[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 726 Introduced in Senate (IS)]
111th CONGRESS
1st Session
S. 726
To amend the Public Health Service Act to provide for the licensing of
biosimilar and biogeneric biological products, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 26, 2009
Mr. Schumer (for himself, Ms. Collins, Mr. Brown, Mr. Vitter, Ms.
Stabenow, Mr. Martinez, and Mrs. Shaheen) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to provide for the licensing of
biosimilar and biogeneric biological products, and for other purposes.
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 ``Promoting Innovation and Access to
Life-Saving Medicine Act''.
SEC. 2. DEFINITIONS.
(a) Licensure.--Section 351(i) of the Public Health Service Act (42
U.S.C. 262(i)) is amended--
(1) by striking ``In this section, the term `biological
product' means'' and inserting the following: ``In this
section:
``(1) The term `biological product' means''; and
(2) by adding at the end the following:
``(2) The term `abbreviated biological product application'
means an abbreviated application for a license of a biological
product that relies in part on data or information in an
application for another biological product licensed under this
section or approved under section 505 of the Federal Food,
Drug, and Cosmetic Act.
``(3) The term `reference product' means the single
licensed biological product, approved under subsection (a) or
(k), against which a biological product is evaluated for
demonstration of safety, potency, or purity.
``(4) The term `final action' means, with respect to an
abbreviated biological product application, the Secretary's
issuance of a final action letter to the sponsor of an
abbreviated biological product application which--
``(A) approves the application; or
``(B) disapproves the application and sets forth in
detail an enumeration of the specific deficiencies in
the particular application and of the specific,
enumerated actions the sponsor would be required to
take in order for the sponsor to receive a final action
letter that approves such application.
``(5) The term `final action date' means, with respect to
an abbreviated biological product application, the date by
which the Secretary must take a final action on the application
pursuant to subsection (k)(13).
``(6) The term `reviewing division' means the division
responsible for the review of an application for approval of a
biological product (including all scientific and medical
matters, chemistry, manufacturing, and controls).''.
(b) Fees.--
(1) Rule of construction.--The definition of a human drug
application in section 735(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379g(1)) shall be construed to include
applications under section 351(k) of the Public Health Service
Act, as added by section 3, in addition to applications under
section 351(a) of such Act.
(2) Supplement.--Section 735(2) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379g(2)) is amended by adding at
the end the following: ``Notwithstanding the preceding
sentence, any request for an interchangeability determination
under section 351(k) of the Public Health Service Act shall be
treated as a supplement for purposes of this part, irrespective
of whether such request is included in an application for
licensure of a biological product or a subsequent
submission.''.
SEC. 3. REGULATION OF BIOSIMILAR AND BIOGENERIC BIOLOGICAL PRODUCTS.
(a) In General.--Section 351 of the Public Health Service Act (42
U.S.C. 262), as amended by section 2, is further amended--
(1) in subsection (a)(1)(A), by inserting ``under this
subsection or subsection (k)'' after ``biologics license''; and
(2) by adding at the end the following subsection:
``(k) Regulation of Biosimilar and Interchangeable Biological
Products.--
``(1) Biosimilar.--In this subsection, the term
`biosimilar' or `biosimilarity', in reference to a biological
product, means no clinically meaningful differences between the
biological product and the reference product would be expected
in terms of the safety, purity, and potency if treatment were
to be initiated with the biological product instead of the
reference product.
``(2) Interchangeability.--In this subsection, the term
`interchangeable' or `interchangeability' means, with respect
to a given condition of use, that--
``(A) the biological product is biosimilar to the
reference product; and
``(B) if the biological product is intended to be
administered more than once to a given patient, the
patient can be switched one or more times between the
reference product and the biological product without an
expected increase in the risk of adverse effects,
including a clinically significant change in
immunogenicity, or diminished effectiveness, compared
to the expected risks from continuing to use the
reference product without such switching.
``(3) Submission of an abbreviated biological product
application.--Any person may file with the Secretary an
abbreviated biological product application. Any such
application shall include the following:
``(A) Information demonstrating that the biological
product and reference product contain highly similar
molecular structural features, notwithstanding minor
differences in heterogeneity profile, impurities, or
degradation patterns.
``(B) Information demonstrating that the biological
product is biosimilar to (as defined in paragraph (1))
or interchangeable with (as defined in paragraph (2))
the reference product for the condition or conditions
of use prescribed, recommended, or suggested in the
proposed labeling based upon, in the discretion of the
Secretary--
``(i) information derived from chemical,
physical, and biological assays, and other non-
clinical laboratory studies; and
``(ii) information from any necessary
clinical study or studies sufficient to confirm
safety, purity, and potency.
Any studies under clause (ii) shall be designed to
avoid duplicative and unethical clinical testing.
``(C) Information demonstrating that the biological
product and reference product utilize the same
mechanism or mechanisms of action for the condition or
conditions of use prescribed, recommended, or suggested
in the proposed labeling, but only to the extent the
mechanism or mechanisms of action are known for the
reference product or can reasonably be determined. If
the applicant seeks to rely on a demonstration of
biosimilarity or interchangeability for a single
condition of use to support approval of additional
conditions of use that share the same mechanism or
mechanisms of action, information demonstrating that
such reliance is scientifically appropriate.
``(D) Information to show that the condition or
conditions of use prescribed, recommended, or suggested
in the proposed labeling for the biological product
have been previously approved for the reference
product.
``(E) Information to show that the route of
administration, the dosage form, and the strength of
the biological product are the same as those of the
reference product.
``(F) Information demonstrating that the facility
in which the biological product is manufactured,
processed, packed, or held meets standards designed to
ensure that the biological product continues to be
safe, pure, and potent.
``(4) Other applications.--Any person, including a person
who has not conducted and does not have a right of reference to
the studies in the application for a reference product, may
submit an abbreviated biological product application under this
paragraph for a biological product that differs from, or
incorporates a change to, the reference product with respect to
one or more characteristics described in subparagraphs (A)
through (E) of paragraph (3), including a difference in safety,
purity, or potency, so long as the application contains
sufficient information to establish the safety, purity, and
potency of the biological product for its proposed condition or
conditions of use.
``(5) Approval of biosimilar or interchangeable biological
products.--
``(A) Determination of biosimilarity.--Upon review
of an application submitted under paragraph (3) for a
biological product and any other information available
to the Secretary, including information in the
application for the reference product, the Secretary
shall issue a biosimilar biological product license for
the conditions of use prescribed, recommended, or
suggested in the proposed labeling for the product,
unless the Secretary finds and informs the applicant
(including provision of a detailed explanation) that--
``(i) information submitted in the
application and any other information available
to the Secretary is insufficient to show that
the biological product and the reference
product contain highly similar molecular
structural features, notwithstanding minor
differences in heterogeneity profile,
impurities, or degradation patterns;
``(ii) information submitted in the
application and any other information available
to the Secretary is insufficient to show that
the biological product is biosimilar to the
reference product for the condition or
conditions of use prescribed, recommended, or
suggested in the labeling proposed in the
application;
``(iii) information submitted in the
application and any other information available
to the Secretary is insufficient to show that
the biological product and reference product
utilize the same mechanism or mechanisms of
action for the conditions of use prescribed,
recommended, or suggested in the proposed
labeling for the biological product, unless the
mechanism or mechanisms of action are not known
and cannot reasonably be determined for the
reference product for such condition or
conditions;
``(iv) if the applicant has demonstrated
biosimilarity for a single condition of use
sharing the same mechanism of action as other
conditions of use of the reference product, and
has sought approval of one or more such other
conditions of use on the basis of such
demonstration, information submitted in the
application and any other information available
to the Secretary is insufficient to show the
safety, purity, and potency of one or more such
other conditions of use;
``(v) information submitted in the
application and any other information available
to the Secretary is insufficient to show that
the route of administration, the dosage form,
and the strength of the biological product are
the same as those of the reference product;
``(vi) information submitted in the
application and any other information available
to the Secretary is insufficient to show that
the condition or conditions of use prescribed,
recommended, or suggested in the proposed
labeling for the biological product are limited
to one or more of the same use or uses as have
been previously approved for the reference
product;
``(vii) information submitted in the
application and any other information available
to the Secretary shows (I) the inactive
ingredients of the biological product are
unsafe for use under the conditions prescribed,
recommended, or suggested in the proposed
labeling for the biological product, or (II)
the composition of the biological product is
unsafe under such conditions because of the
type or quantity of inactive ingredients
included or the manner in which the inactive
ingredients are included;
``(viii) information submitted in the
application and any other information available
to the Secretary fails to demonstrate that the
facility in which the biological product is
manufactured, processed, packed, or held meets
standards designed to ensure that the
biological product continues to be safe, pure,
and potent;
``(ix) the Secretary has, for reasons of
safety, purity, or potency, other than reasons
that are unique to the reference product--
``(I) withdrawn or suspended the
license of the reference product;
``(II) published a notice of
opportunity for hearing to withdraw
such license; or
``(III) determined that the
reference product has been withdrawn
from sale; or
``(x) the application contains an untrue
statement of material fact.
``(B) Determinations on interchangeability.--
Subject to subparagraph (C) and paragraph (11), upon
issuing a product license for a biological product
under subparagraph (A), the Secretary shall make and
publish one of the following determinations:
``(i) Such product is interchangeable with
the reference product for one or more specified
conditions of use prescribed, recommended, or
suggested in the labeling of the biological
product.
``(ii) Interchangeability has not been
established, but the approved product is as
safe and effective for its approved uses as the
reference product.
``(C) Determination of interchangeability of
subsequent biological product.--If the Secretary
determines that an application meets the approval
requirements of subparagraph (A), and, prior to the
issuance of a product license, the Secretary has made a
determination of interchangeability of another
biological product and the reference product for which
the exclusivity period under paragraph (11) has not
expired, the Secretary shall--
``(i) issue the product license for the
subsequent biological product; and
``(ii) defer issuing any determination of
interchangeability as to the subsequent
biological product and the reference product
until the exclusivity period under paragraph
(11) has expired.
``(6) Designation of official name.--
``(A) In general.--If, pursuant to section 508 of
the Federal Food, Drug, and Cosmetic Act, the Secretary
determines that designation of an official name for a
biosimilar biological product is necessary or desirable
in the interests of usefulness or simplicity, the
Secretary shall designate the same official name for
the biosimilar biological product as the Secretary
designated for the reference product.
``(B) Limitation.--This paragraph shall not apply
to products approved under paragraph (7).
``(C) Report to congress.--Not later than 5 years
after the date of the enactment of this subsection, the
Comptroller General of the United States shall submit a
report to the Congress on public health and economic
impacts associated with practices for designating the
official names of biosimilar biological products in the
United States and in other countries that approve
biosimilar biological products.
``(7) Other approval provisions.--The Secretary shall
approve an application for a license submitted under paragraph
(4) if the application and any other information available to
the Secretary, including information in the application for the
reference product, are sufficient to establish the safety,
purity, and potency of the biosimilar biological product for
the proposed condition or conditions of use for such product.
``(8) Establishing interchangeability for biosimilar
biological products.--
``(A) In general.--In an original application or a
supplement to an application under this subsection, an
applicant may submit information to the Secretary to
demonstrate the interchangeability of a biosimilar
biological product and the reference product. An
applicant may withdraw a request for an
interchangeability determination at any time. A request
for an interchangeability determination submitted after
the filing of an application shall be considered a
major amendment to the application. Except as provided
in paragraph (11), nothing in this subsection shall be
construed to prohibit the Secretary from making a
determination of interchangeability at any time after
approval.
``(B) Guidance.--Within 2 years after enactment of
this subsection, the Secretary shall issue guidance
regarding standards and requirements for
interchangeability. The Secretary is authorized to make
determinations of interchangeability under paragraph
(5)(B) prior to issuing guidance under this
subparagraph.
``(9) Interchangeability labeling for interchangeable
biological products.--Except as provided in paragraph (11),
upon a determination of interchangeability, the Secretary
shall, at the request of the applicant, provide for the label
of the interchangeable biological product to include a
statement that the biological product is interchangeable with
the reference product for the conditions of use prescribed,
recommended, or suggested in the labeling for which
interchangeability has been established.
``(10) Delay of approval.--
``(A) Applicable delay period.--
``(i) 5-year period.--If an application
under this subsection refers to a biological
product described in clause (i) of subparagraph
(B), the Secretary may not approve such
application before the expiration of--
``(I) the 5-year period beginning
on such product's approval date; or
``(II) such period, as extended
under subparagraph (D).
``(ii) 3-year period.--If an application
under this subsection refers to a biological
product described in subparagraph (C), the
Secretary may not approve such application for
the conditions of approval of such product
before the expiration of--
``(I) the 3-year period beginning
on such product's approval date; or
``(II) such period, as extended
under subparagraph (D).
``(B) No major substance previously approved.--
``(i) In general.--A biological product is
described in this clause if--
``(I) an application is submitted
for such product under subsection (a);
``(II) no major substance of the
product, nor any highly similar major
substance, has been approved in any
other application under subsection (a);
``(III) the application submitted
for such product is approved after the
date of the enactment of this
subsection; and
``(IV) the application submitted
for such product could not and did not
rely on any clinical safety, purity, or
potency study in any other application
approved under this section or any
clinical safety or effectiveness study
in any application approved under
section 505 of the Federal Food, Drug,
and Cosmetic Act.
``(ii) Exclusions.--Biological products not
described in clause (i) include the following:
``(I) Protein biological products
that differ in structure solely due to
post-translational events, infidelity
of translation or transcription, or
minor differences in amino acid
sequence.
``(II) Polysaccharide biological
products with similar saccharide
repeating units, even if the number of
units differ and even if there are
differences in post-polymerization
modifications.
``(III) Glycosylated protein
products that differ in structure
solely due to post-translational
events, infidelity of translation or
transcription, or minor differences in
amino acid sequence, and if they had
similar saccharide repeating units,
even if the number of units differ and
even if there were differences in post-
polymerization modifications.
``(IV) Polynucleotide biological
products with identical sequence of
purine and pyrimidine bases (or their
derivatives) bound to an identical
sugar backbone (ribose, deoxyribose, or
modifications of these sugars).
``(V) Closely related, complex
partly definable biological products
with similar therapeutic intent, such
as live viral products for the same
indication.
The Secretary may by regulation identify
additional biological products not described in
clause (i).
``(C) Major substance previously approved.--A
biological product is described in this subparagraph
if--
``(i) an application is submitted for such
product under subsection (a);
``(ii) such product includes a major
substance that has been approved in another
application under subsection (a), or any highly
similar major substance;
``(iii) the application submitted for such
product is approved after the date of the
enactment of this subsection;
``(iv) the application submitted for such
product contains reports of new clinical
investigations (other than pharmacokinetic or
pharmacodynamic studies) essential to the
approval of the application and conducted or
sponsored by the applicant; and
``(v) the product represents a significant
therapeutic advance, which may include
demonstration of safety, purity, and potency
for a significant new indication or
subpopulation, other than a pediatric
subpopulation.
``(D)(i) Supplement.--If a supplement to an
application approved under subsection (a) is approved
no later than 1 year before the expiration of a period
to which the applicant is entitled under subparagraph
(A), the period described in subparagraph (A) shall,
except as provided in clause (ii), be extended by 6
months if--
``(I) the supplement contains reports of
new clinical investigations (other than
pharmacokinetic or pharmacodynamic studies)
essential to the approval of the supplement and
conducted or sponsored by the person submitting
the supplement; and
``(II) the change provides a significant
therapeutic advance, which may include
demonstration of safety, purity, and potency
for a significant new indication or
subpopulation, other than a pediatric
subpopulation.
``(ii) Adjustment.--Any period of market
exclusivity extended under subclause (I) or (II) of
clause (i) for a biological product shall be reduced by
3 months if the organization designated under
subparagraph (E) notifies the Secretary that, with
respect to any major substance contained in the
biological product, the combined annual gross sales in
the United States for all biological products--
``(I) containing the major substance; and
``(II) owned or marketed by the applicant
or its affiliates;
exceeded $1,000,000,000 in the calendar year preceding
approval of the supplement involved.
``(iii) Limitation.--Only one extension under this
subparagraph may be granted for any biological product.
``(E)(i) Designation.--The Secretary shall
designate an organization other than the Food and Drug
Administration to make the determination of combined
annual gross sales described in clause (ii). Prior to
designating such organization, the Secretary shall
determine that such organization is independent and is
qualified to evaluate the sales of pharmaceutical
products. The Secretary shall re-evaluate the
designation of such organization once every 3 years.
``(ii) Notification.--The organization designated
under clause (i) shall--
``(I) determine, with respect to each major
substance contained in each biological product
that is the subject of a pending supplement
under subparagraph (D)(i), the amount of the
combined annual gross sales in the United
States in the preceding calendar year for all
biological products--
``(aa) containing the major
substance; and
``(bb) owned or marketed by the
applicant or its affiliates; and
``(II) notify the Secretary of such
determination.
``(F) Definition.--In this paragraph, the term
`approval date' means the date of approval of an
application for the biological product under subsection
(a).
``(11) Exclusivity.--
``(A) In general.--Upon review of an abbreviated
biological product application relying on the same
reference product for which a prior biological product
has received a determination of interchangeability for
any condition of use, the Secretary shall not make a
determination under paragraph (5)(B) that the second or
subsequent biological product is interchangeable for
any condition of use, and no holder of a biological
product license approved under subsection (a) shall
manufacture, market, sell, or distribute a rebranded
interchangeable biological product, directly or
indirectly, or authorize any other person to
manufacture, market, sell, or distribute a rebranded
interchangeable biological product, for any condition
of use, until the earlier of--
``(i) 180 days after the first commercial
marketing of the first interchangeable
biological product to be approved as
interchangeable for that reference product;
``(ii) one year after--
``(I) a final court decision in
favor of the applicant on all patents
in suit in an action instituted under
paragraph (18)(C) against the applicant
that submitted the application for the
first approved interchangeable
biological product; or
``(II) the dismissal with or
without prejudice of an action
instituted under paragraph (18)(C)
against the applicant that submitted
the application for the first approved
interchangeable biological product; or
``(iii)(I) 36 months after approval of the
first interchangeable biological product if the
applicant has been sued under paragraph (18)(C)
and such litigation is still ongoing within
such 36-month period; or
``(II) one year after approval in the event
that the first approved interchangeable
biological product applicant has not been sued
under paragraph (18)(C).
For purposes of this subparagraph, the term `final
court decision' means a final decision of a court from
which no appeal (other than a petition to the United
States Supreme Court for a writ of certiorari) has been
or can be taken.
``(B) Rebranded interchangeable biological
product.--For purposes of this subsection, the term
`rebranded interchangeable biological product'--
``(i) means any rebranded interchangeable
version of the reference product involved that
the holder of the biological product license
approved under subsection (a) for that
reference product seeks to commence marketing,
selling, or distributing, directly or
indirectly; and
``(ii) does not include any product to be
marketed, sold, or distributed--
``(I) by an entity eligible for
exclusivity with respect to such
product under this paragraph; or
``(II) after expiration of any
exclusivity with respect to such
product under this paragraph.
``(12) Hearing.--If the Secretary decides to disapprove an
abbreviated biological product application, the Secretary shall
give the applicant notice of an opportunity for a hearing
before the Secretary on the question of whether such
application is approvable. If the applicant elects to accept
the opportunity for hearing by written request within 30 days
after such notice, such hearing shall commence not more than 90
days after the expiration of such 30 days unless the Secretary
and the applicant otherwise agree. Any such hearing shall
thereafter be conducted on an expedited basis, and the
Secretary's order thereon shall be issued within 90 days after
the date fixed by the Secretary for filing final briefs.
``(13) Final action date.--
``(A) In general.--The Secretary shall take a final
action on an abbreviated biological product application
by the date that is 10 calendar months following the
sponsor's submission of such application, or 180 days
following the Secretary's notification to the applicant
that its application has been accepted for filing,
whichever is earlier.
``(B) Extension.--The final action date provided by
subparagraph (A) with respect to an application may be
extended for such period of time as is agreed to by the
Secretary and the applicant in a jointly executed
written agreement that is counter-signed by the
Secretary and the applicant no later than 30 days prior
to--
``(i) such final action date; or
``(ii) the date on which any prior
extension under this subparagraph expires.
``(14) Request for delay of final action.--Subject to
paragraph (19)(A)(i) and notwithstanding any other provision of
law, the Secretary shall not fail or refuse to take a final
action on an abbreviated biological product application by the
final action date on the basis that a person, other than the
biosimilar biological product applicant, has requested (in a
petition or otherwise) that the Secretary refuse to take or
otherwise defer such final action, and no court shall enjoin
the Secretary from taking final action or stay the effect of
final action previously taken by the Secretary, except by
issuance of a permanent injunction based upon an express
finding of clear and convincing evidence that the person
seeking to have the Secretary refuse to take or otherwise to
defer final action by the final action date--
``(A) has prevailed on the merits of the person's
complaint against the Secretary;
``(B) will suffer imminent and actual irreparable
injury, constituting more than irrecoverable economic
loss, and that also will threaten imminent destruction
of such person's business; and
``(C) has an interest that outweighs the
overwhelming interest that the public has in obtaining
prompt access to a biosimilar biological product.
``(15) Report on extensions of final action date.--The
Secretary shall prepare and submit to the President, the
Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education, Labor,
and Pensions of the Senate a report regarding any jointly
executed written agreement to extend the final action date
under this Act within 15 calendar days after the joint
execution of any such written agreement.
``(16) Report on failure to take final action.--The
Secretary shall prepare and submit annually to the President,
the Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education, Labor,
and Pensions of the Senate a report detailing the specific and
particularized reasons enumerated by the reviewing division for
each instance of the Secretary's failure to take final action
by the final action date in the previous year.
``(17) Regulations.--The Secretary shall establish, by
regulation within 2 years after the date of the enactment of
this subsection, requirements for the efficient review,
approval, suspension, and revocation of abbreviated biological
product applications under this subsection. The Secretary may
not use the absence of final regulations as a basis for the
Secretary to fail to act on an application submitted under this
subsection.
``(18) Patents.--
``(A) Request for patent information.--
``(i) In general.--At any time, including
at the initial stages of development, an
applicant or a prospective applicant under this
subsection may send a written request for
patent information to the holder of the
approved application for the reference product.
The holder of the approved application for the
reference product shall, not later than 60 days
after the date on which the holder receives the
request, provide to the applicant or
prospective applicant a list of all those
patents owned by, licensed to, or otherwise
under the control of, the holder of the
approved application that the holder believes
in good faith relate to the reference product,
including patents that claim the approved
biological product, any formulation of such
product, any method of using such product, any
component of such product, or any method or
process that can be used to manufacture such
product or component, regardless of whether
that method or process is used to manufacture
the reference product.
``(ii) Updates.--For a period of 2 years
beginning on the date on which the holder of
the approved application for the reference
product receives the request for information,
the holder shall send to the applicant or
prospective applicant updates of its response
to the request for information by identifying
all relevant patents issued or licensed to the
holder after the initial response under clause
(i). Any such update must be provided, in the
case of a new patent, not later than 30 days
after the date on which the patent is issued
and, in the case of a license, not later than
30 days after the date on which the holder
obtains the license.
``(iii) Additional requests.--The applicant
may submit additional requests under clause (i)
for patent information, and each such request
shall be subject to the requirements of this
paragraph.
``(iv) Notification to patent holder.--
Within 30 days of receiving a request under
this subparagraph, the holder of the approved
application for the reference product shall
give notice of such request to the owner of any
patent licensed to, or otherwise under the
control of, the holder that is identified by
the holder pursuant to clause (i).
``(B) Patent notifications.--At any time after
submitting an application under this subsection, the
applicant may provide a notice of the application with
respect to any one or more patents identified by the
holder of the reference product pursuant to
subparagraph (A) or with respect to any one or more
patents owned by, licensed to, or otherwise under the
control of the holder of the approved application, but
not identified pursuant to subparagraph (A). An
applicant may submit additional notices at any time,
and each notice shall be subject to the provisions of
this subparagraph. Each notice shall--
``(i) be sent to the holder of the approved
application for the reference product and to
the owner of any patent identified by the
holder pursuant to subparagraph (A);
``(ii) include a detailed statement of the
factual and legal bases for the applicant's
belief that the patents included in the notice
are invalid, are unenforceable, or will not be
infringed by the commercial sale of the product
for which approval is being sought under this
subsection; and
``(iii) be submitted to the Federal Trade
Commission, which shall treat such notice as
confidential.
``(C) Action for infringement.--Within 45 days
after the date on which the holder of the approved
application for the reference product, or the owner of
a patent, receives a notice under subparagraph (B), the
holder or patent owner may bring an action for
infringement only with respect to the patent or patents
included in the notice.
``(D) Limitation on declaratory judgment actions.--
With respect to any patent relating to a product that
is the subject of an application under this subsection,
the recipient of a notice under subparagraph (B) with
respect to that application may not, prior to the
commercial marketing of the product, bring any action
under section 2201 of title 28, United States Code, for
a declaration of infringement, validity, or
enforceability of any such patent that was not
identified in the notice.
``(E) Declaratory judgment action.--
``(i) In general.--With respect to any
patent identified in a notification under
subparagraph (A) or (B) for which the holder,
or the owner of the patent--
``(I) has not brought an action for
infringement under subparagraph (C); or
``(II) has brought an action for
infringement under subparagraph (C),
but subsequently dismissed that action
without prejudice;
the applicant may bring an action for a
declaratory judgment under section 2201 of
title 28, United States Code, that such patent
is invalid or not infringed by the biological
product at issue.
``(ii) Case or controversy.--The courts of
the United States shall have, and shall
exercise, subject matter jurisdiction to hear
such an action to the full extent permitted by
article III of the Constitution.
``(F) Discretion of applicants.--An applicant or
prospective applicant for a biosimilar biological
product under this subsection may not be compelled, by
court order or otherwise, to initiate the procedures
set forth in this paragraph. Nothing in this paragraph
requires an applicant or a prospective applicant to
invoke the procedures set forth in this paragraph.
``(19) Petitions and civil actions regarding approval of
certain applications.--
``(A) In general.--With respect to a pending
application submitted under paragraph (3) or (4), if a
petition is submitted to the Secretary that seeks to
have the Secretary take, or refrain from taking, any
form of action relating to the approval of the
application, including a delay in the effective date of
the application, the following applies, subject to
subparagraph (E):
``(i)(I) The Secretary may not, on the
basis of the petition, delay approval of the
application unless the Secretary determines,
within 30 days after receiving the petition,
that a delay is necessary to protect the public
health. Consideration of a petition shall be
separate and apart from the review and approval
of the application.
``(II) With respect to a determination by
the Secretary under subclause (I) that a delay
is necessary to protect the public health:
``(aa) The Secretary shall publish
on the Internet site of the Food and
Drug Administration a statement
providing the reasons underlying the
determination.
``(bb) Not later than 10 days after
making the determination, the Secretary
shall provide notice to the sponsor of
the application and an opportunity for
a meeting with the Commissioner to
discuss the determination.
``(ii) The Secretary shall take final
agency action on the petition not later than
180 days after the date on which the petition
is submitted. The Secretary shall not extend
such period, even with the consent of the
petitioner, for any reason, including based
upon the submission of comments relating to the
petition or supplemental information supplied
by the petitioner.
``(iii) The Secretary may not consider the
petition for review unless it is signed and
contains the following verification: `I certify
that, to my best knowledge and belief: (a) this
petition includes all information and views
upon which the petition relies; (b) this
petition includes representative data and/or
information known to the petitioner which are
unfavorable to the petition; and (c) I have
taken reasonable steps to ensure that any
representative data and/or information which
are unfavorable to the petition were disclosed
to me. I further certify that the information
upon which I have based the action requested
herein first became known to the party on whose
behalf this petition is submitted on or about
the following date: [___]. I received or expect
to receive payments, including cash and other
forms of consideration, from the following
persons or organizations to file this petition:
[___]. I verify under penalty of perjury that
the foregoing is true and correct.'.
``(B) Denial based on intent to delay.--If the
Secretary determines that a petition or supplement to
the petition was submitted with the primary purpose of
delaying the licensure or the approval of a condition
of use for a biological product, the Secretary may deny
the petition at any point based on such determination.
The Secretary may issue guidance to describe the
factors that will be used to determine under this
subparagraph whether a petition is submitted with the
primary purpose of delaying the approval of an
application.
``(C) Exhaustion of administrative remedies.--
``(i) Final agency action within 180
days.--The Secretary shall be considered to
have taken final agency action on a petition
referred to in subparagraph (A) if--
``(I) during the 180-day period
referred to in clause (ii) of such
subparagraph, the Secretary makes a
final decision within the meaning of
section 10.45(d) of title 21, Code of
Federal Regulations (or any successor
regulations); or
``(II) such period expires without
the Secretary having made such a final
decision, in which case the petition
shall be deemed to have been denied.
``(ii) Dismissal of certain civil
actions.--If a civil action is filed with
respect to a petition referred to in
subparagraph (A) before final agency action
within the meaning of clause (i) has occurred,
the court shall dismiss the action for failure
to exhaust administrative remedies.
``(D) Applicability of certain regulations.--The
provisions of this section are in addition to the
requirements for the submission of a petition to the
Secretary that apply under section 10.30 or 10.35 of
title 21, Code of Federal Regulations (or any successor
regulations).
``(E) Annual report on delays in approvals per
petitions.--The Secretary shall annually submit to the
Congress a report that specifies--
``(i) the number of applications under this
subsection that were approved during the
preceding 12-month period;
``(ii) the number of such applications
whose effective dates were delayed by petitions
referred to in subparagraph (A) during such
period; and
``(iii) the number of days by which the
applications were so delayed.
``(F) Exception.--This paragraph does not apply to
a petition that is made by the sponsor of an
application under this subsection and that seeks only
to have the Secretary take or refrain from taking any
form of action with respect to that application.
``(G) Definition.--For purposes of this paragraph,
the term `petition' includes any request to the
Secretary, without regard to whether the request is
characterized as a petition.
``(20) Authorization of appropriations.--To carry out this
subsection, there are authorized to be appropriated such sums
as may be necessary for fiscal years 2010 and 2011.''.
(b) Additional Amendments.--
(1) Venue.--Section 1404 of title 28, United States Code,
is amended by adding at the end the following:
``(e) Venue in Certain Patent Infringement Disputes.--
``(1) In general.--In any action for patent infringement
brought by the holder or owner of the patent pursuant to
section 351(k)(18)(C) of the Public Health Service Act, the
defendant may move to transfer the action to any other district
in which jurisdiction is proper.
``(2) Timing.--The schedule applicable to a motion under
paragraph (1) is as follows:
``(A) A motion under paragraph (1) shall be filed
by the defendant no later than 45 days after service of
the complaint.
``(B) A response to such a motion, if any, shall be
filed no later than 20 days after service of the
motion.
``(C) A reply to such response, if any, shall be
filed no later than 10 days after service of the
response.
``(D) The schedule set forth in this paragraph may
be modified only by agreement of all parties.
``(3) Resolution.--When ruling on any motion filed under
paragraph (2), the greatest weight shall be given to the
following factors:
``(A) The interest in identifying a district court
in which the case will be adjudicated expeditiously.
``(B) The strong public interest in obtaining
prompt judicial resolution of patent disputes so that
the biological product which is the subject of the
patent dispute may be brought to market as
expeditiously as possible, consistent with fair and
prompt resolution of patent disputes.
``(4) No delay.--An action described in paragraph (1) shall
proceed as expeditiously as possible while the court considers
a motion under this subsection, and the court may not stay the
proceedings because a motion under this subsection has been
filed.''.
(2) Patents.--Section 271(e) of title 35, United States
Code, is amended--
(A) in paragraph (2)--
(i) by striking ``or'' at the end of
subparagraph (A);
(ii) by adding ``or'' at the end of
subparagraph (B);
(iii) by inserting after subparagraph (B)
the following:
``(C) a notice described in section 351(k)(18)(B)
of the Public Health Service Act, but only with respect
to a patent identified in such notice,''; and
(iv) in the matter following subparagraph
(C) (as inserted by clause (iii) of this
subparagraph), by inserting before the period
the following: ``, or if the notice described
in subparagraph (C) is provided in connection
with an application to obtain a license to
engage in the commercial manufacture, use, or
sale of a biological product claimed in a
patent or the use of which is claimed in a
patent before the expiration of such patent'';
(B) by adding at the end the following paragraph:
``(6)(A) This paragraph applies in the case of a patent--
``(i) which is disclosed in a response to a request
for patent information pursuant to subparagraph (A) of
section 351(k)(18) of the Public Health Service Act;
``(ii) with respect to which a notice was provided
pursuant to subparagraph (B) of such section; and
``(iii) for which an action for infringement of the
patent--
``(I) was brought after the expiration of
the 45-day period described in subparagraph (C)
of such section; or
``(II) was brought before the expiration of
the 45-day period described in subclause (I),
but which was dismissed without prejudice or
was not prosecuted to judgment in good faith.
``(B) In an action for infringement of a patent described
in subparagraph (A), the sole and exclusive remedy that may be
granted by a court, upon a finding that the person who
submitted the notice described in subparagraph (A)(ii)
infringed the patent, or that any person induced or contributed
to infringement of the patent, shall be a reasonable royalty.
``(C) The owner or licensee of a patent that should have
been disclosed in response to a request for patent information
made by an applicant pursuant to subparagraph (A) of section
351(k)(18) of the Public Health Service Act, but that was not
timely disclosed under that subparagraph, may not bring an
action under this title for infringement of that patent.'';
(C) in paragraph (5)--
(i) by adding ``(A)'' in front of
``Where''; and
(ii) by adding the following subparagraph:
``(B) Where a person has provided a notice
described in subparagraph (B) of section 351(k)(18) of
the Public Health Service Act, and neither the holder
for the approved biological product or the owner of a
patent identified in the notice brought an action for
infringement of such patent before the expiration of 45
days after the date on which the notice was received,
the courts of the United States shall, to the extent
consistent with the Constitution, have and exercise
subject matter jurisdiction in any action brought by
such person under section 2201 of title 28 for a
declaratory judgement that such patent is invalid or
not infringed.''; and
(D) in paragraph (4), by striking ``in paragraph
(2)'' in both places it appears and inserting ``in
subparagraphs (2)(A) or (2)(B)''.
(3) Conforming amendments.--
(A) Title 28.--Section 2201(b) of title 28, United
States Code, is amended by inserting before the period
the following: ``, or section 351 of the Public Health
Service Act''.
(B) Public health service act.--Subjection (j) of
section 351 of the Public Health Service Act (42 U.S.C.
262) is amended by inserting ``or subsection (k)''
after ``subsection (a)''.
(c) Review of Applications Submitted During Exclusivity Periods.--
(1) User fee goals.--
(A) Revision.--Within 180 days after the date of
the enactment of this Act, the Secretary of Health and
Human Services, in consultation with the relevant
stakeholders, shall revise the PDUFA reauthorization
performance goals and procedures with respect to the
user fee goals for abbreviated biological product
applications under section 351(k) of the Public Health
Service Act, as added by subsection (a) of this
section, that are submitted more than 2 years in
advance of the expiration of any period of exclusive
marketing to which the reference drug is entitled under
subsection (k)(10) or subsection (l) of section 351 of
the Public Health Service Act, as added by subsection
(a) of this section and section 4 respectively.
(B) Considerations.--In revising the user fee goals
for applications described in subparagraph (A), the
Secretary shall consider--
(i) the need to provide sufficient time so
that a decision on whether to approve the
application can be made in advance of the
expiration of any exclusivity, and considering
the possibility that amendments will be
necessary after the initial decision and prior
to approval; and
(ii) the importance of conserving agency
resources.
(2) Review priorities.--In setting priorities with respect
to the review of applications described in paragraph (1)(A),
the Secretary shall take into account the number of years in
advance of the expiration of any exclusivity granted to the
reference drug that an application was submitted.
(3) Submission of revised performance goals to congress.--
The Secretary shall, within 30 days after revising the PDUFA
reauthorization performance goals and procedures under this
subsection, submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a letter
describing the revised goals and the basis for such revisions.
(4) Definitions.--In this subsection:
(A) The terms ``abbreviated biological product
application'' and ``reference product'' have the
meanings given to those terms in section 351(i) of the
Public Health Service Act, as amended by section 2(a).
(B) The term ``PDUFA reauthorization performance
goals and procedures'' means the performance goals and
procedures of the Food and Drug Administration, agreed
to for purposes of the reauthorization of part 2 of
subchapter C of chapter VII of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 279g et seq.; relating to
the prescription drug user fee program) for fiscal year
2008 and succeeding fiscal years.
SEC. 4. PEDIATRIC STUDIES OF BIOLOGICAL PRODUCTS.
Section 351 of the Public Health Service Act (42 U.S.C. 262), as
amended by section 3, is further amended by adding at the end the
following:
``(l) Pediatric Studies.--
``(1) Application of certain provisions.--The provisions of
section 505A of the Federal Food, Drug, and Cosmetic Act shall,
except as inconsistent with this section, apply to biological
products approved under subsection (a) or (k) of this section
to the same extent and in the same manner as such provisions
apply to drugs approved under subsection (c) or (j),
respectively, of section 505 of the Federal Food, Drug, and
Cosmetic Act.
``(2) Market exclusively for new biological products.--If,
prior to approval of an application that is submitted under
subsection (a) of this section, the Secretary determines that
information relating to the use of a new biological product in
the pediatric population may produce health benefits in that
population, the Secretary makes a written request for pediatric
studies (which shall include a timeframe for completing such
studies), the applicant agrees to the request, such studies are
completed using appropriate formulations for each age group for
which the study is requested within any such timeframe, and the
reports thereof are submitted and accepted in accordance with
section 505A(d)(3) of the Federal Food, Drug, and Cosmetic
Act--
``(A) the period for such biological product
referred to in subparagraph (A) of subsection (k)(10),
including any extension under subparagraph (D) of such
subsection, is extended by 6 months; and
``(B) if the biological product is designated under
section 526 for a rare disease or condition, the period
for such biological product referred to in section
527(a) is deemed to be 7 years and 6 months rather than
7 years.
``(3) Market exclusivity for already-marketed biological
products.--If the Secretary determines that information
relating to the use of a licensed biological product in the
pediatric population may produce health benefits in that
population and makes a written request to the holder of an
approved application under subsection (a) of this section for
pediatric studies (which shall include a timeframe for
completing such studies), the holder agrees to the request,
such studies are completed using appropriate formulations for
each age group for which the study is requested within any such
timeframe, and the reports thereof are submitted and accepted
in accordance with section 505A(d)(3) of the Federal Food,
Drug, and Cosmetic Act--
``(A) the period for such biological product
referred to in subparagraph (A) of subsection (k)(10),
including any extension under subparagraph (D) of such
subsection, is extended by 6 months; and
``(B) if the biological product is designated under
section 526 for a rare disease or condition, the period
for such biological product referred to in section
527(a) is deemed to be 7 years and 6 months rather than
7 years.
``(4) Exception.--The Secretary shall not extend the period
referred to in paragraph (2)(A), (2)(B), (3)(A), or (3)(B) if
the determination under section 505A(d)(3) is made later than 9
months prior to the expiration of such period.''.
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