II 

116TH CONGRESS 

1ST SESSION S. 64 

To prohibit brand name drug companies from compensating generic drug 

companies to delay the entry of a generic drug into the market, and 

to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar 

biological products and interchangeable biological products. 

IN THE SENATE OF THE UNITED STATES 

JANUARY 9, 2019 

Ms. KLOBUCHAR (for herself and Mr. GRASSLEY) introduced the following bill; 

which was read twice and referred to the Committee on the Judiciary 

A BILL 

To prohibit brand name drug companies from compensating 

generic drug companies to delay the entry of a generic 

drug into the market, and to prohibit biological product 

manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar 

biological products and interchangeable biological products. 

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. CONGRESSIONAL FINDINGS AND DECLARATION OF 

2 PURPOSES. 

3 (a) FINDINGS.—Congress finds the following: 

4 (1) In 1984, the Drug Price Competition and 

5 Patent Term Restoration Act (Public Law 98–417) 

6 (referred to in this Act as the ‘‘1984 Act’’), was en7 acted with the intent of facilitating the early entry 

8 of generic drugs while preserving incentives for inno9 vation. 

10 (2) Prescription drugs make up approximately 

11 10 percent of the national health care spending. 

12 (3) Initially, the 1984 Act was successful in fa13 cilitating generic competition to the benefit of con14 sumers and health care payers, although 88 percent 

15 of all prescriptions dispensed in the United States 

16 are generic drugs, they account for only 28 percent 

17 of all expenditures. 

18 (4) Generic drugs cost substantially less than 

19 brand name drugs, with discounts off the brand 

20 price averaging 80 to 85 percent. 

21 (5) Federal dollars currently account for over 

22 40 percent of the $325,000,000,000 spent on retail 

23 prescription drugs, and this share is expected to rise 

24 to 47 percent by 2025. 

25 (6)(A) In recent years, the intent of the 1984 

26 Act has been subverted by certain settlement agreeVerDate Sep 11 2014 03:24 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S64.IS S64

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1 ments in which brand name companies transfer 

2 value to their potential generic competitors to settle 

3 claims that the generic company is infringing the 

4 branded company’s patents. 

5 (B) These ‘‘reverse payment’’ settlement agree6 ments— 

7 (i) allow a branded company to share its 

8 monopoly profits with the generic company as a 

9 way to protect the branded company’s monop10 oly; and 

11 (ii) have unduly delayed the marketing of 

12 low-cost generic drugs contrary to free competi13 tion, the interests of consumers, and the prin14 ciples underlying antitrust law. 

15 (C) Because of the price disparity between 

16 brand name and generic drugs, such agreements are 

17 more profitable for both the brand and generic man18 ufacturers than competition and will become increas19 ingly common unless prohibited. 

20 (D) These agreements result in consumers los21 ing the benefits that the 1984 Act was intended to 

22 provide. 

23 (7) In 2010, the Biologics Price Competition 

24 and Innovation Act (Public Law 111–148) (referred 

25 to in this Act as the ‘‘BPCIA’’), was enacted with 


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1 the intent of facilitating the early entry of biosimilar 

2 and interchangeable follow-on versions of branded 

3 biological products while preserving incentives for in4 novation. 

5 (8) Biological drugs play an important role in 

6 treating many serious illnesses, from cancers to ge7 netic disorders. They are also expensive, rep8 resenting more than 40 percent of all prescription 

9 drug spending. 

10 (9) Competition from biosimilar and inter11 changeable biological products promises to lower 

12 drug costs and increase patient access to biological 

13 medicines. But ‘‘reverse payment’’ settlement agree14 ments also threaten to delay the entry of biosimilar 

15 and interchangeable biological products, which would 

16 undermine the goals of BPCIA. 

17 (b) PURPOSES.—The purposes of this Act are— 

18 (1) to enhance competition in the pharma19 ceutical market by stopping anticompetitive agree20 ments between brand name and generic drug and 

21 biosimilar biological product manufacturers that 

22 limit, delay, or otherwise prevent competition from 

23 generic drugs and biosimilar biological products; and 


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1 (2) to support the purpose and intent of anti2 trust law by prohibiting anticompetitive practices in 

3 the pharmaceutical industry that harm consumers. 

4 SEC. 3. UNLAWFUL COMPENSATION FOR DELAY. 

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

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

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

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

9 AND BIOSIMILARS. 

10 ‘‘(a) IN GENERAL.— 

11 ‘‘(1) ENFORCEMENT PROCEEDING.—The Com12 mission may initiate a proceeding to enforce the pro13 visions of this section against the parties to any 

14 agreement resolving or settling, on a final or interim 

15 basis, a patent infringement claim, in connection 

16 with the sale of a drug product or biological product. 

17 ‘‘(2) PRESUMPTION AND VIOLATION.— 

18 ‘‘(A) IN GENERAL.—Subject to subpara19 graph (B), in such a proceeding, an agreement 

20 shall be presumed to have anticompetitive ef21 fects and shall be a violation of this section if— 

22 ‘‘(i) an ANDA filer or a biosimilar bi23 ological product application filer receives 

24 anything of value, including an exclusive li25 cense; and 


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1 ‘‘(ii) the ANDA filer or biosimilar bio2 logical product application filer agrees to 

3 limit or forego research, development, 

4 manufacturing, marketing, or sales of the 

5 ANDA product or biosimilar biological 

6 product, as applicable, for any period of 

7 time. 

8 ‘‘(B) EXCEPTION.—Subparagraph (A) 

9 shall not apply if the parties to such agreement 

10 demonstrate by clear and convincing evidence 

11 that— 

12 ‘‘(i) the value described in subpara13 graph (A)(i) is compensation solely for 

14 other goods or services that the ANDA 

15 filer or biosimilar biological product appli16 cation filer has promised to provide; or 

17 ‘‘(ii) the procompetitive benefits of the 

18 agreement outweigh the anticompetitive ef19 fects of the agreement. 

20 ‘‘(b) LIMITATIONS.—In determining whether the set21 tling parties have met their burden under subsection 

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

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

24 the expiration of the relevant patent or statutory ex25 clusivity; or 


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

2 the ANDA product or biosimilar biological product 

3 prior to the expiration of the relevant patent or stat4 utory exclusivity means that the agreement is pro5 competitive. 

6 ‘‘(c) EXCLUSIONS.—Nothing in this section shall pro7 hibit a resolution or settlement of a patent infringement 

8 claim in which the consideration granted by the NDA 

9 holder or biological product license holder to the ANDA 

10 filer or biosimilar biological product application filer, re11 spectively, as part of the resolution or settlement includes 

12 only one or more of the following: 

13 ‘‘(1) The right to market the ANDA product or 

14 biosimilar biological product in the United States 

15 prior to the expiration of— 

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

17 patent infringement claim; or 

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

19 exclusivity that would prevent the marketing of 

20 such ANDA product or biosimilar biological 

21 product. 

22 ‘‘(2) A payment for reasonable litigation ex23 penses not to exceed $7,500,000. 


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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 a violation of section 5. 

7 ‘‘(2) JUDICIAL REVIEW.— 

8 ‘‘(A) IN GENERAL.—Any party that is sub9 ject to a final order of the Commission, issued 

10 in an administrative adjudicative proceeding 

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

12 within 30 days of the issuance of such order, 

13 petition for review of such order in— 

14 ‘‘(i) the United States Court of Ap15 peals for the District of Columbia Circuit; 

16 ‘‘(ii) the United States Court of Ap17 peals for the circuit in which the ultimate 

18 parent entity, as defined in section 

19 801.1(a)(3) of title 16, Code of Federal 

20 Regulations, or any successor thereto, of 

21 the NDA holder or biological product li22 cense holder is incorporated as of the date 

23 that the NDA or biological product license 

24 application, as applicable, is filed with the 

25 Commissioner of Food and Drugs; or 


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1 ‘‘(iii) the United States Court of Ap2 peals for the circuit in which the ultimate 

3 parent entity of the ANDA filer or bio4 similar biological product application filer 

5 is incorporated as of the date that the 

6 ANDA or biosimilar biological product ap7 plication is filed with the Commissioner of 

8 Food and Drugs. 

9 ‘‘(B) TREATMENT OF FINDINGS.—In a 

10 proceeding for judicial review of a final order of 

11 the Commission, the findings of the Commis12 sion as to the facts, if supported by evidence, 

13 shall be conclusive. 

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

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

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

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

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

19 to unfair methods of competition. Nothing in this section 

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

21 ANDA filer or biosimilar biological product application 

22 filer to assert claims or counterclaims against any person, 

23 under the antitrust laws or other laws relating to unfair 

24 competition. 

25 ‘‘(f) PENALTIES.— 


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

2 assists in the violation of this section shall forfeit 

3 and pay to the United States a civil penalty suffi4 cient to deter violations of this section, but in no 

5 event greater than 3 times the value received by the 

6 party that is reasonably attributable to the violation 

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

8 the NDA holder or biological product license holder, 

9 the penalty to the NDA holder or biological product 

10 license holder shall be sufficient to deter violations, 

11 but in no event greater than 3 times the value given 

12 to the ANDA filer or biosimilar biological product 

13 application filer reasonably attributable to the viola14 tion of this section. Such penalty shall accrue to the 

15 United States and may be recovered in a civil action 

16 brought by the Commission, in its own name by any 

17 of its attorneys designated by it for such purpose, in 

18 a district court of the United States against any 

19 party that violates this section. In such actions, the 

20 United States district courts are empowered to grant 

21 mandatory injunctions and such other and further 

22 equitable relief as they deem appropriate. 

23 ‘‘(2) CEASE AND DESIST.— 

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

25 issued a cease and desist order with respect to 


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1 a party in an administrative adjudicative pro2 ceeding under the authority of subsection 

3 (a)(1), an action brought pursuant to para4 graph (1) may be commenced against such 

5 party at any time before the expiration of 1 

6 year after such order becomes final pursuant to 

7 section 5(g). 

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

9 subparagraph (A), the findings of the Commis10 sion as to the material facts in the administra11 tive adjudicative proceeding with respect to the 

12 violation of this section by a party shall be con13 clusive unless— 

14 ‘‘(i) the terms of such cease and de15 sist order expressly provide that the Com16 mission’s findings shall not be conclusive; 

17 or 

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

19 of section 5(g)(1), in which case such find20 ing shall be conclusive if supported by evi21 dence. 

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

23 amount of the civil penalty described in this section, 

24 the court shall take into account— 


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

2 and gravity of the violation; 

3 ‘‘(B) with respect to the violator, the de4 gree of culpability, any history of violations, the 

5 ability to pay, any effect on the ability to con6 tinue doing business, profits earned by the 

7 NDA holder or biological product license holder, 

8 compensation received by the ANDA filer or 

9 biosimilar biological product application filer, 

10 and the amount of commerce affected; 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 03:24 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S64.IS S64

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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) NDA.—The term ‘NDA’ means a new 

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

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

23 355(b)). 

24 ‘‘(14) NDA HOLDER.—The term ‘NDA holder’ 

25 means— 


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1 ‘‘(A) the holder of an approved NDA appli2 cation for a drug product; 

3 ‘‘(B) a person owning or controlling en4 forcement of the patent listed in the Approved 

5 Drug Products With Therapeutic Equivalence 

6 Evaluations (commonly known as the ‘FDA Or7 ange Book’) in connection with the NDA; or 

8 ‘‘(C) the predecessors, subsidiaries, divi9 sions, groups, and affiliates controlled by, con10 trolling, or under common control with any of 

11 the entities described in subparagraphs (A) and 

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

13 indirect share ownership of 50 percent or great14 er), as well as the licensees, licensors, succes15 sors, and assigns of each of the entities. 

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

17 person, partnership, corporation, or other legal enti18 ty. 

19 ‘‘(16) PATENT INFRINGEMENT.—The term 

20 ‘patent infringement’ means infringement of any 

21 patent or of any filed patent application, extension, 

22 reissue, renewal, division, continuation, continuation 

23 in part, reexamination, patent term restoration, pat24 ents of addition, and extensions thereof. 


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1 ‘‘(17) PATENT INFRINGEMENT CLAIM.—The 

2 term ‘patent infringement claim’ means any allega3 tion made to an ANDA filer or biosimilar biological 

4 product application filer, whether or not included in 

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

6 or ANDA product, or biological product license ap7 plication or biological product, may infringe any pat8 ent held by, or exclusively licensed to, the NDA 

9 holder or biological product license holder of the 

10 drug product or biological product, as applicable. 

11 ‘‘(18) STATUTORY EXCLUSIVITY.—The term 

12 ‘statutory exclusivity’ means those prohibitions on 

13 the approval of drug applications under clauses (ii) 

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

15 data exclusivity), section 527 (orphan drug exclu16 sivity), or section 505A (pediatric exclusivity) of the 

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

18 355(c)(3)(E), 360cc, 355a), or on the licensing of 

19 biological product applications under section 

20 351(k)(7) (12-year exclusivity) or paragraph (2) or 

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

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

23 section 527 of the Federal Food, Drug, and Cos24 metic Act (orphan drug exclusivity).’’. 


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

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

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

4 that Act entered into after June 17, 2013. Section 27(f) 

5 of the Federal Trade Commission Act, as added by this 

6 section, shall apply to agreements entered into on or after 

7 the date of enactment of this Act. 

8 SEC. 4. CERTIFICATION 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 ‘‘(d) CERTIFICATION.—The Chief Executive Officer 

13 or the company official responsible for negotiating any 

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

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

16 filing, shall execute and file with the Assistant Attorney 

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

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

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

20 Federal Trade Commission and the Department of Justice 

21 under section 1112 of subtitle B of title XI of the Medi22 care Prescription Drug, Improvement, and Modernization 

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

24 this certification—’ 


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1 ‘‘(1) represent the complete, final, and exclusive 

2 agreement between the parties; 

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

4 contingent upon, provide a contingent condition for, 

5 or are otherwise related to, the referenced agree6 ment; and 

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

8 agreements, representations, commitments, or prom9 ises between the parties that are responsive to sub10 section (a) or (b) of such section 1112 and have not 

11 been reduced to writing.’’. 

12 SEC. 5. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD. 

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

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

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

16 Commission Act or’’ after ‘‘that the agreement has vio17 lated’’. 

18 SEC. 6. COMMISSION LITIGATION AUTHORITY. 

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

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

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

22 the semicolon; 

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

24 after the semicolon; and 


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1 (3) inserting after subparagraph (E) the fol2 lowing: 

3 ‘‘(F) under section 27;’’. 

4 SEC. 7. STATUTE OF LIMITATIONS. 

5 The Federal Trade Commission shall commence any 

6 enforcement proceeding described in section 27 of the 

7 Federal Trade Commission Act, as added by section 3, ex8 cept for an action described in section 27(f)(2) of the Fed9 eral Trade Commission Act, not later than 6 years after 

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

11 certification under section 1112(d) of the Medicare Pre12 scription Drug Improvement and Modernization Act of 

13 2003 (21 U.S.C. 355 note). 

14 SEC. 8. SEVERABILITY. 

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

16 this Act, or the application of such provision or amend17 ment to any person or circumstance is held to be unconsti18 tutional, the remainder of this Act, the amendments made 

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

20 Act or amendments to any person or circumstance shall 

21 not be affected. 

Æ 


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