To provide substantial savings in health care costs to the Federal government and consumers by fostering competition among generic pharmaceutical manufacturers and ensuring that anti-competitive "pay-for-delay" settlements between brand-name and generic pharmaceutical manufacturers do not block generic drugs from entering the market.

SA 2111. Mr. BINGAMAN (for himself, Mr. Vitter, Mr. Franken, Mrs.
Shaheen, Mr. Kohl, Mr. Udall of New Mexico, Mr. Johnson of South
Dakota, Ms. Klobuchar, Mr. Merkley, and Mr. Sanders) submitted an
amendment intended to be proposed by him to the bill S. 3187, to amend
the Federal Food, Drug, and Cosmetic Act to revise and extend the user-
fee programs for prescription drugs and medical devices, to establish
user-fee programs for generic drugs and biosimilars, and for other
purposes; which was ordered to lie on the table; as follows:

In title IX, add at the end the following:

SEC. 9__. ENSURING THAT VALID GENERIC DRUGS MAY ENTER THE
MARKET.

(a) 180-Day Exclusivity Period Amendments Regarding First
Applicant Status.--
(1) Amendments to the federal food, drug, and cosmetic
act.--
(A) In general.--Section 505(j)(5)(B) (21 U.S.C.
355(j)(5)(B)) is amended--
(i) in clause (iv)(II)--

(I) by striking item (bb); and
(II) by redesignating items (cc) and (dd) as items (bb) and
(cc), respectively; and

(ii) 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.''.
(B) Conforming amendment.--Section 505(j)(5)(D)(i)(IV) (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),''.
(2) Applicability.--The amendments made by paragraph (1)
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.
(b) 180-Day Exclusivity Period Amendments Regarding
Agreements to Defer Commercial Marketing.--
(1) Amendments to federal food, drug, and cosmetic act.--
(A) Limitations on agreements to defer commercial marketing
date.--Section 505(j)(5)(B) (21 U.S.C. 355(j)(5)(B)), as
amended by subsection (a), 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).''.
(B) Notification of fda.--Section 505(j) (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

[[Page S3291]]

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.''.
(C) Prohibited acts.--Section 301(e) (21 U.S.C. 331(e)) is
amended by striking ``505 (i) or (k)'' and inserting ``505
(i), (j)(11), or (k)''.
(2) 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.''.
(3) Applicability.--
(A) Limitations on acceleration of deferred commercial
marketing date.--The amendment made by paragraph (1)(A) shall
apply only with respect to--
(i) 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
(ii) 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.
(B) Notification of fda.--The amendments made by
subparagraphs (B) and (C) of paragraph (1) 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 paragraph (1)(A)) executed after the date of
enactment of this Act.
(c) Technical Amendment.--Section 744B(n), as added by
section 302 of this Act, is amended by striking
``505(j)(5)(B)(iv)(II)(cc)'' and inserting
``505(j)(5)(B)(iv)(II)(bb)''.
______