[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 504 Introduced in Senate (IS)]
113th CONGRESS
1st Session
S. 504
To amend the Federal Food, Drug, and Cosmetic Act to ensure that valid
generic drugs may enter the market.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 7, 2013
Mr. Franken (for himself, Mr. Vitter, Mr. Durbin, Mrs. Shaheen, and Mr.
Sanders) introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to ensure that valid
generic drugs may enter the market.
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 ``Fair And Immediate Release of
Generic Drugs Act'' or the ``FAIR Generics Act''.
SEC. 2. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS REGARDING FIRST APPLICANT
STATUS.
(a) Amendments to Federal Food, Drug, and Cosmetic Act.--
(1) In general.--Section 505(j)(5)(B) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)) is amended--
(A) in clause (iv)(II)--
(i) by striking item (bb); and
(ii) by redesignating items (cc) and (dd)
as items (bb) and (cc), respectively; and
(B) by adding at the end the following:
``(v) First Applicant Defined.--As used in this subsection, the
term `first applicant' means an applicant--
``(I)(aa) that, on the first day on which a substantially
complete application containing a certification described in
paragraph (2)(A)(vii)(IV) is submitted for approval of a drug,
submits a substantially complete application that contains and
lawfully maintains a certification described in paragraph
(2)(A)(vii)(IV) for the drug; and
``(bb) that has not entered into a disqualifying agreement
described under clause (vii)(II); or
``(II)(aa) for the drug that is not described in subclause
(I) and that, with respect to the applicant and drug, each
requirement described in clause (vi) is satisfied; and
``(bb) that has not entered into a disqualifying agreement
described under clause (vii)(II).
``(vi) Requirement.--The requirements described in this clause are
the following:
``(I) The applicant described in clause (v)(II) submitted
and lawfully maintains a certification described in paragraph
(2)(A)(vii)(IV) or a statement described in paragraph
(2)(A)(viii) for each unexpired patent for which a first
applicant described in clause (v)(I) had submitted a
certification described in paragraph (2)(A)(vii)(IV) on the
first day on which a substantially complete application
containing such a certification was submitted.
``(II) With regard to each such unexpired patent for which
the applicant described in clause (v)(II) submitted a
certification described in paragraph (2)(A)(vii)(IV), no action
for patent infringement was brought against such applicant
within the 45-day period specified in paragraph (5)(B)(iii); or
if an action was brought within such time period, such an
action was withdrawn or dismissed by a court (including a
district court) without a decision that the patent was valid
and infringed; or if an action was brought within such time
period and was not withdrawn or so dismissed, such applicant
has obtained the decision of a court (including a district
court) that the patent is invalid or not infringed (including
any substantive determination that there is no cause of action
for patent infringement or invalidity, and including a
settlement order or consent decree signed and entered by the
court stating that the patent is invalid or not infringed).
``(III) If an applicant described in clause (v)(I) has
begun commercial marketing of such drug, the applicant
described in clause (v)(II) does not begin commercial marketing
of such drug until the date that is 30 days after the date on
which the applicant described in clause (v)(I) began such
commercial marketing.''.
(2) Conforming amendment.--Section 505(j)(5)(D)(i)(IV) of
such Act (21 U.S.C. 355(j)(5)(D)(i)(IV)) is amended by striking
``The first applicant'' and inserting ``The first applicant, as
defined in subparagraph (B)(v)(I),''.
(b) Applicability.--The amendments made by subsection (a) shall
apply 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)) to which
the amendments made by section 1102(a) of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173)
apply.
SEC. 3. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS REGARDING AGREEMENTS TO
DEFER COMMERCIAL MARKETING.
(a) Amendments to Federal Food, Drug, and Cosmetic Act.--
(1) Limitations on agreements to defer commercial marketing
date.--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 2,
is further amended by adding at the end the following:
``(vii) Agreement by first applicant to defer commercial
marketing; limitation on acceleration of deferred commercial
marketing date.--
``(I) Agreement to defer approval or commercial
marketing date.--An agreement described in this
subclause is an agreement between a first applicant and
the holder of the application for the listed drug or an
owner of one or more of the patents as to which any
applicant submitted a certification qualifying such
applicant for the 180-day exclusivity period whereby
that applicant agrees, directly or indirectly, (aa) not
to seek an approval of its application that is made
effective on the earliest possible date under this
subparagraph, subparagraph (F) of this paragraph,
section 505A, or section 527, (bb) not to begin the
commercial marketing of its drug on the earliest
possible date after receiving an approval of its
application that is made effective under this
subparagraph, subparagraph (F) of this paragraph,
section 505A, or section 527, or (cc) to both items
(aa) and (bb).
``(II) Agreement that disqualifies applicant from
first applicant status.--An agreement described in this
subclause is an agreement between an applicant and the
holder of the application for the listed drug or an
owner of one or more of the patents as to which any
applicant submitted a certification qualifying such
applicant for the 180-day exclusivity period whereby
that applicant agrees, directly or indirectly, not to
seek an approval of its application or not to begin the
commercial marketing of its drug until a date that is
after the expiration of the 180-day exclusivity period
awarded to another applicant with respect to such drug
(without regard to whether such 180-day exclusivity
period is awarded before or after the date of the
agreement).
``(viii) Limitation on acceleration.--If an agreement
described in clause (vii)(I) includes more than 1 possible date
when an applicant may seek an approval of its application or
begin the commercial marketing of its drug--
``(I) the applicant may seek an approval of its
application or begin such commercial marketing on the
date that is the earlier of--
``(aa) the latest date set forth in the
agreement on which that applicant can receive
an approval that is made effective under this
subparagraph, subparagraph (F) of this
paragraph, section 505A, or section 527, or
begin the commercial marketing of such drug,
without regard to any other provision of such
agreement pursuant to which the commercial
marketing could begin on an earlier date; or
``(bb) 180 days after another first
applicant begins commercial marketing of such
drug; and
``(II) the latest date set forth in the agreement
on which that applicant can receive an approval that is
made effective under this subparagraph, subparagraph
(F) of this paragraph, section 505A, or section 527, or
begin the commercial marketing of such drug, without
regard to any other provision of such agreement
pursuant to which commercial marketing could begin on
an earlier date, shall be the date used to determine
whether an applicant is disqualified from first
applicant status pursuant to clause (vii)(II).''.
(2) Notification of fda.--Section 505(j) of such Act (21
U.S.C. 355(j)) is amended by adding at the end the following:
``(11)(A) The holder of an abbreviated application under this
subsection shall submit to the Secretary a notification that includes--
``(i)(I) the text of any agreement entered into by such
holder described under paragraph (5)(B)(vii)(I); or
``(II) if such an agreement has not been reduced to text, a
written detailed description of such agreement that is
sufficient to disclose all the terms and conditions of the
agreement; and
``(ii) the text, or a written detailed description in the
event of an agreement that has not been reduced to text, of any
other agreements that are contingent upon, provide a contingent
condition for, or are otherwise related to an agreement
described in clause (i).
``(B) The notification described under subparagraph (A) shall be
submitted not later than 10 business days after execution of the
agreement described in subparagraph (A)(i). Such notification is in
addition to any notification required under section 1112 of the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
``(C) Any information or documentary material filed with the
Secretary pursuant to this paragraph 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 paragraph is intended to prevent disclosure to either
body of the Congress or to any duly authorized committee or
subcommittee of the Congress.''.
(3) Prohibited acts.--Section 301(e) of such Act (21 U.S.C.
331(e)) is amended by striking ``505 (i) or (k)'' and inserting
``505 (i), (j)(11), or (k)''.
(b) Infringement of Patent.--Section 271(e) of title 35, United
States Code, is amended by adding at the end the following:
``(7) The exclusive remedy under this section for an infringement
of a patent for which the Secretary of Health and Human Services has
published information pursuant to subsection (b)(1) or (c)(2) of
section 505 of the Federal Food, Drug, and Cosmetic Act shall be an
action brought under this subsection within the 45-day period described
in subsection (j)(5)(B)(iii) or (c)(3)(C) of section 505 of the Federal
Food, Drug, and Cosmetic Act.''.
(c) Applicability.--
(1) Limitations on acceleration of deferred commercial
marketing date.--The amendment made by subsection (a)(1) shall
apply only with respect to--
(A) an application filed under section 505(j) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)) to which the amendments made by section 1102(a)
of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (Public Law 108-173) apply;
and
(B) an agreement described under section
505(j)(5)(B)(vii)(I) of the Federal Food, Drug, and
Cosmetic Act (as added by subsection (a)(1)) executed
after the date of enactment of this Act.
(2) Notification of fda.--The amendments made by paragraphs
(2) and (3) of subsection (a) shall apply only with respect to
an agreement described under section 505(j)(5)(B)(vii)(I) of
the Federal Food, Drug, and Cosmetic Act (as added by
subsection (a)(1)) executed after the date of enactment of this
Act.
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