IB 

Union Calendar No. 576 

116TH CONGRESS 

2D SESSION H. R. 2375 

[Report No. 116–693, Part I] 

To prohibit prescription drug companies from compensating other prescription 

drug companies to delay the entry of a generic drug, biosimilar biological 

product, or interchangeable biological product into the market. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 29, 2019 

Mr. NADLER (for himself, Mr. COLLINS of Georgia, and Mr. CICILLINE) introduced the following bill; which was referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce, for 

a period to be subsequently determined by the Speaker, in each case for 

consideration of such provisions as fall within the jurisdiction of the committee concerned 

DECEMBER 24, 2020 

Additional sponsors: Mr. COHEN and Mr. MEADOWS

DECEMBER 24, 2020 

Reported from the Committee on the Judiciary 

DECEMBER 24, 2020 

Committee on Energy and Commerce discharged; committed to the Committee 

of the Whole House on the State of the Union and ordered to be printed 


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A BILL 

To prohibit prescription drug companies from compensating 

other prescription drug companies to delay the entry 

of a generic drug, biosimilar biological product, or interchangeable biological product into the market. 


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1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Preserve Access to Af5 fordable Generics and Biosimilars Act’’. 

6 SEC. 2. DECLARATION OF PURPOSES. 

7 The purposes of this Act are— 

8 (1) to enhance competition in the pharma9 ceutical market by stopping anticompetitive agree10 ments between manufacturers of brand name and 

11 generic drug products or biosimilar biological prod12 ucts, or among manufacturers of generic drug prod13 ucts or biosimilar biological products, that limit, 

14 delay, or otherwise prevent competition from generic 

15 drugs and biosimilar biological products; and 

16 (2) to support the purpose and intent of anti17 trust law by prohibiting anticompetitive practices in 

18 the pharmaceutical industry that harm consumers. 

19 SEC. 3. UNLAWFUL COMPENSATION FOR DELAY. 

20 (a) IN GENERAL.—The Federal Trade Commission 

21 Act (15 U.S.C. 44 et seq.) is amended by inserting after 

22 section 26 (15 U.S.C. 57c–2) the following: 

23 ‘‘SEC. 27. PRESERVING ACCESS TO AFFORDABLE GENERICS 

24 AND BIOSIMILARS. 

25 ‘‘(a) IN GENERAL.— 


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1 ‘‘(1) ENFORCEMENT PROCEEDING.—The Com2 mission may initiate a proceeding to enforce the pro3 visions of this section against the parties to any 

4 agreement resolving or settling, on a final or interim 

5 basis, a patent claim, in connection with the sale of 

6 a drug product or biological product. 

7 ‘‘(2) PRESUMPTION AND VIOLATION.— 

8 ‘‘(A) IN GENERAL.—Subject to subpara9 graph (B), in such a proceeding, an agreement 

10 shall be presumed to have anticompetitive ef11 fects and shall be a violation of this section if— 

12 ‘‘(i) an ANDA filer or a biosimilar bi13 ological product application filer receives 

14 anything of value, including an exclusive li15 cense; and 

16 ‘‘(ii) the ANDA filer or biosimilar bio17 logical product application filer agrees to 

18 limit or forgo research, development, man19 ufacturing, marketing, or sales of the 

20 ANDA product or biosimilar biological 

21 product, as applicable, for any period of 

22 time. 

23 ‘‘(B) EXCEPTION.—Subparagraph (A) 

24 shall not apply if the parties to such agreement 


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1 demonstrate by clear and convincing evidence 

2 that— 

3 ‘‘(i) the value described in subpara4 graph (A)(i) is compensation solely for 

5 other goods or services that the ANDA 

6 filer or biosimilar biological product appli7 cation filer has promised to provide; or 

8 ‘‘(ii) the procompetitive benefits of the 

9 agreement outweigh the anticompetitive ef10 fects of the agreement. 

11 ‘‘(b) LIMITATIONS.—In determining whether the set12 tling parties have met their burden under subsection 

13 (a)(2)(B), the fact finder shall not presume— 

14 ‘‘(1) that entry would not have occurred until 

15 the expiration of the relevant patent or statutory ex16 clusivity; or 

17 ‘‘(2) that the agreement’s provision for entry of 

18 the ANDA product or biosimilar biological product 

19 prior to the expiration of the relevant patent or stat20 utory exclusivity means that the agreement is pro21 competitive. 

22 ‘‘(c) EXCLUSIONS.—Nothing in this section shall pro23 hibit a resolution or settlement of a patent infringement 

24 claim in which the consideration that the ANDA filer or 

25 biosimilar biological product application filer receives as 


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1 part of the resolution or settlement includes only one or 

2 more of the following: 

3 ‘‘(1) The right to market and secure final regu4 latory approval for the ANDA product or biosimilar 

5 biological product at a date, whether certain or con6 tingent, in the United States prior to the expiration 

7 of— 

8 ‘‘(A) any patent that is the basis for the 

9 patent infringement claim; or 

10 ‘‘(B) any patent right or other statutory 

11 exclusivity that would prevent the marketing of 

12 such ANDA product or biosimilar biological 

13 product. 

14 ‘‘(2) A payment for reasonable litigation ex15 penses not to exceed— 

16 ‘‘(A) for calendar year 2019, $7,500,000; 

17 and 

18 ‘‘(B) for calendar year 2020 and each cal19 endar year thereafter, the amount determined 

20 for the preceding calendar year adjusted to re21 flect the percentage increase (if any) in the 

22 Producer Price Index for Legal Services pub23 lished by the Bureau of Labor Statistics of the 

24 Department of Labor for the then most recent 

25 12-month period ending December 31. 


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1 ‘‘(3) A covenant not to sue on any claim that 

2 the ANDA product or biosimilar biological product 

3 infringes a United States patent. 

4 ‘‘(d) ENFORCEMENT.— 

5 ‘‘(1) ENFORCEMENT.—A violation of this sec6 tion shall be treated as an unfair method of competi7 tion under section 5(a)(1) of the Federal Trade 

8 Commission Act (15 U.S.C. 45(a)(1)). 

9 ‘‘(2) JUDICIAL REVIEW.— 

10 ‘‘(A) IN GENERAL.—Any party that is sub11 ject to a final order of the Commission, issued 

12 in an administrative adjudicative proceeding 

13 under the authority of subsection (a)(1), may, 

14 within 30 days of the issuance of such order, 

15 petition for review of such order in— 

16 ‘‘(i) the United States Court of Ap17 peals for the District of Columbia Circuit; 

18 ‘‘(ii) the United States Court of Ap19 peals for the circuit in which the ultimate 

20 parent entity, as defined in section 

21 801.1(a)(3) of title 16, Code of Federal 

22 Regulations, or any successor thereto, of 

23 the NDA holder or biological product li24 cense holder is incorporated as of the date 

25 that the NDA or biological product license 


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1 application, as applicable, is filed with the 

2 Commissioner of Food and Drugs; or 

3 ‘‘(iii) the United States Court of Ap4 peals for the circuit in which the ultimate 

5 parent entity of the ANDA filer or bio6 similar biological product application filer 

7 is incorporated as of the date that the 

8 ANDA or biosimilar biological product ap9 plication is filed with the Commissioner of 

10 Food and Drugs. 

11 ‘‘(B) TREATMENT OF FINDINGS.—In a 

12 proceeding for judicial review of a final order of 

13 the Commission, the findings of the Commis14 sion as to the facts, if supported by evidence, 

15 shall be conclusive. 

16 ‘‘(e) ANTITRUST LAWS.—Nothing in this section 

17 shall modify, impair, limit, or supersede the applicability 

18 of the antitrust laws as defined in subsection (a) of the 

19 first section of the Clayton Act (15 U.S.C. 12(a)), and 

20 of section 5 of this Act to the extent that section 5 applies 

21 to unfair methods of competition. Nothing in this section 

22 shall modify, impair, limit, or supersede the right of an 

23 ANDA filer or biosimilar biological product application 

24 filer to assert claims or counterclaims against any person, 


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1 under the antitrust laws or other laws relating to unfair 

2 competition. 

3 ‘‘(f) PENALTIES.— 

4 ‘‘(1) FORFEITURE.—Each party that violates or 

5 assists in the violation of this section shall forfeit 

6 and pay to the United States a civil penalty suffi7 cient to deter violations of this section, but in no 

8 event greater than 3 times the value received by the 

9 party that is reasonably attributable to the violation 

10 of this section. If no such value has been received by 

11 the NDA holder, biological product license holder, 

12 the ANDA filer, or biosimilar biological product ap13 plication filer the penalty to the NDA holder, bio14 logical product license holder, the ANDA filer, or 

15 biosimilar biological product application filer shall be 

16 sufficient to deter violations, but in no event greater 

17 than 3 times the value given to an ANDA filer or 

18 biosimilar biological product application filer reason19 ably attributable to the violation of this section. 

20 Such penalty shall accrue to the United States and 

21 may be recovered in a civil action brought by the 

22 Commission, in its own name by any of its attorneys 

23 designated by it for such purpose, in a district court 

24 of the United States against any party that violates 

25 this section. In such actions, the United States disVerDate Sep 11 2014 18:10 Dec 26, 2020 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H2375.RH H2375

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1 trict courts are empowered to grant mandatory in2 junctions and such other and further equitable relief 

3 as they deem appropriate. 

4 ‘‘(2) CEASE AND DESIST.— 

5 ‘‘(A) IN GENERAL.—If the Commission has 

6 issued a cease and desist order with respect to 

7 a party in an administrative adjudicative pro8 ceeding under the authority of subsection 

9 (a)(1), an action brought pursuant to para10 graph (1) may be commenced against such 

11 party at any time before the expiration of 1 

12 year after such order becomes final pursuant to 

13 section 5(g). 

14 ‘‘(B) EXCEPTION.—In an action under 

15 subparagraph (A), the findings of the Commis16 sion as to the material facts in the administra17 tive adjudicative proceeding with respect to the 

18 violation of this section by a party shall be con19 clusive unless— 

20 ‘‘(i) the terms of such cease and de21 sist order expressly provide that the Com22 mission’s findings shall not be conclusive; 

23 or 

24 ‘‘(ii) the order became final by reason 

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1 ing shall be conclusive if supported by evi2 dence. 

3 ‘‘(3) CIVIL PENALTY.—In determining the 

4 amount of the civil penalty described in this section, 

5 the court shall take into account— 

6 ‘‘(A) the nature, circumstances, extent, 

7 and gravity of the violation; 

8 ‘‘(B) with respect to the violator, the de9 gree of culpability, any history of violations, the 

10 ability to pay, any effect on the ability to con11 tinue doing business, profits earned by the 

12 NDA holder, biological product license holder, 

13 the ANDA filer, or biosimilar biological product 

14 application filer, compensation received by the 

15 ANDA filer or biosimilar biological product ap16 plication filer, and the amount of commerce af17 fected; and 

18 ‘‘(C) other matters that justice requires. 

19 ‘‘(4) REMEDIES IN ADDITION.—Remedies pro20 vided in this subsection are in addition to, and not 

21 in lieu of, any other remedy provided by Federal 

22 law. Nothing in this paragraph shall be construed to 

23 affect any authority of the Commission under any 

24 other provision of law. 

25 ‘‘(g) DEFINITIONS.—In this section: 


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1 ‘‘(1) AGREEMENT.—The term ‘agreement’ 

2 means anything that would constitute an agreement 

3 under section 1 of the Sherman Act (15 U.S.C. 1) 

4 or section 5 of this Act. 

5 ‘‘(2) AGREEMENT RESOLVING OR SETTLING A

6 PATENT INFRINGEMENT CLAIM.—The term ‘agree7 ment resolving or settling a patent infringement 

8 claim’ includes any agreement that is entered into 

9 within 30 days of the resolution or the settlement of 

10 the claim, or any other agreement that is contingent 

11 upon, provides a contingent condition for, or is oth12 erwise related to the resolution or settlement of the 

13 claim. 

14 ‘‘(3) ANDA.—The term ‘ANDA’ means an ab15 breviated new drug application filed under section 

16 505(j) of the Federal Food, Drug, and Cosmetic Act 

17 (21 U.S.C. 355(j)) or a new drug application filed 

18 under section 505(b)(2) of the Federal Food, Drug, 

19 and Cosmetic Act (21 U.S.C. 355(b)(2)). 

20 ‘‘(4) ANDA FILER.—The term ‘ANDA filer’ 

21 means a party that owns or controls an ANDA filed 

22 with the Food and Drug Administration or has the 

23 exclusive rights under such ANDA to distribute the 

24 ANDA product. 


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1 ‘‘(5) ANDA PRODUCT.—The term ‘ANDA 

2 product’ means the product to be manufactured 

3 under the ANDA that is the subject of the patent 

4 infringement claim. 

5 ‘‘(6) BIOLOGICAL PRODUCT.—The term ‘bio6 logical product’ has the meaning given such term in 

7 section 351(i)(1) of the Public Health Service Act 

8 (42 U.S.C. 262(i)(1)). 

9 ‘‘(7) BIOLOGICAL PRODUCT LICENSE APPLICA10 TION.—The term ‘biological product license applica11 tion’ means an application under section 351(a) of 

12 the Public Health Service Act (42 U.S.C. 262(a)). 

13 ‘‘(8) BIOLOGICAL PRODUCT LICENSE HOLD14 ER.—The term ‘biological product license holder’ 

15 means— 

16 ‘‘(A) the holder of an approved biological 

17 product license application for a biological prod18 uct; 

19 ‘‘(B) a person owning or controlling en20 forcement of any patents that claim the biologi21 cal product that is the subject of such approved 

22 application; or 

23 ‘‘(C) the predecessors, subsidiaries, divi24 sions, groups, and affiliates controlled by, con25 trolling, or under common control with any of 


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1 the entities described in subparagraphs (A) and 

2 (B) (such control to be presumed by direct or 

3 indirect share ownership of 50 percent or great4 er), as well as the licensees, licensors, succes5 sors, and assigns of each of the entities. 

6 ‘‘(9) BIOSIMILAR BIOLOGICAL PRODUCT.—The 

7 term ‘biosimilar biological product’ means the prod8 uct to be manufactured under the biosimilar biologi9 cal product application that is the subject of the pat10 ent infringement claim. 

11 ‘‘(10) BIOSIMILAR BIOLOGICAL PRODUCT APPLI12 CATION.—The term ‘biosimilar biological product ap13 plication’ means an application under section 351(k) 

14 of the Public Health Service Act (42 U.S.C. 262(k)) 

15 for licensure of a biological product as biosimilar to, 

16 or interchangeable with, a reference product. 

17 ‘‘(11) BIOSIMILAR BIOLOGICAL PRODUCT APPLI18 CATION FILER.—The term ‘biosimilar biological 

19 product application filer’ means a party that owns or 

20 controls a biosimilar biological product application 

21 filed with the Food and Drug Administration or has 

22 the exclusive rights under such application to dis23 tribute the biosimilar biological product. 

24 ‘‘(12) DRUG PRODUCT.—The term ‘drug prod25 uct’ has the meaning given such term in section 


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1 314.3(b) of title 21, Code of Federal Regulations (or 

2 any successor regulation). 

3 ‘‘(13) MARKET.—The term ‘market’ means the 

4 promote, offer for sale, sell, or distribute a drug 

5 product. 

6 ‘‘(14) NDA.—The term ‘NDA’ means a new 

7 drug application filed under section 505(b) of the 

8 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

9 355(b)). 

10 ‘‘(15) NDA HOLDER.—The term ‘NDA holder’ 

11 means— 

12 ‘‘(A) the holder of an approved NDA appli13 cation for a drug product; 

14 ‘‘(B) a person owning or controlling en15 forcement of the patent listed in the Approved 

16 Drug Products With Therapeutic Equivalence 

17 Evaluations (commonly known as the ‘FDA Or18 ange Book’) in connection with the NDA; or 

19 ‘‘(C) the predecessors, subsidiaries, divi20 sions, groups, and affiliates controlled by, con21 trolling, or under common control with any of 

22 the entities described in subparagraphs (A) and 

23 (B) (such control to be presumed by direct or 

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1 er), as well as the licensees, licensors, succes2 sors, and assigns of each of the entities. 

3 ‘‘(16) PARTY.—The term ‘party’ means any 

4 person, partnership, corporation, or other legal enti5 ty. 

6 ‘‘(17) PATENT INFRINGEMENT.—The term 

7 ‘patent infringement’ means infringement of any 

8 patent or of any filed patent application, including 

9 any extension, reissue, renewal, division, continu10 ation, continuation in part, reexamination, patent 

11 term restoration, patents of addition, and extensions 

12 thereof. 

13 ‘‘(18) PATENT INFRINGEMENT CLAIM.—The 

14 term ‘patent infringement claim’ means any allega15 tion made to an ANDA filer or biosimilar biological 

16 product application filer, whether or not included in 

17 a complaint filed with a court of law, that its ANDA 

18 or ANDA product, or biological product license ap19 plication or biological product, may infringe any pat20 ent held by, or exclusively licensed to, the NDA 

21 holder or biological product license holder, biological 

22 product license holder, the ANDA filer, or biosimilar 

23 biological product application filer of the drug prod24 uct or biological product, as applicable. 


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1 ‘‘(19) STATUTORY EXCLUSIVITY.—The term 

2 ‘statutory exclusivity’ means those prohibitions on 

3 the approval of drug applications under clauses (ii) 

4 through (iv) of section 505(c)(3)(E) (5- and 3-year 

5 data exclusivity), section 527 (orphan drug exclu6 sivity), or section 505A (pediatric exclusivity) of the 

7 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

8 355(c)(3)(E), 360cc, 355a), or on the licensing of 

9 biological product applications under section 

10 351(k)(7) (12-year exclusivity) or paragraph (2) or 

11 (3) of section 351(m) (pediatric exclusivity) of the 

12 Public Health Service Act (42 U.S.C. 262) or under 

13 section 527 of the Federal Food, Drug, and Cos14 metic Act (orphan drug exclusivity).’’. 

15 (b) EFFECTIVE DATE.—Section 27 of the Federal 

16 Trade Commission Act, as added by this section, shall 

17 apply to all agreements described in section 27(a)(1) of 

18 that Act entered into on or after the date of enactment 

19 of this Act. 

20 SEC. 4. NOTICE AND CERTIFICATION OF AGREEMENTS. 

21 (a) NOTICE OF ALL AGREEMENTS.—Section 1111(7) 

22 of the Medicare Prescription Drug, Improvement, and 

23 Modernization Act of 2003 (21 U.S.C. 355 note) is 

24 amended by inserting ‘‘or the owner of a patent for which 

25 a claim of infringement could reasonably be asserted 


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1 against any person for making, using, offering to sell, sell2 ing, or importing into the United States a biological prod3 uct that is the subject of a biosimilar biological product 

4 application’’ before the period at the end. 

5 (b) CERTIFICATION OF AGREEMENTS.—Section 1112 

6 of the Medicare Prescription Drug, Improvement, and 

7 Modernization Act of 2003 (21 U.S.C. 355 note) is 

8 amended by adding at the end the following: 

9 ‘‘(d) CERTIFICATION.—The Chief Executive Officer 

10 or the company official responsible for negotiating any 

11 agreement under subsection (a) or (b) that is required to 

12 be filed under subsection (c), within 30 days after such 

13 filing, shall execute and file with the Assistant Attorney 

14 General and the Commission a certification as follows: ‘I 

15 declare that the following is true, correct, and complete 

16 to the best of my knowledge: The materials filed with the 

17 Federal Trade Commission and the Department of Justice 

18 under section 1112 of subtitle B of title XI of the Medi19 care Prescription Drug, Improvement, and Modernization 

20 Act of 2003, with respect to the agreement referenced in 

21 this certification— 

22 ‘‘ ‘(1) represent the complete, final, and exclu23 sive agreement between the parties; 

24 ‘‘ ‘(2) include any ancillary agreements that are 

25 contingent upon, provide a contingent condition for, 


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1 or are otherwise related to, the referenced agree2 ment; and 

3 ‘‘ ‘(3) include written descriptions of any oral 

4 agreements, representations, commitments, or prom5 ises between the parties that are responsive to sub6 section (a) or (b) of such section 1112 and have not 

7 been reduced to writing.’.’’. 

8 SEC. 5. NOTIFICATION OF AGREEMENTS. 

9 Section 1112 of the Medicare Prescription Drug, Im10 provement, and Modernization Act of 2003 (21 U.S.C. 

11 355 note) is amended by adding at the end the following: 

12 ‘‘(4) RULE OF CONSTRUCTION.— 

13 ‘‘(A) An agreement that is required in sub14 section (a) or (b) shall include agreements re15 solving any outstanding disputes, including 

16 agreements resolving or settling a Patent Trial 

17 and Appeal Board proceeding. 

18 ‘‘(B) For purposes of subparagraph (A), 

19 the term ‘Patent Trial and Appeal Board pro20 ceeding’ means a proceeding conducted by the 

21 United States Patent and Trademark Office 

22 Patent Trial and Appeal Board, including but 

23 not limited to inter parties review, post-grant 

24 review, the transitional program for covered 


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1 business method patents, and derivation pro2 ceedings.’’. 

3 SEC. 6. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD. 

4 Section 505(j)(5)(D)(i)(V) of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(V)) 

6 is amended by inserting ‘‘section 27 of the Federal Trade 

7 Commission Act or’’ after ‘‘that the agreement has vio8 lated’’. 

9 SEC. 7. COMMISSION LITIGATION AUTHORITY. 

10 Section 16(a)(2) of the Federal Trade Commission 

11 Act (15 U.S.C. 56(a)(2)) is amended— 

12 (1) in subparagraph (D), by striking ‘‘or’’ after 

13 the semicolon; 

14 (2) in subparagraph (E), by inserting ‘‘or’’ 

15 after the semicolon; and 

16 (3) inserting after subparagraph (E) the fol17 lowing: 

18 ‘‘(F) under section 27;’’. 

19 SEC. 8. REPORT ON ADDITIONAL EXCLUSION. 

20 Within 1 year of enactment, the Federal Trade Com21 mission shall provide a recommendation, and the Commis22 sion’s basis for it, to the Committee on the Judiciary of 

23 the House of Representatives and the Committee on the 

24 Judiciary of the Senate regarding a potential amendment 

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1 sion Act, an additional exclusion for consideration granted 

2 by an NDA holder or biological product license holder to 

3 the ANDA filer or biosimilar biological product application 

4 filer, respectively, as part of the resolution or settlement, 

5 a release, waiver, or limitation of a claim for damages or 

6 other monetary relief. 

7 SEC. 9. STATUTE OF LIMITATIONS. 

8 The Federal Trade Commission shall commence any 

9 enforcement proceeding described in section 27 of the 

10 Federal Trade Commission Act, as added by section 3, ex11 cept for an action described in section 27(f)(2) of the Fed12 eral Trade Commission Act, not later than 6 years after 

13 the date on which the parties to the agreement file the 

14 certification under section 1112(d) of the Medicare Pre15 scription Drug, Improvement, and Modernization Act of 

16 2003 (21 U.S.C. 355 note). 

17 SEC. 10. SEVERABILITY. 

18 If any provision of this Act, an amendment made by 

19 this Act, or the application of such provision or amend20 ment to any person or circumstance is held to be unconsti21 tutional, the remainder of this Act, the amendments made 

22 by this Act, and the application of the provisions of such 

23 Act or amendments to any person or circumstance shall 

24 not be affected. 


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Union Calendar No. 576 

116TH CONGRESS 

2D SESSION H. R. 2375 

[Report No. 116–693, Part I] 

A BILL 

To prohibit prescription drug companies from comproduct into the market. logical product, or interchangeable biological delay the entry of a generic drug, biosimilar bio- pensating other prescription drug companies to 

DECEMBER 24, 2020 

Reported from the Committee on the Judiciary 

DECEMBER 24, 2020 

Committee on Energy and Commerce discharged; comState of the Union and ordered to be printed mitted to the Committee of the Whole House on the 


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