Greater Access to Affordable Pharmaceuticals Act - Amends the Federal Food, Drug, and Cosmetic Act to: (1) limit a brand name drug manufacturer to one Food and Drug Administration (FDA) 30-month stay of competition in a patent infringement suit against a generic drug applicant; (2) permit a generic applicant being sued to file a counterclaim to correct or delete patent information; (3) limit damages that a brand name manufacturer may recover in an instance where such manufacturer failed to file certain patent information; (4) permit a generic drug applicant to seek declaratory judgment regarding patent infringement prior to marketing a drug; (5) forfeit the180-day market exclusivity period for a first generic drug applicant to a subsequent generic applicant if the first applicant engages in certain activities which impede such drug's timely marketing; and (6) permit alternative means to determine bioequivalence for drugs that are not absorbed into the bloodstream.
[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 1225 Introduced in Senate (IS)]
108th CONGRESS
1st Session
S. 1225
Entitled the ``Greater Access to Affordable Pharmaceuticals Act''.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 10, 2003
Mr. Gregg (for himself, Mr. Schumer, Mr. McCain, and Mr. Kennedy)
introduced the following bill; which was read twice and referred to the
Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
Entitled the ``Greater Access to Affordable Pharmaceuticals Act''.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Greater Access to Affordable
Pharmaceuticals Act''.
SEC. 2. 30-MONTH STAY-OF-EFFECTIVENESS PERIOD.
(a) Abbreviated New Drug Applications.--Section 505(j) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) is amended--
(1) in paragraph (2)(A)(vii), by inserting after ``each
patent'' the following: ``published by the Secretary under
subsection (b)(1) or (c)(2) at least 1 day before the date on
which the application is filed''; and
(2) in paragraph (5)--
(A) in subparagraph (B)(iii)--
(i) by striking ``paragraph (2)(B)(i)''
each place it appears and inserting ``paragraph
(2)(B)'';
(ii) in the first sentence, by inserting
after ``of a patent'' the following:
``published by the Secretary under subsection
(b)(1) or (c)(2) at least 1 day before the date
on which the application is filed''; and
(iii) in subclauses (I), (II), and (III) of
the second sentence, by striking ``the court''
and inserting ``the United States district
court presiding over the matter'';
(B) by redesignating subparagraphs (C) and (D) as
subparagraphs (E) and (F), respectively; and
(C) by inserting after subparagraph (B) the
following:
``(C) Availability of 30-month period.--
``(i) In general.--The 30-month period
provided under subparagraph (B)(iii) shall be
available only with respect to a patent
published by the Secretary under subsection
(b)(1) or (c)(2) at least 1 day before the date
on which the application is filed.
``(ii) Subsequently published patents.--
``(I) In general.--If a patent is
published by the Secretary under
subsection (b)(1) or (c)(2) subsequent
to the filing of an application
described in paragraph (2)(A) but
before approval of that application
(referred to in this clause as a
`subsequently published patent'), and
the patent claims the listed drug
referred to in paragraph (2)(A)(i) or a
use for the listed drug for which the
applicant is seeking approval under
this subsection and for which
information is required to be filed
under subsection (b) or (c), the
applicant shall amend the application
to include a certification described in
paragraph (2)(A)(vii) or a statement
described in paragraph (2)(A)(viii) for
the patent.
``(II) No additional 30-month
period.--The 30-month period described
in subparagraph (B)(iii) shall not be
available with respect to a
certification described in paragraph
(2)(A)(vii)(IV) when the subject of
that certification is a subsequently
published patent.
``(III) Challenge to subsequently
published patent in separate
proceeding.--If the same applicant
makes a certification described in
paragraph (2)(A)(vii)(IV) with respect
to the subsequently published patent in
a separate application under this
subsection, the 30-month period
provided under subparagraph (B)(iii)
shall be available in connection with
the separate application.
``(iii) Civil action to obtain patent
certainty.--
``(I) Declaratory judgment absent
infringement action.--If the owner of a
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 provided under paragraph
(2)(B) was received, the applicant may
bring a civil action against the owner
of the patent for a declaratory
judgment under section 2201 of title
28, United States Code, that the patent
is invalid, is unenforceable, or will
not otherwise be infringed by the new
drug for which the person seeks
approval.
``(II) Counterclaim to infringement
action.--
``(aa) In general.--If the
owner of the patent brings a
patent infringement action
against the applicant, the
applicant may assert a
counterclaim seeking an order
requiring the patent owner to
correct or delete patent
information filed by the patent
owner under subsection (b) or
(c) on the ground that the
patent does not claim--
``(AA) the drug for
which the application
was approved; or
``(BB) an approved
method of using the
drug.
``(bb) No damages.--An
applicant shall not be entitled
to damages on a counterclaim
under item (aa).
``(cc) No independent cause
of action.--Item (aa) does not
authorize the assertion of a
claim described in item (aa) in
any civil action or proceeding
other than a counterclaim
described in item (aa).''.
(b) Applications Generally.--Section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355) is amended--
(1) in subsection (b)(2)(A), by inserting after ``each
patent'' the following: ``published by the Secretary under
paragraph (1) or subsection (c)(2) at least 1 day before the
date on which the application is filed''; and
(2) in subsection (c)--
(A) in paragraph (3)(C)--
(i) by striking ``paragraph (3)(B)'' each
place it appears and inserting ``paragraph
(3)'';
(ii) in the first sentence, by inserting
after ``of a patent'' the following:
``published by the Secretary under paragraph
(2) or subsection (b)(1) at least 1 day before
the date on which the application is filed'';
and
(iii) in clauses (i), (ii), and (iii) of
the second sentence, by striking ``the court''
and inserting ``the United States district
court presiding over the matter'';
(B) by redesignating paragraph (4) as paragraph
(5); and
(C) by inserting after paragraph (3) the following:
``(4) Availability of 30-month period.--
``(A) In general.--The 30-month period provided
under paragraph (3)(C) shall be available only with
respect to a patent published by the Secretary under
paragraph (2) or subsection (b)(1) at least 1 day
before the date on which the application is filed.
``(B) Subsequently published patents.--
``(i) In general.--If a patent is published
by the Secretary under paragraph (2) or
subsection (b)(1) subsequent to the filing of
an application described in subsection (b)(2)
but before approval of that application
(referred to in this subparagraph as a
`subsequently published patent'), and the
patent claims the listed drug or a use for the
listed drug for which the applicant is seeking
approval, the applicant shall amend the
application to include a certification
described in subsection (b)(2)(A) or a
statement described in subsection (b)(2)(B) for
the patent.
``(ii) No additional 30-month period.--The
30-month period described in paragraph (3)(C)
shall not be available with respect to a
certification described in subsection
(b)(2)(A)(iv) when the subject of that
certification is a subsequently published
patent.
``(iii) Challenge to subsequently published
patent in separate proceeding.--If the same
applicant makes a certification described in
subsection (b)(2)(A)(iv) with respect to the
subsequently published patent in a separate
application under this subsection, the 30-month
period provided under paragraph (3)(C) shall be
available in connection with the separate
application.
``(C) Civil action to obtain patent certainty.--
``(i) Declaratory judgment absent
infringement action.--If the owner of a 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 provided under paragraph
(2)(B) was received, the applicant may bring a
civil action against the owner of the patent
for a declaratory judgment under section 2201
of title 28, United States Code, that the
patent is invalid, is unenforceable, or will
not otherwise be infringed by the new drug for
which the person seeks approval.
``(ii) Counterclaim to infringement
action.--
``(I) In general.--If the owner of
the patent brings a patent infringement
action against the applicant, the
applicant may assert a counterclaim
seeking an order requiring the patent
owner to correct or delete patent
information filed by the patent owner
under subsection (b) or (c) on the
ground that the patent either does not
claim the drug for which the
application was approved or does not
claim--
``(aa) the drug for which
the application was approved;
or
``(bb) an approved method
of using the drug.
``(II) No damages.--An applicant
shall not be entitled to damages on a
counterclaim under subclause (I).
``(III) No independent cause of
action.--Subclause (I) does
not authorize the assertion of a claim described in subclause (I) in
any civil action or proceeding other than a counterclaim described in
subclause (I).''.
(c) Infringement Actions.--Section 271(e) of title 35, United
States Code, is amended by adding at the end the following:
``(5) Case or controversy.--The filing of an application
described in paragraph (2) that includes a 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),
and the failure of the owner of the patent to bring an action
for infringement of a patent that is the subject of the
certification before the expiration of 45 days after the date
on which the notice provided under subsection (b)(3) or
(j)(2)(B) of that section is received, shall establish an
actual controversy between the applicant and the patent owner
sufficient to confer subject matter jurisdiction in the courts
of the United States for any action brought by the applicant
under section 2201 of title 28 for a declaratory judgment that
any patent that is the subject of the certification is invalid,
unenforceable, or not infringed.''.
(d) Effective Date.--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 or in an amendment to an application filed under
subsection (b)(2) or (j) of that section.
SEC. 3. 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 2) is
amended--
(1) in subparagraph (B)(iv), 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 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 otherwise
infringed;''; and
(2) by inserting after subparagraph (C) the following:
``(D) Forfeiture of 180-day exclusivity period.--
``(i) Definition of forfeiture event.--In
this subparagraph, the term `forfeiture event',
with respect to an application under this
subsection, means the occurrence of any of the
following:
``(I) 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 subparagraph (B)(iii); 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
otherwise infringed, the date
that is 60 days after 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) in
the last of those civil actions
to be decided.
``(II) Withdrawal of application.--
The applicant withdraws the
application.
``(III) Amendment of
certification.--The applicant amends
the certification from a certification
under paragraph (2)(A)(vii)(IV) to a
certification under paragraph
(2)(A)(vii)(III).
``(IV) Failure to obtain tentative
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 a
change in the requirements for approval
of the application imposed after the
date on which the application is filed.
``(V) 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)--
``(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).
``(VI) Agreement with patent
owner.--The applicant enters into an
agreement with the owner of the
patent--
``(aa) that is the subject
of the certification under
paragraph (2)(A)(vii)(IV); and
``(bb) that the Federal
Trade Commission determines 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).
``(ii) Forfeiture.--The 180-day exclusivity
period described in subparagraph (B)(iv) shall
be forfeited by an applicant if a forfeiture
event occurs.
``(iii) Subsequent applicant.--If an
applicant forfeits the 180-day exclusivity
period under clause (ii)--
``(I) a subsequent application
containing a certification described in
paragraph (2)(A)(vii)(IV) shall become
effective immediately on approval; and
``(II) the subsequent applicant
shall not be eligible for a 180-day
exclusivity period under subparagraph
(B)(iv).
``(E) Availability.--The 180-day period under
subparagraph (B)(iv) 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.''.
(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)(VI) 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 the applicant made a certification under section
505(j)(2)(A)(vii)(IV).
SEC. 4. 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:
``(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 absorbed into
the bloodstream, the Secretary may assess bioavailability by
scientifically valid measurements intended to reflect the rate
and extent and extent to which the active ingredient or active
moeity 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 absorbed into
the bloodstream, the Secretary may establish 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
therapeutic 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. 5. REMEDIES FOR INFRINGEMENT.
Section 287 of title 35, United States Code, is amended by adding
at the end the following:
``(d) Consideration.--In making a determination with respect to
remedy brought for infringement of a patent that claims a drug or a
method or using a drug, the court shall consider whether information on
the patent was filed as required under 21 U.S.C. 355 (b) or (c), and,
if such information was required to be filed but was not, the court may
refuse to award treble damages under section 284.''.
SEC. 6. CONFORMING AMENDMENTS.
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), 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)''.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.
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