IB 

Union Calendar No. 30 

116TH CONGRESS 

1ST SESSION H. R. 1499 

[Report No. 116–52, Part I] 

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 

MAY 10, 2019 

Additional sponsors: Mr. PALLONE, Mr. RUIZ, Mrs. DINGELL, Mrs. CRAIG, 

Ms. ESHOO, Mr. KENNEDY, Ms. MATSUI, Mr. VAN DREW, Ms. CLARKE

of New York, Mr. KHANNA, Ms. SCHAKOWSKY, Mr. PAPPAS, Mr. COHEN, 

Mr. WELCH, Mr. LARSON of Connecticut, Mr. HASTINGS, Mr. NEGUSE, 

Ms. FINKENAUER, Mr. CASE, Mr. QUIGLEY, Ms. WILD, Mr. LANGEVIN, 

Mr. COOPER, Mr. RASKIN, Mr. DAVID SCOTT of Georgia, Ms. 

MUCARSEL-POWELL, Mr. THOMPSON of Mississippi, Ms. STEVENS, Mr. 

CISNEROS, Ms. KELLY of Illinois, Mr. CASTEN of Illinois, Ms. 

HOULAHAN, Mr. CARSON of Indiana, Mr. CARBAJAL, Ms. DAVIDS of 

Kansas, Mr. SMITH of Washington, Mr. CONNOLLY, and Ms. UNDERWOOD


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MAY 10, 2019 

Reported from the Committee on Energy and Commerce with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

MAY 10, 2019 

Committee on the Judiciary discharged; committed to the Committee of the 

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

[For text of introduced bill, see copy of bill as introduced on March 5, 2019] 

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. 


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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 ‘‘Protecting Consumer 

5 Access to Generic Drugs Act of 2019’’. 

6 SEC. 2. UNLAWFUL AGREEMENTS. 

7 (a) AGREEMENTS PROHIBITED.—Subject to sub8 sections (b) and (c), it shall be unlawful for an NDA or 

9 BLA holder and a subsequent filer (or for two subsequent 

10 filers) to enter into, or carry out, an agreement resolving 

11 or settling a covered patent infringement claim on a final 

12 or interim basis if under such agreement— 

13 (1) a subsequent filer directly or indirectly re14 ceives from such holder (or in the case of such an 

15 agreement between two subsequent filers, the other 

16 subsequent filer) anything of value, including a li17 cense; and 

18 (2) the subsequent filer agrees to limit or forego 

19 research on, or development, manufacturing, mar20 keting, or sales, for any period of time, of the covered 

21 product that is the subject of the application described 

22 in subparagraph (A) or (B) of subsection (g)(8). 

23 (b) EXCLUSION.—It shall not be unlawful under sub24 section (a) if a party to an agreement described in such 

25 subsection demonstrates by clear and convincing evidence 


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1 that the value described in subsection (a)(1) is compensa2 tion solely for other goods or services that the subsequent 

3 filer has promised to provide. 

4 (c) LIMITATION.—Nothing in this section shall pro5 hibit an agreement resolving or settling a covered patent 

6 infringement claim in which the consideration granted by 

7 the NDA or BLA holder to the subsequent filer (or from 

8 one subsequent filer to another) as part of the resolution 

9 or settlement includes only one or more of the following: 

10 (1) The right to market the covered product that 

11 is the subject of the application described in subpara12 graph (A) or (B) of subsection (g)(8) in the United 

13 States before the expiration of— 

14 (A) any patent that is the basis of the cov15 ered patent infringement claim; or 

16 (B) any patent right or other statutory ex17 clusivity that would prevent the marketing of 

18 such covered product. 

19 (2) A payment for reasonable litigation expenses 

20 not to exceed $7,500,000 in the aggregate. 

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

22 covered product infringes a patent. 

23 (d) ENFORCEMENT BY FEDERAL TRADE COMMIS24 SION.— 


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1 (1) GENERAL APPLICATION.—The requirements 

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

3 NDA or BLA holder or subsequent filer that is— 

4 (A) a person, partnership, or corporation 

5 over which the Commission has authority pursu6 ant to section 5(a)(2) of the Federal Trade Com7 mission Act (15 U.S.C. 45(a)(2)); or 

8 (B) a person, partnership, or corporation 

9 over which the Commission would have authority 

10 pursuant to such section but for the fact that 

11 such person, partnership, or corporation is not 

12 organized to carry on business for its own profit 

13 or that of its members. 

14 (2) UNFAIR OR DECEPTIVE ACTS OR PRACTICES

15 ENFORCEMENT AUTHORITY.— 

16 (A) IN GENERAL.—A violation of this sec17 tion shall be treated as an unfair or deceptive 

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

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

20 45(a)(1)). 

21 (B) POWERS OF COMMISSION.—Except as 

22 provided in subparagraph (C) and paragraphs 

23 (1)(B) and (3)— 

24 (i) the Commission shall enforce this 

25 section in the same manner, by the same 


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1 means, and with the same jurisdiction, 

2 powers, and duties as though all applicable 

3 terms and provisions of the Federal Trade 

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

5 incorporated into and made a part of this 

6 section; and 

7 (ii) any NDA or BLA holder or subse8 quent filer that violates this section shall be 

9 subject to the penalties and entitled to the 

10 privileges and immunities provided in the 

11 Federal Trade Commission Act. 

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

13 cease and desist order issued by the Commission 

14 under section 5 of the Federal Trade Commission 

15 Act (15 U.S.C. 45) for violation of this section, 

16 a party to such order may obtain judicial review 

17 of such order as provided in such section 5, ex18 cept that— 

19 (i) such review may only be obtained 

20 in— 

21 (I) the United States Court of Ap22 peals for the District of Columbia Cir23 cuit; 

24 (II) the United States Court of 

25 Appeals for the circuit in which the ulVerDate Sep 11 2014 02:13 May 11, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6203 E:\BILLS\H1499.RH H1499

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1 timate parent entity, as defined in sec2 tion 801.1(a)(3) of title 16, Code of 

3 Federal Regulations, or any successor 

4 thereto, of the NDA or BLA holder (if 

5 any such holder is a party to such 

6 order) is incorporated as of the date 

7 that the application described in sub8 paragraph (A) or (B) of subsection 

9 (g)(8) or an approved application that 

10 is deemed to be a license for a biologi11 cal product under section 351(k) of the 

12 Public Health Service Act (42 U.S.C. 

13 262(k)) pursuant to section 7002(e)(4) 

14 of the Biologics Price Competition and 

15 Innovation Act of 2009 (Public Law 

16 111–148; 124 Stat. 817) is submitted 

17 to the Commissioner of Food and 

18 Drugs; or 

19 (III) the United States Court of 

20 Appeals for the circuit in which the ul21 timate parent entity, as so defined, of 

22 any subsequent filer that is a party to 

23 such order is incorporated as of the 

24 date that the application described in 

25 subparagraph (A) or (B) of subsection 


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1 (g)(8) is submitted to the Commis2 sioner of Food and Drugs; and 

3 (ii) the petition for review shall be 

4 filed in the court not later than 30 days 

5 after such order is served on the party seek6 ing review. 

7 (3) ADDITIONAL ENFORCEMENT AUTHORITY.— 

8 (A) CIVIL PENALTY.—The Commission may 

9 commence a civil action to recover a civil pen10 alty in a district court of the United States 

11 against any NDA or BLA holder or subsequent 

12 filer that violates this section. 

13 (B) SPECIAL RULE FOR RECOVERY OF PEN14 ALTY IF CEASE AND DESIST ORDER ISSUED.— 

15 (i) IN GENERAL.—If the Commission 

16 has issued a cease and desist order in a pro17 ceeding under section 5 of the Federal Trade 

18 Commission Act (15 U.S.C. 45) for viola19 tion of this section— 

20 (I) the Commission may com21 mence a civil action under subpara22 graph (A) to recover a civil penalty 

23 against any party to such order at any 

24 time before the expiration of the 1-year 

25 period beginning on the date on which 


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1 such order becomes final under section 

2 5(g) of such Act (15 U.S.C. 45(g)); and 

3 (II) in such civil action, the find4 ings of the Commission as to the mate5 rial facts in such proceeding shall be 

6 conclusive, unless— 

7 (aa) the terms of such order 

8 expressly provide that the Com9 mission’s findings shall not be 

10 conclusive; or 

11 (bb) such order became final 

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

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

14 which case such findings shall be 

15 conclusive if supported by evi16 dence. 

17 (ii) RELATIONSHIP TO PENALTY FOR

18 VIOLATION OF AN ORDER.—The penalty 

19 provided in clause (i) for violation of this 

20 section is separate from and in addition to 

21 any penalty that may be incurred for viola22 tion of an order of the Commission under 

23 section 5(l) of the Federal Trade Commis24 sion Act (15 U.S.C. 45(l)). 

25 (C) AMOUNT OF PENALTY.— 


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1 (i) IN GENERAL.—The amount of a 

2 civil penalty imposed in a civil action 

3 under subparagraph (A) on a party to an 

4 agreement described in subsection (a) shall 

5 be sufficient to deter violations of this sec6 tion, but in no event greater than— 

7 (I) if such party is the NDA or 

8 BLA holder (or, in the case of an 

9 agreement between two subsequent fil10 ers, the subsequent filer who gave the 

11 value described in subsection (a)(1)), 

12 the greater of— 

13 (aa) 3 times the value re14 ceived by such NDA or BLA hold15 er (or by such subsequent filer) 

16 that is reasonably attributable to 

17 the violation of this section; or 

18 (bb) 3 times the value given 

19 to the subsequent filer (or to the 

20 other subsequent filer) reasonably 

21 attributable to the violation of 

22 this section; and 

23 (II) if such party is the subse24 quent filer (or, in the case of an agree25 ment between two subsequent filers, the 


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1 subsequent filer who received the value 

2 described in subsection (a)(1)), 3 times 

3 the value received by such subsequent 

4 filer that is reasonably attributable to 

5 the violation of this section. 

6 (ii) FACTORS FOR CONSIDERATION.— 

7 In determining such amount, the court shall 

8 take into account— 

9 (I) the nature, circumstances, ex10 tent, and gravity of the violation; 

11 (II) with respect to the violator, 

12 the degree of culpability, any history of 

13 violations, the ability to pay, any effect 

14 on the ability to continue doing busi15 ness, profits earned by the NDA or 

16 BLA holder (or, in the case of an 

17 agreement between two subsequent fil18 ers, the subsequent filer who gave the 

19 value described in subsection (a)(1)), 

20 compensation received by the subse21 quent filer (or, in the case of an agree22 ment between two subsequent filers, the 

23 subsequent filer who received the value 

24 described in subsection (a)(1)), and the 

25 amount of commerce affected; and 


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1 (III) other matters that justice re2 quires. 

3 (D) INJUNCTIONS AND OTHER EQUITABLE

4 RELIEF.—In a civil action under subparagraph 

5 (A), the United States district courts are empow6 ered to grant mandatory injunctions and such 

7 other and further equitable relief as they deem 

8 appropriate. 

9 (4) REMEDIES IN ADDITION.—Remedies provided 

10 in this subsection are in addition to, and not in lieu 

11 of, any other remedy provided by Federal law. 

12 (5) PRESERVATION OF AUTHORITY OF COMMIS13 SION.—Nothing in this section shall be construed to 

14 affect any authority of the Commission under any 

15 other provision of law. 

16 (e) FEDERAL TRADE COMMISSION RULEMAKING.—The 

17 Commission may, in its discretion, by rule promulgated 

18 under section 553 of title 5, United States Code, exempt 

19 from this section certain agreements described in subsection 

20 (a) if the Commission finds such agreements to be in fur21 therance of market competition and for the benefit of con22 sumers. 

23 (f) ANTITRUST LAWS.—Nothing in this section shall 

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

25 antitrust laws as defined in subsection (a) of the first secVerDate Sep 11 2014 02:13 May 11, 2019 Jkt 089200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6203 E:\BILLS\H1499.RH H1499

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

2 5 of the Federal Trade Commission Act (15 U.S.C. 45) to 

3 the extent that such section 5 applies to unfair methods of 

4 competition. Nothing in this section shall modify, impair, 

5 limit, or supersede the right of a subsequent filer to assert 

6 claims or counterclaims against any person, under the anti7 trust laws or other laws relating to unfair competition. 

8 (g) DEFINITIONS.—In this section: 

9 (1) AGREEMENT RESOLVING OR SETTLING A COV10 ERED PATENT INFRINGEMENT CLAIM.—The term 

11 ‘‘agreement resolving or settling a covered patent in12 fringement claim’’ means any agreement that— 

13 (A) resolves or settles a covered patent in14 fringement claim; or 

15 (B) is contingent upon, provides for a con16 tingent condition for, or is otherwise related to 

17 the resolution or settlement of a covered patent 

18 infringement claim. 

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

20 means the Federal Trade Commission. 

21 (3) COVERED PATENT INFRINGEMENT CLAIM.— 

22 The term ‘‘covered patent infringement claim’’ means 

23 an allegation made by the NDA or BLA holder to a 

24 subsequent filer (or, in the case of an agreement be25 tween two subsequent filers, by one subsequent filer to 


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1 another), whether or not included in a complaint filed 

2 with a court of law, that— 

3 (A) the submission of the application de4 scribed in subparagraph (A) or (B) of paragraph 

5 (9), or the manufacture, use, offering for sale, 

6 sale, or importation into the United States of a 

7 covered product that is the subject of such an ap8 plication— 

9 (i) in the case of an agreement between 

10 an NDA or BLA holder and a subsequent 

11 filer, infringes any patent owned by, or ex12 clusively licensed to, the NDA or BLA hold13 er of the covered product; or 

14 (ii) in the case of an agreement be15 tween two subsequent filers, infringes any 

16 patent owned by the subsequent filer; or 

17 (B) in the case of an agreement between an 

18 NDA or BLA holder and a subsequent filer, the 

19 covered product to be manufactured under such 

20 application uses a covered product as claimed in 

21 a published patent application. 

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

23 product’’ means a drug (as defined in section 201(g) 

24 of the Federal Food, Drug, and Cosmetic Act (21 

25 U.S.C. 321(g))), including a biological product (as 


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1 defined in section 351(i) of the Public Health Service 

2 Act (42 U.S.C. 262(i)). 

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

4 BLA holder’’ means— 

5 (A) the holder of— 

6 (i) an approved new drug application 

7 filed under section 505(b)(1) of the Federal 

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

9 355(b)(1)) for a covered product; or 

10 (ii) a biologics license application filed 

11 under section 351(a) of the Public Health 

12 Service Act (42 U.S.C. 262(a)) with respect 

13 to a biological product; 

14 (B) a person owning or controlling enforce15 ment of the patent on— 

16 (i) the list published under section 

17 505(j)(7) of the Federal Food, Drug, and 

18 Cosmetic Act (21 U.S.C. 355(j)(7)) in con19 nection with the application described in 

20 subparagraph (A)(i); or 

21 (ii) any list published under section 

22 351 of the Public Health Service Act (42 

23 U.S.C. 262) comprised of patents associated 

24 with biologics license applications filed 


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

2 262(a)); or 

3 (C) the predecessors, subsidiaries, divisions, 

4 groups, and affiliates controlled by, controlling, 

5 or under common control with any entity de6 scribed in subparagraph (A) or (B) (such control 

7 to be presumed by direct or indirect share owner8 ship of 50 percent or greater), as well as the li9 censees, licensors, successors, and assigns of each 

10 of the entities. 

11 (6) PATENT.—The term ‘‘patent’’ means a pat12 ent issued by the United States Patent and Trade13 mark Office. 

14 (7) STATUTORY EXCLUSIVITY.—The term ‘‘statu15 tory exclusivity’’ means those prohibitions on the sub16 mission or approval of drug applications under 

17 clauses (ii) through (iv) of section 505(c)(3)(E) (5- 

18 and 3-year exclusivity), clauses (ii) through (iv) of 

19 section 505(j)(5)(F) (5-year and 3-year exclusivity), 

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

21 527 (orphan drug exclusivity), section 505A (pedi22 atric exclusivity), or section 505E (qualified infec23 tious disease product exclusivity) of the Federal Food, 

24 Drug, and Cosmetic Act (21 U.S.C. 355(c)(3)(E), 

25 355(j)(5)(B)(iv), 355(j)(5)(F), 360cc, 355a, 355f), or 


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1 prohibitions on the submission or licensing of bio2 logics license applications under section 351(k)(6) 

3 (interchangeable biological product exclusivity) or sec4 tion 351(k)(7) (biological product reference product 

5 exclusivity) of the Public Health Service Act (42 

6 U.S.C. 262(k)(6), (7)). 

7 (8) SUBSEQUENT FILER.—The term ‘‘subsequent 

8 filer’’ means— 

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

10 or controls an abbreviated new drug application 

11 submitted pursuant to section 505(j) of the Fed12 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

13 355(j)) or a new drug application submitted 

14 pursuant to section 505(b)(2) of the Federal 

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

16 355(b)(2)) and filed under section 505(b)(1) of 

17 such Act (21 U.S.C. 355(b)(1)) or has the exclu18 sive rights to distribute the covered product that 

19 is the subject of such application; or 

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

21 party that owns or controls an application filed 

22 with the Food and Drug Administration under 

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

24 (42 U.S.C. 262(k)) or has the exclusive rights to 


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1 distribute the biological product that is the sub2 ject of such application. 

3 (h) EFFECTIVE DATE.—This section applies with re4 spect to agreements described in subsection (a) entered into 

5 on or after the date of the enactment of this Act. 

6 SEC. 3. NOTICE AND CERTIFICATION OF AGREEMENTS. 

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

8 of the Medicare Prescription Drug, Improvement, and Mod9 ernization Act of 2003 (21 U.S.C. 355 note) is amended 

10 by inserting ‘‘or the owner of a patent for which a claim 

11 of infringement could reasonably be asserted against any 

12 person for making, using, offering to sell, selling, or import13 ing into the United States a biological product that is the 

14 subject of a biosimilar biological product application’’ be15 fore the period at the end. 

16 (b) CERTIFICATION OF AGREEMENTS.—Section 1112 

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

18 at the end the following: 

19 ‘‘(d) CERTIFICATION.—The Chief Executive Officer or 

20 the company official responsible for negotiating any agree21 ment under subsection (a) or (b) that is required to be filed 

22 under subsection (c) shall, within 30 days of such filing, 

23 execute and file with the Assistant Attorney General and 

24 the Commission a certification as follows: ‘I declare that 

25 the following is true, correct, and complete to the best of 


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1 my knowledge: The materials filed with the Federal Trade 

2 Commission and the Department of Justice under section 

3 1112 of the Medicare Prescription Drug, Improvement, and 

4 Modernization Act of 2003, with respect to the agreement 

5 referenced in this certification— 

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

7 agreement between the parties; 

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

9 contingent upon, provide a contingent condition for, 

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

11 related to, the referenced agreement; and 

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

13 agreements, representations, commitments, or prom14 ises between the parties that are responsive to sub15 section (a) or (b) of such section 1112 and have not 

16 been reduced to writing.’.’’. 

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

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

19 and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(V)) is amend20 ed by inserting ‘‘section 2 of the Protecting Consumer Access 

21 to Generic Drugs Act of 2019 or’’ after ‘‘that the agreement 

22 has violated’’. 

23 SEC. 5. COMMISSION LITIGATION AUTHORITY. 

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

25 (15 U.S.C. 56(a)(2)) is amended— 


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

2 the semicolon; 

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

4 the semicolon; and 

5 (3) by inserting after subparagraph (E) the fol6 lowing: 

7 ‘‘(F) under section 2(d)(3)(A) of the Pro8 tecting Consumer Access to Generic Drugs Act of 

9 2019;’’. 

10 SEC. 6. STATUTE OF LIMITATIONS. 

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

12 (b), the Commission shall commence any administrative 

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

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

15 to the agreement file the Notice of Agreement as provided 

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

17 Drug, Improvement, and Modernization Act of 2003 (21 

18 U.S.C. 355 note). 

19 (b) CIVIL ACTION AFTER ISSUANCE OF CEASE AND

20 DESIST ORDER.—If the Commission has issued a cease and 

21 desist order under section 5 of the Federal Trade Commis22 sion Act (15 U.S.C. 45) for violation of section 2 of this 

23 Act and the proceeding for the issuance of such order was 

24 commenced within the period required by subsection (a) of 

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1 ment, after such period, of a civil action under section 

2 2(d)(3)(A) against a party to such order or a civil action 

3 under subsection (l) of such section 5 for violation of such 

4 order. 


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Union Calendar No. 30 

116TH CONGRESS 

1ST SESSION H. R. 1499 

[Report No. 116–52, Part I] 

A BILL 

To prohibit brand name drug manufacturers from 

for other purposes. of biosimilar and interchangeable products, and changeable product manufacturers to delay entry turers from compensating biosimilar and interket, and to prohibit biological product manufacdelay the entry of a generic drug into the marcompensating generic drug manufacturers to 

MAY 10, 2019 

Reported from the Committee on Energy and Commerce 

with an amendment 

MAY 10, 2019 

Committee on the Judiciary discharged; committed to the 

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


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