I 

117TH CONGRESS 

1ST SESSION H. R. 153 

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 

JANUARY 4, 2021 

Mr. RUSH (for himself, Mr. CASTEN, Mr. COHEN, Mr. CONNOLLY, Mr. 

DESAULNIER, Mr. NEGUSE, Mr. RUIZ, Ms. UNDERWOOD, and Mr. VAN

DREW) 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 2021’’. 

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 (or for two subsequent 

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

9 or settling a covered patent infringement claim on a final 

10 or interim basis if under such agreement— 

11 (1) a subsequent filer directly or indirectly re12 ceives from such holder (or in the case of such an 

13 agreement between two subsequent filers, the other 

14 subsequent filer) anything of value, including a li15 cense; and 

16 (2) the subsequent filer agrees to limit or fore17 go research on, or development, manufacturing, 

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

19 covered product that is the subject of the application 

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

21 (g)(8). 

22 (b) EXCLUSION.—It shall not be unlawful under sub23 section (a) if a party to an agreement described in such 

24 subsection demonstrates by clear and convincing evidence 

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1 tion solely for other goods or services that the subsequent 

2 filer has promised to provide. 

3 (c) LIMITATION.—Nothing in this section shall pro4 hibit an agreement resolving or settling a covered patent 

5 infringement claim in which the consideration granted by 

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

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

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

9 (1) The right to market the covered product 

10 that is the subject of the application described in 

11 subparagraph (A) or (B) of subsection (g)(8) in the 

12 United States before the expiration of— 

13 (A) any patent that is the basis of the cov14 ered patent infringement claim; or 

15 (B) any patent right or other statutory ex16 clusivity that would prevent the marketing of 

17 such covered product. 

18 (2) A payment for reasonable litigation ex19 penses not to exceed $7,500,000 in the aggregate. 

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

21 such covered product infringes a patent. 

22 (d) ENFORCEMENT BY FEDERAL TRADE COMMIS23 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 pur6 suant to section 5(a)(2) of the Federal Trade 

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

8 (B) a person, partnership, or corporation 

9 over which the Commission would have author10 ity pursuant to such section but for the fact 

11 that such person, partnership, or corporation is 

12 not organized to carry on business for its own 

13 profit 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.) 

5 were incorporated into and made a part of 

6 this section; and 

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

9 be subject to the penalties and entitled to 

10 the privileges and immunities provided in 

11 the Federal Trade Commission Act. 

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

13 cease and desist order issued by the Commis14 sion under section 5 of the Federal Trade Com15 mission Act (15 U.S.C. 45) for violation of this 

16 section, a party to such order may obtain judi17 cial review of such order as provided in such 

18 section 5, except that— 

19 (i) such review may only be obtained 

20 in— 

21 (I) the United States Court of 

22 Appeals for the District of Columbia 

23 Circuit; 

24 (II) the United States Court of 

25 Appeals for the circuit in which the 


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1 ultimate parent entity, as defined in 

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

3 of Federal Regulations, or any suc4 cessor thereto, of the NDA or BLA 

5 holder (if any such holder is a party 

6 to such order) is incorporated as of 

7 the date that the application described 

8 in subparagraph (A) or (B) of sub9 section (g)(8) or an approved applica10 tion that is deemed to be a license for 

11 a biological product under section 

12 351(k) of the Public Health Service 

13 Act (42 U.S.C. 262(k)) pursuant to 

14 section 7002(e)(4) of the Biologics 

15 Price Competition and Innovation Act 

16 of 2009 (Public Law 111–148; 124 

17 Stat. 817) is submitted to the Com18 missioner of Food and Drugs; or 

19 (III) the United States Court of 

20 Appeals for the circuit in which the 

21 ultimate parent entity, as so defined, 

22 of any subsequent filer that is a party 

23 to 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 

6 seeking review. 

7 (3) ADDITIONAL ENFORCEMENT AUTHORITY.— 

8 (A) CIVIL PENALTY.—The Commission 

9 may commence a civil action to recover a civil 

10 penalty 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

14 PENALTY IF CEASE AND DESIST ORDER

15 ISSUED.— 

16 (i) IN GENERAL.—If the Commission 

17 has issued a cease and desist order in a 

18 proceeding under section 5 of the Federal 

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

20 violation of this section— 

21 (I) the Commission may com22 mence a civil action under subpara23 graph (A) to recover a civil penalty 

24 against any party to such order at 

25 any time before the expiration of the 


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1 1-year period beginning on the date 

2 on which such order becomes final 

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

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

5 (II) in such civil action, the find6 ings of the Commission as to the ma7 terial facts in such proceeding shall be 

8 conclusive, unless— 

9 (aa) the terms of such order 

10 expressly provide that the Com11 mission’s findings shall not be 

12 conclusive; or 

13 (bb) such order became final 

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

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

16 which case such findings shall be 

17 conclusive if supported by evi18 dence. 

19 (ii) RELATIONSHIP TO PENALTY FOR

20 VIOLATION OF AN ORDER.—The penalty 

21 provided in clause (i) for violation of this 

22 section is separate from and in addition to 

23 any penalty that may be incurred for viola24 tion of an order of the Commission under 


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1 section 5(l) of the Federal Trade Commis2 sion Act (15 U.S.C. 45(l)). 

3 (C) AMOUNT OF PENALTY.— 

4 (i) IN GENERAL.—The amount of a 

5 civil penalty imposed in a civil action under 

6 subparagraph (A) on a party to an agree7 ment described in subsection (a) shall be 

8 sufficient to deter violations of this section, 

9 but in no event greater than— 

10 (I) if such party is the NDA or 

11 BLA holder (or, in the case of an 

12 agreement between two subsequent fil13 ers, the subsequent filer who gave the 

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

15 the greater of— 

16 (aa) 3 times the value re17 ceived by such NDA or BLA 

18 holder (or by such subsequent 

19 filer) that is reasonably attrib20 utable to the violation of this sec21 tion; or 

22 (bb) 3 times the value given 

23 to the subsequent filer (or to the 

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1 ably attributable to the violation 

2 of this section; and 

3 (II) if such party is the subse4 quent filer (or, in the case of an 

5 agreement between two subsequent fil6 ers, the subsequent filer who received 

7 the value described in subsection 

8 (a)(1)), 3 times the value received by 

9 such subsequent filer that is reason10 ably attributable to the violation of 

11 this section. 

12 (ii) FACTORS FOR CONSIDERATION.— 

13 In determining such amount, the court 

14 shall take into account— 

15 (I) the nature, circumstances, ex16 tent, and gravity of the violation; 

17 (II) with respect to the violator, 

18 the degree of culpability, any history 

19 of violations, the ability to pay, any 

20 effect on the ability to continue doing 

21 business, profits earned by the NDA 

22 or BLA holder (or, in the case of an 

23 agreement between two subsequent fil24 ers, the subsequent filer who gave the 

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


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1 compensation received by the subse2 quent filer (or, in the case of an 

3 agreement between two subsequent fil4 ers, the subsequent filer who received 

5 the value described in subsection 

6 (a)(1)), and the amount of commerce 

7 affected; and 

8 (III) other matters that justice 

9 requires. 

10 (D) INJUNCTIONS AND OTHER EQUITABLE

11 RELIEF.—In a civil action under subparagraph 

12 (A), the United States district courts are em13 powered to grant mandatory injunctions and 

14 such other and further equitable relief as they 

15 deem appropriate. 

16 (4) REMEDIES IN ADDITION.—Remedies pro17 vided in this subsection are in addition to, and not 

18 in lieu of, any other remedy provided by Federal 

19 law. 

20 (5) PRESERVATION OF AUTHORITY OF COMMIS21 SION.—Nothing in this section shall be construed to 

22 affect any authority of the Commission under any 

23 other provision of law. 

24 (e) FEDERAL TRADE COMMISSION RULEMAKING.— 

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1 gated under section 553 of title 5, United States Code, 

2 exempt from this section certain agreements described in 

3 subsection (a) if the Commission finds such agreements 

4 to be in furtherance of market competition and for the 

5 benefit of consumers. 

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

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

8 antitrust laws as defined in subsection (a) of the first sec9 tion of the Clayton Act (15 U.S.C. 12(a)), and of section 

10 5 of the Federal Trade Commission Act (15 U.S.C. 45) 

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

12 of competition. Nothing in this section shall modify, im13 pair, limit, or supersede the right of a subsequent filer 

14 to assert claims or counterclaims against any person, 

15 under the antitrust laws or other laws relating to unfair 

16 competition. 

17 (g) DEFINITIONS.—In this section: 

18 (1) AGREEMENT RESOLVING OR SETTLING A

19 COVERED PATENT INFRINGEMENT CLAIM.—The 

20 term ‘‘agreement resolving or settling a covered pat21 ent infringement claim’’ means any agreement 

22 that— 

23 (A) resolves or settles a covered patent in24 fringement claim; or 


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1 (B) is contingent upon, provides for a con2 tingent condition for, or is otherwise related to 

3 the resolution or settlement of a covered patent 

4 infringement claim. 

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

6 means the Federal Trade Commission. 

7 (3) COVERED PATENT INFRINGEMENT CLAIM.— 

8 The term ‘‘covered patent infringement claim’’ 

9 means an allegation made by the NDA or BLA hold10 er to a subsequent filer (or, in the case of an agree11 ment between two subsequent filers, by one subse12 quent filer to another), whether or not included in 

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

14 (A) the submission of the application de15 scribed in subparagraph (A) or (B) of para16 graph (8), or the manufacture, use, offering for 

17 sale, sale, or importation into the United States 

18 of a covered product that is the subject of such 

19 an application— 

20 (i) in the case of an agreement be21 tween an NDA or BLA holder and a sub22 sequent filer, infringes any patent owned 

23 by, or exclusively licensed to, the NDA or 

24 BLA holder of the covered product; or 


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1 (ii) in the case of an agreement be2 tween two subsequent filers, infringes any 

3 patent owned by the subsequent filer; or 

4 (B) in the case of an agreement between 

5 an NDA or BLA holder and a subsequent filer, 

6 the covered product to be manufactured under 

7 such application uses a covered product as 

8 claimed in a published patent application. 

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

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

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

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

13 defined in section 351(i) of the Public Health Serv14 ice Act (42 U.S.C. 262(i))). 

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

16 or BLA holder’’ means— 

17 (A) the holder of— 

18 (i) an approved new drug application 

19 filed under section 505(b)(1) of the Fed20 eral Food, Drug, and Cosmetic Act (21 

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

22 or 

23 (ii) a biologics license application filed 

24 under section 351(a) of the Public Health 


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1 Service Act (42 U.S.C. 262(a)) for a cov2 ered product; 

3 (B) a person owning or controlling enforce4 ment of the patent on— 

5 (i) the list published under section 

6 505(j)(7) of the Federal Food, Drug, and 

7 Cosmetic Act (21 U.S.C. 355(j)(7)) in con8 nection with the application described in 

9 subparagraph (A)(i); or 

10 (ii) any list published under section 

11 351 of the Public Health Service Act (42 

12 U.S.C. 262) comprised of patents associ13 ated with biologics license applications filed 

14 under section 351(a) of such Act (42 

15 U.S.C. 262(a)); or 

16 (C) the predecessors, subsidiaries, divi17 sions, groups, and affiliates controlled by, con18 trolling, or under common control with any en19 tity described in subparagraph (A) or (B) (such 

20 control to be presumed by direct or indirect 

21 share ownership of 50 percent or greater), as 

22 well as the licensees, licensors, successors, and 

23 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 submission or approval of drug applications 

7 under clauses (ii) through (iv) of section 

8 505(c)(3)(E) (5- and 3-year exclusivity), clauses (ii) 

9 through (iv) of section 505(j)(5)(F) (5-year and 3- 

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

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

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

13 (qualified infectious disease product exclusivity) of 

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

15 U.S.C. 355(c)(3)(E), 355(j)(5)(B)(iv), 355(j)(5)(F), 

16 360cc, 355a, 355f), or prohibitions on the submis17 sion or licensing of biologics license applications 

18 under section 351(k)(6) (interchangeable biological 

19 product exclusivity) or section 351(k)(7) (biological 

20 product reference product exclusivity) of the Public 

21 Health Service Act (42 U.S.C. 262(k)(6), (7)). 

22 (8) SUBSEQUENT FILER.—The term ‘‘subse23 quent filer’’ means— 

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

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1 cation submitted pursuant to section 505(j) of 

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

3 U.S.C. 355(j)) or a new drug application sub4 mitted pursuant to section 505(b)(2) of the 

5 Federal Food, Drug, and Cosmetic Act (21 

6 U.S.C. 355(b)(2)) and filed under section 

7 505(b)(1) of such Act (21 U.S.C. 355(b)(1)) or 

8 has the exclusive rights to distribute the cov9 ered product that is the subject of such applica10 tion; or 

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

12 party that owns or controls an application filed 

13 with the Food and Drug Administration under 

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

15 (42 U.S.C. 262(k)) or has the exclusive rights 

16 to distribute the biological product that is the 

17 subject of such application. 

18 (h) EFFECTIVE DATE.—This section applies with re19 spect to agreements described in subsection (a) entered 

20 into on or after the date of the enactment of this Act. 

21 SEC. 3. NOTICE AND CERTIFICATION OF AGREEMENTS. 

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

23 of the Medicare Prescription Drug, Improvement, and 

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

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


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1 a claim of infringement could reasonably be asserted 

2 against any person for making, using, offering to sell, sell3 ing, or importing into the United States a biological prod4 uct that is the subject of a biosimilar biological product 

5 application’’ before the period at the end. 

6 (b) CERTIFICATION OF AGREEMENTS.—Section 1112 

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

8 at the end the following: 

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

10 or the company official responsible for negotiating any 

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

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

13 filing, execute and file with the Assistant Attorney General 

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

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

16 of my knowledge: The materials filed with the Federal 

17 Trade Commission and the Department of Justice under 

18 section 1112 of the Medicare Prescription Drug, Improve19 ment, and Modernization Act of 2003, with respect to the 

20 agreement referenced in this certification— 

21 ‘‘ ‘(1) represent the complete, final, and exclu22 sive agreement between the parties; 

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

24 contingent upon, provide a contingent condition for, 


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

2 related to, the referenced agreement; and 

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

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

7 been reduced to writing.’.’’. 

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

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

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

11 is amended by inserting ‘‘section 2 of the Protecting Con12 sumer Access to Generic Drugs Act of 2021 or’’ after 

13 ‘‘that the agreement has violated’’. 

14 SEC. 5. COMMISSION LITIGATION AUTHORITY. 

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

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

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

18 the semicolon; 

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

20 after the semicolon; and 

21 (3) by inserting after subparagraph (E) the fol22 lowing: 

23 ‘‘(F) under section 2(d)(3)(A) of the Pro24 tecting Consumer Access to Generic Drugs Act 

25 of 2021;’’. 


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1 SEC. 6. STATUTE OF LIMITATIONS. 

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

3 (b), the Commission shall commence any administrative 

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

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

6 to the agreement file the Notice of Agreement as provided 

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

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

9 U.S.C. 355 note). 

10 (b) CIVIL ACTION AFTER ISSUANCE OF CEASE AND

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

12 and desist order under section 5 of the Federal Trade 

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

14 2 of this Act and the proceeding for the issuance of such 

15 order was commenced within the period required by sub16 section (a) of this section, such subsection does not pro17 hibit the commencement, after such period, of a civil ac18 tion under section 2(d)(3)(A) against a party to such 

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

20 5 for violation of such order. 

Æ 


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