[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 623 Introduced in Senate (IS)]
110th CONGRESS
1st Session
S. 623
To amend the Public Health Service Act to provide for the licensing of
comparable and interchangeable biological products, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
February 15, 2007
Mr. Schumer (for himself, Mrs. Clinton, Mr. Vitter, Ms. Collins, Mr.
Leahy, and Ms. Stabenow) 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
comparable and interchangeable 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 ``Access to Life-Saving Medicine
Act''.
SEC. 2. DEFINITIONS.
(a) Amendments.--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 containing the same, or similar, active ingredient as a
reference product.
``(3) The term `reference product' means the single
licensed biological product, approved under subsection (a) or
subsection (k), against which a biological product is evaluated
for demonstration of safety, potency, or purity.
``(4) The term `comparable' or `comparability' in reference
to a biological product means the absence of clinically
meaningful differences between the biological product and the
reference product in terms of the safety, purity, and potency
of the product based upon--
``(A) data derived from chemical, physical, and
biological assays, and other non-clinical laboratory
studies; and
``(B) data from any necessary clinical study or
studies sufficient to confirm safety, purity, and
potency in one or more appropriate conditions of use
for which the reference product is licensed and
intended to be used.
Any studies under subparagraph (B) shall be designed to avoid
duplicative and unethical clinical testing.
``(5) The terms `interchangeable' and `interchangeability'
mean, with respect to the condition of use involved, that the
biological product--
``(A) is comparable to the reference product; and
``(B) can be expected to produce the same clinical
result as the reference product in any given patient.
``(6) The term `thorough characterization' means an
analysis of structural features based upon appropriate
analytical and functional testing sufficient to identify
differences between a biological product and reference product
relevant to safety, purity or potency.
``(7) 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.
``(8) 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)(11).
``(9) 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) Rule of Construction.--Nothing in this Act or the amendments
made by this Act shall be construed to exclude an application for
licensure of a biological product under section 351(k) from the
definition of a human drug application in section 735(1)(C) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)(C)).
SEC. 3. REGULATION OF COMPARABLE AND INTERCHANGEABLE BIOLOGICAL
PRODUCTS.
(a) In General.--Section 351 of the Public Health Service Act (42
U.S.C. 262) is 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 Comparable and Interchangeable Biological
Products.--
``(1) 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) Data demonstrating that the biological
product is comparable to or interchangeable with the
reference product.
``(B) Data demonstrating that the biological
product and reference product contain highly similar
principal molecular structural features,
notwithstanding minor differences in heterogeneity
profile, impurities, or degradation patterns. The
Secretary shall find the following types of products to
contain highly similar principal molecular structural
features:
``(i) Two protein biological products with
differences in structure between them solely
due to post-translational events, infidelity of
translation or transcription, or minor
differences in amino acid sequence.
``(ii) Two 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) Two glycosylated protein products
with differences in structure between them
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) Two 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 two live viral
products for the same indication.
Two biological products not enumerated in the foregoing
clauses may be demonstrated to contain highly similar
principal molecular structural features based upon such
data and other information characterizing the two
products as the Secretary determines to be necessary.
``(C) Data 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.
``(D) Information to show that the condition or
conditions of use prescribed, recommended, or suggested
in the labeling proposed 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) Data demonstrating that the facility in which
the biological product is manufactured, processed,
packed, or held meets standards designed to assure that
the biological product continues to be safe, pure, and
potent.
``(G) At the applicant's option, publicly-available
information regarding the Secretary's previous
determination that the reference product is safe, pure,
and potent.
``(H) Any additional data and information in
support of the application, including publicly-
available information with respect to the reference
product or another biological product.
``(2) 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 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 (1),
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
relative to the reference product for its proposed condition or
conditions of use.
``(3) FDA review of abbreviated biological product
applications.--
``(A) Guidance regarding review of applications.--
The Secretary shall issue guidance for the individuals
who review applications submitted under paragraph (1)
or (2), which shall relate to promptness in conducting
the review, technical excellence, lack of bias and
conflict of interest, and knowledge of regulatory and
scientific standards, and which shall apply equally to
all individuals who review such applications.
``(B) Meetings with sponsors and applicants.--The
Secretary shall meet with a sponsor of an investigation
or an applicant for approval of a comparable or
interchangeable biological product under this
subsection if the sponsor or applicant makes a
reasonable written request for a meeting for the
purpose of reaching agreement on the design and size of
studies needed for approval of the application. The
sponsor or applicant shall provide information
necessary for discussion and agreement on the design
and size of such studies. Minutes of any such meeting
shall be prepared by the Secretary and made available
to the sponsor or applicant.
``(C) Agreements.--Any agreement regarding the
parameters of design and size of the studies of a
biological product under this paragraph that is reached
between the Secretary and a sponsor or applicant shall
be reduced to writing and made part of the
administrative record by the Secretary. Such agreement
shall not be changed after the testing begins, except--
``(i) with the written agreement of the
sponsor or applicant; or
``(ii) pursuant to a decision, made in
accordance with subparagraph (D) by the
director of the reviewing division, that a
substantial scientific issue essential to
determining the safety, purity, and potency of
the biological product has been identified
after the testing has begun.
``(D) Procedure regarding certain decisions.--A
decision under subparagraph (C)(ii) by the director
shall be in writing and the Secretary shall provide to
the sponsor or applicant an opportunity for a meeting
at which the director and the sponsor or applicant will
be present and at which the director will document the
scientific issue involved.
``(E) Effect of decisions.--The written decisions
of the reviewing division shall be binding upon, and
may not directly or indirectly be changed by, the field
or compliance office personnel unless such field or
compliance office personnel demonstrate to the
reviewing division why such decision should be
modified.
``(F) Delays by reviewing divisions.--No action by
the reviewing division may be delayed because of the
unavailability of information from or action by field
personnel unless the reviewing division determines that
a delay is necessary to assure the marketing of a safe,
pure, and potent biological product.
``(4) Approval of comparable or interchangeable biological
products.--
``(A) Determination of comparability.--Upon review
of an application submitted under paragraph (1) or (2)
for a biological product, the Secretary shall issue a
comparable biological product license for all
conditions of use of the reference product sharing the
same mechanism or mechanisms of action for which the
applicant has demonstrated comparability for a single
condition of use, or, if the mechanism or mechanisms of
action are unknown, for the condition or conditions of
use for which the data submitted establishes
comparability, unless the Secretary finds and informs
the applicant that--
``(i) information submitted in the
application or any other information available
to the Secretary is insufficient to show that
the biological product is comparable to the
reference product for the condition or
conditions of use prescribed, recommended, or
suggested in the labeling proposed in the
application;
``(ii) information submitted in the
application or any other information available
to the Secretary is insufficient to show that
the biological product and the reference
product contain highly similar principal
molecular structural features, notwithstanding
minor differences in heterogeneity profile,
impurities, or degradation patterns;
``(iii) information submitted in the
application or 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 labeling
proposed for the biological product, unless the
mechanism or mechanisms of action are not known
for the reference product for such condition or
conditions;
``(iv) information submitted in the
application or 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;
``(v) information submitted in the
application or any other information available
to the Secretary is insufficient to show that
the condition or conditions of use prescribed,
recommended, or suggested in the labeling
proposed 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;
``(vi) information submitted in the
application or 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 labeling
proposed 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;
``(vii) information submitted in the
application or 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 assure that the
biological product continues to be safe, pure,
and potent;
``(viii) the Secretary has withdrawn or
suspended the license of the reference product,
for safety or effectiveness reasons, or has
published a notice of opportunity for hearing
to withdraw such license for safety or
effectiveness reasons, or the Secretary has
determined that the reference product has been
withdrawn from sale for safety or effectiveness
reasons; or
``(ix) the application contains an untrue
statement of material fact; and
provides the applicant with a detailed explanation for
the decision.
``(B) Determinations on interchangeability.--
Subject to subparagraph (C) and paragraph (10), 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.
``(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 (10) 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
(10) has expired.
``(5) Postmarketing studies for applications submitted
under paragraph (1).--If the Secretary has agreed with the
sponsor of the reference product, at the time of approval or
any time thereafter, that the sponsor shall conduct one or more
postmarketing safety studies, a person submitting an
application for a biological product under paragraph (1) may
agree with the Secretary to conduct a similar postmarketing
safety study or studies upon a reasonable showing that such
study or studies would provide relevant information not
available from the studies on the reference product. The
Secretary shall not, as a condition of approval, propose any
additional postmarketing studies for such biological product.
``(6) Designation of official name.--If, pursuant to
section 508 of the Federal Food, Drug, and Cosmetic Act, the
Secretary determines that designation of an official name for a
comparable biological product is necessary or desirable in the
interests of usefulness or simplicity, the Secretary shall
designate the same official name for the comparable biological
product as the Secretary designated for the reference product.
This paragraph shall not apply to products approved under
paragraph (7).
``(7) Other approval provisions.--The Secretary shall
approve, under the provisions of paragraph (4)(A), an
application for a license submitted under paragraph (2), except
that the Secretary shall approve such an application that would
otherwise be disapproved by reason of one or more of
subparagraphs (A) through (E) of paragraph (4)(A), if the
application and any other information available to the
Secretary are sufficient to establish the safety, purity, and
potency of the comparable biological product relative to the
reference product for the proposed condition or conditions of
use for such product.
``(8) Establishing interchangeability for comparable
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 comparable
biological product and the reference product. An
applicant may withdraw an interchangeability submission
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. 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 one year after enactment of
the Access to Life-Saving Medicine Act, the Secretary
shall issue guidance regarding standards and
requirements for interchangeability. The Secretary may
make determinations of interchangeability under
paragraph (4)(B) prior to issuing guidance under this
subparagraph.
``(9) Interchangeability labeling for comparable biological
products.--Upon a determination of interchangeability, the
Secretary, if requested by the applicant, shall provide for the
label of the comparable 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) 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 (4)(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
comparable biological product to be approved as
interchangeable for that reference product;
``(ii) one year after--
``(I) a final court decision on all
patents in suit in an action instituted
under paragraph (17)(C) against the
applicant that submitted the
application for the first approved
interchangeable comparable biological
product; or
``(II) the dismissal with or
without prejudice of an action
instituted under paragraph (17)(C)
against the applicant that submitted
the application for the first approved
interchangeable comparable biological
product; or
``(iii)(I) 36 months after approval of the
first interchangeable comparable biological
product if the applicant has been sued under
paragraph (17)(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
comparable applicant has not been sued under
paragraph (17)(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.
``(11) 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 thirty
days after such notice, such hearing shall commence not more
than ninety days after the expiration of such thirty 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
ninety days after the date fixed by the Secretary for filing
final briefs.
``(12) Final action date.--
``(A) In general.--The Secretary shall take a final
action on an abbreviated biological product application
by the date that is 8 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 such date.
``(13) Request for delay of final action.--Notwithstanding
paragraph (18) or 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 comparable
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 comparable biological product.
``(14) 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.
``(15) 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.
``(16) 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.
``(17) 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, or licensed to, 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 method of
using such product, any component of such
product, or any method or process of
manufacturing such product or component.
``(ii) Costs of complying with request.--
The application holder may demand payment of
not more than $1,000 to offset the cost of
responding to the request for information.
``(iii) Updates.--For a period of two 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.
``(iv) Additional requests.--The applicant
may submit additional requests for patent
information, subject to the requirements of
this paragraph, at any time.
``(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). 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) identify 1 or more judicial
districts in which the applicant consents to
such suit being brought.
``(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, and only in a judicial district
identified pursuant to subparagraph (B)(iii).
``(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. With respect to any such
patent identified in the notice, any such action may,
notwithstanding chapter 87 of title 28, United States
Code, be brought only in a judicial district identified
in the notice.
``(E) Discretion of applicants.--An applicant or
prospective applicant for a comparable 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.
``(18) Petitions and civil actions regarding approval of
certain applications.--
``(A) In general.--With respect to a pending
application submitted under paragraph (1) or (2), 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) 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.
``(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.
``(C) 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).
``(D) 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.
``(E) 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.
``(F) 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.''.
(b) Additional Amendments.--
(1) 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)(17)(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'';
and
(B) by adding at the end the following paragraph:
``(6)(A) This paragraph applies, in lieu of paragraph (4), 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)(17) 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 of a patent that should have been disclosed
in response to a request for patent information made by an
applicant pursuant to subparagraph (A)(i) of section 351(k)(17)
of the Public Health Service Act, but that was not timely
disclosed under that subparagraph, may not bring an action
under this section for infringement of that patent.''.
(2) 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)''.
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