```

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 1224 Reported in Senate (RS)]

<DOC>

                                                       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.

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

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Stop Significant and Time-
wasting Abuse Limiting Legitimate Innovation of New Generics Act'' or 
the ``Stop STALLING Act''.</DELETED>

<DELETED>SEC. 2. FEDERAL TRADE COMMISSION ENFORCEMENT AGAINST SHAM 
              PETITIONS.</DELETED>

<DELETED>    (a) Definitions.--In this section:</DELETED>
        <DELETED>    (1) Commission.--The term ``Commission'' means the 
        Federal Trade Commission.</DELETED>
        <DELETED>    (2) Covered application.--The term ``covered 
        application'' means an application filed pursuant to subsection 
        (b)(2) or (j) of section 505 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355) or section 351(k) of the Public 
        Health Service Act (42 U.S.C. 262(k)).</DELETED>
        <DELETED>    (3) Covered petition.--The term ``covered 
        petition'' means a petition, or a supplement to a petition, 
        filed under section 505(q) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355(q)).</DELETED>
        <DELETED>    (4) Person.--The term ``person''--</DELETED>
                <DELETED>    (A) means an individual or entity; 
                and</DELETED>
                <DELETED>    (B) includes--</DELETED>
                        <DELETED>    (i) a director, officer, employee, 
                        agent, representative, successor, and assign of 
                        an entity;</DELETED>
                        <DELETED>    (ii) a joint venture, subsidiary, 
                        partnership, division, group, and affiliate 
                        controlled by an entity; and</DELETED>
                        <DELETED>    (iii) a director, officer, 
                        employee, agent, representative, successor, and 
                        assign of a joint venture, subsidiary, 
                        partnership, division, group, and affiliate 
                        controlled by an entity.</DELETED>
        <DELETED>    (5) Series of covered petitions.--The term 
        ``series of covered petitions'' means any group of more than 1 
        covered petition.</DELETED>
        <DELETED>    (6) Sham.--The term ``sham'' means a covered 
        petition that is objectively baseless and that attempts to use 
        a governmental process, as opposed to the outcome of that 
        process, to interfere with the business of a competitor, or a 
        series of covered petitions that attempts to use a governmental 
        process, as opposed to the outcome of that process, to 
        interfere with the business of a competitor.</DELETED>
<DELETED>    (b) Violation.--A person submitting or causing the 
submission of a covered petition or a series of covered petitions that 
is a sham shall be liable for engaging in an unfair method of 
competition under section 5(a)(1) of the Federal Trade Commission Act 
(15 U.S.C. 45(a)(1)).</DELETED>
<DELETED>    (c) Civil Action.--</DELETED>
        <DELETED>    (1) In general.--If the Commission has reason to 
        believe that the submission of a covered petition or a series 
        of covered petitions constitutes a violation of section 5(a)(1) 
        of the Federal Trade Commission Act (15 U.S.C. 45(a)(1)), the 
        Commission may commence a civil action to recover a civil 
        penalty and seek other appropriate relief in a district court 
        of the United States against any person that submitted or 
        caused to be submitted such covered petition or such series of 
        covered petitions, including successors or assigns.</DELETED>
        <DELETED>    (2) Presumption.--In a civil action under 
        paragraph (1), a covered petition shall be presumed to be part 
        of a series of covered petitions that is a sham under 
        subsection (b) of this section if the Secretary of Health and 
        Human Services has determined that the covered petition was 
        submitted with the primary purpose of delaying the approval of 
        a covered application and was part of a series of covered 
        petitions, and has referred such determination to the Federal 
        Trade Commission in writing, with a reasoned basis for the 
        determination.</DELETED>
        <DELETED>    (3) Exception.--The presumption in paragraph (2) 
        shall not apply if the defendant establishes, by a 
        preponderance of the evidence, that the series of covered 
        petitions that includes the covered petition referred to the 
        Commission by the Secretary of Health and Human Services is not 
        a sham.</DELETED>
        <DELETED>    (4) Civil penalty.--In an action under paragraph 
        (1), any person that has been found liable for a violation of 
        section 5(a)(1) of the Federal Trade Commission Act (15 U.S.C. 
        45(a)(1)) shall be subject to a civil penalty for each 
        violation of not more than the greater of--</DELETED>
                <DELETED>    (A) any revenue earned from the sale by 
                such person of any drug product, referenced in a 
                covered application that was the subject of a covered 
                petition or a series of covered petitions that is a 
                sham, during the period in which the covered petition 
                or series of covered petitions was under review by the 
                Secretary of Health and Human Services; or</DELETED>
                <DELETED>    (B) $50,000 for each calendar day that 
                each covered petition that is a sham or that was part 
                of a series of covered petitions that is a sham was 
                under review by the Secretary of Health and Human 
                Services.</DELETED>
        <DELETED>    (5) Antitrust laws.--Nothing in this section shall 
        modify, impair, limit, or supersede the applicability of the 
        antitrust laws as defined in subsection (a) of the first 
        section of the Clayton Act (15 U.S.C. 12(a)), and of section 5 
        of the Federal Trade Commission Act (15 U.S.C. 45) to the 
        extent that it applies to unfair methods of 
        competition.</DELETED>
        <DELETED>    (6) Rule of construction.--The civil penalty 
        provided in this subsection is in addition to, and not in lieu 
        of, any other remedies provided by Federal law, including under 
        section 16 of the Clayton Act (15 U.S.C. 26) or under section 
        13(b) of the Federal Trade Commission Act (15 U.S.C. 53(b)). 
        Nothing in this paragraph shall be construed to affect any 
        authority of the Commission under any other provision of 
        law.</DELETED>
<DELETED>    (d) Applicability.--This section shall apply to any 
covered petition submitted on or after the date of enactment of this 
Act.</DELETED>

<DELETED>SEC. 3. SEVERABILITY.</DELETED>

<DELETED>    If any provision of this Act or the application of such 
provision to any person or circumstance is held to be unconstitutional, 
the remainder of this Act and the application of the provisions of such 
Act to any person or circumstance shall not be affected.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Stop Significant and Time-wasting 
Abuse Limiting Legitimate Innovation of New Generics Act'' or the 
``Stop STALLING Act''.

SEC. 2. FEDERAL TRADE COMMISSION ENFORCEMENT AGAINST SHAM PETITIONS.

    (a) Definitions.--In this section:
            (1) Commission.--The term ``Commission'' means the Federal 
        Trade Commission.
            (2) Covered application.--The term ``covered application'' 
        means an application filed pursuant to subsection (b)(2) or (j) 
        of section 505 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355) or section 351(k) of the Public Health Service Act 
        (42 U.S.C. 262(k)).
            (3) Covered petition.--The term ``covered petition'' means 
        a petition, or a supplement to a petition, filed under section 
        505(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355(q)).
            (4) Person.--The term ``person''--
                    (A) means an individual or entity; and
                    (B) includes--
                            (i) a successor and an assign of an entity; 
                        and
                            (ii) a joint venture, subsidiary, 
                        partnership, division, group, and affiliate 
                        controlled by an entity, and
                            (iii) a successor and an assign of a joint 
                        venture, subsidiary, partnership, division, 
                        group, and affiliate controlled by an entity.
            (5) Series of covered petitions.--The term ``series of 
        covered petitions'' means any group of more than 1 covered 
        petition relating to the same covered application.
            (6) Sham.--The term ``sham'' means a covered petition that 
        is objectively baseless and that attempts to use a governmental 
        process, as opposed to the outcome of that process, to 
        interfere with the business of a competitor, or a series of 
        covered petitions that attempts to use a governmental process, 
        as opposed to the outcome of that process, to interfere with 
        the business of a competitor.
    (b) Violation.--A person submitting or causing the submission of a 
covered petition or a series of covered petitions that is a sham shall 
be liable for engaging in an unfair method of competition under section 
5(a)(1) of the Federal Trade Commission Act (15 U.S.C. 45(a)(1)).
    (c) Civil Action.--
            (1) In general.--If the Commission has reason to believe 
        that the submission of a covered petition or a series of 
        covered petitions constitutes a violation of section 5(a)(1) of 
        the Federal Trade Commission Act (15 U.S.C. 45(a)(1)), the 
        Commission may commence a civil action to recover a civil 
        penalty and seek other appropriate relief in a district court 
        of the United States against any person that submitted or 
        caused to be submitted such covered petition or such series of 
        covered petitions, including successors or assigns.
            (2) Presumption.--In a civil action under paragraph (1), a 
        covered petition shall be presumed to be part of a series of 
        covered petitions that is a sham under subsection (b) of this 
        section if--
                    (A) the Secretary of Health and Human Services--
                            (i) has determined that the covered 
                        petition was submitted with the primary purpose 
                        of delaying the approval of a covered 
                        application; and
                            (ii) has referred such determination to the 
                        Federal Trade Commission in writing, including 
                        a reasoned basis for the determination; and
                    (B) the covered petition was part of a series of 
                covered petitions.
            (3) Exception.--The presumption in paragraph (2) shall not 
        apply if the defendant establishes, by a preponderance of the 
        evidence, that the series of covered petitions that includes 
        the covered petition referred to the Commission by the 
        Secretary of Health and Human Services is not a sham.
            (4) Civil penalty.--In an action under paragraph (1), any 
        person that has been found liable for a violation of section 
        5(a)(1) of the Federal Trade Commission Act (15 U.S.C. 
        45(a)(1)) shall be subject to a civil penalty for each 
        violation of not more than the greater of--
                    (A) any revenue earned from the sale by such person 
                of any drug product, referenced in a covered 
                application that was the subject of a covered petition 
                or a series of covered petitions that is a sham, during 
                the period in which the covered petition or series of 
                covered petitions was under review by the Secretary of 
                Health and Human Services; or
                    (B) $50,000 for each calendar day that each covered 
                petition that is a sham or that was part of a series of 
                covered petitions that is a sham was under review by 
                the Secretary of Health and Human Services.
            (5) Antitrust laws.--Nothing in this section shall modify, 
        impair, limit, or supersede the applicability of the antitrust 
        laws as defined in subsection (a) of the first section of the 
        Clayton Act (15 U.S.C. 12(a)), and of section 5 of the Federal 
        Trade Commission Act (15 U.S.C. 45) to the extent that it 
        applies to unfair methods of competition.
            (6) Rule of construction.--The civil penalty provided in 
        this subsection is in addition to, and not in lieu of, any 
        other remedies provided by Federal law, including under section 
        16 of the Clayton Act (15 U.S.C. 26) or under section 13(b) of 
        the Federal Trade Commission Act (15 U.S.C. 53(b)). Nothing in 
        this paragraph shall be construed to affect any authority of 
        the Commission under any other provision of law.
    (d) Applicability.--This section shall apply to any covered 
petition submitted on or after the date of enactment of this Act.

SEC. 3. SEVERABILITY.

    If any provision of this Act or the application of such provision 
to any person or circumstance is held to be unconstitutional, the 
remainder of this Act and the application of the provisions of such Act 
to any person or circumstance 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.''.
                                                       Calendar No. 130

116th CONGRESS

  1st Session

                                S. 1224

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                June 28 (legislative day, June 27), 2019

        Reported with an amendment and an amendment to the title
```