I
107TH CONGRESS
2D SESSION
H. R. 5272
To amend the Federal Food, Drug, and Cosmetic Act to provide greater
access to affordable pharmaceuticals.
IN THE HOUSE OF REPRESENTATIVES
JULY 26, 2002
Mr. BROWN of Ohio (for himself and Mr. WAXMAN) introduced the following
bill; which was referred to the Committee on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
provide greater access to affordable pharmaceuticals.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Prescription Drug Fair Competition Act of 2002’’.
(b) TABLE OF CONTENTS.—The table of contents of
this Act is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Filing of patent information with the Food and Drug Administration.
Sec. 3. Limitation of 30-month stay to certain patents.
Sec. 4. Exclusivity for accelerated generic drug applicants.
Sec. 5. Fair treatment for innovators.
Sec. 6. Bioequivalence.
Sec. 7. Additional uses.
Sec. 8. Report.
Sec. 9. Conforming and technical amendments.
SEC. 2. FILING OF PATENT INFORMATION WITH THE FOOD
AND DRUG ADMINISTRATION.
(a) FILING AFTER APPROVAL
OF
AN APPLICA-
TION.—
(1) IN GENERAL.—Section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) (as
amended by section 9(a)(2)(B)(ii)) is amended in
subsection (c) by striking paragraph (2) and insert-
ing the following:
‘‘(2) PATENT INFORMATION.—
‘‘(A) IN
GENERAL.—Not later than the
date that is 30 days after the date of an order
approving an application under subsection (b)
(unless the Secretary extends the date because
of extraordinary or unusual circumstances), the
holder of the application shall file with the Sec-
retary the patent information described in sub-
paragraph (C) with respect to any patent—
‘‘(i)(I) that claims the drug for which
the application was approved; or
‘‘(II) that claims an approved method
of using the drug; and
‘‘(ii) with respect to which a claim of
patent infringement could reasonably be
asserted if a person not licensed by the
owner engaged in the manufacture, use, or
sale of the drug.
‘‘(B) SUBSEQUENTLY ISSUED PATENTS.—
In a case in which a patent described in sub-
paragraph (A) is issued after the date of an
order approving an application under subsection
(b), the holder of the application shall file with
the Secretary the patent information described
in subparagraph (C) not later than the date
that is 30 days after the date on which the pat-
ent is issued (unless the Secretary extends the
date because of extraordinary or unusual cir-
cumstances).
‘‘(C) PATENT INFORMATION.—The patent
information required to be filed under subpara-
graph (A) or (B) includes—
‘‘(i) the patent number;
‘‘(ii) the expiration date of the patent;
‘‘(iii) with respect to each claim of the
patent—
‘‘(I) whether the patent claims
the drug or claims a method of using
the drug; and
‘‘(II) whether the claim covers—
‘‘(i) IN GENERAL.—A person that has
filed an application under subsection (b)(2)
or (j) for a drug, or a person with standing
to bring an infringement action on a pat-
ent that claims an approved drug or claims
an approved method of using the drug,
may bring a civil action against the holder
of the approved application for the drug
seeking an order requiring that the holder
of the application amend the application—
‘‘(I) to correct patent information
filed under subparagraph (A);
‘‘(II) to add patent information
required under subparagraph (A) or
(B); or
‘‘(III) to delete the patent infor-
mation in its entirety for the reason
that—
‘‘(aa) the patent does not
claim the drug for which the ap-
plication was approved; or
‘‘(bb) the patent does not
claim an approved method of
using the drug.
person with standing to bring an infringement
action commences an action against the holder
of the application under subparagraph (E) to
compel the filing of the patent information
within 90 days of the approval of the holder’s
application or the issuance of the patent, which-
ever occurs later, and obtains final judgment
requiring the listing.’’.
(2) TRANSITION PROVISION.—
(A) FILING OF PATENT INFORMATION.—
Each holder of an application for approval of a
new drug under section 505(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(b)) that has been approved before the date
of enactment of this Act shall amend the appli-
cation to include the patent information re-
quired under the amendment made by para-
graph (1) not later than the date that is 30
days after the date of enactment of this Act
(unless the Secretary of Health and Human
Services extends the date because of extraor-
dinary or unusual circumstances).
(B) NO
CLAIM
FOR
PATENT
INFRINGE-
MENT.—A person with standing to bring an in-
fringement action on a patent with respect to
which a holder of an application under sub-
section (b) of section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) fails
to file information on or before the date re-
quired under subparagraph (A) shall be barred
from bringing a civil action for infringement of
the patent against a person that—
(i) has filed an application under sub-
section (b)(2) or (j) of that section; or
(ii) manufactures, uses, offers to sell,
or sells a drug approved under an applica-
tion under subsection (b)(2) or (j) of that
section;
unless, neither the holder of the application nor
any of its affiliates has any rights under the
patent, including without limitation, ownership,
license, option, or right of refusal, in which case
an infringement action may be brought if the
person with standing to bring an infringement
action commences an action against the holder
of 
the 
application 
under 
subsection
505(c)(2)(E) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) to compel the fil-
ing of the patent information within 90 days of
the approval of the holder’s application or the
issuance of the patent, whichever occurs later,
and obtains final judgment requiring the listing.
(b) FILING WITH AN APPLICATION.—Section 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355) is amended—
(1) in subsection (b)(2)—
(A) in subparagraph (A), by striking
‘‘and’’ at the end;
(B) in subparagraph (B), by striking the
period at the end and inserting ‘‘; and’’; and
(C) by adding at the end the following:
‘‘(C) with respect to a patent that claims
both the drug and a method of using the drug
or claims more than 1 method of using the drug
for which the application is filed—
‘‘(i) a certification under subpara-
graph (A)(iv) on a claim-by-claim basis;
and
‘‘(ii) a statement under subparagraph
(B) regarding the method of use claim.’’;
and
(2) in subsection (j)(2)(A), by inserting after
clause (viii) the following:
‘‘With respect to a patent that claims both the drug and
a method of using the drug or claims more than 1 method
of using the drug for which the application is filed, the
application shall contain a certification under clause
(vii)(IV) on a claim-by-claim basis and a statement under
clause (viii) regarding the method of use claim.’’.
SEC. 3. LIMITATION OF 30-MONTH STAY TO CERTAIN PAT-
ENTS.
(a) ABBREVIATED NEW DRUG APPLICATIONS.—Sec-
tion 505(j)(5) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)(5)) is amended—
(1) in subparagraph (B)—
(A) in clause (iii)—
(i) by striking ‘‘(iii) If the applicant
made a certification described in subclause
(IV) of paragraph (2)(A)(vii),’’ and insert-
ing the following:
‘‘(iii) SUBCLAUSE (IV) CERTIFICATION
WITH RESPECT TO CERTAIN PATENTS.—If
the applicant made a certification de-
scribed in paragraph (2)(A)(vii)(IV) with
respect to a patent (other than a patent
that claims a process for manufacturing
the listed drug) for which patent informa-
tion was filed with the Secretary under
subsection (c)(2)(A),’’; and
(ii) by adding at the end the fol-
lowing: ‘‘The 30-month period provided
under the second sentence of this clause
shall not apply to a certification under
paragraph (2)(A)(vii)(IV) made with re-
spect to a patent for which patent informa-
tion was filed with the Secretary under
subsection (c)(2)(B).’’;
(B) by redesignating clause (iv) as clause
(v); and
(C) by inserting after clause (iii) the fol-
lowing:
‘‘(iv) SUBCLAUSE (IV) CERTIFICATION
WITH RESPECT TO OTHER PATENTS.—
‘‘(I) IN GENERAL.—If the appli-
cant made a certification described in
paragraph (2)(A)(vii)(IV) with respect
to a patent not described in clause
(iii) for which patent information was
published by the Secretary under sub-
section (c)(2)(D), the approval shall
be made effective on the date that is
45 days after the date on which the
notice 
provided 
under 
paragraph
(2)(B) was received, unless a civil ac-
tion for infringement of the patent,
accompanied by a motion for prelimi-
nary injunction to enjoin the applicant
from engaging in the commercial
manufacture or sale of the drug, was
filed on or before the date that is 45
days after the date on which the no-
tice was received, in which case the
approval shall be made effective—
‘‘(aa) on the date of a court
action declining to grant a pre-
liminary injunction; or
‘‘(bb) if the court has grant-
ed a preliminary injunction pro-
hibiting the applicant from en-
gaging in the commercial manu-
facture or sale of the drug—
‘‘(AA) on issuance by a
court of a determination
that the patent is invalid or
is not infringed;
‘‘(BB) on issuance by a
court of an order revoking
the preliminary injunction or
permitting the applicant to
engage in the commercial
manufacture or sale of the
drug; or
‘‘(CC) on the date spec-
ified in a court order under
section 271(e)(4)(A) of title
35, United States Code, if
the court determines that
the patent is infringed.
‘‘(II) COOPERATION.—Each of
the parties shall reasonably cooperate
in expediting a civil action under sub-
clause (I).
‘‘(III) 
EXPEDITED
NOTIFICA-
TION.—If the notice under paragraph
(2)(B) contains an address for the re-
ceipt of expedited notification of a
civil action under subclause (I), the
plaintiff shall, on the date on which
the complaint is filed, simultaneously
cause a notification of the civil action
to be delivered to that address by the
next business day.’’; and
(2) by inserting after subparagraph (B) the fol-
lowing:
‘‘(C) FAILURE TO BRING INFRINGEMENT
ACTION.—If, in connection with an application
under this subsection, the applicant provides an
owner of a patent notice under paragraph
(2)(B) with respect to the patent, and the
owner of the patent fails to bring a civil action
against the applicant for infringement of the
patent on or before the date that is 45 days
after the date on which the notice is received,
the owner of the patent shall be barred from
bringing a civil action for infringement of the
patent in connection with the development,
manufacture, use, offer to sell, or sale of the
drug for which the application was filed or ap-
proved under this subsection.’’.
(b) OTHER APPLICATIONS.—Section 505(c)) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c))
(as amended by section 9(a)(3)(A)(iii)) is amended—
(1) in paragraph (3)—
(A) in subparagraph (C)—
(i) by striking ‘‘(C) If the applicant
made a certification described in clause
(iv) of subsection (b)(2)(A),’’ and inserting
the following:
‘‘(C) CLAUSE (iv) CERTIFICATION
WITH
RESPECT TO CERTAIN PATENTS.—If the appli-
cant made a certification described in sub-
section (b)(2)(A)(iv) with respect to a patent
(other than a patent that claims a process for
manufacturing the listed drug) for which patent
information was filed with the Secretary under
paragraph (2)(A),’’; and
(ii) by adding at the end the fol-
lowing: ‘‘The 30-month period provided
under the second sentence of this subpara-
graph shall not apply to a certification
under subsection (b)(2)(A)(iv) made with
respect to a patent for which patent infor-
mation was filed with the Secretary under
paragraph (2)(B).’’; and
(B) by inserting after subparagraph (C)
the following:
‘‘(D) CLAUSE (iv) CERTIFICATION
WITH
RESPECT TO OTHER PATENTS.—
‘‘(i) IN
GENERAL.—If the applicant
made a certification described in sub-
section (b)(2)(A)(iv) with respect to a pat-
ent not described in subparagraph (C) for
which patent information was published by
the Secretary under paragraph (2)(D), the
approval shall be made effective on the
date that is 45 days after the date on
which the notice provided under subsection
(b)(3) was received, unless a civil action
for infringement of the patent, accom-
panied by a motion for preliminary injunc-
tion to enjoin the applicant from engaging
in the commercial manufacture or sale of
the drug, was filed on or before the date
that is 45 days after the date on which the
notice was received, in which case the ap-
proval shall be made effective—
‘‘(I) on the date of a court action
declining to grant a preliminary in-
junction; or
‘‘(II) if the court has granted a
preliminary injunction prohibiting the
applicant from engaging in the com-
mercial manufacture or sale of the
drug—
‘‘(aa) on issuance by a court
of a determination that the pat-
ent is invalid or is not infringed;
‘‘(bb) on issuance by a court
of an order revoking the prelimi-
nary injunction or permitting the
applicant to engage in the com-
mercial manufacture or sale of
the drug; or
‘‘(cc) on the date specified
in a court order under section
271(e)(4)(A) of title 35, United
States Code, if the court deter-
mines that the patent is in-
fringed.
‘‘(ii) COOPERATION.—Each of the
parties shall reasonably cooperate in expe-
diting a civil action under clause (i).
‘‘(iii) EXPEDITED NOTIFICATION.—If
the notice under subsection (b)(3) contains
an address for the receipt of expedited no-
tification of a civil action under clause (i),
the plaintiff shall, on the date on which the
complaint is filed, simultaneously cause a
notification of the civil action to be deliv-
ered to that address by the next business
day.’’; and
(2) by inserting after paragraph (3) the fol-
lowing:
‘‘(4) FAILURE
TO
BRING
INFRINGEMENT
AC-
TION.—If, in connection with an application under
subsection (b)(2), the applicant provides an owner of
a patent notice under subsection (b)(3) with respect
to the patent, and the owner of the patent fails to
bring a civil action against the applicant for in-
fringement of the patent on or before the date that
is 45 days after the date on which the notice is re-
ceived, the owner of the patent shall be barred from
bringing a civil action for infringement of the patent
in connection with the development, manufacture,
use, offer to sell, or sale of the drug for which the
application was filed or approved under subsection
(b)(2).’’.
(c) EFFECTIVE DATE.—
(1) IN GENERAL.—The amendments made by
subsections (a) and (b) shall be effective with re-
spect 
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) made after the date of enactment of
this Act in an application filed under subsection
(b)(2) or (j) of that section.
(2) TRANSITION PROVISION.—In the case of ap-
plications under section 505(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(b)) filed be-
fore the date of enactment of this Act—
(A) a patent (other than a patent that
claims a process for manufacturing a listed
drug) for which information was submitted to
the Secretary of Health and Human Services
under section 505(b)(1) of the Federal Food,
Drug, and Cosmetic Act (as in effect on the day
before the date of enactment of this Act) shall
be 
subject 
to 
subsections 
(c)(3)(C) 
and
(j)(5)(B)(iii) of section 505 of the Federal
Food, Drug, and Cosmetic Act (as amended by
this section); and
(B) any other patent (including a patent
for which information was submitted to the
Secretary under section 505(c)(2) of that Act
(as in effect on the day before the date of en-
actment of this Act)) shall be subject to sub-
sections (c)(3)(D) and (j)(5)(B)(iv) of section
505 of the Federal Food, Drug, and Cosmetic
Act (as amended by this section).
SEC. 4. EXCLUSIVITY FOR ACCELERATED GENERIC DRUG
APPLICANTS.
(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 3(a)) is amended—
(1) in subparagraph (B)(v), by striking sub-
clause (II) and inserting the following:
‘‘(II) the earlier of—
‘‘(aa) the date of a final de-
cision of a court (from which no
appeal has been or can be taken,
other than a petition to the Su-
preme Court for a writ of certio-
rari) holding that the patent that
is the subject of the certification
is invalid or not infringed; or
‘‘(bb) the date of a settle-
ment order or consent decree
signed by a Federal judge that
enters a final judgment and in-
cludes a finding that the patent
that is the subject of the certifi-
cation is invalid or not in-
fringed;’’; and
(2) by inserting after subparagraph (C) the fol-
lowing:
‘‘(D) FORFEITURE OF 180-DAY PERIOD.—
‘‘(i) DEFINITIONS.—In this subpara-
graph:
‘‘(I) APPLICATION.—The term
‘application’ means an application for
approval of a drug under this sub-
section 
containing 
a 
certification
under paragraph (2)(A)(vii)(IV) with
respect to a patent.
‘‘(II) FIRST APPLICATION.—The
term ‘first application’ means the first
application to be filed for approval of
the drug.
‘‘(III) 
FORFEITURE
EVENT.—
The term ‘forfeiture event’, with re-
spect to an application under this sub-
section, means the occurrence of any
of the following:
‘‘(aa) FAILURE
TO
MAR-
KET.—The 
applicant 
fails 
to
market the drug by the later of—
‘‘(AA) the date that is
60 days after the date on
which the approval of the
application for the drug is
made effective under clause
(iii) or (iv) of subparagraph
(B) (unless the Secretary ex-
tends the date because of ex-
traordinary or unusual cir-
cumstances); or
‘‘(BB) if 1 or more civil
actions have been brought
against the applicant for in-
fringement of a patent sub-
ject to a certification under
paragraph (2)(A)(vii)(IV) or
1 or more civil actions have
been brought by the appli-
cant for a declaratory judg-
ment that such a patent is
invalid or not infringed, the
date that is 60 days after
the date of a final decision
(from which no appeal has
been or can be taken, other
than a petition to the Su-
preme Court for a writ of
certiorari) in the last of
those civil actions to be de-
cided (unless the Secretary
extends the date because of
extraordinary 
or 
unusual
circumstances).
‘‘(bb) WITHDRAWAL OF AP-
PLICATION.—The applicant with-
draws the application.
‘‘(cc) AMENDMENT OF CER-
TIFICATION.—The applicant, vol-
untarily or as a result of a settle-
ment or defeat in patent litiga-
tion, amends the certification
from a certification under para-
graph (2)(A)(vii)(IV) to a certifi-
cation 
under 
paragraph
(2)(A)(vii)(III).
‘‘(dd) FAILURE TO OBTAIN
APPROVAL.—The applicant fails
to obtain tentative approval of an
application within 30 months
after the date on which the appli-
cation is filed, unless the failure
is caused by—
‘‘(AA) a change in the
requirements for approval of
the 
application 
imposed
after the date on which the
application is filed; or
‘‘(BB) other extraor-
dinary circumstances war-
ranting an exception, as de-
termined by the Secretary.
‘‘(ee) FAILURE
TO
CHAL-
LENGE
PATENT.—In a case in
which, after the date on which
the applicant submitted the ap-
plication, new patent information
is submitted under subsection
(c)(2) for the listed drug for a
patent for which certification is
required under paragraph (2)(A),
the applicant fails to submit, not
later than the date that is 60
days after the date on which the
Secretary publishes the new pat-
ent information under paragraph
(7)(A)(iii) (unless the Secretary
extends the date because of ex-
traordinary 
or 
unusual 
cir-
cumstances)—
‘‘(AA) a certification
described 
in 
paragraph
(2)(A)(vii)(IV) with respect
to the patent to which the
new patent information re-
lates; or
‘‘(BB) a statement that
any method of use claim of
that patent does not claim a
use for which the applicant
is seeking approval under
this subsection in accord-
ance 
with 
paragraph
(2)(A)(viii).
‘‘(ff) 
UNLAWFUL
CON-
DUCT.—The Federal Trade Com-
mission determines that the ap-
plicant engaged in unlawful con-
duct with respect to the applica-
tion in violation of section 1 of
the Sherman Act (15 U.S.C. 1).
‘‘(IV) 
SUBSEQUENT
APPLICA-
TION.—The term ‘subsequent applica-
tion’ means an application for ap-
proval of a drug that is filed subse-
quent to the filing of a first applica-
tion for approval of that drug.
‘‘(ii) FORFEITURE
OF
180-DAY
PE-
RIOD.—
‘‘(I) IN
GENERAL.—Except as
provided in subclause (II), if a for-
feiture event occurs with respect to a
first application—
‘‘(aa) the 180-day period
under subparagraph (B)(v) shall
be forfeited by the first applicant;
and
‘‘(bb) any subsequent appli-
cation shall become effective as
provided under clause (i), (ii),
(iii), or (iv) of subparagraph (B),
and clause (v) of subparagraph
(B) shall not apply to the subse-
quent application.
‘‘(II) FORFEITURE
TO
FIRST
SUBSEQUENT APPLICANT.—If the sub-
sequent application that is the first to
be made effective under subclause (I)
was the first among a number of sub-
sequent applications to be filed—
‘‘(aa) that first subsequent
application shall be treated as
the first application under this
subparagraph 
(including 
sub-
clause (I)) and as the previous
application under subparagraph
(B)(v); and
‘‘(bb) any other subsequent
applications shall become effec-
tive as provided under clause (i),
(ii), (iii), or (iv) of subparagraph
(B), but clause (v) of subpara-
graph (B) shall apply to any such
subsequent application.
‘‘(iii) AVAILABILITY.—The 180-day
period under subparagraph (B)(v) shall be
available to a first applicant submitting an
application for a drug with respect to any
patent without regard to whether an appli-
cation has been submitted for the drug
under this subsection containing such a
certification with respect to a different pat-
ent.
‘‘(iv) APPLICABILITY.—The 180-day
period described in subparagraph (B)(v)
shall apply to an application only if a civil
action is brought against the applicant for
infringement of a patent that is the subject
of the certification.’’.
(b) APPLICABILITY.—The amendment made by sub-
section (a) shall be effective only with respect to an appli-
cation 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,
except that if a forfeiture event described in section
505(j)(5)(D)(i)(III)(ff) of that Act occurs in the case of
an applicant, the applicant shall forfeit the 180-day period
under section 505(j)(5)(B)(v) of that Act without regard
to when the applicant made a certification under section
505(j)(2)(A)(vii)(IV) of that Act.
SEC. 5. FAIR TREATMENT FOR INNOVATORS.
(a) BASIS FOR APPLICATION.—Section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)
is amended—
(1) in subsection (b)(3)(B), by striking the sec-
ond sentence and inserting ‘‘The notice shall include
a detailed statement of the factual and legal basis of
the applicant’s opinion that, as of the date of the no-
tice, the patent is not valid or is not infringed, and
shall include, as appropriate for the relevant patent,
a description of the applicant’s proposed drug sub-
stance, drug formulation, drug composition, or meth-
od of use. All information disclosed under this sub-
paragraph shall be treated as confidential and may
be used only for purposes relating to patent adju-
dication. Nothing in this subparagraph precludes the
applicant from amending the factual or legal basis
on which the applicant relies in patent litigation.’’;
and
(2) in subsection (j)(2)(B)(ii), by striking the
second sentence and inserting ‘‘The notice shall in-
clude a detailed statement of the factual and legal
basis of the opinion of the applicant that, as of the
date of the notice, the patent is not valid or is not
infringed, and shall include, as appropriate for the
relevant patent, a description of the applicant’s pro-
posed drug substance, drug formulation, drug com-
position, or method of use. All information disclosed
under this subparagraph shall be treated as con-
fidential and may be used only for purposes relating
to patent adjudication. Nothing in this subparagraph
precludes the applicant from amending the factual
or legal basis on which the applicant relies in patent
litigation.’’.
(b) INJUNCTIVE RELIEF.—Section 505(j)(5)(B) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(5)(B)) (as amended by section 3(a)(1)) is
amended—
(1) in clause (iii), by adding at the end the fol-
lowing: ‘‘A court shall not regard the extent of the
ability of an applicant to pay monetary damages as
a whole or partial basis on which to deny a prelimi-
nary or permanent injunction under this clause.’’;
and
(2) in clause (iv), by adding at the end the fol-
lowing:
‘‘(IV) INJUNCTIVE RELIEF.—A court shall
not regard the extent of the ability of an appli-
cant to pay monetary damages as a whole or
partial basis on which to deny a preliminary or
permanent injunction under this clause.’’.
SEC. 6. BIOEQUIVALENCE.
(a) IN GENERAL.—The amendments to part 320 of
title 21, Code of Federal Regulations, promulgated by the
Commissioner of Food and Drugs on July 17, 1991 (57
Fed. Reg. 17997 (April 28, 1992)), shall continue in effect
as an exercise of authorities under sections 501, 502, 505,
and 701 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 351, 352, 355, 371).
(b) EFFECT.—Subsection (a) does not affect the au-
thority of the Commissioner of Food and Drugs to amend
part 320 of title 21, Code of Federal Regulations.
(c) EFFECT OF SECTION.—This section shall not be
construed to alter the authority of the Secretary of Health
and Human Services to regulate biological products under
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
et seq.). Any such authority shall be exercised under that
Act as in effect on the day before the date of enactment
of this Act.
SEC. 7. 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.’’.
SEC. 8. REPORT.
(a) IN GENERAL.—Not later than the date that is
5 years after the date of enactment of this Act, the Fed-
eral Trade Commission shall submit to Congress a report
describing the extent to which implementation of the
amendments made by this Act—
(1) has enabled products to come to market in
a fair and expeditious manner, consistent with the
rights of patent owners under intellectual property
law; and
(2) has promoted lower prices of drugs and
greater access to drugs through price competition.
(b) AUTHORIZATION OF APPROPRIATIONS.—There is
authorized to be appropriated to carry out this section
$5,000,000.
SEC. 9. CONFORMING AND TECHNICAL AMENDMENTS.
(a) SECTION 505.—Section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) is amended—
(1) in subsection (a), by striking ‘‘(a) No per-
son’’ and inserting ‘‘(a) IN GENERAL.—No person’’;
(2) in subsection (b)—
(A) by striking ‘‘(b)(1) Any person’’ and
inserting the following:
‘‘(b) APPLICATIONS.—
‘‘(1) REQUIREMENTS.—
‘‘(A) IN GENERAL.—Any person’’;
(B) in paragraph (1)—
(i) in the second sentence—
(I) by redesignating subpara-
graphs (A) through (F) as clauses (i)
through (vi), respectively, and adjust-
ing the margins appropriately;
(II) by striking ‘‘Such persons’’
and inserting the following:
‘‘(B) INFORMATION
TO
BE
SUBMITTED
WITH APPLICATION.—A person that submits an
application under subparagraph (A)’’; and
(III) by striking ‘‘application’’
and inserting ‘‘application—’’;
(ii) by striking the third through fifth
sentences; and
(iii) in the sixth sentence—
(I) by striking ‘‘The Secretary’’
and inserting the following:
‘‘(C) GUIDANCE.—The Secretary’’; and
(II) by striking ‘‘clause (A)’’ and
inserting ‘‘subparagraph (B)(i)’’; and
(C) in paragraph (2)—
(i) by striking ‘‘clause (A) of such
paragraph’’ 
and 
inserting 
‘‘paragraph
(1)(B)(i)’’;
(ii) in subparagraphs (A) and (B), by
striking ‘‘paragraph (1) or’’; and
(iii) in subparagraph (B)—
(I) 
by 
striking 
‘‘paragraph
(1)(A)’’ and inserting ‘‘paragraph
(1)(B)(i)’’; and
(II) by striking ‘‘patent’’ each
place 
it 
appears 
and 
inserting
‘‘claim’’; and
(3) in subsection (c)—
(A) in paragraph (3)—
(i) in subparagraph (A)—
(I) by striking ‘‘(A) If the appli-
cant’’ and inserting the following:
‘‘(A) CLAUSE (i) OR (ii) CERTIFICATION.—
If the applicant’’; and
(II) by striking ‘‘may’’ and in-
serting ‘‘shall’’;
(ii) in subparagraph (B)—
(I) by striking ‘‘(B) If the appli-
cant’’ and inserting the following:
‘‘(B) CLAUSE (iii) CERTIFICATION.—If the
applicant’’; and
(II) by striking ‘‘may’’ and in-
serting ‘‘shall’’;
(iii) by redesignating subparagraph
(D) as subparagraph (E); and
(iv) in subparagraph (E) (as redesig-
nated by clause (iii)), by striking ‘‘clause
(A) of subsection (b)(1)’’ each place it ap-
pears 
and 
inserting 
‘‘subsection
(b)(1)(B)(i)’’; and
(B) by redesignating paragraph (4) as
paragraph (5); and
(4) in subsection (j)—
(A) in paragraph (2)(A)—
(i) in clause (vi), by striking ‘‘clauses
(B) through ((F)’’ and inserting ‘‘sub-
clauses (ii) through (vi) of subsection
(b)(1)’’;
(ii) in clause (vii), by striking ‘‘(b)
or’’; and
(iii) in clause (viii)—
(I) by striking ‘‘(b) or’’; and
(II) by striking ‘‘patent’’ each
place 
it 
appears 
and 
inserting
‘‘claim’’; and
(B) in paragraph (5)—
(i) in subparagraph (B)—
(I) in clause (i)—
(aa) by striking ‘‘(i) If the
applicant’’ and inserting the fol-
lowing:
‘‘(i) SUBCLAUSE (I) OR (II) CERTIFI-
CATION.—If the applicant’’; and
(bb) by striking ‘‘may’’ and
inserting ‘‘shall’’;
(II) in clause (ii)—
(aa) by striking ‘‘(ii) If the
applicant’’ and inserting the fol-
lowing:
‘‘(i) 
SUBCLAUSE
(III)
CERTIFI-
CATION.—If the applicant’’; and
(bb) by striking ‘‘may’’ and
inserting ‘‘shall’’;
(III) in clause (iii), by striking
‘‘(2)(B)(i)’’ each place it appears and
inserting ‘‘(2)(B)’’; and
(IV) in clause (v) (as redesig-
nated by section 4(a)(1)(B)), by strik-
ing ‘‘continuing’’ and inserting ‘‘con-
taining’’; and
(ii) by redesignating subparagraphs
(C) and (D) as subparagraphs (E) and
(F), respectively.
(b) SECTION 505A.—Section 505A of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is
amended—
(1) 
in 
subsections 
(b)(1)(A)(i) 
and
(c)(1)(A)(i)—
(A) by striking ‘‘(c)(3)(D)(ii)’’ each place
it appears and inserting ‘‘(c)(3)(E)(ii)’’; and
(B) 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)—
(A) by striking ‘‘(c)(3)(D)’’ each place it
appears and inserting ‘‘(c)(3)(E)’’; and
(B) by striking ‘‘(j)(5)(D)’’ each place it
appears and inserting ‘‘(j)(5)(F)’’;
(3) in subsections (e) and (l)—
(A) by striking ‘‘505(c)(3)(D)’’ each place
it appears and inserting ‘‘505(c)(3)(E)’’; and
(B) by striking ‘‘505(j)(5)(D)’’ each place
it appears and inserting ‘‘505(j)(5)(F)’’; and
(4) 
in 
subsection 
(k), 
by 
striking
‘‘505(j)(5)(B)(iv)’’ and inserting ‘‘505(j)(5)(B)(v)’’.
(c) SECTION 527.—Section 527(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360cc(a)) is
amended in the second sentence by striking ‘‘505(c)(2)’’
and inserting ‘‘505(c)(1)(B)’’.
Æ