89–006 

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: 


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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 


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(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; 


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• 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 


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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. 

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 PurVerDate Sep 11 2014 00:43 May 07, 2019 Jkt 089006 PO 00000 Frm 00005 Fmt 6659 Sfmt 6602 E:\HR\OC\HR048.XXX HR048

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ple 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. 


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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. 


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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 


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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 


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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 biologiVerDate Sep 11 2014 00:43 May 07, 2019 Jkt 089006 PO 00000 Frm 00010 Fmt 6659 Sfmt 6601 E:\HR\OC\HR048.XXX HR048

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cal 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 


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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 publiclyavailable 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 


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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). 


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(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. 


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(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 


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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 

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mally, 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 


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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) APPLI- CANT.—Not later than 60 days after receipt of the list 

under subparagraph (A), the subsection (k) applicant— 


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(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. 


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(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 PROD- UCT 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). 


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(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.— 


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(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 

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logical 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. 

* * * * * * * 

Æ 


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