```

[House Report 116-48]
[From the U.S. Government Publishing Office]

116th Congress    }                                     {       Report
                        HOUSE OF REPRESENTATIVES
 1st Session      }                                     {       116-48

======================================================================

 
                   PURPLE BOOK CONTINUITY ACT OF 2019

                                _______
                                

  May 3, 2019.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

 Mr. Pallone, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 1520]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 1520) to amend the Public Health Service Act to 
provide for the publication of a list of licensed biological 
products, and for other purposes, having considered the same, 
report favorably thereon with an amendment and recommend that 
the bill as amended do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     3
Background and Need for the Legislation..........................     3
Committee Hearings...............................................     3
Committee Consideration..........................................     4
Committee Votes..................................................     4
Oversight Findings...............................................     4
New Budget Authority, Entitlement Authority, and Tax Expenditures     4
Congressional Budget Office Estimate.............................     5
Federal Mandates Statement.......................................     6
Statement of General Performance Goals and Objectives............     6
Duplication of Federal Programs..................................     7
Committee Cost Estimate..........................................     7
Earmarks, Limited Tax Benefits, and Limited Tariff Benefits......     7
Advisory Committee Statement.....................................     7
Applicability to Legislative Branch..............................     7
Section-by-Section Analysis of the Legislation...................     7
Changes in Existing Law Made by the Bill, as Reported............     8

    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Purple Book Continuity Act of 2019''.

SEC. 2. PUBLIC LISTING.

  Section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) is 
amended by adding at the end the following:
          ``(9) Public listing.--
                  ``(A) In general.--
                          ``(i) Initial publication.--Not later than 
                        180 days after the date of enactment of the 
                        Purple Book Continuity Act of 2019, the 
                        Secretary shall publish and make available to 
                        the public in a searchable, electronic format--
                                  ``(I) a list in alphabetical order of 
                                the nonproprietary or proper name of 
                                each biological product for which a 
                                biologics license under subsection (a) 
                                or this subsection is in effect, or 
                                that has been deemed to be licensed 
                                under this section pursuant to section 
                                7002(e)(4) of the Biologics Price 
                                Competition and Innovation Act of 2009, 
                                as of such date of enactment;
                                  ``(II) the date of approval of the 
                                marketing application and the 
                                application number; and
                                  ``(III) the marketing or licensure 
                                status of the biological product for 
                                which a biologics license under 
                                subsection (a) or this subsection is in 
                                effect or that has been deemed to be 
                                licensed under this section pursuant to 
                                section 7002(e)(4) of the Biologics 
                                Price Competition and Innovation Act of 
                                2009.
                          ``(ii) Revisions.--Every 30 days after the 
                        publication of the first list under clause (i), 
                        the Secretary shall revise the list to include 
                        each biological product which has been licensed 
                        under subsection (a) or this subsection during 
                        the 30-day period.
                          ``(iii) Patent information.--Not later than 
                        30 days after a list of patents under 
                        subsection (l)(3)(A), or a supplement to such 
                        list under subsection (l)(7), has been provided 
                        by the reference product sponsor to the 
                        subsection (k) applicant respecting a 
                        biological product included on the list 
                        published under this subparagraph, the 
                        reference product sponsor shall provide such 
                        list of patents (or supplement thereto) and 
                        their corresponding expiry dates to the 
                        Secretary, and the Secretary shall, in 
                        revisions made under clause (ii), include such 
                        information for such biological product. Within 
                        30 days of providing any subsequent or 
                        supplemental list of patents to any subsequent 
                        subsection (k) applicant under subsection 
                        (l)(3)(A) or (l)(7), the reference product 
                        sponsor shall update the information provided 
                        to the Secretary under this clause with any 
                        additional patents from such subsequent or 
                        supplemental list and their corresponding 
                        expiry dates.
                          ``(iv) Listing of exclusivities.--For each 
                        biological product included on the list 
                        published under this subparagraph, the 
                        Secretary shall specify each exclusivity period 
                        that is applicable and has not concluded under 
                        paragraph (6) or paragraph (7).
                  ``(B) Withdrawal or suspension of licensure.--If the 
                licensing of a biological product was withdrawn or 
                suspended for safety, purity, or potency reasons, it 
                may not be published in the list under subparagraph 
                (A). If the withdrawal or suspension occurred after its 
                publication in such list, the reference product sponsor 
                shall notify the Secretary that--
                          ``(i) the biological product shall be 
                        immediately removed from such list--
                                  ``(I) for the same period as the 
                                withdrawal or suspension; or
                                  ``(II) if the biological product has 
                                been withdrawn from sale, for the 
                                period of withdrawal from sale or, if 
                                earlier, the period ending on the date 
                                the Secretary determines that the 
                                withdrawal from sale is not for safety, 
                                purity, or potency reasons; and
                          ``(ii) a notice of the removal shall be 
                        published in the Federal Register.''.

SEC. 3. REVIEW AND REPORT ON TYPES OF INFORMATION TO BE LISTED.

  Not later than 3 years after the date of enactment of this Act, the 
Secretary of Health and Human Services shall--
          (1) solicit public comment regarding the type of information, 
        if any, that should be added to or removed from the list 
        required by paragraph (9) of section 351(k) of the Public 
        Health Service Act (42 U.S.C. 262(k)), as added by section 2; 
        and
          (2) transmit to Congress an evaluation of such comments, 
        including any recommendations about the types of information 
        that should be added to or removed from the list.

                          Purpose and Summary

    H.R. 1520, the ``Purple Book Continuity Act of 2019'' was 
introduced on March 5, 2019, by Rep. Anna G. Eshoo (D-CA) and 
referred to the Committee on Energy and Commerce. H.R. 1520 
amends the Public Health Service Act (PHS Act) to codify 
publication of approved biological products in the Purple Book 
in a searchable, electronic format, specify that the Purple 
Book should be published electronically on the website of the 
Food and Drug Administration (FDA) and updated routinely, list 
relevant patents and exclusivities for biological products, and 
direct the FDA to consider the types of patents that should be 
listed in the Purple Book.

                  Background and Need for Legislation

    In September 2014, the FDA published the first edition of 
the ``Purple Book.'' Similar to the ``Orange Book,'' which 
lists patents and exclusivities for small molecule drug 
products, the ``Purple Book'' lists biological products, 
including biosimilar and interchangeable biological products, 
that have been licensed by FDA under the PHS Act. The current 
``Purple Book'' also includes the date the biological product 
was licensed and whether FDA evaluated the product for 
reference product exclusivity under section 351(k)(7) of the 
PHS Act. Publication of this list is not a statutory 
requirement and is currently published as a static document.
    Stakeholders, such as prescribers, pharmacists, and 
manufacturers, utilize the ``Purple Book'' as a reference for 
product information and for development purposes. Some 
stakeholders have recommended that the ``Purple Book'' be 
improved to make it more functional, including making such 
information available in a searchable, electronic format, as 
well as to provide information regarding relevant exclusivities 
and to have such information updated more routinely.
    H.R. 1520 would codify publication of the ``Purple Book,'' 
outline specific requirements for the information that should 
be included in such publication, and directs FDA to solicit 
feedback about what further information should be included in 
the ``Purple Book.''

                           Committee Hearings

    For the purposes of section 103(i) of H. Res. 6 of the 
116th Congress, the following hearing was used to develop or 
consider H.R. 1520:
    The Subcommittee on Health held a legislative hearing 
entitled ``Lowing the Cost of Prescription Drugs: Reducing 
Barriers to Market Competition'' on March 13, 2019. The hearing 
considered H.R. 1520, the ``Purple Book Continuity Act of 
2019'', and six other bills. The Subcommittee received 
testimony from the following witnesses:
           Lou Kennedy, Chief Executive Officer and 
        Owner, Nephron Pharmaceuticals;
           Anthony Barrueta, Senior Vice President for 
        Government Relations, Kaiser Permanente;
           Michael Carrier, Distinguished Professor, 
        Rutgers Law School;
           Kurt Karst, Director, Hyman, Phelps & 
        McNamara, P.C.;
           Jeff Kushan, Partner, Sidley Austin LLP;
           Marc M. Boutin, JD, Chief Executive Officer, 
        National Health Council; and
           Chester ``Chip'' Davis, Jr., President and 
        Chief Executive Officer, Association for Accessible 
        Medicines.

                        Committee Consideration

    H.R. 1520, the ``Purple Book Continuity Act of 2019'', was 
introduced on March 5, 2019, by Rep. Eshoo (D-CA), and referred 
to the Committee on Energy and Commerce. The bill was 
subsequently referred to the Subcommittee on Health on March 6, 
2019. Following legislative hearings, the Subcommittee met in 
open markup session on H.R. 1520, pursuant to notice, on March 
27, 2019, for consideration of the bill. A manager's amendment 
offered by Ms. Eshoo was adopted by a voice vote. Subsequently, 
the Subcommittee on Health agreed to a motion by Ms. Eshoo, 
Chairwoman of the Subcommittee, to favorably forward H.R. 1520 
to the full Committee on Energy and Commerce, amended, by a 
voice vote.
    The Committee on Energy and Commerce met in open markup 
session, pursuant to notice, on April 3, 2019, to consider H.R. 
1520, as amended by the subcommittee. A bipartisan manager's 
amendment, offered by Ms. Eshoo and supported by Mr. Burgess, 
was adopted by a voice vote. At the conclusion of consideration 
and markup of the bill, the Committee agreed to a motion by Mr. 
Pallone, Chairman of the Committee, to order H.R. 1520 
favorably reported to the House, amended, by a voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list each record vote 
on the motion to report legislation and amendments thereto. The 
Committee advises that there were no record votes taken on H.R. 
1520 during Committee markup. A motion by Mr. Pallone to order 
H.R. 1520 favorably reported to the House, amended, was agreed 
to by a voice vote.

                           Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1) 
of rule X of the Rules of the House of Representatives, the 
oversight findings and recommendations of the Committee are 
reflected in the descriptive portion of the report.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    Pursuant to 3(c)(2) of rule XIII of the Rules of the House 
of Representatives, the Committee adopts as its own the 
estimate of new budget authority, entitlement authority, or tax 
expenditures or revenues contained in the cost estimate 
prepared by the Director of the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1974.

                  Congressional Budget Office Estimate

    With respect to the requirements of clause (3)(c)(3) of 
rule XIII of the Rules of the House of Representatives and 
section 402 of the Congressional Budget Act of 1974, the 
Committee has received the following cost estimate for H.R. 
1520 from the Director of the Congressional Budget Office:

                                     U.S. Congress,
                               Congressional Budget Office,
                                       Washington, DC, May 3, 2019.
Hon. Frank Pallone, Jr.,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 1520, the Purple 
Book Continuity Act of 2019.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Julia 
Christensen.
            Sincerely,
                                                Keith Hall,
                                                          Director.
    Enclosure.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    

    Under current law, the Food and Drug Administration (FDA) 
publishes a reference guide for biological products, Lists of 
Licensed Biological Products with Reference Product Exclusivity 
and Biosimilarity or Interchangeability Evaluations, commonly 
known as the ``Purple Book.'' H.R. 1520 would codify 
publication of the Purple Book by FDA, require that the agency 
include more detailed information in the compendium, make the 
data available in a searchable electronic format, and update it 
every 30 days.
    The Purple Book currently specifies whether a biological 
product licensed and marketed under section 351(k) of the 
Public Health Service Act (PHS) has been determined by FDA to 
be biosimilar to (or interchangeable with) the reference 
biological product. The Purple Book also includes the date a 
biological product was licensed for marketing under 351(a) of 
the PHS Act and whether FDA evaluated the biological product 
for reference product exclusivity. Information contained in the 
Purple Book is useful to health care practitioners and 
developers of biosimilar or interchangeable products and is 
updated periodically by FDA.
    H.R. 1520 would require that the FDA proactively determine 
the reference product exclusivity for each licensed biological 
product listed in the Purple Book. The determination of 
reference product exclusivity is a complex, resource intensive 
assessment for the agency to make; thus, under current law it 
is generally made either for reasons of regulatory necessity or 
because the license holder that submitted the application 
requested the determination. The bill also would direct FDA to 
solicit public comments regarding the type of information that 
should be contained in the Purple Book and transmit a report to 
the Congress within three years after the date of enactment.
    Based on the cost of similar activities, CBO expects that 
the FDA would require the equivalent of about 5 full-time 
employees in 2020 to cover the increased workload to comply 
with the listing and reporting requirements at cost of about 
$300,000 per employee. CBO expects that fewer employees would 
be needed in later years and that by 2023, ongoing personnel-
related expenses to fulfill the bill's requirements would total 
less than $500,000 annually. CBO estimates that implementing 
the bill would cost FDA about $3 million over the 2020-2024 
period. Such spending would be subject to the availability of 
appropriated funds.
    H.R. 1520 would impose a private-sector mandate as defined 
in the Unfunded Mandates Reform Act (UMRA) by requiring 
biological product manufacturers to provide the FDA with 
certain patent information when that information is shared with 
biosimilar product manufacturers. CBO estimates the cost of the 
mandate would fall well below the private-sector threshold 
established in UMRA ($164 million in 2019, adjusted annually 
for inflation).
    The CBO staff contacts for this estimate are Julia 
Christensen (for federal costs) and Andrew Laughlin (for 
mandates). The estimate was reviewed by Leo Lex, Deputy 
Assistant Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

         Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to amend 
the PHS Act to provide for the publication of a list of 
licensed biological products and the patents and exclusivities 
related to such products, and to direct FDA to solicit public 
comment regarding the types of information that should be added 
or removed from the ``Purple Book'' and to transmit to Congress 
an evaluation of such comments.

                    Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 1520 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111-139 or the 
most recent Catalog of Federal Domestic Assistance.

                        Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, the Committee 
adopts as its own the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974.

      Earmarks, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 1520 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation

Section 1. Short title

    Section 1 designates that this Act may be cited as the 
``Purple Book Continuity Act of 2019''.

Section 2. Public listing

    Section 2 amends Section 351(k) of the PHS Act (42 U.S.C. 
262(k)) to require the FDA to publish electronically within 180 
days of enactment: a list of the nonproprietary or proper name 
of each biological product for which a biologics license is in 
effect or that has been deemed to be licensed; the date of 
approval of the marketing application and the application 
number; and the marketing or licensure status of the biological 
product for which a biologics license is in effect or that has 
been deemed to be licensed.
    This section also requires the Secretary of Health and 
Human Services (the Secretary) to update the list every 30 days 
to include each new biological product that has been licensed 
during the previous 30-day period. The Secretary is required to 
include patent information provided by the reference product 
sponsor on the list no later than 30 days after a list of 
patents under subsection (l)(3)(A) of the PHS Act is provided 
to the subsection (k) applicant respecting a biological product 
on the list. In addition, the Secretary shall include on the 
list any applicable exclusivity periods for each biological 
product that has not concluded.
    This section also specifies that any biological product 
that has had its licensing withdrawn or suspended for safety, 
purity, or potency reasons must be removed from the book. If 
the withdrawal or suspension of the license occurred after 
publication in the list, the reference product sponsor is 
required to notify the Secretary that: the biological product 
shall be immediately removed from the list for the same period 
as the withdrawal or suspension, or withdrawal of sale period; 
and a notice of removal will be published in the Federal 
Register.

Section 3. Review and report on types of biological products patents to 
        be listed

    Section 3 requires the Secretary to solicit public comment 
regarding the types of information that should be included in 
or removed from the list no later than 3 years after the date 
of enactment of this Act and requires an evaluation of such 
comments and any recommendations be transmitted to Congress.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (new matter is 
printed in italic and existing law in which no change is 
proposed is shown in roman):

                       PUBLIC HEALTH SERVICE ACT

           *       *       *       *       *       *       *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

           *       *       *       *       *       *       *

    Part F--Licensing--Biological Products and Clinical Laboratories

                     Subpart 1--Biological Products

                   regulation of biological products

  Sec. 351. (a)(1) No person shall introduce or deliver for 
introduction into interstate commerce any biological product 
unless--
          (A) a biologics license under this subsection or 
        subsection (k) is in effect for the biological product; 
        and
          (B) each package of the biological product is plainly 
        marked with--
                  (i) the proper name of the biological product 
                contained in the package;
                  (ii) the name, address, and applicable 
                license number of the manufacturer of the 
                biological product; and
                  (iii) the expiration date of the biological 
                product.
  (2)(A) The Secretary shall establish, by regulation, 
requirements for the approval, suspension, and revocation of 
biologics licenses.
          (B) Pediatric studies.--A person that submits an 
        application for a license under this paragraph shall 
        submit to the Secretary as part of the application any 
        assessments required under section 505B of the Federal 
        Food, Drug, and Cosmetic Act.
  (C) The Secretary shall approve a biologics license 
application--
          (i) on the basis of a demonstration that--
                  (I) the biological product that is the 
                subject of the application is safe, pure, and 
                potent; and
                  (II) 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; and
          (ii) if 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).
  (D) Postmarket Studies and Clinical Trials; Labeling; Risk 
Evaluation and Mitigation Strategy.--A person that submits an 
application for a license under this paragraph is subject to 
sections 505(o), 505(p), and 505-1 of the Federal Food, Drug, 
and Cosmetic Act.
  (E)(i) The Secretary may rely upon qualified data summaries 
to support the approval of a supplemental application, with 
respect to a qualified indication for a drug, submitted under 
this subsection, if such supplemental application complies with 
the requirements of subparagraph (B) of section 505(c)(5) of 
the Federal Food, Drug, and Cosmetic Act.
  (ii) In this subparagraph, the terms ``qualified indication'' 
and ``qualified data summary'' have the meanings given such 
terms in section 505(c)(5) of the Federal Food, Drug, and 
Cosmetic Act.
  (3) The Secretary shall prescribe requirements under which a 
biological product undergoing investigation shall be exempt 
from the requirements of paragraph (1).
  (b) No person shall falsely label or mark any package or 
container of any biological product or alter any label or mark 
on the package or container of the biological product so as to 
falsify the label or mark.
  (c) Any officer, agent, or employee of the Department of 
Health and Human Services, authorized by the Secretary for the 
purpose, may during all reasonable hours enter and inspect any 
establishment for the propagation or manufacture and 
preparation of any biological product.
  (d)(1) Upon a determination that a batch, lot, or other 
quantity of a product licensed under this section presents an 
imminent or substantial hazard to the public health, the 
Secretary shall issue an order immediately ordering the recall 
of such batch, lot, or other quantity of such product. An order 
under this paragraph shall be issued in accordance with section 
554 of title 5, United States Code.
  (2) Any violation of paragraph (1) shall subject the violator 
to a civil penalty of up to $100,000 per day of violation. The 
amount of a civil penalty under this paragraph shall, effective 
December 1 of each year beginning 1 year after the effective 
date of this paragraph, be increased by the percent change in 
the Consumer Price Index for the base quarter of such year over 
the Consumer Price Index for the base quarter of the preceding 
year, adjusted to the nearest \1/10\ of 1 percent. For purposes 
of this paragraph, the term ``base quarter'', as used with 
respect to a year, means the calendar quarter ending on 
September 30 of such year and the price index for a base 
quarter is the arithmetical mean of such index for the 3 months 
comprising such quarter.
  (e) No person shall interfere with any officer, agent, or 
employee of the Service in the performance of any duty imposed 
upon him by this section or by regulations made by authority 
thereof.
  (f) Any person who shall violate, or aid or abet in 
violating, any of the provisions of this section shall be 
punished upon conviction by a fine not exceeding $500 or by 
imprisonment not exceeding one year, or by both such fine and 
imprisonment, in the discretion of the court.
  (g) Nothing contained in this Act shall be construed as in 
any way affecting, modifying, repealing, or superseding the 
provisions of the Federal Food, Drug, and Cosmetic Act (U.S.C., 
1940 edition, title 21, ch. 9).
  (h) A partially processed biological product which--
          (1) is not in a form applicable to the prevention, 
        treatment, or cure of diseases or injuries of man;
          (2) is not intended for sale in the United States; 
        and
          (3) is intended for further manufacture into final 
        dosage form outside the United States,
shall be subject to no restriction on the export of the product 
under this Act or the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321 et. seq.) if the product is manufactured, processed, 
packaged, and held in conformity with current good 
manufacturing practice requirements or meets international 
manufacturing standards as certified by an international 
standards organization recognized by the Secretary and meets 
the requirements of section 801(e)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(e)).
  (i) In this section:
          (1) The term ``biological product'' means a virus, 
        therapeutic serum, toxin, antitoxin, vaccine, blood, 
        blood component or derivative, allergenic product, 
        protein (except any chemically synthesized 
        polypeptide), or analogous product, or arsphenamine or 
        derivative of arsphenamine (or any other trivalent 
        organic arsenic compound), applicable to the 
        prevention, treatment, or cure of a disease or 
        condition of human beings.
          (2) The term ``biosimilar'' or ``biosimilarity'', in 
        reference to a biological product that is the subject 
        of an application under subsection (k), means--
                  (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 ``interchangeable'' or 
        ``interchangeability'', in reference to a biological 
        product that is shown to meet the standards described 
        in subsection (k)(4), means that the biological product 
        may be substituted for the reference product without 
        the intervention of the health care provider who 
        prescribed the reference product.
          (4) 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).
  (j) The Federal Food, Drug, and Cosmetic Act, including the 
requirements under sections 505(o), 505(p), and 505-1 of such 
Act, applies to a biological product subject to regulation 
under this section, except that a product for which a license 
has been approved under subsection (a) shall not be required to 
have an approved application under section 505 of such Act.
  (k) Licensure of Biological Products as Biosimilar or 
Interchangeable.--
          (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) 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, in the 
                        Secretary's discretion, that an element 
                        described in 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) Interchangeability.--An application (or a 
                supplement to an application) submitted under 
                this subsection may include information 
                demonstrating that the biological product meets 
                the standards described in paragraph (4).
          (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), and therefore is 
                        interchangeable with 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 
        interchangeability.--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--
                  (A) 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
                  (B) 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.
          (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 interchangeable 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 interchangeability for any condition 
        of use, the Secretary shall not make a determination 
        under paragraph (4) that the second or subsequent 
        biological product is interchangeable for any condition 
        of use until the earlier of--
                  (A) 1 year after the first commercial 
                marketing of the first interchangeable 
                biosimilar biological product to be approved as 
                interchangeable 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 
                        interchangeable 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 interchangeable 
                        biosimilar biological product; or
                  (C)(i) 42 months after approval of the first 
                interchangeable 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 
                interchangeable 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.--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).
                  (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.--Subparagraphs (A) and 
                (B) shall not apply to a license for or 
                approval of--
                          (i) a supplement for the biological 
                        product that is the reference product; 
                        or
                          (ii) a subsequent application filed 
                        by the same sponsor or manufacturer of 
                        the biological product that is the 
                        reference product (or a licensor, 
                        predecessor in interest, or other 
                        related entity) for--
                                  (I) a change (not including a 
                                modification to the structure 
                                of the biological product) that 
                                results in a new indication, 
                                route of administration, dosing 
                                schedule, dosage form, delivery 
                                system, delivery device, or 
                                strength; or
                                  (II) a modification to the 
                                structure of the biological 
                                product that does not result in 
                                a change in safety, purity, or 
                                potency.
          (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).
                  (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.
          (9) Public listing.--
                  (A) In general.--
                          (i) Initial publication.--Not later 
                        than 180 days after the date of 
                        enactment of the Purple Book Continuity 
                        Act of 2019, the Secretary shall 
                        publish and make available to the 
                        public in a searchable, electronic 
                        format--
                                  (I) a list in alphabetical 
                                order of the nonproprietary or 
                                proper name of each biological 
                                product for which a biologics 
                                license under subsection (a) or 
                                this subsection is in effect, 
                                or that has been deemed to be 
                                licensed under this section 
                                pursuant to section 7002(e)(4) 
                                of the Biologics Price 
                                Competition and Innovation Act 
                                of 2009, as of such date of 
                                enactment;
                                  (II) the date of approval of 
                                the marketing application and 
                                the application number; and
                                  (III) the marketing or 
                                licensure status of the 
                                biological product for which a 
                                biologics license under 
                                subsection (a) or this 
                                subsection is in effect or that 
                                has been deemed to be licensed 
                                under this section pursuant to 
                                section 7002(e)(4) of the 
                                Biologics Price Competition and 
                                Innovation Act of 2009.
                          (ii) Revisions.--Every 30 days after 
                        the publication of the first list under 
                        clause (i), the Secretary shall revise 
                        the list to include each biological 
                        product which has been licensed under 
                        subsection (a) or this subsection 
                        during the 30-day period.
                          (iii) Patent information.--Not later 
                        than 30 days after a list of patents 
                        under subsection (l)(3)(A), or a 
                        supplement to such list under 
                        subsection (l)(7), has been provided by 
                        the reference product sponsor to the 
                        subsection (k) applicant respecting a 
                        biological product included on the list 
                        published under this subparagraph, the 
                        reference product sponsor shall provide 
                        such list of patents (or supplement 
                        thereto) and their corresponding expiry 
                        dates to the Secretary, and the 
                        Secretary shall, in revisions made 
                        under clause (ii), include such 
                        information for such biological 
                        product. Within 30 days of providing 
                        any subsequent or supplemental list of 
                        patents to any subsequent subsection 
                        (k) applicant under subsection 
                        (l)(3)(A) or (l)(7), the reference 
                        product sponsor shall update the 
                        information provided to the Secretary 
                        under this clause with any additional 
                        patents from such subsequent or 
                        supplemental list and their 
                        corresponding expiry dates.
                          (iv) Listing of exclusivities.--For 
                        each biological product included on the 
                        list published under this subparagraph, 
                        the Secretary shall specify each 
                        exclusivity period that is applicable 
                        and has not concluded under paragraph 
                        (6) or paragraph (7).
                  (B) Withdrawal or suspension of licensure.--
                If the licensing of a biological product was 
                withdrawn or suspended for safety, purity, or 
                potency reasons, it may not be published in the 
                list under subparagraph (A). If the withdrawal 
                or suspension occurred after its publication in 
                such list, the reference product sponsor shall 
                notify the Secretary that--
                          (i) the biological product shall be 
                        immediately removed from such list--
                                  (I) for the same period as 
                                the withdrawal or suspension; 
                                or
                                  (II) if the biological 
                                product has been withdrawn from 
                                sale, for the period of 
                                withdrawal from sale or, if 
                                earlier, the period ending on 
                                the date the Secretary 
                                determines that the withdrawal 
                                from sale is not for safety, 
                                purity, or potency reasons; and
                          (ii) a notice of the removal shall be 
                        published in the Federal Register.
  (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.
                  (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.
  (m) Pediatric Studies.--
          (1) Application of certain provisions.--The 
        provisions of subsections (a), (d), (e), (f), (h), (i), 
        (j), (k), (l), (n), and (p) 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)(4) of the Federal Food, Drug, and Cosmetic 
        Act--
                  (A) the periods for such biological product 
                referred to in subsection (k)(7) are deemed to 
                be 4 years and 6 months rather than 4 years and 
                12 years and 6 months rather than 12 years; 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)(4) of the Federal Food, Drug, and Cosmetic 
        Act--
                  (A) the periods for such biological product 
                referred to in subsection (k)(7) are deemed to 
                be 4 years and 6 months rather than 4 years and 
                12 years and 6 months rather than 12 years; 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)(4) 
        is made later than 9 months prior to the expiration of 
        such period.
  (n) Date of Approval in the Case of Recommended Controls 
Under the CSA.--
          (1) In general.--In the case of an application under 
        subsection (a) with respect to a biological product for 
        which the Secretary provides notice to the sponsor that 
        the Secretary intends to issue a scientific and medical 
        evaluation and recommend controls under the Controlled 
        Substances Act, approval of such application shall not 
        take effect until the interim final rule controlling 
        the biological product is issued in accordance with 
        section 201(j) of the Controlled Substances Act.
          (2) Date of approval.--For purposes of this section, 
        with respect to an application described in paragraph 
        (1), references to the date of approval of such 
        application, or licensure of the product subject to 
        such application, shall mean the later of--
                  (A) the date an application is approved under 
                subsection (a); or
                  (B) the date of issuance of the interim final 
                rule controlling the biological product.

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