
the date the agreements are executed.
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SEC. 1114. DISCLOSURE EXEMPTION. 
Any information or documentary material filed with 
the Commission pursuant to this subtitle shall be exempt 
from disclosure under section 552 of title 5, United States 
Code, and no such information or documentary material 
may be made public, except as may be relevant to any 
administrative or judicial action or proceeding. Nothing in 
this section is intended to prevent disclosure to either body 
of Congress or to any duly authorized committee or sub-
committee of the Congress. 
SEC. 1115. ENFORCEMENT. 
(a) CIVIL PENALTY.—Any brand name drug com-
pany or generic drug applicant which fails to comply with 
any provision of this subtitle shall be liable for a civil pen-
alty of not more than $11,000, for each day during which 
such entity 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 procedures established in section 16(a)(1) of the Fed-
eral Trade Commission Act (15 U.S.C. 56(a)). 
(b) COMPLIANCE AND EQUITABLE RELIEF.—If any 
brand name drug company or generic drug applicant fails 
to comply with any provision of this subtitle, the United 
States district court may order compliance, and may grant 
such other equitable relief as the court in its discretion
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determines necessary or appropriate, upon application of 
the Commission. 
SEC. 1116. RULEMAKING. 
The Commission, by rule in accordance with section 
553 of title 5, United States Code, consistent with the pur-
poses of this subtitle—
(1) may define the terms used in this subtitle; 
(2) may exempt classes of persons or agree-
ments from the requirements of this subtitle; and 
(3) may prescribe such other rules as may be 
necessary and appropriate to carry out the purposes 
of this subtitle. 
SEC. 1117. SAVINGS CLAUSE. 
Any action taken by the Commission, or any failure 
of the Commission to take action, under this subtitle shall 
not at any time bar any proceeding or any action with 
respect to any agreement between a brand name drug 
company and a generic drug applicant, or any agreement 
between generic drug applicants, under any other provi-
sion of law, nor shall any filing under this subtitle con-
stitute or create a presumption of any violation of any 
competition laws. 
SEC. 1118. EFFECTIVE DATE. 
This subtitle shall—
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(1) take effect 30 days after the date of enact-
ment of this Act; and 
(2) shall apply to agreements described in sec-
tion 1112 that are entered into 30 days after the 
date of enactment of this Act. 
Subtitle C—Importation of 
Prescription Drugs 
SEC. 1121. IMPORTATION OF PRESCRIPTION DRUGS. 
(a) IN GENERAL.—Chapter VIII of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) 
is amended by striking section 804 and inserting the fol-
lowing: 
‘‘SEC. 804. IMPORTATION OF PRESCRIPTION DRUGS. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) IMPORTER.—The term ‘importer’ means a 
pharmacist or wholesaler. 
‘‘(2) PHARMACIST.—The term ‘pharmacist’ 
means a person licensed by a State to practice phar-
macy, including the dispensing and selling of pre-
scription drugs. 
‘‘(3) PRESCRIPTION
DRUG.—The term ‘pre-
scription drug’ means a drug subject to section 
503(b), other than—
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‘‘(A) a controlled substance (as defined in 
section 102 of the Controlled Substances Act 
(21 U.S.C. 802)); 
‘‘(B) a biological product (as defined in 
section 351 of the Public Health Service Act 
(42 U.S.C. 262)); 
‘‘(C) an infused drug (including a peri-
toneal dialysis solution); 
‘‘(D) an intravenously injected drug; 
‘‘(E) a drug that is inhaled during surgery; 
or 
‘‘(F) a drug which is a parenteral drug, 
the importation of which pursuant to subsection 
(b) is determined by the Secretary to pose a 
threat to the public health, in which case sec-
tion 801(d)(1) shall continue to apply. 
‘‘(4) QUALIFYING
LABORATORY.—The term 
‘qualifying laboratory’ means a laboratory in the 
United States that has been approved by the Sec-
retary for the purposes of this section. 
‘‘(5) WHOLESALER.—
‘‘(A) IN GENERAL.—The term ‘wholesaler’ 
means a person licensed as a wholesaler or dis-
tributor of prescription drugs in the United 
States under section 503(e)(2)(A).
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‘‘(B) EXCLUSION.—The term ‘wholesaler’ 
does not include a person authorized to import 
drugs under section 801(d)(1). 
‘‘(b) REGULATIONS.—The Secretary shall promul-
gate regulations permitting pharmacists and wholesalers 
to import prescription drugs from Canada into the United 
States. 
‘‘(c) LIMITATION.—The regulations under subsection 
(b) shall—
‘‘(1) require that each prescription drug im-
ported under the regulations complies with section 
505 (including with respect to being safe and effec-
tive for the intended use of the prescription drug), 
with sections 501 and 502, and with all other appli-
cable requirements of this Act; 
‘‘(2) require that an importer of a prescription 
drug under the regulations comply with subsections 
(d)(1) and (e); 
‘‘(3) require that any prescription drug from 
Canada imported by a domestic pharmacist or 
wholesaler under this section be contained in pack-
aging which the Secretary has determined to be rea-
sonably certain to be tamper-resistant and not capa-
ble of counterfeiting;
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‘‘(4) require that all prescription drugs from 
Canada imported by a domestic pharmacist or a 
wholesaler under this section contain a statement 
designed to inform the end-user of such drug that 
such drug has been imported from a foreign seller 
other than a manufacturer; 
‘‘(5) require that only prescription drugs which 
have not left the possession of the first Canadian re-
cipient of such prescription drugs after receipt from 
the manufacturer of such prescription drugs be eligi-
ble for importation into the United States under this 
section; 
‘‘(6) require, if determined appropriate by the 
Secretary, that all prescription drugs imported from 
Canada under this section by domestic pharmacists 
and wholesalers enter the United States through 
ports of entry designated by the Secretary for pur-
poses of this section; 
‘‘(7) contain any additional provisions deter-
mined by the Secretary to be appropriate to protect 
the public health; and 
‘‘(8) contain any additional provisions deter-
mined by the Secretary to be appropriate to facili-
tate the importation of prescription drugs that do 
not jeopardize the public health.
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‘‘(d) INFORMATION AND RECORDS.—
‘‘(1) IN GENERAL.—The regulations under sub-
section (b) shall require an importer of a prescrip-
tion drug under subsection (b) to submit to the Sec-
retary the following information and documentation: 
‘‘(A) The name and quantity of the active 
ingredient of the prescription drug. 
‘‘(B) A description of the dosage form of 
the prescription drug. 
‘‘(C) The date on which the prescription 
drug is shipped. 
‘‘(D) The quantity of the prescription drug 
that is shipped. 
‘‘(E) The point of origin and destination of 
the prescription drug. 
‘‘(F) The price paid and the price charged 
by the importer for the prescription drug. 
‘‘(G) Documentation from the foreign sell-
er specifying—
‘‘(i) the original source of the pre-
scription drug; and 
‘‘(ii) the quantity of each lot of the 
prescription drug originally received by the 
seller from that source.
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‘‘(H) The lot or control number assigned 
to the prescription drug by the manufacturer of 
the prescription drug. 
‘‘(I) The name, address, telephone number, 
and professional license number (if any) of the 
importer. 
‘‘(J)(i) Documentation demonstrating that 
the prescription drug was received by the recipi-
ent from the manufacturer and subsequently 
shipped by the first foreign recipient to the im-
porter. 
‘‘(ii) Documentation of the quantity of 
each lot of the prescription drug received by the 
first foreign recipient demonstrating that the 
quantity being imported into the United States 
is not more than the quantity that was received 
by the first foreign recipient. 
‘‘(iii) In the case of an initial imported 
shipment, documentation demonstrating that 
each batch of the prescription drug in the ship-
ment was statistically sampled and tested for 
authenticity and degradation. 
‘‘(K) Certification from the importer or 
manufacturer of the prescription drug that the 
prescription drug—
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‘‘(i) is approved for marketing in the 
United States and is not adulterated or 
misbranded; and 
‘‘(ii) meets all labeling requirements 
under this Act. 
‘‘(L) Laboratory records, including com-
plete data derived from all tests necessary to 
ensure that the prescription drug is in compli-
ance with established specifications and stand-
ards. 
‘‘(M) Documentation demonstrating that 
the testing required by subparagraphs (J) and 
(L) was conducted at a qualifying laboratory. 
‘‘(N) Any other information that the Sec-
retary determines is necessary to ensure the 
protection of the public health. 
‘‘(2) MAINTENANCE BY THE SECRETARY.—The 
Secretary shall maintain information and docu-
mentation submitted under paragraph (1) for such 
period of time as the Secretary determines to be nec-
essary. 
‘‘(e) TESTING.—The regulations under subsection (b) 
shall require—
‘‘(1) that testing described in subparagraphs 
(J) and (L) of subsection (d)(1) be conducted by the
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importer or by the manufacturer of the prescription 
drug at a qualified laboratory; 
‘‘(2) if the tests are conducted by the im-
porter—
‘‘(A) that information needed to—
‘‘(i) authenticate the prescription drug 
being tested; and 
‘‘(ii) confirm that the labeling of the 
prescription drug complies with labeling re-
quirements under this Act; 
be supplied by the manufacturer of the pre-
scription drug to the pharmacist or wholesaler; 
and 
‘‘(B) that the information supplied under 
subparagraph (A) be kept in strict confidence 
and used only for purposes of testing under this 
section; and 
‘‘(3) may include such additional provisions as 
the Secretary determines to be appropriate to pro-
vide for the protection of trade secrets and commer-
cial or financial information that is privileged or 
confidential. 
‘‘(f) REGISTRATION OF FOREIGN SELLERS.—Any es-
tablishment within Canada engaged in the distribution of 
a prescription drug that is imported or offered for impor-
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tation into the United States shall register with the Sec-
retary the name and place of business of the establishment 
and the name of the United States agent for the establish-
ment. 
‘‘(g) SUSPENSION OF IMPORTATION.—The Secretary 
shall require that importations of a specific prescription 
drug or importations by a specific importer under sub-
section (b) be immediately suspended on discovery of a 
pattern of importation of that specific prescription drug 
or by that specific importer of drugs that are counterfeit 
or in violation of any requirement under this section, until 
an investigation is completed and the Secretary deter-
mines that the public is adequately protected from coun-
terfeit and violative prescription drugs being imported 
under subsection (b). 
‘‘(h) APPROVED LABELING.—The manufacturer of a 
prescription drug shall provide an importer written au-
thorization for the importer to use, at no cost, the ap-
proved labeling for the prescription drug. 
‘‘(i) 
CHARITABLE
CONTRIBUTIONS.—Notwith-
standing any other provision of this section, section 
801(d)(1) continues to apply to a prescription drug that 
is donated or otherwise supplied at no charge by the man-
ufacturer of the drug to a charitable or humanitarian or-
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ganization (including the United Nations and affiliates) 
or to a government of a foreign country. 
‘‘(j) WAIVER AUTHORITY FOR IMPORTATION BY IN-
DIVIDUALS.—The Secretary may, for drugs being im-
ported from a licensed Canadian pharmacy, grant to indi-
viduals, by regulation or on a case-by-case basis, a waiver 
of the prohibition of importation of a prescription drug 
or device or class of prescription drugs or devices, under 
such conditions as the Secretary determines to be appro-
priate. Such conditions shall include conditions that such 
drug or device be—
‘‘(1) in the possession of an individual when the 
individual enters the United States; 
‘‘(2) imported by such individual from a li-
censed pharmacy for personal use by the individual, 
not for resale, in quantities that do not exceed a 90-
day supply, which individual will use the drug or de-
vice (or for a family member of such individual); 
‘‘(3) accompanied by a copy of a valid prescrip-
tion; 
‘‘(4) imported from Canada, from a seller reg-
istered with the Secretary; 
‘‘(5) a prescription drug approved by the Sec-
retary under chapter V that is not adulterated or 
misbranded;
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‘‘(6) in the form of a final finished dosage that 
was manufactured in an establishment registered 
under section 510; and 
‘‘(7) imported under such other conditions as 
the Secretary determines to be necessary to ensure 
public safety. 
‘‘(k) STUDIES; REPORTS.—
‘‘(1) BY THE INSTITUTE OF MEDICINE OF THE 
NATIONAL ACADEMY OF SCIENCES.—
‘‘(A) STUDY.—
‘‘(i) IN
GENERAL.—The Secretary 
shall request that the Institute of Medicine 
of the National Academy of Sciences con-
duct a study of—
‘‘(I) importations of prescription 
drugs made under the regulations 
under subsection (b); and 
‘‘(II) 
information 
and 
docu-
mentation submitted under subsection 
(d). 
‘‘(ii) REQUIREMENTS.—In conducting 
the study, the Institute of Medicine shall—
‘‘(I) evaluate the compliance of 
importers with the regulations under 
subsection (b);
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‘‘(II) compare the number of 
shipments 
under 
the 
regulations 
under subsection (b) during the study 
period that are determined to be 
counterfeit, misbranded, or adulter-
ated, and compare that number with 
the number of shipments made during 
the study period within the United 
States that are determined to be 
counterfeit, misbranded, or adulter-
ated; and 
‘‘(III) consult with the Secretary 
to evaluate the effect of importations 
under the regulations under sub-
section (b) on trade and patent rights 
under Federal law. 
‘‘(B) REPORT.—Not later than 2 years 
after the effective date of the regulations under 
subsection (b), the Institute of Medicine shall 
submit to Congress a report describing the find-
ings of the study under subparagraph (A). 
‘‘(2) BY THE COMPTROLLER GENERAL.—
‘‘(A) STUDY.—The Comptroller General of 
the United States shall conduct a study to de-
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termine the effect of this section on the price of 
prescription drugs sold to consumers at retail. 
‘‘(B) REPORT.—Not later than 18 months 
after the effective date of the regulations under 
subsection (b), the Comptroller General of the 
United States shall submit to Congress a report 
describing the findings of the study under sub-
paragraph (A). 
‘‘(l) CONSTRUCTION.—Nothing in this section limits 
the authority of the Secretary relating to the importation 
of prescription drugs, other than with respect to section 
801(d)(1) as provided in this section. 
‘‘(m) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated such sums as are nec-
essary to carry out this section. 
‘‘(n) CONDITIONS.—This section shall become effec-
tive only if the Secretary demonstrates to the Congress 
that the implementation of this section will—
‘‘(1) pose no additional risk to the public’s 
health and safety; and 
‘‘(2) result in a significant reduction in the cost 
of prescription drugs to the American consumer.’’. 
(b) 
CONFORMING
AMENDMENTS.—The 
Federal 
Food, Drug, and Cosmetic Act is amended—