1.This Act may be cited as the
Pathway for Biosimilars
Act
.
2.The table of contents
for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Title I—Amendments to Public Health Service Act
Sec. 101. Approval pathway for biosimilar biological
products.
Sec. 102. Fees relating to biosimilar biological
products.
Title II—Amendments to Patent Act
Sec. 201. Amendments to certain patent provisions.
<enum>I</enum><header>Amendments to
Public Health Service Act</header>
<section id="HB4506578D56A4243BAE3239CB078C143"><enum>101.</enum><header>Licensure
pathway for biosimilar biological products</header>
<subsection id="H99EE6B14C148498CAA5B65C04B4DBA1C"><enum>(a)</enum><header>Licensure of
Biological Products as Biosimilar or Interchangeable</header><text>Section 351
of the Public Health Service Act (42 U.S.C. 262) is amended—</text>
<paragraph id="H66685E790075442886A877790095C54E"><enum>(1)</enum><text>in subsection
(a)(1)(A), by inserting <quote>under this subsection or subsection (k)</quote>
after <quote>biologics license</quote>; and</text>
</paragraph><paragraph id="HA74BFFAF2E8F4C38A95D0067FDED16C7"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="H1024BCA81AC246D599E3141BE418378B" style="OLC">
<subsection id="H64DA4FD85B0140FEAC04165433FF4CD"><enum>(k)</enum><header>Licensure of
biological products as biosimilar</header>
<paragraph id="H1CE5207FCD5F4B67800505B0A606109D"><enum>(1)</enum><header>In
general</header><text>Any person may submit an application for licensure of a
biological product under this subsection.</text>
</paragraph><paragraph id="H210F4A508B144D40B3A9DF5BDC55B9B9"><enum>(2)</enum><header>Content</header>
<subparagraph id="HF7798531C98E4DFDB43609050010BF78"><enum>(A)</enum><header>Required
information</header><text>An application submitted under this subsection shall
include information demonstrating that—</text>
<clause id="H4AB5AA13BEE646DB882ECBFFA3BFC760"><enum>(i)</enum><text>the biological
product is biosimilar to a reference product based upon data derived
from—</text>
<subclause id="H41225BA0E3BD463E877EAFC0438CD361"><enum>(I)</enum><text>analytical studies
that demonstrate that the biological product is highly similar to the reference
product notwithstanding minor differences in clinically inactive
components;</text>
</subclause><subclause id="HA7A1FB31E0544E87BE4622C97425286C"><enum>(II)</enum><text>animal studies
(including the assessment of toxicity); and</text>
</subclause><subclause id="H94E9FBDD3446450EBB474EA8AE7FE555"><enum>(III)</enum><text>a clinical study
or studies (including, but not limited to, the assessment of immunogenicity and
pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate
safety, purity, and potency for each condition of use for which the reference
product is approved;</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="H53941FA37FA54089A32BCAD4EA4297A0"><enum>(ii)</enum><text display-inline="yes-display-inline">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;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H03D5CDE2501147948C02AA7FD8A87800"><enum>(iii)</enum><text display-inline="yes-display-inline">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;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="H64E8FEE7EB2B44C59DC0710875EE1C37"><enum>(iv)</enum><text display-inline="yes-display-inline">the route of administration, the dosage
form, and the strength of the biological product are the same as those of the
reference product; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HE1651C669C4245D08D6E85DD6EDB535B"><enum>(v)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H237E2842AD664324AD8DFC2855D00C7"><enum>(B)</enum><header>Waiver regarding
analytical studies, animal studies, and clinical studies</header>
<clause id="H9EAEBCB7DD7F4CF795D22F9451F48568"><enum>(i)</enum><header>In
general</header><text>The Secretary may, in the Secretary's discretion,
determine that an element described in subclause (I), (II), or (III) of
subparagraph (A)(i) is unnecessary and waive the requirement that such element
be submitted in an application under this subsection.</text>
</clause><clause id="H175A2B314ECB4A089E57FE08A751CE00"><enum>(ii)</enum><header>Assessments of
immunogenicity</header><text display-inline="yes-display-inline">Notwithstanding clause (i), the Secretary
may determine that an assessment of immunogenicity described in subparagraph
(A)(i)(III) is unnecessary and waive the requirement that such an assessment be
submitted in an application under this subsection only if the Secretary has
published a final guidance, following receipt and consideration of public
comments on a draft guidance—</text>
<subclause id="HE943BB58A3EB46389E00BB845EF77C3D"><enum>(I)</enum><text>advising that it
is feasible in the current state of scientific knowledge to make determinations
on immunogenicity with respect to products in the product class to which the
biological product belongs; and</text>
</subclause><subclause id="H119BF0837FAA4C15B23E50CF705D099F"><enum>(II)</enum><text>explaining the
data that will be required to support such a determination.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE4DBDF66D4444C8FAB87F2C718C56880"><enum>(C)</enum><header>Additional
information</header><text>An application submitted under this
subsection—</text>
<clause commented="no" display-inline="no-display-inline" id="H7CC27692214841338776C0F258E46543"><enum>(i)</enum><text display-inline="yes-display-inline">shall include publicly available
information regarding the Secretary’s previous determination that the reference
product is safe, pure, and potent; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="HD88D35B335E8424CB98F595734B4545"><enum>(ii)</enum><text display-inline="yes-display-inline">may include any additional information in
support of the application, including publicly available information with
respect to the reference product or another biological product.</text>
</clause></subparagraph></paragraph><paragraph id="H27A70732699F455A84C6D8EB46D2FE5"><enum>(3)</enum><header>Evaluation by
Secretary</header><text>Upon review of an application (or a supplement to an
application) submitted under this subsection, the Secretary shall approve the
application (or the supplement) if—</text>
<subparagraph id="HD1B406FDEC74462EA553717662A8AD42"><enum>(A)</enum><text>the Secretary
determines that the information submitted in the application (or the
supplement) is sufficient to show that the biological product is biosimilar to
the reference product with respect to each condition of use for which the
reference product is approved; and</text>
</subparagraph><subparagraph id="HDB5F9CAEF06F46A1817301AAA99BF5B"><enum>(B)</enum><text>the applicant (or
other appropriate person) consents to the inspection of the facility that is
the subject of the application, in accordance with subsection (c).</text>
</subparagraph></paragraph><paragraph commented="no" id="H180872DDF3954C0D99934E62C2B1133B"><enum>(4)</enum><header>Safety standards
for determining interchangeability</header>
<subparagraph id="HA85208E6E9114EC1B1866D329F22001D"><enum>(A)</enum><header>Determination</header><text>Upon
review of an application submitted under this subsection or any supplement to
such application, the Secretary shall determine the biological product to be
interchangeable with the reference product if the Secretary determines that the
information submitted in the application (or a supplement to such application)
is sufficient to show that—</text>
<clause commented="no" id="H4A33DAEBD9A244B79B8C06112D1B589D"><enum>(i)</enum><text>the biological
product—</text>
<subclause commented="no" id="H8CBE2372B80A48DDA532FE4736B6E900"><enum>(I)</enum><text display-inline="yes-display-inline">is biosimilar to the reference product and
any biological product licensed under this subsection that has been determined
to be interchangeable with the reference product; and</text>
</subclause><subclause commented="no" id="H01C7042FE47C42C0BBFD27A8961550BE"><enum>(II)</enum><text display-inline="yes-display-inline">can be expected to produce the same
clinical result as the reference product in any given patient for each
condition of use prescribed, recommended, or suggested in the labeling of the
reference product; and</text>
</subclause></clause><clause commented="no" id="H72457C88D6D54985B3C3DECFC9D001B"><enum>(ii)</enum><text display-inline="yes-display-inline">for a biological product that is
administered more than once to an individual, the risk of alternating or
switching between use of the biological product and the reference product (in
terms of safety, diminished efficacy, and reduced or enhanced potency) is not
greater than the risk of using the reference product without such alternation
or switching.</text>
</clause></subparagraph><subparagraph id="HC4733BF7E3154AE093379654AB15452"><enum>(B)</enum><header>Guidelines</header><text display-inline="yes-display-inline">Notwithstanding subparagraph (A), the
Secretary may not make a determination that a biological product licensed under
this subsection is interchangeable with the reference product unless the
Secretary has published a final guidance, following receipt and consideration
of public comments on a draft guidance—</text>
<clause id="H64CAF8E2B71F46B5BB158CE482E8341E"><enum>(i)</enum><text>advising that it
is feasible in the current state of scientific knowledge to make such
determinations with respect to products in the product class to which that
biological product belongs; and</text>
</clause><clause id="HFD8234C64FB54B7E9E8277C00ED133E"><enum>(ii)</enum><text>explaining the
data that will be required to support such a determination.</text>
</clause></subparagraph><subparagraph commented="no" id="H9C506CE4A1FF4AA19FC3DA302095A5B3"><enum>(C)</enum><header>Preservation of
State authority</header><text>Nothing in this subsection shall be construed as
preempting or otherwise affecting the authority of a State to require or
regulate prescriptions.</text>
</subparagraph></paragraph><paragraph commented="no" id="HDDB5F70EA8BC493100196EF4C58B46FD"><enum>(5)</enum><header>General
rules</header>
<subparagraph commented="no" id="HC97CE5F49F584D66B217C8AA759097D"><enum>(A)</enum><header>One reference
product per application</header><text>A biological product, in an application
submitted under this subsection, may not be evaluated against more than 1
reference product.</text>
</subparagraph><subparagraph commented="no" id="HE590305979FF46E999676FCF8950703E"><enum>(B)</enum><header>Review</header><text>An
application submitted under this subsection shall be reviewed by the division
within the Food and Drug Administration that is responsible for the review and
approval of the application under which the reference product is
licensed.</text>
</subparagraph><subparagraph commented="no" id="H5056A992BB9048AA87F2C2497C80849F"><enum>(C)</enum><header>Risk evaluation
and mitigation strategies</header><text>The authority of the Secretary with
respect to risk evaluation and mitigation strategies under the Federal Food,
Drug, and Cosmetic Act shall apply to biological products licensed under this
subsection in the same manner as such authority applies to biological products
licensed under subsection (a).</text>
</subparagraph><subparagraph commented="no" id="H4115F1271A7D4C30BE3DBE005D7DC721"><enum>(D)</enum><header>Restrictions on
biological products containing dangerous ingredients</header><text display-inline="yes-display-inline">If information in an application submitted
under this subsection, in a supplement to such an application, or otherwise
available to the Secretary shows that a biological product—</text>
<clause id="HE21E60FD9AF14164A906ECDC82D88911"><enum>(i)</enum><text>is, bears, or
contains a select agent or toxin listed in section 73.3 or 73.4 of title 42,
section 121.3 or 121.4 of title 9, or section 331.3 of title 7, Code of Federal
Regulations (or any successor regulations); or</text>
</clause><clause id="HA4736D5C438741CCA2D054EE77168E97"><enum>(ii)</enum><text>is, bears, or
contains a controlled substance in schedule I or II of section 202 of the
Controlled Substances Act, as listed in part 1308 of title 21, Code of Federal
Regulations (or any successor regulations);</text>
</clause><continuation-text continuation-text-level="subparagraph">the
Secretary shall not license the biological product under this subsection unless
the Secretary determines, after consultation with appropriate national security
and drug enforcement agencies, that there would be no increased risk to the
security or health of the public from licensing such biological product under
this subsection.</continuation-text></subparagraph></paragraph><paragraph id="H3F7B91173EC44FBEB5008EB2BC9DDA3D"><enum>(6)</enum><header>Exclusivity for
first interchangeable biological product</header><text display-inline="yes-display-inline">The Secretary shall not make a
determination under paragraph (4) that a second or subsequent biological
product is interchangeable with the same reference product for which a prior
biological product has received a determination of interchangeability until 24
months after the later of—</text>
<subparagraph id="HEB96816FBD094AD9B98D5E6161DDB115"><enum>(A)</enum><text>the date of the
first commercial marketing of the first biosimilar biological product
determined to be interchangeable for that reference product; or</text>
</subparagraph><subparagraph id="H9362622BC92B400198632F31F038D3B0"><enum>(B)</enum><text>with respect to a
product marketed before the date the product is determined to be
interchangeable, the date that the product is determined to be
interchangeable.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF307B01DF2B84E3581FDFFB6AF444100"><enum>(7)</enum><header>Exclusivity for
reference product</header>
<subparagraph id="H8C9329FEC44C4B0F8D576C662FFF0087"><enum>(A)</enum><header>Effective date
of biosimilar application licensure</header><text>Subject to subparagraph (D)
and paragraph (8), approval of an application under this subsection may not be
made effective by the Secretary until the date that is 12 years after the date
on which the reference product was first licensed under subsection (a).</text>
</subparagraph><subparagraph id="HF7D648AA0B0B4E40932F4D5741E83498"><enum>(B)</enum><header>Filing
period</header><text>An application under this subsection may not be submitted
to the Secretary until the later of—</text>
<clause id="H48789B2103EE4BD4AC34A0E28D39AF00"><enum>(i)</enum><text display-inline="yes-display-inline">the date of commencement of a proceeding
for issuance of guidance pursuant to paragraph (9) with respect to the product
class within which the product that is the subject of such application falls;
or</text>
</clause><clause id="HB33313F8C0024F949600BE230080E1AC"><enum>(ii)</enum><text>the date that is
4 years after the date on which the reference product was first licensed under
subsection (a).</text>
</clause></subparagraph><subparagraph id="HFA6D57CE72F24359BE03882FD5A8409F"><enum>(C)</enum><header>First
licensure</header><text>For purposes of this paragraph, the date on which the
reference product was first licensed under subsection (a) does not include the
date of approval of a supplement or of a subsequent application for a new
indication, route of administration, dosage form, or strength for the
previously licensed reference product.</text>
</subparagraph><subparagraph id="HF608647DE74F4A4B82146136D81E9D79"><enum>(D)</enum><header>Medically
significant new indication</header><text>If, during the 8-year period following
licensure of the reference product, the Secretary approves a supplement to the
application for the reference product that seeks approval to market the
reference product for a new indication that, if approved, would be a
significant improvement, compared to marketed products, in the treatment,
diagnosis, or prevention of disease, approval of an application submitted under
this subsection may not be made effective by the Secretary until the date that
is 14 years after the date on which the reference product was first licensed
under subsection (a).</text>
</subparagraph></paragraph><paragraph display-inline="no-display-inline" id="H5F08524DFDC94C2DBCAF164B578C0864"><enum>(8)</enum><header>Pediatric
studies</header>
<subparagraph display-inline="no-display-inline" id="HDBC3FA0E10D147D99DC80182A9579D62"><enum>(A)</enum><header>Exclusivity</header><text display-inline="yes-display-inline">If, before or after licensure of the
reference product under subsection (a) of this section, the Secretary
determines that information relating to the use of such 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 or holder of the approved
application 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—</text>
<clause id="H5E1A415745E34B28B4AF78AEA0B3A861"><enum>(i)</enum><text>the period
referred to in paragraph (7)(A) of this subsection is deemed to be 12 years and
6 months rather than 12 years; and</text>
</clause><clause id="H7F5966F12398430CB4D971751EA60096"><enum>(ii)</enum><text display-inline="yes-display-inline">if paragraph (7)(D) of this subsection
applies, the period referred to in such paragraph is deemed to be 14 years and
6 months rather than 14 years.</text>
</clause></subparagraph><subparagraph display-inline="no-display-inline" id="H048F7D2B1F364B21B239228E2CB48876"><enum>(B)</enum><header>Exception</header><text>The
Secretary shall not extend the period referred to in subparagraph (A)(i) or
(A)(ii) of this paragraph if the determination under section 505A(d)(3) of the
Federal Food, Drug, and Cosmetic Act is made later than 9 months prior to the
expiration of such period.</text>
</subparagraph><subparagraph id="H6CBCF2E3F9214F4DAF21BB1B425DF7B"><enum>(C)</enum><header>Application of
certain provisions</header><text>The provisions of subsections (a), (d), (e),
(f), (h), (j), (k), and (l) of section 505A of the Federal Food, Drug, and
Cosmetic Act shall apply with respect to the extension of a period under
subparagraph (A) of this paragraph to the same extent and in the same manner as
such provisions apply with respect to the extension of a period under
subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic
Act.</text>
</subparagraph></paragraph><paragraph id="HA2E6B793AE234D80AE6D57A782932E19"><enum>(9)</enum><header>Guidance
documents</header>
<subparagraph id="HCA761A09918B458E92FC2033E6AD8ED9"><enum>(A)</enum><header>In
general</header><text>The Secretary shall, after opportunity for public
comment, issue final guidance with respect to the licensure under this
subsection of a biological product or product class. Such guidance shall be
issued in accordance, except as provided in subparagraph (B)(i), with section
701(h) of the Federal Food, Drug, and Cosmetic Act.</text>
</subparagraph><subparagraph id="H195F1EE794CF42A6BCC08268D42DD95"><enum>(B)</enum><header>Public
comment</header>
<clause id="HA551B2F9C2EC415684E89BE1AA41047C"><enum>(i)</enum><header>In
general</header><text>Before issuing final guidance under subparagraph (A), the
Secretary shall publish a proposed guidance, provide an opportunity for the
public to comment on the proposed guidance, and publish a response to comments
received under this clause.</text>
</clause><clause id="H5F5F1F475CA649E992A9155898F00F4"><enum>(ii)</enum><header>Input regarding
most valuable guidance</header><text>The Secretary shall establish a process
through which the public may provide the Secretary with input regarding
priorities for issuing guidance.</text>
</clause></subparagraph><subparagraph commented="no" id="H67524B3A3B2541DD9D16DF4BBF2CAFD5"><enum>(C)</enum><header>Certain product
classes</header>
<clause commented="no" id="HB46FAD42868147A3A0C0033352CB8F63"><enum>(i)</enum><header>Guidance</header><text display-inline="yes-display-inline">The Secretary may indicate in a guidance
document under subparagraph (A) that the Secretary will not license a product
or product class (not including any recombinant protein) under this subsection
because the science and experience, as of the date of such guidance, does not
allow such licensure.</text>
</clause><clause commented="no" id="H388873C026F3441C8539D78DB9B7B131"><enum>(ii)</enum><header>Modification or
reversal</header><text>The Secretary may issue a subsequent guidance document
under subparagraph (A) to modify or reverse a guidance document under clause
(i).</text>
</clause></subparagraph><subparagraph commented="no" id="HED57DC86CD764C91A64B9CE79FDE401D"><enum>(D)</enum><header>Petition for
initiation of guidance for certain products</header><text>In the case of a
reference product that was licensed by the Secretary more than 7 years prior to
the date of the enactment of the Pathway for Biosimilars Act, a person may
petition the Secretary at any time to commence the process for issuing final
guidance under subparagraph (A) for the product class to which the reference
product belongs. Any such petition shall include a description of the
scientific feasibility and rationale for the request. For guidance petitioned
under this subparagraph, the Secretary shall, within 2 years of such petition,
issue final guidance with respect to that product class.</text>
</subparagraph><subparagraph id="H6D9E0CA1AD804BDD98A19D466EC86F3D"><enum>(E)</enum><header>Requirement for
application consideration</header><text>The Secretary may not accept an
application under this subsection until the Secretary has initiated a
proceeding for issuance of guidance with respect to the product class within
which the product that is the subject of the application falls. The Secretary
may not approve an application under this subsection until the Secretary has
completed the proceeding for issuance of guidance with respect to the product
class within which the product that is the subject of the application
falls.</text>
</subparagraph><subparagraph id="H0769B315A6084D2FA5A039C8B337CA60"><enum>(F)</enum><header>Requirement for
product class-specific guidance</header><text display-inline="yes-display-inline">Product class-specific guidance issued
under subparagraph (A) shall include a description of—</text>
<clause id="HA94FB926DE8C437CA4F34645A0751B52"><enum>(i)</enum><text>the criteria that
the Secretary will use to determine whether a biological product is biosimilar
to a reference product in such product class;</text>
</clause><clause id="H9F96770901A24B69A643C343F6F3DD1C"><enum>(ii)</enum><text>the criteria, if
available, that the Secretary will use to determine whether a biological
product meets the standards for interchangeability described in paragraph (4);
and</text>
</clause><clause id="H80073818976946D9987FF664D55BA941"><enum>(iii)</enum><text display-inline="yes-display-inline">the criteria, if available, that the
Secretary will use to assess immunogenicity.</text>
</clause></subparagraph></paragraph><paragraph id="H512027F2413A48A280096F59FDAA2DF2"><enum>(10)</enum><header>Naming</header><text display-inline="yes-display-inline">The Secretary shall ensure that the
labeling and packaging of each biological product licensed under this
subsection bears a name that uniquely identifies the biological product and
distinguishes it from the reference product and any other biological products
licensed under this subsection following evaluation against such reference
product.</text>
</paragraph></subsection><subsection commented="no" id="H9D0BC18AE0624E94B346005732C28800"><enum>(l)</enum><header>Patent notices;
relationship to final approval</header>
<paragraph commented="no" id="H4005D712B7DE40B6A9B0EC6C23B62817"><enum>(1)</enum><header>Definitions</header><text>For
the purposes of this subsection, the term—</text>
<subparagraph commented="no" id="H2E114A9AE01B4438B0BE4500CFDF00E"><enum>(A)</enum><text><quote>biosimilar
product</quote> means the biological product that is the subject of the
application under subsection (k);</text>
</subparagraph><subparagraph commented="no" id="H32C7CC9BD23D4826B4FA3179D344361"><enum>(B)</enum><text><quote>relevant
patent</quote> means a patent that—</text>
<clause commented="no" id="H0FFF8AC3D5B14797B68800C3B2CEF2D"><enum>(i)</enum><text>expires after the
date specified in subsection (k)(7)(A) that applies to the reference product;
and</text>
</clause><clause commented="no" id="H50AB69672E4E47CD87F9A991B9DA1675"><enum>(ii)</enum><text>could reasonably
be asserted against the applicant due to the unauthorized making, use, sale, or
offer for sale within the United States, or the importation into the United
States of the biosimilar product, or materials used in the manufacture of the
biosimilar product, or due to a use of the biosimilar product in a method of
treatment that is indicated in the application;</text>
</clause></subparagraph><subparagraph commented="no" id="H53FC8A818826489AA799253C88A322E6"><enum>(C)</enum><text><quote>reference
product sponsor</quote> means the holder of an approved application or license
for the reference product; and</text>
</subparagraph><subparagraph commented="no" id="H5ACB92C2BC234A2E99D374DBDC04BDDD"><enum>(D)</enum><text><quote>interested
third party</quote> means a person other than the reference product sponsor
that owns a relevant patent, or has the right to commence or participate in an
action for infringement of a relevant patent.</text>
</subparagraph></paragraph><paragraph commented="no" id="H1AC62955FFF3419C0020860099F8C531"><enum>(2)</enum><header>Handling of
confidential information</header><text>Any entity receiving confidential
information pursuant to this subsection shall designate one or more individuals
to receive such information. Each individual so designated shall execute an
agreement in accordance with regulations promulgated by the Secretary. The
regulations shall require each such individual to take reasonable steps to
maintain the confidentiality of information received pursuant to this
subsection and use the information solely for purposes authorized by this
subsection. The obligations imposed on an individual who has received
confidential information pursuant to this subsection shall continue until the
individual returns or destroys the confidential information, a court imposes a
protective order that governs the use or handling of the confidential
information, or the party providing the confidential information agrees to
other terms or conditions regarding the handling or use of the confidential
information.</text>
</paragraph><paragraph commented="no" id="HC57DB17C40E24EB181983D89BEC976EA"><enum>(3)</enum><header>Public notice by
secretary</header><text>Within 30 days of acceptance by the Secretary of an
application filed under subsection (k), the Secretary shall publish a notice
identifying—</text>
<subparagraph id="HB4A9DAC4EABB41AD9EB4269C97C70387"><enum>(A)</enum><text>the reference
product identified in the application; and</text>
</subparagraph><subparagraph id="H359A20E8D01841A789FF630168F08297"><enum>(B)</enum><text>the name and
address of an agent designated by the applicant to receive notices pursuant to
paragraph (4)(B).</text>
</subparagraph></paragraph><paragraph commented="no" id="H238E541A69C84843B4FEADD3E2BDD9D0"><enum>(4)</enum><header>Exchanges
concerning patents</header>
<subparagraph commented="no" id="HC548C52C744C46188454E385F5A219BA"><enum>(A)</enum><header>Exchanges with
reference product sponsor</header>
<clause commented="no" id="H343B9B7857B24F049C8126C311EA8828"><enum>(i)</enum><text>Within 30 days of
the date of acceptance of the application by the Secretary, the applicant shall
provide the reference product sponsor with a copy of the application and
information concerning the biosimilar product and its production. This
information shall include a detailed description of the biosimilar product, its
method of manufacture, and the materials used in the manufacture of the
product.</text>
</clause><clause commented="no" id="HA7183B91D46B4617A5ABC740B2D3D827"><enum>(ii)</enum><text>Within 60 days of
the date of receipt of the information required to be provided under clause
(i), the reference product sponsor shall provide to the applicant a list of
relevant patents owned by the reference product sponsor, or in respect of which
the reference product sponsor has the right to commence an action of
infringement or otherwise has an interest in the patent as such patent concerns
the biosimilar product.</text>
</clause><clause commented="no" id="HDA79635D72A4403C949D64AF181245F6"><enum>(iii)</enum><text>If the reference
product sponsor is issued or acquires an interest in a relevant patent after
the date on which the reference product sponsor provides the list required by
clause (ii) to the applicant, the reference product sponsor shall identify that
patent to the applicant within 30 days of the date of issue of the patent, or
the date of acquisition of the interest in the patent, as applicable.</text>
</clause></subparagraph><subparagraph commented="no" id="H07033689CDDB450A8C7CED73BFAF21D"><enum>(B)</enum><header>Exchanges with
interested third parties</header>
<clause commented="no" id="H7E1CC92EEBAD45C98990AAF00EFED45"><enum>(i)</enum><text>At any time after
the date on which the Secretary publishes a notice for an application under
paragraph (3), any interested third party may provide notice to the designated
agent of the applicant that the interested third party owns or has rights under
1 or more patents that may be relevant patents. The notice shall identify at
least 1 patent and shall designate an individual who has executed an agreement
in accordance with paragraph (2) to receive confidential information from the
applicant.</text>
</clause><clause commented="no" id="HCE38949760F141378E5E8FBA4F783E9F"><enum>(ii)</enum><text>Within 30 days of
the date of receiving notice pursuant to clause (i), the applicant shall send
to the individual designated by the interested third party the information
specified in subparagraph (A)(i), unless the applicant and interested third
party otherwise agree.</text>
</clause><clause commented="no" id="HD701AE006B884DCDABF0A9123F2E316"><enum>(iii)</enum><text>Within 90 days of
the date of receiving information pursuant to clause (ii), the interested third
party shall provide to the applicant a list of relevant patents which the
interested third party owns, or in respect of which the interested third party
has the right to commence or participate in an action for infringement.</text>
</clause><clause commented="no" id="H8A0C032E2F0F4586A2D1C1FCB4C2401D"><enum>(iv)</enum><text>If the interested
third party is issued or acquires an interest in a relevant patent after the
date on which the interested third party provides the list required by clause
(iii), the interested third party shall identify that patent within 30 days of
the date of issue of the patent, or the date of acquisition of the interest in
the patent, as applicable.</text>
</clause></subparagraph><subparagraph commented="no" id="H6C460202927146CBA875363D04DA2EBC"><enum>(C)</enum><header>Identification
of basis for infringement</header><text>For any patent identified under clause
(ii) or (iii) of subparagraph (A) or under clause (iii) or (iv) of subparagraph
(B), the reference product sponsor or the interested third party, as
applicable—</text>
<clause commented="no" id="HC00A9F75CFE14525BCB25D984C397D75"><enum>(i)</enum><text>shall explain in
writing why the sponsor or the interested third party believes the relevant
patent would be infringed by the making, use, sale, or offer for sale within
the United States, or importation into the United States, of the biosimilar
product or by a use of the biosimilar product in treatment that is indicated in
the application;</text>
</clause><clause commented="no" id="H6CEC9FEF40D547679212E423C962CAD1"><enum>(ii)</enum><text>may specify
whether the relevant patent is available for licensing; and</text>
</clause><clause commented="no" id="H1214564434F3404B9716CDB496E631CA"><enum>(iii)</enum><text>shall specify
the number and date of expiration of the relevant patent.</text>
</clause></subparagraph><subparagraph commented="no" id="HF07CD9338A2146E7B233A52D72AF8AD"><enum>(D)</enum><header>Certification by
applicant concerning identified relevant patents</header><text display-inline="yes-display-inline">Not later than 45 days after the date on
which a patent is identified under clause (ii) or (iii) of subparagraph (A) or
under clause (iii) or (iv) of subparagraph (B), the applicant shall send a
written statement regarding each identified patent to the party that identified
the patent. Such statement shall either—</text>
<clause commented="no" id="HB4D0C34536314B76802C8221CA4BB48C"><enum>(i)</enum><text>state that the
applicant will not commence marketing of the biosimilar product and has
requested the Secretary to not grant final approval of the application before
the date of expiration of the noticed patent; or</text>
</clause><clause commented="no" id="HDBD95D5827854D9EAA97AA4E00007B59"><enum>(ii)</enum><text>provide a
detailed written explanation setting forth the reasons why the applicant
believes—</text>
<subclause id="H252E6101771947CDA07CD3AEA4B100B3"><enum>(I)</enum><text>the making, use,
sale, or offer for sale within the United States, or the importation into the
United States, of the biosimilar product, or the use of the biosimilar product
in a treatment indicated in the application, would not infringe the patent;
or</text>
</subclause><subclause id="H5F0CBD77D20D444D866B00F4E2F035F"><enum>(II)</enum><text>the patent is
invalid or unenforceable.</text>
</subclause></clause></subparagraph></paragraph><paragraph id="H2537C729E74748CEB53EBEA45133A47D"><enum>(5)</enum><header>Action for
infringement involving reference product sponsor</header><text display-inline="yes-display-inline">If an action for infringement concerning a
relevant patent identified by the reference product sponsor under clause (ii)
or (iii) of paragraph (4)(A), or by an interested third party under clause
(iii) or (iv) of paragraph (4)(B), is brought within 60 days of the date of
receipt of a statement under paragraph (4)(D)(ii), and the court in which such
action has been commenced determines the patent is infringed prior to the date
applicable under subsection (k)(7)(A), (k)(7)(D), or (k)(8) the Secretary shall
make approval of the application effective on the day after the date of
expiration of the patent that has been found to be infringed. If more than one
such patent is found to be infringed by the court, the approval of the
application shall be made effective on the day after the date that the last
such patent expires.</text>
</paragraph><paragraph commented="no" id="H195EFED1198A4644B2572EDA5203088"><enum>(6)</enum><header>Limitations on
actions for declaratory judgment</header><text display-inline="yes-display-inline">With respect to a patent that is the
subject of an explanation under paragraph (4)(D)(ii), no action for a
declaratory judgment that the patent is invalid, unenforceable, or not
infringed may be brought under section 2201 of title 28, United States Code, by
an applicant prior to the date that is the later of—</text>
<subparagraph commented="no" id="HF0D9B00A403442EC82636B66A0D798F5"><enum>(A)</enum><text>3 years prior to
the date applicable under subsection (k)(7)(A); or</text>
</subparagraph><subparagraph commented="no" id="H81D3601F11C94D40952CD96701899D1"><enum>(B)</enum><text>120 days after such
explanation has been
provided.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="H75C806F1DE43428E952E147BAC0079A4"><enum>(b)</enum><header>Products
Previously Approved Under Section 505</header>
<paragraph id="H10DFEFDED2CA4C1E953BDE28A900D51C"><enum>(1)</enum><header>Requirement to
follow section 351</header><text>Except as provided in paragraph (2), an
application for a biological product shall be submitted under section 351 of
the Public Health Service Act (42 U.S.C. 262) (as amended by this Act).</text>
</paragraph><paragraph id="H5151B88674594AC18E834E5EDEF076B4"><enum>(2)</enum><header>Exception</header><text>An
application for a biological product may be submitted under section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) if—</text>
<subparagraph id="HC6BF195634864356A4506C21FB251871"><enum>(A)</enum><text>such biological
product is in a product class for which a biological product in such product
class is the subject of an application approved under such section 505 not
later than the date of enactment of this Act; and</text>
</subparagraph><subparagraph id="HA74651B34A0E4943BC9566F0A008087"><enum>(B)</enum><text>such
application—</text>
<clause id="H18E31E061B534368B32893D01E6BBB5D"><enum>(i)</enum><text>has
been submitted to the Secretary of Health and Human Services (referred to in
this Act as the <quote>Secretary</quote>) before the date of enactment of this
Act; or</text>
</clause><clause id="HBCCBE95A74D84CDF8E63A5B579F8AC89"><enum>(ii)</enum><text>is
submitted to the Secretary not later than the date that is 10 years after the
date of enactment of this Act.</text>
</clause></subparagraph></paragraph><paragraph id="HBA3A9CC2C4DD4A4780DF76C6EC3C88A"><enum>(3)</enum><header>Limitation</header><text>Notwithstanding
paragraph (2), an application for a biological product may not be submitted
under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)
if there is another biological product approved under subsection (a) of section
351 of the Public Health Service Act that could be a reference product with
respect to such application (within the meaning of such section 351) if such
application were submitted under subsection (k) of such section 351.</text>
</paragraph><paragraph id="HDD222639CEB941E1B3135B67E4D0A6F8"><enum>(4)</enum><header>Deemed approved
under section 351</header><text>An approved application for a biological
product under section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) shall be deemed to be a license for the biological product under
such section 351 on the date that is 10 years after the date of enactment of
this Act.</text>
</paragraph><paragraph id="H9B3E460D414D47FFAB8E288F81AB955C"><enum>(5)</enum><header>Definitions</header><text>For
purposes of this subsection, the term <term>biological product</term> has the
meaning given such term under section 351 of the Public Health Service Act (42
U.S.C. 262) (as amended by this Act).</text>
</paragraph></subsection></section><section display-inline="no-display-inline" id="HEE6C8EB1CB6E4BC693D98D53EA058254" section-type="subsequent-section"><enum>102.</enum><header>Fees relating to
biosimilar biological products</header><text display-inline="no-display-inline">Subparagraph (B) of section 735(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is amended by
inserting <quote>, including licensure of a biological product under section
351(k) of such Act</quote> before the period at the end.</text>
</section><enum>II</enum><header>Amendments to
Patent Act</header>
<section commented="no" id="H4358824C14D14F918820B2005DC48900"><enum>201.</enum><header>Amendments to
certain patent provisions</header><text display-inline="no-display-inline">Section 271(e)(2) of title 35, United States
Code is amended—</text>
<paragraph commented="no" id="H5BA66A06F38A4C51918B00006C66B7B1"><enum>(1)</enum><text>in subparagraph
(A), by striking <quote>or</quote> after <quote>patent</quote>;</text>
</paragraph><paragraph commented="no" id="H3E455512923D4B8FB69F2283ADE0A8F4"><enum>(2)</enum><text>in subparagraph
(B), by adding <quote>or</quote> after the comma at the end; and</text>
</paragraph><paragraph commented="no" id="H2249F29998F14B1ABCE16F1D77DDD167"><enum>(3)</enum><text>by inserting the
following after subparagraph (B):</text>
<quoted-block id="H795B3346D5B249FD93317EBBAC49003B" style="OLC">
<subparagraph commented="no" id="H30BF7599F7E54FF48338E6F66B8B66FE"><enum>(C)</enum><text>a statement under
section 351(l)(4)(D)(ii) of the Public Health Service
Act,</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section>