I 

116TH CONGRESS 

1ST SESSION H. R. 1499 

To prohibit brand name drug manufacturers from compensating generic drug 

manufacturers to delay the entry of a generic drug into the market, 

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

biosimilar and interchangeable products, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 5, 2019 

Mr. RUSH introduced the following bill; which was referred to the Committee 

on Energy and Commerce, and in addition to the Committee on the Judiciary, 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 brand name drug manufacturers from compensating generic drug manufacturers to delay the entry 

of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to 

delay entry of biosimilar and interchangeable products, 

and for other purposes. 

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


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Protecting Consumer 

3 Access to Generic Drugs Act of 2019’’. 

4 SEC. 2. UNLAWFUL AGREEMENTS. 

5 (a) AGREEMENTS PROHIBITED.—Subject to sub6 sections (b) and (c), it shall be unlawful for an NDA or 

7 BLA holder and a subsequent filer to enter into, or carry 

8 out, an agreement resolving or settling a covered patent 

9 infringement claim on a final or interim basis if under 

10 such agreement— 

11 (1) a subsequent filer directly or indirectly re12 ceives from such holder anything of value, including 

13 an exclusive license; and 

14 (2) the subsequent filer agrees to limit or fore15 go research on, or development, manufacturing, 

16 marketing, or sales, for any period of time, of the 

17 covered product that is the subject of the application 

18 described in subparagraph (A) or (B) of subsection 

19 (f)(8). 

20 (b) EXCLUSION.—It shall not be unlawful under sub21 section (a) if a party to an agreement described in such 

22 subsection demonstrates by clear and convincing evidence 

23 that the value described in subsection (a)(1) is compensa24 tion solely for other goods or services that the subsequent 

25 filer has promised to provide. 


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1 (c) LIMITATION.—Nothing in this section shall pro2 hibit an agreement resolving or settling a covered patent 

3 infringement claim in which the consideration granted by 

4 the NDA or BLA holder to the subsequent filer as part 

5 of the resolution or settlement includes only one or more 

6 of the following: 

7 (1) The right to market the covered product 

8 that is the subject of the application described in 

9 subparagraph (A) or (B) of subsection (f)(8) in the 

10 United States before the expiration of— 

11 (A) any patent that is the basis of the cov12 ered patent infringement claim; or 

13 (B) any patent right or other statutory ex14 clusivity that would prevent the marketing of 

15 such covered product. 

16 (2) A payment for reasonable litigation ex17 penses not to exceed $7,500,000 in the aggregate. 

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

19 such covered product infringes a patent. 

20 (d) ENFORCEMENT BY FEDERAL TRADE COMMIS21 SION.— 

22 (1) GENERAL APPLICATION.—The requirements 

23 of this section apply, according to their terms, to an 

24 NDA or BLA holder or subsequent filer that is— 


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1 (A) a person, partnership, or corporation 

2 over which the Commission has authority pur3 suant to section 5(a)(2) of the Federal Trade 

4 Commission Act (15 U.S.C. 45(a)(2)); or 

5 (B) a person, partnership, or corporation 

6 over which the Commission would have author7 ity pursuant to such section but for the fact 

8 that such person, partnership, or corporation is 

9 not organized to carry on business for its own 

10 profit or that of its members. 

11 (2) UNFAIR OR DECEPTIVE ACTS OR PRACTICES

12 ENFORCEMENT AUTHORITY.— 

13 (A) IN GENERAL.—A violation of this sec14 tion shall be treated as an unfair or deceptive 

15 act or practice in violation of section 5(a)(1) of 

16 the Federal Trade Commission Act (15 U.S.C. 

17 45(a)(1)). 

18 (B) POWERS OF COMMISSION.—Except as 

19 provided in subparagraph (C) and paragraphs 

20 (1)(B) and (3)— 

21 (i) the Commission shall enforce this 

22 section in the same manner, by the same 

23 means, and with the same jurisdiction, 

24 powers, and duties as though all applicable 

25 terms and provisions of the Federal Trade 


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1 Commission Act (15 U.S.C. 41 et seq.) 

2 were incorporated into and made a part of 

3 this section; and 

4 (ii) any NDA or BLA holder or subse5 quent filer that violates this section shall 

6 be subject to the penalties and entitled to 

7 the privileges and immunities provided in 

8 the Federal Trade Commission Act. 

9 (C) JUDICIAL REVIEW.—In the case of a 

10 cease and desist order issued by the Commis11 sion under section 5 of the Federal Trade Com12 mission Act (15 U.S.C. 45) for violation of this 

13 section, a party to such order may obtain judi14 cial review of such order as provided in such 

15 section 5, except that— 

16 (i) such review may only be obtained 

17 in— 

18 (I) the United States Court of 

19 Appeals for the District of Columbia 

20 Circuit; 

21 (II) the United States Court of 

22 Appeals for the circuit in which the 

23 ultimate parent entity, as defined in 

24 section 801.1(a)(3) of title 16, Code 

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1 cessor thereto, of the NDA or BLA 

2 holder is incorporated as of the date 

3 that the application described in sub4 paragraph (A) or (B) of subsection 

5 (f)(8) is submitted to the Commis6 sioner of Food and Drugs; or 

7 (III) the United States Court of 

8 Appeals for the circuit in which the 

9 ultimate parent entity, as so defined, 

10 of the subsequent filer is incorporated 

11 as of the date that the application de12 scribed in subparagraph (A) or (B) of 

13 subsection (f)(8) is submitted to the 

14 Commissioner of Food and Drugs; 

15 and 

16 (ii) the petition for review shall be 

17 filed in the court not later than 30 days 

18 after such order is served on the party 

19 seeking review. 

20 (3) ADDITIONAL ENFORCEMENT AUTHORITY.— 

21 (A) CIVIL PENALTY.—The Commission 

22 may commence a civil action to recover a civil 

23 penalty in a district court of the United States 

24 against any NDA or BLA holder or subsequent 

25 filer that violates this section. 


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1 (B) SPECIAL RULE FOR RECOVERY OF

2 PENALTY IF CEASE AND DESIST ORDER

3 ISSUED.— 

4 (i) IN GENERAL.—If the Commission 

5 has issued a cease and desist order in a 

6 proceeding under section 5 of the Federal 

7 Trade Commission Act (15 U.S.C. 45) for 

8 violation of this section— 

9 (I) the Commission may com10 mence a civil action under subpara11 graph (A) to recover a civil penalty 

12 against any party to such order at 

13 any time before the expiration of the 

14 1-year period beginning on the date 

15 on which such order becomes final 

16 under section 5(g) of such Act (15 

17 U.S.C. 45(g)); and 

18 (II) in such civil action, the find19 ings of the Commission as to the ma20 terial facts in such proceeding shall be 

21 conclusive, unless— 

22 (aa) the terms of such order 

23 expressly provide that the Com24 mission’s findings shall not be 

25 conclusive; or 


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1 (bb) such order became final 

2 by reason of section 5(g)(1) of 

3 such Act (15 U.S.C. 45(g)(1)), in 

4 which case such findings shall be 

5 conclusive if supported by evi6 dence. 

7 (ii) RELATIONSHIP TO PENALTY FOR

8 VIOLATION OF AN ORDER.—The penalty 

9 provided in clause (i) for violation of this 

10 section is separate from and in addition to 

11 any penalty that may be incurred for viola12 tion of an order of the Commission under 

13 section 5(l) of the Federal Trade Commis14 sion Act (15 U.S.C. 45(l)). 

15 (C) AMOUNT OF PENALTY.— 

16 (i) IN GENERAL.—The amount of a 

17 civil penalty imposed in a civil action under 

18 subparagraph (A) on a party to an agree19 ment described in subsection (a) shall be 

20 sufficient to deter violations of this section, 

21 but in no event greater than— 

22 (I) if such party is the NDA or 

23 BLA holder, the greater of— 

24 (aa) 3 times the value re25 ceived by such NDA or BLA 


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1 holder that is reasonably attrib2 utable to the violation of this sec3 tion; or 

4 (bb) 3 times the value given 

5 to the subsequent filer reasonably 

6 attributable to the violation of 

7 this section; and 

8 (II) if such party is the subse9 quent filer, 3 times the value received 

10 by such subsequent filer that is rea11 sonably attributable to the violation of 

12 this section. 

13 (ii) FACTORS FOR CONSIDERATION.— 

14 In determining such amount, the court 

15 shall take into account— 

16 (I) the nature, circumstances, ex17 tent, and gravity of the violation; 

18 (II) with respect to the violator, 

19 the degree of culpability, any history 

20 of violations, the ability to pay, any 

21 effect on the ability to continue doing 

22 business, profits earned by the NDA 

23 or BLA holder, compensation received 

24 by the subsequent filer, and the 

25 amount of commerce affected; and 


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1 (III) other matters that justice 

2 requires. 

3 (D) INJUNCTIONS AND OTHER EQUITABLE

4 RELIEF.—In a civil action under subparagraph 

5 (A), the United States district courts are em6 powered to grant mandatory injunctions and 

7 such other and further equitable relief as they 

8 deem appropriate. 

9 (4) REMEDIES IN ADDITION.—Remedies pro10 vided in this subsection are in addition to, and not 

11 in lieu of, any other remedy provided by Federal 

12 law. 

13 (5) PRESERVATION OF AUTHORITY OF COMMIS14 SION.—Nothing in this section shall be construed to 

15 affect any authority of the Commission under any 

16 other provision of law. 

17 (e) ANTITRUST LAWS.—Nothing in this section shall 

18 modify, impair, limit, or supersede the applicability of the 

19 antitrust laws as defined in subsection (a) of the first sec20 tion of the Clayton Act (15 U.S.C. 12(a)), and of section 

21 5 of the Federal Trade Commission Act (15 U.S.C. 45) 

22 to the extent that such section 5 applies to unfair methods 

23 of competition. Nothing in this section shall modify, im24 pair, limit, or supersede the right of a subsequent filer 

25 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) DEFINITIONS.—In this section: 

4 (1) AGREEMENT RESOLVING OR SETTLING A

5 COVERED PATENT INFRINGEMENT CLAIM.—The 

6 term ‘‘agreement resolving or settling a covered pat7 ent infringement claim’’ means any agreement 

8 that— 

9 (A) resolves or settles a covered patent in10 fringement claim; or 

11 (B) is contingent upon, provides for a con12 tingent condition for, or is otherwise related to 

13 the resolution or settlement of a covered patent 

14 infringement claim. 

15 (2) COMMISSION.—The term ‘‘Commission’’ 

16 means the Federal Trade Commission. 

17 (3) COVERED PATENT INFRINGEMENT CLAIM.— 

18 The term ‘‘covered patent infringement claim’’ 

19 means an allegation made by the NDA or BLA hold20 er to a subsequent filer, whether or not included in 

21 a complaint filed with a court of law, that— 

22 (A) the submission of the application de23 scribed in clause (i) or (ii) of paragraph (5)(A), 

24 or the manufacture, use, offering for sale, sale, 

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1 ered product that is the subject of such an ap2 plication, infringes any patent owned by, or ex3 clusively licensed to, the NDA or BLA holder of 

4 the covered product; or 

5 (B) the covered product to be manufac6 tured under such application uses a covered 

7 product as claimed in a published patent appli8 cation. 

9 (4) COVERED PRODUCT.—The term ‘‘covered 

10 product’’ means— 

11 (A) a new drug (as defined in section 

12 201(p) of the Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 321(p))); or 

14 (B) a biological product (as defined in sec15 tion 351(i) of the Public Health Service Act (42 

16 U.S.C. 262(i))). 

17 (5) NDA OR BLA HOLDER.—The term ‘‘NDA 

18 or BLA holder’’ means— 

19 (A) the holder of— 

20 (i) an approved new drug application 

21 filed under section 505(b)(1) of the Fed22 eral Food, Drug, and Cosmetic Act (21 

23 U.S.C. 355(b)(1)) for a covered product; 

24 or 


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1 (ii) an application approved under sec2 tion 351(a) of the Public Health Service 

3 Act (42 U.S.C. 262(a)) with respect to a 

4 biological product; 

5 (B) a person owning or controlling enforce6 ment of the patent on— 

7 (i) the list published under section 

8 505(j)(7) of the Federal Food, Drug, and 

9 Cosmetic Act (21 U.S.C. 355(j)(7)) in con10 nection with the application described in 

11 subparagraph (A)(i); or 

12 (ii) the equivalent list published under 

13 section 351 of the Public Health Service 

14 Act (42 U.S.C. 262) comprised of patents 

15 associated with applications filed under 

16 section 351(a) of such Act (42 U.S.C. 

17 262(a)); or 

18 (C) the predecessors, subsidiaries, divi19 sions, groups, and affiliates controlled by, con20 trolling, or under common control with any en21 tity described in subparagraph (A) or (B) (such 

22 control to be presumed by direct or indirect 

23 share ownership of 50 percent or greater), as 

24 well as the licensees, licensors, successors, and 

25 assigns of each of the entities. 


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1 (6) PATENT.—The term ‘‘patent’’ means a pat2 ent issued by the United States Patent and Trade3 mark Office. 

4 (7) STATUTORY EXCLUSIVITY.—The term 

5 ‘‘statutory exclusivity’’ means those prohibitions on 

6 the approval of drug applications under clauses (ii) 

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

8 data exclusivity), section 505(j)(5)(B)(iv) (180-day 

9 exclusivity), section 527 (orphan drug exclusivity), 

10 section 505A (pediatric exclusivity), or section 505E 

11 (qualified infectious disease product exclusivity) of 

12 the Federal Food, Drug, and Cosmetic Act (21 

13 U.S.C. 355(c)(3)(E), 355(j)(5)(B)(iv), 360cc, 355a, 

14 355f), or section 351(k)(6) (interchangeable biologi15 cal product exclusivity) or section 351(k)(7) (biologi16 cal product reference product exclusivity) of the 

17 Public Health Service Act (42 U.S.C. 262(k)(6), 

18 (7)). 

19 (8) SUBSEQUENT FILER.—The term ‘‘subse20 quent filer’’ means— 

21 (A) in the case of a drug, a party that 

22 owns or controls an abbreviated new drug appli23 cation filed under section 505(j) of the Federal 

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

25 355(j)) or a new drug application filed under 


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1 section 505(b)(2) of such Act (21 U.S.C. 

2 355(b)(2)) or has the exclusive rights to dis3 tribute the covered product that is the subject 

4 of such application; or 

5 (B) in the case of a biological product, a 

6 party that owns or controls an application filed 

7 with the Food and Drug Administration under 

8 section 351(k) of the Public Health Service Act 

9 (42 U.S.C. 262(k)) or has the exclusive rights 

10 to distribute the biological product that is the 

11 subject of such application. 

12 (g) EFFECTIVE DATE.—This section shall apply to 

13 all agreements described in subsection (a) entered into 

14 after June 17, 2013, except that a civil penalty may only 

15 be obtained under subsection (d)(3)(A) with respect to 

16 such an agreement entered into on or after the date of 

17 enactment of this Act. 

18 SEC. 3. NOTICE AND CERTIFICATION OF AGREEMENTS. 

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

20 of the Medicare Prescription Drug, Improvement, and 

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

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

23 a claim of infringement could reasonably be asserted 

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1 uct that is the subject of a biosimilar biological product 

2 application’’ before the period at the end. 

3 (b) CERTIFICATION OF AGREEMENTS.—Section 1112 

4 of such Act (21 U.S.C. 355 note) is amended by adding 

5 at the end the following: 

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

7 or the company official responsible for negotiating any 

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

9 be filed under subsection (c) shall, within 30 days of such 

10 filing, execute and file with the Assistant Attorney General 

11 and the Commission a certification as follows: ‘I declare 

12 that the following is true, correct, and complete to the best 

13 of my knowledge: The materials filed with the Federal 

14 Trade Commission and the Department of Justice under 

15 section 1112 of the Medicare Prescription Drug, Improve16 ment, and Modernization Act of 2003, with respect to the 

17 agreement referenced in this certification— 

18 ‘‘ ‘(1) represent the complete, final, and exclu19 sive agreement between the parties; 

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

21 contingent upon, provide a contingent condition for, 

22 were entered into within 30 days of, or are otherwise 

23 related to, the referenced agreement; and 

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

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1 ises between the parties that are responsive to sub2 section (a) or (b) of such section 1112 and have not 

3 been reduced to writing.’.’’. 

4 SEC. 4. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD. 

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

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

7 is amended by inserting ‘‘section 2 of the Protecting Con8 sumer Access to Generic Drugs Act of 2019 or’’ after 

9 ‘‘that the agreement has violated’’. 

10 SEC. 5. COMMISSION LITIGATION AUTHORITY. 

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

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

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

14 the semicolon; 

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

16 after the semicolon; and 

17 (3) by inserting after subparagraph (E) the fol18 lowing: 

19 ‘‘(F) under section 2(d)(3)(A) of the Pro20 tecting Consumer Access to Generic Drugs Act 

21 of 2019;’’. 

22 SEC. 6. STATUTE OF LIMITATIONS. 

23 (a) IN GENERAL.—Except as provided in subsection 

24 (b), the Commission shall commence any administrative 

25 proceeding or civil action to enforce section 2 of this Act 


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1 not later than 6 years after the date on which the parties 

2 to the agreement file the Notice of Agreement as provided 

3 by section 1112(c)(2) and (d) of the Medicare Prescription 

4 Drug Improvement and Modernization Act of 2003 (21 

5 U.S.C. 355 note). 

6 (b) CIVIL ACTION AFTER ISSUANCE OF CEASE AND

7 DESIST ORDER.—If the Commission has issued a cease 

8 and desist order under section 5 of the Federal Trade 

9 Commission Act (15 U.S.C. 45) for violation of section 

10 2 of this Act and the proceeding for the issuance of such 

11 order was commenced within the period required by sub12 section (a) of this section, such subsection does not pro13 hibit the commencement, after such period, of a civil ac14 tion under section 2(d)(3)(A) against a party to such 

15 order or a civil action under subsection (l) of such section 

16 5 for violation of such order. 

Æ 


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