S.Amdt. 3293

SA 3293. Mr. McCAIN submitted an amendment intended to be proposed to
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr.
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal
Revenue Code of 1986 to modify the first-time homebuyers credit in the
case of members of the Armed Forces and certain other Federal
employees, and for other purposes; which was ordered to lie on the
table; as follows:

Beginning on page 1859, strike line 6 and all that follows
through line 5 on page 1906, and insert the following:

Subtitle A--Patient Access to Safe and Competitive Biologics

SEC. 7001. SHORT TITLE.

(a) In General.--This subtitle may be cited as the
``Patient Access to Safe and Competitive Biologics Act''.
(b) Sense of the Senate.--It is the sense of the Senate
that a biosimilars pathway balancing innovation and consumer
interests should be established.

SEC. 7002. APPROVAL PATHWAY FOR BIOSIMILAR BIOLOGICAL
PRODUCTS.

(a) Licensure of Biological Products as Biosimilar or
Therapeutically Equivalent.--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:
``(k) Licensure of Biological Products as Biosimilar or
Therapeutically Equivalent.--
``(1) In general.--Any person may submit an application for
licensure of a biological product under this subsection.
``(2) Content.--
``(A) In general.--
``(i) Required information.--An application submitted under
this subsection shall include information demonstrating
that--

``(I) the biological product is biosimilar to a reference
product based upon data derived from--

``(aa) analytical studies that demonstrate that the
biological product is highly similar to the reference product
notwithstanding minor differences in clinically inactive
components;
``(bb) animal studies (including the assessment of
toxicity); and
``(cc) a clinical study or studies (including the
assessment of immunogenicity and pharmacokinetics or
pharmacodynamics) conducted by the applicant that are
sufficient to demonstrate safety, purity, and potency in 1 or
more appropriate conditions of use for which the reference
product is licensed and intended to be used and for which
licensure is sought for the biological product;

``(II) 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;
``(III) 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;
``(IV) the route of administration, the dosage form, and
the strength of the biological product are the same as those
of the reference product; and
``(V) 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.

``(ii) Determination by secretary.--The Secretary may
determine, after public notice and comment, that an element
described in item (aa) or (bb) of clause (i)(I) is
unnecessary in an application submitted under this
subsection.
``(iii) Additional information.--An application submitted
under this subsection--

``(I) shall include publicly-available information
regarding the Secretary's previous determination that the
reference product is safe, pure, and potent; and
``(II) may include any additional information in support of
the application, including publicly-available information
with respect to the reference product or another biological
product.

``(B) Therapeutic equivalence.--If a sponsor submits an
application (or supplement to an application) under this
subsection claiming that the biologics product is
therapeutically equivalent to the reference product, such
application (or supplement) shall include information
demonstrating that the biological product meets the standards
described in paragraph (4)(A).
``(3) Evaluation by secretary.--Upon review of an
application (or a supplement to an application) submitted
under this subsection, the Secretary shall license the
biological product under this subsection if--
``(A) the Secretary determines that the information
submitted in the application (or the supplement) is
sufficient to show that the biological product--
``(i) is biosimilar to the reference product; or
``(ii) meets the standards described in paragraph (4)(A),
and therefore is therapeutically equivalent to the reference
product; and
``(B) 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).
``(4) Safety standards for determining therapeutic
equivalence.--
``(A) Determination by the secretary.--Upon review of an
application submitted under this subsection or any supplement
to such application, the Secretary shall determine the
biological product to have demonstrated therapeutic
equivalence to 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--
``(i) the biological product--

``(I) is biosimilar to the reference product; and
``(II) can be expected to produce the same clinical result
as the reference product in any given patient; and

``(ii) for a biological product that is administered more
than once to an individual, the risk in terms of safety or
diminished efficacy of alternating or switching between use
of the biological product and the reference product is not
greater than the risk of using the reference product without
such alternation or switch.
``(B) Application of therapeutic equivalence only with
prescription.--Notwithstanding any other provision of law, no
biological product determined to be therapeutically
equivalent to a reference product under subparagraph (A)
shall be deemed to be therapeutically appropriate with
respect to an individual unless so determined by a health
care professional treating such individual.
``(5) General rules.--
``(A) One reference product per application.--A biological
product, in an application submitted under this subsection,
may not be evaluated against more than 1 reference product.
``(B) Review.--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.
``(C) Risk evaluation and mitigation strategies.--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).
``(6) Exclusivity for first therapeutically equivalent
biological product.--Upon review of an application submitted
under this subsection relying on the same reference product
for which a prior biological product has received a
determination of therapeutic equivalence for any condition of
use, the Secretary shall not make a determination under
paragraph (4)(A) that the second or subsequent biological
product is therapeutically equivalent for any condition of
use until the earlier of--
``(A) 1 year after the first commercial marketing of the
first biosimilar biological product to be approved as
therapeutically equivalent for that reference product;
``(B) 18 months after--
``(i) a final court decision on all patents in suit in an
action instituted under subsection (l)(6) against the
applicant that submitted the application for the first
approved therapeutically equivalent biosimilar biological
product; or
``(ii) the dismissal with or without prejudice of an action
instituted under subsection (l)(6) against the applicant that
submitted the application for the first approved
therapeutically equivalent biosimilar biological product; or
``(C)(i) 42 months after approval of the first
therapeutically equivalent biosimilar biological product if
the applicant that submitted such application has been sued
under subsection (l)(6) and such litigation is still ongoing
within such 42-month period; or
``(ii) 18 months after approval of the first
therapeutically equivalent biosimilar biological product if
the applicant that submitted such application has not been
sued under subsection (l)(6).

For purposes of this paragraph, 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.
``(7) Exclusivity for reference product.--
``(A) Effective date of biosimilar application approval.--
``(i) In general.--Except as provided in clause (ii) and
(iii), approval of an application under this subsection may
not be made effective by the Secretary until the date that is
10 years after the date on which the reference product was
first licensed under subsection (a).
``(ii) Extension of exclusivity.--The period of exclusivity
described in clause (i) for a reference product shall be
extended for an additional 2 years beyond the 10 years
provided in such clause if the sponsor or manufacturer of the
reference product submits a subsequent application for a
change (not including a modification to the structure of the
reference product) that results in a new indication for the
reference product.
``(iii) Significant therapeutic advancement.--If a
reference product represents a

[[Page S13634]]

significant therapeutic advancement (including a modification
that results in a new dosage form, new dosing regimen, or new
route of administration of such biological product) of a
biological product that was previously licensed under
subsection (a) and that has the same sponsor or manufacturer
as such reference product, then the period of exclusivity for
such reference product shall be the number of years equal to
the sum of--

``(I) the remaining period of exclusivity under clause (i)
for biological product on which the reference product
representing the significant therapeutic advancement was
based, plus
``(II) 2 years.

``(iv) No extension for significant therapeutic
advancement.--In no case may the period of exclusivity under
clause (iii) be extended.
``(B) Filing period.--An application under this subsection
may not be submitted to the Secretary until the date that is
4 years after the date on which the reference product was
first licensed under subsection (a).
``(C) First licensure.--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.
``(8) Guidance documents.--
``(A) In general.--The Secretary may, after opportunity for
public comment, issue guidance in accordance, except as
provided in subparagraph (B)(i), with section 701(h) of the
Federal Food, Drug, and Cosmetic Act with respect to the
licensure of a biological product under this subsection. Any
such guidance may be general or specific.
``(B) Public comment.--
``(i) In general.--The Secretary shall provide the public
an opportunity to comment on any proposed guidance issued
under subparagraph (A) before issuing final guidance.
``(ii) Input regarding most valuable guidance.--The
Secretary shall establish a process through which the public
may provide the Secretary with input regarding priorities for
issuing guidance.
``(C) No requirement for application consideration.--The
issuance (or non-issuance) of guidance under subparagraph (A)
shall not preclude the review of, or action on, an
application submitted under this subsection.
``(D) Requirement for product class-specific guidance.--If
the Secretary issues product class-specific guidance under
subparagraph (A), such guidance shall include a description
of--
``(i) the criteria that the Secretary will use to determine
whether a biological product is highly similar to a reference
product in such product class; and
``(ii) the criteria, if available, that the Secretary will
use to determine whether a biological product meets the
standards described in paragraph (4)(A).
``(E) Certain product classes.--
``(i) Guidance.--The Secretary may indicate in a guidance
document that the science and experience, as of the date of
such guidance, with respect to a product or product class
(not including any recombinant protein) does not allow
approval of an application for a license as provided under
this subsection for such product or product class.
``(ii) Modification or reversal.--The Secretary may issue a
subsequent guidance document under subparagraph (A) to modify
or reverse a guidance document under clause (i).
``(iii) No effect on ability to deny license.--Clause (i)
shall not be construed to require the Secretary to approve a
product with respect to which the Secretary has not indicated
in a guidance document that the science and experience, as
described in clause (i), does not allow approval of such an
application.
``(l) Patents.--
``(1) Confidential access to subsection (k) application.--
``(A) Application of paragraph.--Unless otherwise agreed to
by a person that submits an application under subsection (k)
(referred to in this subsection as the `subsection (k)
applicant') and the sponsor of the application for the
reference product (referred to in this subsection as the
`reference product sponsor'), the provisions of this
paragraph shall apply to the exchange of information
described in this subsection.
``(B) In general.--
``(i) Provision of confidential information.--When a
subsection (k) applicant submits an application under
subsection (k), such applicant shall provide to the persons
described in clause (ii), subject to the terms of this
paragraph, confidential access to the information required to
be produced pursuant to paragraph (2) and any other
information that the subsection (k) applicant determines, in
its sole discretion, to be appropriate (referred to in this
subsection as the `confidential information').
``(ii) Recipients of information.--The persons described in
this clause are the following:

``(I) Outside counsel.--One or more attorneys designated by
the reference product sponsor who are employees of an entity
other than the reference product sponsor (referred to in this
paragraph as the `outside counsel'), provided that such
attorneys do not engage, formally or informally, in patent
prosecution relevant or related to the reference product.
``(II) In-house counsel.--One attorney that represents the
reference product sponsor who is an employee of the reference
product sponsor, provided that such attorney does not engage,
formally or informally, in patent prosecution relevant or
related to the reference product.

``(iii) Patent owner access.--A representative of the owner
of a patent exclusively licensed to a reference product
sponsor with respect to the reference product and who has
retained a right to assert the patent or participate in
litigation concerning the patent may be provided the
confidential information, provided that the representative
informs the reference product sponsor and the subsection (k)
applicant of his or her agreement to be subject to the
confidentiality provisions set forth in this paragraph,
including those under clause (ii).
``(C) Limitation on disclosure.--No person that receives
confidential information pursuant to subparagraph (B) shall
disclose any confidential information to any other person or
entity, including the reference product sponsor employees,
outside scientific consultants, or other outside counsel
retained by the reference product sponsor, without the prior
written consent of the subsection (k) applicant, which shall
not be unreasonably withheld.
``(D) Use of confidential information.--Confidential
information shall be used for the sole and exclusive purpose
of determining, with respect to each patent assigned to or
exclusively licensed by the reference product sponsor,
whether a claim of patent infringement could reasonably be
asserted if the subsection (k) applicant engaged in the
manufacture, use, offering for sale, sale, or importation
into the United States of the biological product that is the
subject of the application under subsection (k).
``(E) Ownership of confidential information.--The
confidential information disclosed under this paragraph is,
and shall remain, the property of the subsection (k)
applicant. By providing the confidential information pursuant
to this paragraph, the subsection (k) applicant does not
provide the reference product sponsor or the outside counsel
any interest in or license to use the confidential
information, for purposes other than those specified in
subparagraph (D).
``(F) Effect of infringement action.--In the event that the
reference product sponsor files a patent infringement suit,
the use of confidential information shall continue to be
governed by the terms of this paragraph until such time as a
court enters a protective order regarding the information.
Upon entry of such order, the subsection (k) applicant may
redesignate confidential information in accordance with the
terms of that order. No confidential information shall be
included in any publicly-available complaint or other
pleading. In the event that the reference product sponsor
does not file an infringement action by the date specified in
paragraph (6), the reference product sponsor shall return or
destroy all confidential information received under this
paragraph, provided that if the reference product sponsor
opts to destroy such information, it will confirm destruction
in writing to the subsection (k) applicant.
``(G) Rule of construction.--Nothing in this paragraph
shall be construed--
``(i) as an admission by the subsection (k) applicant
regarding the validity, enforceability, or infringement of
any patent; or
``(ii) as an agreement or admission by the subsection (k)
applicant with respect to the competency, relevance, or
materiality of any confidential information.
``(H) Effect of violation.--The disclosure of any
confidential information in violation of this paragraph shall
be deemed to cause the subsection (k) applicant to suffer
irreparable harm for which there is no adequate legal remedy
and the court shall consider immediate injunctive relief to
be an appropriate and necessary remedy for any violation or
threatened violation of this paragraph.
``(2) Subsection (k) application information.--Not later
than 20 days after the Secretary notifies the subsection (k)
applicant that the application has been accepted for review,
the subsection (k) applicant--
``(A) shall provide to the reference product sponsor a copy
of the application submitted to the Secretary under
subsection (k), and such other information that describes the
process or processes used to manufacture the biological
product that is the subject of such application; and
``(B) may provide to the reference product sponsor
additional information requested by or on behalf of the
reference product sponsor.
``(3) List and description of patents.--
``(A) List by reference product sponsor.--Not later than 60
days after the receipt of the application and information
under paragraph (2), the reference product sponsor shall
provide to the subsection (k) applicant--
``(i) a list of patents for which the reference product
sponsor believes a claim of patent infringement could
reasonably be asserted by the reference product sponsor, or
by a patent owner that has granted an exclusive license to
the reference product sponsor with respect to the reference
product, if a person not licensed by the reference product
sponsor engaged in the making, using, offering to sell,
selling, or importing into the United States of the
biological product that is the subject of the subsection (k)
application; and
``(ii) an identification of the patents on such list that
the reference product sponsor would be prepared to license to
the subsection (k) applicant.

[[Page S13635]]

``(B) List and description by subsection (k) applicant.--
Not later than 60 days after receipt of the list under
subparagraph (A), the subsection (k) applicant--
``(i) may provide to the reference product sponsor a list
of patents to which the subsection (k) applicant believes a
claim of patent infringement could reasonably be asserted by
the reference product sponsor if a person not licensed by the
reference product sponsor engaged in the making, using,
offering to sell, selling, or importing into the United
States of the biological product that is the subject of the
subsection (k) application;
``(ii) shall provide to the reference product sponsor, with
respect to each patent listed by the reference product
sponsor under subparagraph (A) or listed by the subsection
(k) applicant under clause (i)--

``(I) a detailed statement that describes, on a claim by
claim basis, the factual and legal basis of the opinion of
the subsection (k) applicant that such patent is invalid,
unenforceable, or will not be infringed by the commercial
marketing of the biological product that is the subject of
the subsection (k) application; or
``(II) a statement that the subsection (k) applicant does
not intend to begin commercial marketing of the biological
product before the date that such patent expires; and

``(iii) shall provide to the reference product sponsor a
response regarding each patent identified by the reference
product sponsor under subparagraph (A)(ii).
``(C) Description by reference product sponsor.--Not later
than 60 days after receipt of the list and statement under
subparagraph (B), the reference product sponsor shall provide
to the subsection (k) applicant a detailed statement that
describes, with respect to each patent described in
subparagraph (B)(ii)(I), on a claim by claim basis, the
factual and legal basis of the opinion of the reference
product sponsor that such patent will be infringed by the
commercial marketing of the biological product that is the
subject of the subsection (k) application and a response to
the statement concerning validity and enforceability provided
under subparagraph (B)(ii)(I).
``(4) Patent resolution negotiations.--
``(A) In general.--After receipt by the subsection (k)
applicant of the statement under paragraph (3)(C), the
reference product sponsor and the subsection (k) applicant
shall engage in good faith negotiations to agree on which, if
any, patents listed under paragraph (3) by the subsection (k)
applicant or the reference product sponsor shall be the
subject of an action for patent infringement under paragraph
(6).
``(B) Failure to reach agreement.--If, within 15 days of
beginning negotiations under subparagraph (A), the subsection
(k) applicant and the reference product sponsor fail to agree
on a final and complete list of which, if any, patents listed
under paragraph (3) by the subsection (k) applicant or the
reference product sponsor shall be the subject of an action
for patent infringement under paragraph (6), the provisions
of paragraph (5) shall apply to the parties.
``(5) Patent resolution if no agreement.--
``(A) Number of patents.--The subsection (k) applicant
shall notify the reference product sponsor of the number of
patents that such applicant will provide to the reference
product sponsor under subparagraph (B)(i)(I).
``(B) Exchange of patent lists.--
``(i) In general.--On a date agreed to by the subsection
(k) applicant and the reference product sponsor, but in no
case later than 5 days after the subsection (k) applicant
notifies the reference product sponsor under subparagraph
(A), the subsection (k) applicant and the reference product
sponsor shall simultaneously exchange--

``(I) the list of patents that the subsection (k) applicant
believes should be the subject of an action for patent
infringement under paragraph (6); and
``(II) the list of patents, in accordance with clause (ii),
that the reference product sponsor believes should be the
subject of an action for patent infringement under paragraph
(6).

``(ii) Number of patents listed by reference product
sponsor.--

``(I) In general.--Subject to subclause (II), the number of
patents listed by the reference product sponsor under clause
(i)(II) may not exceed the number of patents listed by the
subsection (k) applicant under clause (i)(I).
``(II) Exception.--If a subsection (k) applicant does not
list any patent under clause (i)(I), the reference product
sponsor may list 1 patent under clause (i)(II).

``(6) Immediate patent infringement action.--
``(A) Action if agreement on patent list.--If the
subsection (k) applicant and the reference product sponsor
agree on patents as described in paragraph (4), not later
than 30 days after such agreement, the reference product
sponsor shall bring an action for patent infringement with
respect to each such patent.
``(B) Action if no agreement on patent list.--If the
provisions of paragraph (5) apply to the parties as described
in paragraph (4)(B), not later than 30 days after the
exchange of lists under paragraph (5)(B), the reference
product sponsor shall bring an action for patent infringement
with respect to each patent that is included on such lists.
``(C) Notification and publication of complaint.--
``(i) Notification to secretary.--Not later than 30 days
after a complaint is served to a subsection (k) applicant in
an action for patent infringement described under this
paragraph, the subsection (k) applicant shall provide the
Secretary with notice and a copy of such complaint.
``(ii) Publication by secretary.--The Secretary shall
publish in the Federal Register notice of a complaint
received under clause (i).
``(7) Newly issued or licensed patents.--In the case of a
patent that--
``(A) is issued to, or exclusively licensed by, the
reference product sponsor after the date that the reference
product sponsor provided the list to the subsection (k)
applicant under paragraph (3)(A); and
``(B) the reference product sponsor reasonably believes
that, due to the issuance of such patent, a claim of patent
infringement could reasonably be asserted by the reference
product sponsor if a person not licensed by the reference
product sponsor engaged in the making, using, offering to
sell, selling, or importing into the United States of the
biological product that is the subject of the subsection (k)
application,

not later than 30 days after such issuance or licensing, the
reference product sponsor shall provide to the subsection (k)
applicant a supplement to the list provided by the reference
product sponsor under paragraph (3)(A) that includes such
patent, not later than 30 days after such supplement is
provided, the subsection (k) applicant shall provide a
statement to the reference product sponsor in accordance with
paragraph (3)(B), and such patent shall be subject to
paragraph (8).
``(8) Notice of commercial marketing and preliminary
injunction.--
``(A) Notice of commercial marketing.--The subsection (k)
applicant shall provide notice to the reference product
sponsor not later than 180 days before the date of the first
commercial marketing of the biological product licensed under
subsection (k).
``(B) Preliminary injunction.--After receiving the notice
under subparagraph (A) and before such date of the first
commercial marketing of such biological product, the
reference product sponsor may seek a preliminary injunction
prohibiting the subsection (k) applicant from engaging in the
commercial manufacture or sale of such biological product
until the court decides the issue of patent validity,
enforcement, and infringement with respect to any patent that
is--
``(i) included in the list provided by the reference
product sponsor under paragraph (3)(A) or in the list
provided by the subsection (k) applicant under paragraph
(3)(B); and
``(ii) not included, as applicable, on--

``(I) the list of patents described in paragraph (4); or
``(II) the lists of patents described in paragraph (5)(B).

``(C) Reasonable cooperation.--If the reference product
sponsor has sought a preliminary injunction under
subparagraph (B), the reference product sponsor and the
subsection (k) applicant shall reasonably cooperate to
expedite such further discovery as is needed in connection
with the preliminary injunction motion.
``(9) Limitation on declaratory judgment action.--
``(A) Subsection (k) application provided.--If a subsection
(k) applicant provides the application and information
required under paragraph (2)(A), neither the reference
product sponsor nor the subsection (k) applicant may, prior
to the date notice is received under paragraph (8)(A), bring
any action under section 2201 of title 28, United States
Code, for a declaration of infringement, validity, or
enforceability of any patent that is described in clauses (i)
and (ii) of paragraph (8)(B).
``(B) Subsequent failure to act by subsection (k)
applicant.--If a subsection (k) applicant fails to complete
an action required of the subsection (k) applicant under
paragraph (3)(B)(ii), paragraph (5), paragraph (6)(C)(i),
paragraph (7), or paragraph (8)(A), the reference product
sponsor, but not the subsection (k) applicant, may bring an
action under section 2201 of title 28, United States Code,
for a declaration of infringement, validity, or
enforceability of any patent included in the list described
in paragraph (3)(A), including as provided under paragraph
(7).
``(C) Subsection (k) application not provided.--If a
subsection (k) applicant fails to provide the application and
information required under paragraph (2)(A), the reference
product sponsor, but not the subsection (k) applicant, may
bring an action under section 2201 of title 28, United States
Code, for a declaration of infringement, validity, or
enforceability of any patent that claims the biological
product or a use of the biological product.''.
(b) Definitions.--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'';
(2) in paragraph (1), as so designated, by inserting
``protein (except any chemically synthesized polypeptide),''
after ``allergenic product,''; and
(3) by adding at the end the following:
``(2) The term `biosimilar' or `biosimilarity', in
reference to a biological product that is the subject of an
application under subsection (k), means--

[[Page S13636]]

``(A) that the biological product is highly similar to the
reference product notwithstanding minor differences in
clinically inactive components; and
``(B) there are no clinically meaningful differences
between the biological product and the reference product in
terms of the safety, purity, and potency of the product.
``(3) The term `reference product' means the single
biological product licensed under subsection (a) against
which a biological product is evaluated in an application
submitted under subsection (k).
``(4) The term `therapeutically equivalent' or `therapeutic
equivalence', in reference to a biological product, means
that such product has been determined to meet the standards
described in subsection (k)(4).''.
(c) Conforming Amendments Relating to Patents.--
(1) Patents.--Section 271(e) of title 35, United States
Code, is amended--
(A) in paragraph (2)--
(i) in subparagraph (A), by striking ``or'' at the end;
(ii) in subparagraph (B), by adding ``or'' at the end; and
(iii) by inserting after subparagraph (B) the following:
``(C)(i) with respect to a patent that is identified in the
list of patents described in section 351(l)(3) of the Public
Health Service Act (including as provided under section
351(l)(7) of such Act), an application seeking approval of a
biological product, or
``(ii) if the applicant for the application fails to
provide the application and information required under
section 351(l)(2)(A) of such Act, an application seeking
approval of a biological product for a patent that could be
identified pursuant to section 351(l)(3)(A)(i) of such
Act,''; and
(iv) in the matter following subparagraph (C) (as added by
clause (iii)), by striking ``or veterinary biological
product'' and inserting ``, veterinary biological product, or
biological product'';
(B) in paragraph (4)--
(i) in subparagraph (B), by--

(I) striking ``or veterinary biological product'' and
inserting ``, veterinary biological product, or biological
product''; and
(II) striking ``and'' at the end;

(ii) in subparagraph (C), by--

(I) striking ``or veterinary biological product'' and
inserting ``, veterinary biological product, or biological
product''; and
(II) striking the period and inserting ``, and'';

(iii) by inserting after subparagraph (C) the following:
``(D) the court shall order a permanent injunction
prohibiting any infringement of the patent by the biological
product involved in the infringement until a date which is
not earlier than the date of the expiration of the patent
that has been infringed under paragraph (2)(C), provided the
patent is the subject of a final court decision, as defined
in section 351(k)(6) of the Public Health Service Act, in an
action for infringement of the patent under section 351(l)(6)
of such Act, and the biological product has not yet been
approved because of section 351(k)(7) of such Act.''; and
(iv) in the matter following subparagraph (D) (as added by
clause (iii)), by striking ``and (C)'' and inserting ``(C),
and (D)''; and
(C) by adding at the end the following:
``(6)(A) Subparagraph (B) applies, in lieu of paragraph
(4), in the case of a patent--
``(i) that is identified, as applicable, in the list of
patents described in section 351(l)(4) of the Public Health
Service Act or the lists of patents described in section
351(l)(5)(B) of such Act with respect to a biological
product; and
``(ii) for which an action for infringement of the patent
with respect to the biological product--
``(I) was brought after the expiration of the 30-day period
described in subparagraph (A) or (B), as applicable, of
section 351(l)(6) of such Act; or
``(II) was brought before the expiration of the 30-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 making, using,
offering to sell, selling, or importation into the United
States of the biological product that is the subject of the
action infringed the patent, shall be a reasonable royalty.
``(C) The owner of a patent that should have been included
in the list described in section 351(l)(3)(A) of the Public
Health Service Act, including as provided under section
351(l)(7) of such Act for a biological product, but was not
timely included in such list, may not bring an action under
this section for infringement of the patent with respect to
the biological product.''.
(2) Conforming amendment under 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''.
(d) Conforming Amendments Under the Federal Food, Drug, and
Cosmetic Act.--
(1) Content and review of applications.--Section
505(b)(5)(B) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(b)(5)(B)) is amended by inserting before the
period at the end of the first sentence the following: ``or,
with respect to an applicant for approval of a biological
product under section 351(k) of the Public Health Service
Act, any necessary clinical study or studies''.
(2) New active ingredient.--Section 505B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355c) is amended by
adding at the end the following:
``(n) New Active Ingredient.--
``(1) Non-therapeutically equivalent biosimilar biological
product.--A biological product that is biosimilar to a
reference product under section 351 of the Public Health
Service Act, and that the Secretary has not determined to
meet the standards described in subsection (k)(4) of such
section for therapeutic equivalence with the reference
product, shall be considered to have a new active ingredient
under this section.
``(2) Therapeutically equivalent biosimilar biological
product.--A biological product that is therapeutically
equivalent with a reference product under section 351 of the
Public Health Service Act shall not be considered to have a
new active ingredient under this section.''.
(e) Products Previously Approved Under Section 505.--
(1) Requirement to follow section 351.--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).
(2) Exception.--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--
(A) 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
(B) such application--
(i) has been submitted to the Secretary of Health and Human
Services (referred to in this subtitle as the ``Secretary'')
before the date of enactment of this Act; or
(ii) is submitted to the Secretary not later than the date
that is 10 years after the date of enactment of this Act.
(3) Limitation.--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.
(4) Deemed approved under section 351.--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.
(5) Definitions.--For purposes of this subsection, the term
``biological product'' 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).
(f) Follow-on Biologics User Fees.--
(1) Development of user fees for biosimilar biological
products.--
(A) In general.--Beginning not later than October 1, 2010,
the Secretary shall develop recommendations to present to
Congress with respect to the goals, and plans for meeting the
goals, for the process for the review of biosimilar
biological product applications submitted under section
351(k) of the Public Health Service Act (as added by this
Act) for the first 5 fiscal years after fiscal year 2012. In
developing such recommendations, the Secretary shall consult
with--
(i) the Committee on Health, Education, Labor, and Pensions
of the Senate;
(ii) the Committee on Energy and Commerce of the House of
Representatives;
(iii) scientific and academic experts;
(iv) health care professionals;
(v) representatives of patient and consumer advocacy
groups; and
(vi) the regulated industry.
(B) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
(i) present the recommendations developed under
subparagraph (A) to the Congressional committees specified in
such subparagraph;
(ii) publish such recommendations in the Federal Register;
(iii) provide for a period of 30 days for the public to
provide written comments on such recommendations;
(iv) hold a meeting at which the public may present its
views on such recommendations; and
(v) after consideration of such public views and comments,
revise such recommendations as necessary.
(C) Transmittal of recommendations.--Not later than January
15, 2012, the Secretary shall transmit to Congress the
revised recommendations under subparagraph (B), a summary of
the views and comments received under such subparagraph, and
any changes made to the recommendations in response to such
views and comments.
(2) Establishment of user fee program.--It is the sense of
the Senate that, based on the recommendations transmitted to
Congress by the Secretary pursuant to paragraph (1)(C),
Congress should authorize a program, effective on October 1,
2012, for the collection of user fees relating to the
submission of biosimilar biological product applications
under section 351(k) of the Public Health Service Act (as
added by this Act).

[[Page S13637]]

(3) Transitional provisions for user fees for biosimilar
biological products.--
(A) Application of the prescription drug user fee
provisions.--Section 735(1)(B) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379g(1)(B)) is amended by striking
``section 351'' and inserting ``subsection (a) or (k) of
section 351''.
(B) Evaluation of costs of reviewing biosimilar biological
product applications.--During the period beginning on the
date of enactment of this Act and ending on October 1, 2010,
the Secretary shall collect and evaluate data regarding the
costs of reviewing applications for biological products
submitted under section 351(k) of the Public Health Service
Act (as added by this Act) during such period.
(C) Audit.--
(i) In general.--On the date that is 2 years after first
receiving a user fee applicable to an application for a
biological product under section 351(k) of the Public Health
Service Act (as added by this Act), and on a biennial basis
thereafter until October 1, 2013, the Secretary shall perform
an audit of the costs of reviewing such applications under
such section 351(k). Such an audit shall compare--

(I) the costs of reviewing such applications under such
section 351(k) to the amount of the user fee applicable to
such applications; and
(II)(aa) such ratio determined under subclause (I); to
(bb) the ratio of the costs of reviewing applications for
biological products under section 351(a) of such Act (as
amended by this Act) to the amount of the user fee applicable
to such applications under such section 351(a).

(ii) Alteration of user fee.--If the audit performed under
clause (i) indicates that the ratios compared under subclause
(II) of such clause differ by more than 5 percent, then the
Secretary shall alter the user fee applicable to applications
submitted under such section 351(k) to more appropriately
account for the costs of reviewing such applications.
(iii) Accounting standards.--The Secretary shall perform an
audit under clause (i) in conformance with the accounting
principles, standards, and requirements prescribed by the
Comptroller General of the United States under section 3511
of title 31, United State Code, to ensure the validity of any
potential variability.
(4) Authorization of appropriations.--There is authorized
to be appropriated to carry out this subsection such sums as
may be necessary for each of fiscal years 2010 through 2012.
(g) Pediatric Studies of Biological Products.--
(1) In general.--Section 351 of the Public Health Service
Act (42 U.S.C. 262) is amended by adding at the end the
following:
``(m) Pediatric Studies.--
``(1) Application of certain provisions.--The provisions of
subsections (a), (d), (e), (f), (i), (j), (k), (l), (p), and
(q) of section 505A of the Federal Food, Drug, and Cosmetic
Act shall apply with respect to the extension of a period
under paragraphs (2) and (3) 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.
``(2) Market exclusivity for new biological products.--If,
prior to approval of an application that is submitted under
subsection (a), the Secretary determines that information
relating to the use of a new biological product in the
pediatric population may produce health benefits in that
population, the Secretary makes a written request for
pediatric studies (which shall include a timeframe for
completing such studies), the applicant agrees to the
request, such studies are completed using appropriate
formulations for each age group for which the study is
requested within any such timeframe, and the reports thereof
are submitted and accepted in accordance with section
505A(d)(3) of the Federal Food, Drug, and Cosmetic Act--
``(A) the periods for such biological product referred to
in subsection (k)(7)(B) are deemed to be 4 years and 6 months
rather than 4 years and the date that is 6 months after the
date described in subsection (k)(7)(A) rather than the date
described in such subsection; and; and
``(B) if the biological product is designated under section
526 for a rare disease or condition, the period for such
biological product referred to in section 527(a) is deemed to
be 7 years and 6 months rather than 7 years.
``(3) Market exclusivity for already-marketed biological
products.--If the Secretary determines that information
relating to the use of a licensed biological product in the
pediatric population may produce health benefits in that
population and makes a written request to the holder of an
approved application under subsection (a) for pediatric
studies (which shall include a timeframe for completing such
studies), the holder agrees to the request, such studies are
completed using appropriate formulations for each age group
for which the study is requested within any such timeframe,
and the reports thereof are submitted and accepted in
accordance with section 505A(d)(3) of the Federal Food, Drug,
and Cosmetic Act--
``(A) the periods for such biological product referred to
in subsection (k)(7)(B) are deemed to be 4 years and 6 months
rather than 4 years and the date that is 6 months after the
date described in subsection (k)(7)(A) rather than the date
described in such subsection; and
``(B) if the biological product is designated under section
526 for a rare disease or condition, the period for such
biological product referred to in section 527(a) is deemed to
be 7 years and 6 months rather than 7 years.
``(4) Exception.--The Secretary shall not extend a period
referred to in paragraph (2)(A), (2)(B), (3)(A), or (3)(B) if
the determination under section 505A(d)(3) is made later than
9 months prior to the expiration of such period.''.
(2) Studies regarding pediatric research.--
(A) Program for pediatric study of drugs.--Subsection
(a)(1) of section 409I of the Public Health Service Act (42
U.S.C. 284m) is amended by inserting ``, biological
products,'' after ``including drugs''.
(B) Institute of medicine study.--Section 505A(p) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355b(p)) is
amended by striking paragraphs (4) and (5) and inserting the
following:
``(4) review and assess the number and importance of
biological products for children that are being tested as a
result of the amendments made by the Patient Access to Safe
and Competitive Biologics Act and the importance for
children, health care providers, parents, and others of
labeling changes made as a result of such testing;
``(5) review and assess the number, importance, and
prioritization of any biological products that are not being
tested for pediatric use; and
``(6) offer recommendations for ensuring pediatric testing
of biological products, including consideration of any
incentives, such as those provided under this section or
section 351(m) of the Public Health Service Act.''.
(h) Orphan Products.--If a reference product, as defined in
section 351 of the Public Health Service Act (42 U.S.C. 262)
(as amended by this Act) has been designated under section
526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bb) for a rare disease or condition, a biological product
seeking approval for such disease or condition under
subsection (k) of such section 351 as biosimilar or
therapeutically equivalent to, such reference product may be
licensed by the Secretary only after the expiration for such
reference product of the later of--
(1) the 7-year period described in section 527(a) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc(a));
and
(2) the period of exclusivity described in subsection
(k)(7)(A) of such section 351.

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