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 Homeland Security and Governmental Affairs
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.
`(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;
`(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.
`(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.
`(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: XXXXXXX. I received
or expect to receive payments, including cash and other forms of consideration,
from the following persons or organizations to file this petition:
XXXXXXXX. 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--
(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)'.
END
