II 

Calendar No. 130 

116TH CONGRESS 

1ST SESSION S. 1224 

To enable the Federal Trade Commission to deter filing of sham citizen 

petitions to cover an attempt to interfere with approval of a competing 

generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public 

heath concerns, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

APRIL 29, 2019 

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

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

JUNE 28 (legislative day, JUNE 27), 2019 

Reported by Mr. GRAHAM, with an amendment and an amendment to the title 

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

A BILL 

To enable the Federal Trade Commission to deter filing 

of sham citizen petitions to cover an attempt to interfere 

with approval of a competing generic drug or biosimilar, 

to foster competition, and facilitate the efficient review 

of petitions filed in good faith to raise legitimate public 

heath concerns, 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 ‘‘Stop Significant and 

3 Time-wasting Abuse Limiting Legitimate Innovation of 

4 New Generics Act’’ or the ‘‘Stop STALLING Act’’. 

5 SEC. 2. FEDERAL TRADE COMMISSION ENFORCEMENT 

6 AGAINST SHAM PETITIONS. 

7 (a) DEFINITIONS.—In this section: 

8 (1) COMMISSION.—The term ‘‘Commission’’ 

9 means the Federal Trade Commission. 

10 (2) COVERED APPLICATION.—The term ‘‘cov11 ered application’’ means an application filed pursu12 ant to subsection (b)(2) or (j) of section 505 of the 

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

14 355) or section 351(k) of the Public Health Service 

15 Act (42 U.S.C. 262(k)). 

16 (3) COVERED PETITION.—The term ‘‘covered 

17 petition’’ means a petition, or a supplement to a pe18 tition, filed under section 505(q) of the Federal 

19 Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)). 

20 (4) PERSON.—The term ‘‘person’’— 

21 (A) means an individual or entity; and 

22 (B) includes— 

23 (i) a director, officer, employee, agent, 

24 representative, successor, and assign of an 

25 entity; 


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1 (ii) a joint venture, subsidiary, part2 nership, division, group, and affiliate con3 trolled by an entity; and 

4 (iii) a director, officer, employee, 

5 agent, representative, successor, and assign 

6 of a joint venture, subsidiary, partnership, 

7 division, group, and affiliate controlled by 

8 an entity. 

9 (5) SERIES OF COVERED PETITIONS.—The 

10 term ‘‘series of covered petitions’’ means any group 

11 of more than 1 covered petition. 

12 (6) SHAM.—The term ‘‘sham’’ means a covered 

13 petition that is objectively baseless and that at14 tempts to use a governmental process, as opposed to 

15 the outcome of that process, to interfere with the 

16 business of a competitor, or a series of covered peti17 tions that attempts to use a governmental process, 

18 as opposed to the outcome of that process, to inter19 fere with the business of a competitor. 

20 (b) VIOLATION.—A person submitting or causing the 

21 submission of a covered petition or a series of covered peti22 tions that is a sham shall be liable for engaging in an 

23 unfair method of competition under section 5(a)(1) of the 

24 Federal Trade Commission Act (15 U.S.C. 45(a)(1)). 

25 (c) CIVIL ACTION.— 


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1 (1) IN GENERAL.—If the Commission has rea2 son to believe that the submission of a covered peti3 tion or a series of covered petitions constitutes a vio4 lation of section 5(a)(1) of the Federal Trade Com5 mission Act (15 U.S.C. 45(a)(1)), the Commission 

6 may commence a civil action to recover a civil pen7 alty and seek other appropriate relief in a district 

8 court of the United States against any person that 

9 submitted or caused to be submitted such covered 

10 petition or such series of covered petitions, including 

11 successors or assigns. 

12 (2) PRESUMPTION.—In a civil action under 

13 paragraph (1), a covered petition shall be presumed 

14 to be part of a series of covered petitions that is a 

15 sham under subsection (b) of this section if the Sec16 retary of Health and Human Services has deter17 mined that the covered petition was submitted with 

18 the primary purpose of delaying the approval of a 

19 covered application and was part of a series of cov20 ered petitions, and has referred such determination 

21 to the Federal Trade Commission in writing, with a 

22 reasoned basis for the determination. 

23 (3) EXCEPTION.—The presumption in para24 graph (2) shall not apply if the defendant estab25 lishes, by a preponderance of the evidence, that the 


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1 series of covered petitions that includes the covered 

2 petition referred to the Commission by the Secretary 

3 of Health and Human Services is not a sham. 

4 (4) CIVIL PENALTY.—In an action under para5 graph (1), any person that has been found liable for 

6 a violation of section 5(a)(1) of the Federal Trade 

7 Commission Act (15 U.S.C. 45(a)(1)) shall be sub8 ject to a civil penalty for each violation of not more 

9 than the greater of— 

10 (A) any revenue earned from the sale by 

11 such person of any drug product, referenced in 

12 a covered application that was the subject of a 

13 covered petition or a series of covered petitions 

14 that is a sham, during the period in which the 

15 covered petition or series of covered petitions 

16 was under review by the Secretary of Health 

17 and Human Services; or 

18 (B) $50,000 for each calendar day that 

19 each covered petition that is a sham or that was 

20 part of a series of covered petitions that is a 

21 sham was under review by the Secretary of 

22 Health and Human Services. 

23 (5) ANTITRUST LAWS.—Nothing in this section 

24 shall modify, impair, limit, or supersede the applica25 bility of the antitrust laws as defined in subsection 


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1 (a) of the first section of the Clayton Act (15 U.S.C. 

2 12(a)), and of section 5 of the Federal Trade Com3 mission Act (15 U.S.C. 45) to the extent that it ap4 plies to unfair methods of competition. 

5 (6) RULE OF CONSTRUCTION.—The civil pen6 alty provided in this subsection is in addition to, and 

7 not in lieu of, any other remedies provided by Fed8 eral law, including under section 16 of the Clayton 

9 Act (15 U.S.C. 26) or under section 13(b) of the 

10 Federal Trade Commission Act (15 U.S.C. 53(b)). 

11 Nothing in this paragraph shall be construed to af12 fect any authority of the Commission under any 

13 other provision of law. 

14 (d) APPLICABILITY.—This section shall apply to any 

15 covered petition submitted on or after the date of enact16 ment of this Act. 

17 SEC. 3. SEVERABILITY. 

18 If any provision of this Act or the application of such 

19 provision to any person or circumstance is held to be un20 constitutional, the remainder of this Act and the applica21 tion of the provisions of such Act to any person or cir22 cumstance shall not be affected. 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Stop Significant and 

3 Time-wasting Abuse Limiting Legitimate Innovation of 

4 New Generics Act’’ or the ‘‘Stop STALLING Act’’. 

5 SEC. 2. FEDERAL TRADE COMMISSION ENFORCEMENT 

6 AGAINST SHAM PETITIONS. 

7 (a) DEFINITIONS.—In this section: 

8 (1) COMMISSION.—The term ‘‘Commission’’ 

9 means the Federal Trade Commission. 

10 (2) COVERED APPLICATION.—The term ‘‘covered 

11 application’’ means an application filed pursuant to 

12 subsection (b)(2) or (j) of section 505 of the Federal 

13 Food, Drug, and Cosmetic Act (21 U.S.C. 355) or sec14 tion 351(k) of the Public Health Service Act (42 

15 U.S.C. 262(k)). 

16 (3) COVERED PETITION.—The term ‘‘covered pe17 tition’’ means a petition, or a supplement to a peti18 tion, filed under section 505(q) of the Federal Food, 

19 Drug, and Cosmetic Act (21 U.S.C. 355(q)). 

20 (4) PERSON.—The term ‘‘person’’— 

21 (A) means an individual or entity; and 

22 (B) includes— 

23 (i) a successor and an assign of an en24 tity; and 


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1 (ii) a joint venture, subsidiary, part2 nership, division, group, and affiliate con3 trolled by an entity, and 

4 (iii) a successor and an assign of a 

5 joint venture, subsidiary, partnership, divi6 sion, group, and affiliate controlled by an 

7 entity. 

8 (5) SERIES OF COVERED PETITIONS.—The term 

9 ‘‘series of covered petitions’’ means any group of more 

10 than 1 covered petition relating to the same covered 

11 application. 

12 (6) SHAM.—The term ‘‘sham’’ means a covered 

13 petition that is objectively baseless and that attempts 

14 to use a governmental process, as opposed to the out15 come of that process, to interfere with the business of 

16 a competitor, or a series of covered petitions that at17 tempts to use a governmental process, as opposed to 

18 the outcome of that process, to interfere with the busi19 ness of a competitor. 

20 (b) VIOLATION.—A person submitting or causing the 

21 submission of a covered petition or a series of covered peti22 tions that is a sham shall be liable for engaging in an un23 fair method of competition under section 5(a)(1) of the Fed24 eral Trade Commission Act (15 U.S.C. 45(a)(1)). 

25 (c) CIVIL ACTION.— 


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1 (1) IN GENERAL.—If the Commission has reason 

2 to believe that the submission of a covered petition or 

3 a series of covered petitions constitutes a violation of 

4 section 5(a)(1) of the Federal Trade Commission Act 

5 (15 U.S.C. 45(a)(1)), the Commission may commence 

6 a civil action to recover a civil penalty and seek other 

7 appropriate relief in a district court of the United 

8 States against any person that submitted or caused to 

9 be submitted such covered petition or such series of 

10 covered petitions, including successors or assigns. 

11 (2) PRESUMPTION.—In a civil action under 

12 paragraph (1), a covered petition shall be presumed 

13 to be part of a series of covered petitions that is a 

14 sham under subsection (b) of this section if— 

15 (A) the Secretary of Health and Human 

16 Services— 

17 (i) has determined that the covered pe18 tition was submitted with the primary pur19 pose of delaying the approval of a covered 

20 application; and 

21 (ii) has referred such determination to 

22 the Federal Trade Commission in writing, 

23 including a reasoned basis for the deter24 mination; and 


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1 (B) the covered petition was part of a series 

2 of covered petitions. 

3 (3) EXCEPTION.—The presumption in paragraph 

4 (2) shall not apply if the defendant establishes, by a 

5 preponderance of the evidence, that the series of cov6 ered petitions that includes the covered petition re7 ferred to the Commission by the Secretary of Health 

8 and Human Services is not a sham. 

9 (4) CIVIL PENALTY.—In an action under para10 graph (1), any person that has been found liable for 

11 a violation of section 5(a)(1) of the Federal Trade 

12 Commission Act (15 U.S.C. 45(a)(1)) shall be subject 

13 to a civil penalty for each violation of not more than 

14 the greater of— 

15 (A) any revenue earned from the sale by 

16 such person of any drug product, referenced in 

17 a covered application that was the subject of a 

18 covered petition or a series of covered petitions 

19 that is a sham, during the period in which the 

20 covered petition or series of covered petitions was 

21 under review by the Secretary of Health and 

22 Human Services; or 

23 (B) $50,000 for each calendar day that each 

24 covered petition that is a sham or that was part 

25 of a series of covered petitions that is a sham 


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1 was under review by the Secretary of Health and 

2 Human Services. 

3 (5) ANTITRUST LAWS.—Nothing in this section 

4 shall modify, impair, limit, or supersede the applica5 bility of the antitrust laws as defined in subsection 

6 (a) of the first section of the Clayton Act (15 U.S.C. 

7 12(a)), and of section 5 of the Federal Trade Commis8 sion Act (15 U.S.C. 45) to the extent that it applies 

9 to unfair methods of competition. 

10 (6) RULE OF CONSTRUCTION.—The civil penalty 

11 provided in this subsection is in addition to, and not 

12 in lieu of, any other remedies provided by Federal 

13 law, including under section 16 of the Clayton Act 

14 (15 U.S.C. 26) or under section 13(b) of the Federal 

15 Trade Commission Act (15 U.S.C. 53(b)). Nothing in 

16 this paragraph shall be construed to affect any au17 thority of the Commission under any other provision 

18 of law. 

19 (d) APPLICABILITY.—This section shall apply to any 

20 covered petition submitted on or after the date of enactment 

21 of this Act. 

22 SEC. 3. SEVERABILITY. 

23 If any provision of this Act or the application of such 

24 provision to any person or circumstance is held to be uncon25 stitutional, the remainder of this Act and the application 


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1 of the provisions of such Act to any person or circumstance 

2 shall not be affected. 

Amend the title so as to read: ‘‘A bill to enable the 

Federal Trade Commission to deter filing of sham citizen 

petitions to cover an attempt to interfere with approval 

of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions 

filed in good faith to raise legitimate public health concerns, and for other purposes.’’. 


pamtmann on DSKBFK8HB2PROD with BILLS

pamtmann on DSKBFK8HB2PROD with BILLS
Calendar No. 130 

116TH CONGRESS 

1ST SESSION S. 1224 

A BILL 

To enable the Federal Trade Commission to deter 

concerns, and for other purposes. filed in good faith to raise legitimate public heath and facilitate the efficient review of petitions generic drug or biosimilar, to foster competition, tempt to interfere with approval of a competing filing of sham citizen petitions to cover an atJUNE 28 (legislative day, JUNE 27), 2019 

Reported with an amendment and an amendment to the 

title 


pamtmann on DSKBFK8HB2PROD with BILLS