Requires applicants (pharmaceutical companies) to register their patents with the Food and Drug Administration (FDA) within 30 days of approval (or issuance for subsequently issued patents).
Makes failure to timely register a bar to civil actions for patent infringement.
Requires applications for new drugs (NDA) or abbreviated new drug applications (ANDA) which rely upon investigations not conducted by or for the applicant and which concern a patent that claims both the drug and a method of use or more than one method of use to include a certification on a claim-by-claim basis that the patent is invalid or will not be infringed (known as a Paragraph IV filing/certification) by the new drug's (generic) manufacture and a statement regarding the method(s) of use claim.
Prohibits (for subsequently issued patents) an extension of the 30 month stay of FDA approval for any new drug where an ANDA or NDA contains a Paragraph IV filing/certification and the patent holder indicates an intention to bring a patent infringement suit against the new (generic) drug's manufacturer.
Makes failure to timely file a civil action for infringement a bar to later action.
Requires the first generic applicant with a Paragraph IV filing to forfeit the 180 day marketing exclusivity period to a subsequent generic applicant if the first generic applicant engages in certain behaviors which delay or prevent the marketing of the generic drug.
Revises notice requirements for Paragraph IV filings to include and protect certain proposed formulation, composition, or method of use information.
Excludes an applicants's ability to pay damages from a court's consideration of whether or not to provide injunctive relief before the expiration of the 30 month stay of approval period.
[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5272 Introduced in House (IH)]
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 Representatives 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 Application.--
(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 inserting 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 Secretary the patent information
described in subparagraph (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 subparagraph (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 patent is
issued (unless the Secretary extends the date because
of extraordinary or unusual circumstances).
``(C) Patent information.--The patent information
required to be filed under subparagraph (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--
``(aa) a drug substance;
``(bb) a drug formulation;
``(cc) a drug composition;
or
``(dd) a method of use;
``(iv) if the patent claims a method of
use, the approved use covered by the claim;
``(v) the identity of the owner of the
patent (including the identity of any agent of
the patent owner); and
``(vi) a declaration that the applicant, as
of the date of the filing, has provided
complete and accurate patent information for
all patents described in subparagraph (A).
``(D) Publication.--On filing of patent information
required under subparagraph (A) or (B), the Secretary
shall--
``(i) immediately publish the information
described in clauses (i) through (iv) of
subparagraph (C); and
``(ii) make the information described in
clauses (v) and (vi) of subparagraph (C)
available to the public on request.
``(E) Civil action for correction or deletion of
patent information.--
``(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 patent 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
information in its entirety for the
reason that--
``(aa) the patent does not
claim the drug for which the
application was approved; or
``(bb) the patent does not
claim an approved method of
using the drug.
``(ii) Limitations.--Clause (i) does not
authorize--
``(I) a civil action to correct
patent information filed under
subparagraph (B); or
``(II) an award of damages in a
civil action under clause (i).
``(F) No claim for patent infringement.--A person
with standing to bring an infringement action on a
patent with respect to which a holder of an application
fails to file information on or before the date
required under subparagraph (A) or (B) shall be barred
from bringing a civil action for infringement of the
patent against a person that--
``(i) has filed an application under
subsection (b)(2) or (j); or
``(ii) manufactures, uses, offers to sell,
or sells a drug approved under an application
under subsection (b)(2) or (j);
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
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,
whichever 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 application to
include the patent information required under the
amendment made by paragraph (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 extraordinary or unusual
circumstances).
(B) No claim for patent infringement.--A person
with standing to bring an infringement action on a
patent with respect to which a holder of an application
under subsection (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 required 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
subsection (b)(2) or (j) of that section; or
(ii) manufactures, uses, offers to sell, or
sells a drug approved under an application
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 filing 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 subparagraph
(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 PATENTS.
(a) Abbreviated New Drug Applications.--Section 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 inserting
the following:
``(iii) Subclause (iv) certification with
respect to certain patents.--If the applicant
made a certification described 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
information was filed with the Secretary under
subsection (c)(2)(A),''; and
(ii) by adding at the end the following:
``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 respect to a patent for which patent
information 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 following:
``(iv) Subclause (iv) certification with
respect to other patents.--
``(I) In general.--If the applicant
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
subsection (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
action for infringement of the patent,
accompanied by a motion for preliminary
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 notice was
received, in which case the approval
shall be made effective--
``(aa) on the date of a
court action declining to grant
a preliminary injunction; or
``(bb) if the court has
granted a preliminary
injunction prohibiting the
applicant from engaging in the
commercial manufacture 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
specified 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
subclause (I).
``(III) Expedited notification.--If
the notice under paragraph (2)(B)
contains an address for the receipt 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 following:
``(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
approved 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 applicant made a certification
described in subsection (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 following:
``The 30-month period provided under the second
sentence of this subparagraph shall not apply
to a certification under subsection
(b)(2)(A)(iv) made with respect to a patent for
which patent information 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 subsection
(b)(2)(A)(iv) with respect to a patent 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,
accompanied by a motion for preliminary
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
notice was received, in which case the approval
shall be made effective--
``(I) on the date of a court action
declining to grant a preliminary
injunction; or
``(II) if the court has granted a
preliminary injunction prohibiting the
applicant from engaging in the
commercial manufacture 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
specified 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 clause (i).
``(iii) Expedited notification.--If the
notice under subsection (b)(3) contains an
address for the receipt of expedited
notification 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
delivered to that address by the next business
day.''; and
(2) by inserting after paragraph (3) the following:
``(4) Failure to bring infringement action.--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
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 approved under subsection
(b)(2).''.
(c) Effective Date.--
(1) In general.--The amendments made by subsections (a) and
(b) shall be effective 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)
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 applications
under section 505(b) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(b)) filed before 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 enactment of this Act)) shall be
subject to subsections (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 subclause (II) and
inserting the following:
``(II) the earlier of--
``(aa) the date of a final
decision of a court (from which
no appeal has been or can be
taken, other than a petition to
the Supreme Court for a writ of
certiorari) holding that the
patent that is the subject of
the certification is invalid or
not infringed; or
``(bb) the date of a
settlement order or consent
decree signed by a Federal
judge that enters a final
judgment and includes a finding
that the patent that is the
subject of the certification is
invalid or not infringed;'';
and
(2) by inserting after subparagraph (C) the following:
``(D) Forfeiture of 180-day period.--
``(i) Definitions.--In this subparagraph:
``(I) Application.--The term
`application' means an application for
approval of a drug under this
subsection 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 respect to an
application under this subsection,
means the occurrence of any of the
following:
``(aa) Failure to market.--
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 extends the
date because of
extraordinary or
unusual circumstances);
or
``(BB) if 1 or more
civil actions have been
brought against the
applicant for
infringement of a
patent subject to a
certification under
paragraph
(2)(A)(vii)(IV) or 1 or
more civil actions have
been brought by the
applicant for a
declaratory judgment
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 Supreme
Court for a writ of
certiorari) in the last
of those civil actions
to be decided (unless
the Secretary extends
the date because of
extraordinary or
unusual circumstances).
``(bb) Withdrawal of
application.--The applicant
withdraws the application.
``(cc) Amendment of
certification.--The applicant,
voluntarily or as a result of a
settlement or defeat in patent
litigation, amends the
certification from a
certification under paragraph
(2)(A)(vii)(IV) to a
certification 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
application 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
extraordinary
circumstances
warranting an
exception, as
determined by the
Secretary.
``(ee) Failure to challenge
patent.--In a case in which,
after the date on which the
applicant submitted the
application, 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
patent information under
paragraph (7)(A)(iii) (unless
the Secretary extends the date
because of extraordinary or
unusual circumstances)--
``(AA) a
certification described
in paragraph
(2)(A)(vii)(IV) with
respect to the patent
to which the new patent
information relates; 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 accordance with
paragraph (2)(A)(viii).
``(ff) Unlawful conduct.--
The Federal Trade Commission
determines that the applicant
engaged in unlawful conduct
with respect to the application
in violation of section 1 of
the Sherman Act (15 U.S.C. 1).
``(IV) Subsequent application.--The
term `subsequent application' means an
application for approval of a drug that
is filed subsequent to the filing of a
first application for approval of that
drug.
``(ii) Forfeiture of 180-day period.--
``(I) In general.--Except as
provided in subclause (II), if a
forfeiture 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
application 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
subsequent application.
``(II) Forfeiture to first
subsequent applicant.--If the
subsequent application that is the
first to be made effective under
subclause (I) was the first among a
number of subsequent applications to be
filed--
``(aa) that first
subsequent application shall be
treated as the first
application under this
subparagraph (including
subclause (I)) and as the
previous application under
subparagraph (B)(v); and
``(bb) any other subsequent
applications shall become
effective as provided under
clause (i), (ii), (iii), or
(iv) of subparagraph (B), but
clause (v) of subparagraph (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
application has been submitted for the drug under this subsection
containing such a certification with respect to a different patent.
``(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 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, 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 second
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 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
proposed drug substance, drug formulation, drug composition, or
method of use. All information disclosed under this
subparagraph shall be treated as confidential 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.''; and
(2) in subsection (j)(2)(B)(ii), by striking the second
sentence and inserting ``The notice shall include 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
proposed drug substance, drug formulation, drug composition, or
method of use. All information disclosed under this
subparagraph shall be treated as confidential 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 following:
``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 preliminary or permanent injunction under
this clause.''; and
(2) in clause (iv), by adding at the end the following:
``(IV) Injunctive relief.--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 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 authority 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 Cosmetic 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 labeling of the drug omits a use or any other aspect of
labeling when the omitted use or other aspect is protected by patent or
by exclusivity under clause (iii) or (iv) of paragraph (5)(D).
``(B) Notwithstanding clauses (iii) and (iv) of paragraph (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 appropriate
contraindications, warnings, or precautions; and
``(ii) a statement that, because of marketing exclusivity
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 Federal 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 person'' 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 subparagraphs
(A) through (F) as clauses (i) through
(vi), respectively, and adjusting 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
applicant'' and inserting the
following:
``(A) Clause (i) or (ii) certification.--If the
applicant''; and
(II) by striking ``may'' and
inserting ``shall'';
(ii) in subparagraph (B)--
(I) by striking ``(B) If the
applicant'' and inserting the
following:
``(B) Clause (iii) certification.--If the
applicant''; and
(II) by striking ``may'' and
inserting ``shall'';
(iii) by redesignating subparagraph (D) as
subparagraph (E); and
(iv) in subparagraph (E) (as redesignated
by clause (iii)), by striking ``clause (A) of
subsection (b)(1)'' each place it appears 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 ``subclauses
(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 following:
``(i) Subclause (i) or (ii)
certification.--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 following:
``(i) Subclause (iii) certification.--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 redesignated
by section 4(a)(1)(B)), by striking
``continuing'' and inserting
``containing''; 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)''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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