I 

116TH CONGRESS 

1ST SESSION H. R. 2375 

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 

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. 

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’’. 


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1 SEC. 2. DECLARATION OF PURPOSES. 

2 The purposes of this Act are— 

3 (1) to enhance competition in the pharma4 ceutical market by stopping anticompetitive agree5 ments between manufacturers of brand name and 

6 generic drug products or biosimilar biological prod7 ucts, or among manufacturers of generic drug prod8 ucts or biosimilar biological products, that limit, 

9 delay, or otherwise prevent competition from generic 

10 drugs and biosimilar biological products; and 

11 (2) to support the purpose and intent of anti12 trust law by prohibiting anticompetitive practices in 

13 the pharmaceutical industry that harm consumers. 

14 SEC. 3. UNLAWFUL COMPENSATION FOR DELAY. 

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

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

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

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

19 AND BIOSIMILARS. 

20 ‘‘(a) IN GENERAL.— 

21 ‘‘(1) ENFORCEMENT PROCEEDING.—The Com22 mission may initiate a proceeding to enforce the pro23 visions of this section against the parties to any 

24 agreement resolving or settling, on a final or interim 

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

26 a drug product or biological product. 


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1 ‘‘(2) PRESUMPTION AND VIOLATION.— 

2 ‘‘(A) IN GENERAL.—Subject to subpara3 graph (B), in such a proceeding, an agreement 

4 shall be presumed to have anticompetitive ef5 fects and shall be a violation of this section if— 

6 ‘‘(i) an ANDA filer or a biosimilar bi7 ological product application filer receives 

8 anything of value, including an exclusive li9 cense; and 

10 ‘‘(ii) the ANDA filer or biosimilar bio11 logical product application filer agrees to 

12 limit or forgo research, development, man13 ufacturing, marketing, or sales of the 

14 ANDA product or biosimilar biological 

15 product, as applicable, for any period of 

16 time. 

17 ‘‘(B) EXCEPTION.—Subparagraph (A) 

18 shall not apply if the parties to such agreement 

19 demonstrate by clear and convincing evidence 

20 that— 

21 ‘‘(i) the value described in subpara22 graph (A)(i) is compensation solely for 

23 other goods or services that the ANDA 

24 filer or biosimilar biological product appli25 cation filer has promised to provide; or 


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1 ‘‘(ii) the procompetitive benefits of the 

2 agreement outweigh the anticompetitive ef3 fects of the agreement. 

4 ‘‘(b) LIMITATIONS.—In determining whether the set5 tling parties have met their burden under subsection 

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

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

8 the expiration of the relevant patent or statutory ex9 clusivity; or 

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

11 the ANDA product or biosimilar biological product 

12 prior to the expiration of the relevant patent or stat13 utory exclusivity means that the agreement is pro14 competitive. 

15 ‘‘(c) EXCLUSIONS.—Nothing in this section shall pro16 hibit a resolution or settlement of a patent infringement 

17 claim in which the consideration that the ANDA filer or 

18 biosimilar biological product application filer receives as 

19 part of the resolution or settlement includes only one or 

20 more of the following: 

21 ‘‘(1) The right to market and secure final regu22 latory approval for the ANDA product or biosimilar 

23 biological product at a date, whether certain or con24 tingent, in the United States prior to the expiration 

25 of— 


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

2 patent infringement claim; or 

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

4 exclusivity that would prevent the marketing of 

5 such ANDA product or biosimilar biological 

6 product. 

7 ‘‘(2) A payment for reasonable litigation ex8 penses not to exceed— 

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

10 and 

11 ‘‘(B) for calendar year 2020 and each cal12 endar year thereafter, the amount determined 

13 for the preceding calendar year adjusted to re14 flect the percentage increase (if any) in the 

15 Producer Price Index for Legal Services pub16 lished by the Bureau of Labor Statistics of the 

17 Department of Labor for the then most recent 

18 12-month period ending December 31. 

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

20 the ANDA product or biosimilar biological product 

21 infringes a United States patent. 

22 ‘‘(d) ENFORCEMENT.— 

23 ‘‘(1) ENFORCEMENT.—A violation of this sec24 tion shall be treated as an unfair method of competiVerDate Sep 11 2014 01:50 Apr 30, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2375.IH H2375

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1 tion under section 5(a)(1) of the Federal Trade 

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

3 ‘‘(2) JUDICIAL REVIEW.— 

4 ‘‘(A) IN GENERAL.—Any party that is sub5 ject to a final order of the Commission, issued 

6 in an administrative adjudicative proceeding 

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

8 within 30 days of the issuance of such order, 

9 petition for review of such order in— 

10 ‘‘(i) the United States Court of Ap11 peals for the District of Columbia Circuit; 

12 ‘‘(ii) the United States Court of Ap13 peals for the circuit in which the ultimate 

14 parent entity, as defined in section 

15 801.1(a)(3) of title 16, Code of Federal 

16 Regulations, or any successor thereto, of 

17 the NDA holder or biological product li18 cense holder is incorporated as of the date 

19 that the NDA or biological product license 

20 application, as applicable, is filed with the 

21 Commissioner of Food and Drugs; or 

22 ‘‘(iii) the United States Court of Ap23 peals for the circuit in which the ultimate 

24 parent entity of the ANDA filer or bio25 similar biological product application filer 


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1 is incorporated as of the date that the 

2 ANDA or biosimilar biological product ap3 plication is filed with the Commissioner of 

4 Food and Drugs. 

5 ‘‘(B) TREATMENT OF FINDINGS.—In a 

6 proceeding for judicial review of a final order of 

7 the Commission, the findings of the Commis8 sion as to the facts, if supported by evidence, 

9 shall be conclusive. 

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

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

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

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

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

15 to unfair methods of competition. Nothing in this section 

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

17 ANDA filer or biosimilar biological product application 

18 filer to assert claims or counterclaims against any person, 

19 under the antitrust laws or other laws relating to unfair 

20 competition. 

21 ‘‘(f) PENALTIES.— 

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

23 assists in the violation of this section shall forfeit 

24 and pay to the United States a civil penalty suffi25 cient to deter violations of this section, but in no 


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1 event greater than 3 times the value received by the 

2 party that is reasonably attributable to the violation 

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

4 the NDA holder, biological product license holder, 

5 the ANDA filer, or biosimilar biological product ap6 plication filer the penalty to the NDA holder, bio7 logical product license holder, the ANDA filer, or 

8 biosimilar biological product application filer shall be 

9 sufficient to deter violations, but in no event greater 

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

11 biosimilar biological product application filer reason12 ably attributable to the violation of this section. 

13 Such penalty shall accrue to the United States and 

14 may be recovered in a civil action brought by the 

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

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

17 of the United States against any party that violates 

18 this section. In such actions, the United States dis19 trict courts are empowered to grant mandatory in20 junctions and such other and further equitable relief 

21 as they deem appropriate. 

22 ‘‘(2) CEASE AND DESIST.— 

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

24 issued a cease and desist order with respect to 

25 a party in an administrative adjudicative proVerDate Sep 11 2014 00:28 Apr 30, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H2375.IH H2375

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1 ceeding under the authority of subsection 

2 (a)(1), an action brought pursuant to para3 graph (1) may be commenced against such 

4 party at any time before the expiration of 1 

5 year after such order becomes final pursuant to 

6 section 5(g). 

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

8 subparagraph (A), the findings of the Commis9 sion as to the material facts in the administra10 tive adjudicative proceeding with respect to the 

11 violation of this section by a party shall be con12 clusive unless— 

13 ‘‘(i) the terms of such cease and de14 sist order expressly provide that the Com15 mission’s findings shall not be conclusive; 

16 or 

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

18 of section 5(g)(1), in which case such find19 ing shall be conclusive if supported by evi20 dence. 

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

22 amount of the civil penalty described in this section, 

23 the court shall take into account— 

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

25 and gravity of the violation; 


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1 ‘‘(B) with respect to the violator, the de2 gree of culpability, any history of violations, the 

3 ability to pay, any effect on the ability to con4 tinue doing business, profits earned by the 

5 NDA holder, biological product license holder, 

6 the ANDA filer, or biosimilar biological product 

7 application filer, compensation received by the 

8 ANDA filer or biosimilar biological product ap9 plication filer, and the amount of commerce af10 fected; and 

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

12 ‘‘(4) REMEDIES IN ADDITION.—Remedies pro13 vided in this subsection are in addition to, and not 

14 in lieu of, any other remedy provided by Federal 

15 law. Nothing in this paragraph shall be construed to 

16 affect any authority of the Commission under any 

17 other provision of law. 

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

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

20 means anything that would constitute an agreement 

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

22 or section 5 of this Act. 

23 ‘‘(2) AGREEMENT RESOLVING OR SETTLING A

24 PATENT INFRINGEMENT CLAIM.—The term ‘agree25 ment resolving or settling a patent infringement 


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1 claim’ includes any agreement that is entered into 

2 within 30 days of the resolution or the settlement of 

3 the claim, or any other agreement that is contingent 

4 upon, provides a contingent condition for, or is oth5 erwise related to the resolution or settlement of the 

6 claim. 

7 ‘‘(3) ANDA.—The term ‘ANDA’ means an ab8 breviated new drug application filed under section 

9 505(j) of the Federal Food, Drug, and Cosmetic Act 

10 (21 U.S.C. 355(j)) or a new drug application filed 

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

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

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

14 means a party that owns or controls an ANDA filed 

15 with the Food and Drug Administration or has the 

16 exclusive rights under such ANDA to distribute the 

17 ANDA product. 

18 ‘‘(5) ANDA PRODUCT.—The term ‘ANDA 

19 product’ means the product to be manufactured 

20 under the ANDA that is the subject of the patent 

21 infringement claim. 

22 ‘‘(6) BIOLOGICAL PRODUCT.—The term ‘bio23 logical product’ has the meaning given such term in 

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

25 (42 U.S.C. 262(i)(1)). 


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1 ‘‘(7) BIOLOGICAL PRODUCT LICENSE APPLICA2 TION.—The term ‘biological product license applica3 tion’ means an application under section 351(a) of 

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

5 ‘‘(8) BIOLOGICAL PRODUCT LICENSE HOLD6 ER.—The term ‘biological product license holder’ 

7 means— 

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

9 product license application for a biological prod10 uct; 

11 ‘‘(B) a person owning or controlling en12 forcement of any patents that claim the biologi13 cal product that is the subject of such approved 

14 application; or 

15 ‘‘(C) the predecessors, subsidiaries, divi16 sions, groups, and affiliates controlled by, con17 trolling, or under common control with any of 

18 the entities described in subparagraphs (A) and 

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

20 indirect share ownership of 50 percent or great21 er), as well as the licensees, licensors, succes22 sors, and assigns of each of the entities. 

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

24 term ‘biosimilar biological product’ means the prod25 uct to be manufactured under the biosimilar biologiVerDate Sep 11 2014 00:28 Apr 30, 2019 Jkt 089200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H2375.IH H2375

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1 cal product application that is the subject of the pat2 ent infringement claim. 

3 ‘‘(10) BIOSIMILAR BIOLOGICAL PRODUCT APPLI4 CATION.—The term ‘biosimilar biological product ap5 plication’ means an application under section 351(k) 

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

7 for licensure of a biological product as biosimilar to, 

8 or interchangeable with, a reference product. 

9 ‘‘(11) BIOSIMILAR BIOLOGICAL PRODUCT APPLI10 CATION FILER.—The term ‘biosimilar biological 

11 product application filer’ means a party that owns or 

12 controls a biosimilar biological product application 

13 filed with the Food and Drug Administration or has 

14 the exclusive rights under such application to dis15 tribute the biosimilar biological product. 

16 ‘‘(12) DRUG PRODUCT.—The term ‘drug prod17 uct’ has the meaning given such term in section 

18 314.3(b) of title 21, Code of Federal Regulations (or 

19 any successor regulation). 

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

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

22 product. 

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

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


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

2 355(b)). 

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

4 means— 

5 ‘‘(A) the holder of an approved NDA appli6 cation for a drug product; 

7 ‘‘(B) a person owning or controlling en8 forcement of the patent listed in the Approved 

9 Drug Products With Therapeutic Equivalence 

10 Evaluations (commonly known as the ‘FDA Or11 ange Book’) in connection with the NDA; or 

12 ‘‘(C) the predecessors, subsidiaries, divi13 sions, groups, and affiliates controlled by, con14 trolling, or under common control with any of 

15 the entities described in subparagraphs (A) and 

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

17 indirect share ownership of 50 percent or great18 er), as well as the licensees, licensors, succes19 sors, and assigns of each of the entities. 

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

21 person, partnership, corporation, or other legal enti22 ty. 

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

24 ‘patent infringement’ means infringement of any 

25 patent or of any filed patent application, including 


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1 any extension, reissue, renewal, division, continu2 ation, continuation in part, reexamination, patent 

3 term restoration, patents of addition, and extensions 

4 thereof. 

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

6 term ‘patent infringement claim’ means any allega7 tion made to an ANDA filer or biosimilar biological 

8 product application filer, whether or not included in 

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

10 or ANDA product, or biological product license ap11 plication or biological product, may infringe any pat12 ent held by, or exclusively licensed to, the NDA 

13 holder or biological product license holder, biological 

14 product license holder, the ANDA filer, or biosimilar 

15 biological product application filer of the drug prod16 uct or biological product, as applicable. 

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

18 ‘statutory exclusivity’ means those prohibitions on 

19 the approval of drug applications under clauses (ii) 

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

21 data exclusivity), section 527 (orphan drug exclu22 sivity), or section 505A (pediatric exclusivity) of the 

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

24 355(c)(3)(E), 360cc, 355a), or on the licensing of 

25 biological product applications under section 


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1 351(k)(7) (12-year exclusivity) or paragraph (2) or 

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

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

4 section 527 of the Federal Food, Drug, and Cos5 metic Act (orphan drug exclusivity).’’. 

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

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

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

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

10 of this Act. 

11 SEC. 4. NOTICE AND CERTIFICATION OF AGREEMENTS. 

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

13 of the Medicare Prescription Drug, Improvement, and 

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

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

16 a claim of infringement could reasonably be asserted 

17 against any person for making, using, offering to sell, sell18 ing, or importing into the United States a biological prod19 uct that is the subject of a biosimilar biological product 

20 application’’ before the period at the end. 

21 (b) CERTIFICATION OF AGREEMENTS.—Section 1112 

22 of the Medicare Prescription Drug, Improvement, and 

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

24 amended by adding at the end the following: 


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

2 or the company official responsible for negotiating any 

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

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

5 filing, shall execute and file with the Assistant Attorney 

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

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

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

9 Federal Trade Commission and the Department of Justice 

10 under section 1112 of subtitle B of title XI of the Medi11 care Prescription Drug, Improvement, and Modernization 

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

13 this certification— 

14 ‘‘ ‘(1) represent the complete, final, and exclu15 sive agreement between the parties; 

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

17 contingent upon, provide a contingent condition for, 

18 or are otherwise related to, the referenced agree19 ment; and 

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

21 agreements, representations, commitments, or prom22 ises between the parties that are responsive to sub23 section (a) or (b) of such section 1112 and have not 

24 been reduced to writing.’.’’. 


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1 SEC. 5. NOTIFICATION OF AGREEMENTS. 

2 Section 1112 of the Medicare Prescription Drug, Im3 provement, and Modernization Act of 2003 (21 U.S.C. 

4 355 note) is amended by adding at the end the following: 

5 ‘‘(4) RULE OF CONSTRUCTION.— 

6 ‘‘(A) An agreement that is required in sub7 section (a) or (b) shall include agreements re8 solving any outstanding disputes, including 

9 agreements resolving or settling a Patent Trial 

10 and Appeal Board proceeding. 

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

12 the term ‘Patent Trial and Appeal Board pro13 ceeding’ means a proceeding conducted by the 

14 United States Patent and Trademark Office 

15 Patent Trial and Appeal Board, including but 

16 not limited to inter parties review, post-grant 

17 review, the transitional program for covered 

18 business method patents, and derivation pro19 ceedings.’’. 

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

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

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

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

24 Commission Act or’’ after ‘‘that the agreement has vio25 lated’’. 


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1 SEC. 7. COMMISSION LITIGATION AUTHORITY. 

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

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

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

5 the semicolon; 

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

7 after the semicolon; and 

8 (3) inserting after subparagraph (E) the fol9 lowing: 

10 ‘‘(F) under section 27;’’. 

11 SEC. 8. REPORT ON ADDITIONAL EXCLUSION. 

12 Within 1 year of enactment, the Federal Trade Com13 mission shall provide a recommendation, and the Commis14 sion’s basis for it, to the Committee on the Judiciary of 

15 the House of Representatives and the Committee on the 

16 Judiciary of the Senate regarding a potential amendment 

17 to include in section 27(c) of the Federal Trade Commis18 sion Act, an additional exclusion for consideration granted 

19 by an NDA holder or biological product license holder to 

20 the ANDA filer or biosimilar biological product application 

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

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

23 other monetary relief. 

24 SEC. 9. STATUTE OF LIMITATIONS. 

25 The Federal Trade Commission shall commence any 

26 enforcement proceeding described in section 27 of the 


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1 Federal Trade Commission Act, as added by section 3, ex2 cept for an action described in section 27(f)(2) of the Fed3 eral Trade Commission Act, not later than 6 years after 

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

5 certification under section 1112(d) of the Medicare Pre6 scription Drug, Improvement, and Modernization Act of 

7 2003 (21 U.S.C. 355 note). 

8 SEC. 10. SEVERABILITY. 

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

10 this Act, or the application of such provision or amend11 ment to any person or circumstance is held to be unconsti12 tutional, the remainder of this Act, the amendments made 

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

14 Act or amendments to any person or circumstance shall 

15 not be affected. 

Æ 


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