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Preserve Access to Affordable Generics and Biosimilars Act

USA116th CongressHR-2375| House 
| Updated: 12/24/2020
Jerrold Nadler

Jerrold Nadler

Democratic Representative

New York

Cosponsors (4)
Mark Meadows (Republican)David N. Cicilline (Democratic)Steve Cohen (Democratic)Doug Collins (Republican)

Health Subcommittee, Judiciary Committee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Preserve Access to Affordable Generics and Biosimilars Act This bill authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar. An agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects. When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC concerning the agreement contains the complete agreement and any agreements related to that main agreement, including descriptions of any oral agreements or representations. The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.

Bill Text Versions

View Text
2 versions available

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Timeline
Jan 9, 2019

Latest Companion Bill Action

S 116-64
Introduced in Senate
Apr 29, 2019
Introduced in House
Apr 29, 2019
Referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce, 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.
Apr 30, 2019
Referred to the Subcommittee on Health.
Apr 30, 2019
Committee Consideration and Mark-up Session Held.
Apr 30, 2019
Ordered to be Reported by Voice Vote.
Dec 24, 2020
Placed on the Union Calendar, Calendar No. 576.
Dec 24, 2020
Reported by the Committee on Judiciary. H. Rept. 116-693, Part I.
Dec 24, 2020
Committee on Energy and Commerce discharged.
  • January 9, 2019

    Latest Companion Bill Action

    S 116-64
    Introduced in Senate


  • April 29, 2019
    Introduced in House


  • April 29, 2019
    Referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce, 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.


  • April 30, 2019
    Referred to the Subcommittee on Health.


  • April 30, 2019
    Committee Consideration and Mark-up Session Held.


  • April 30, 2019
    Ordered to be Reported by Voice Vote.


  • December 24, 2020
    Placed on the Union Calendar, Calendar No. 576.


  • December 24, 2020
    Reported by the Committee on Judiciary. H. Rept. 116-693, Part I.


  • December 24, 2020
    Committee on Energy and Commerce discharged.

Health

Related Bills

  • HR 116-1344: Competitive DRUGS Act of 2019
  • S 116-64: Preserve Access to Affordable Generics and Biosimilars Act
Administrative law and regulatory proceduresCivil actions and liabilityCompetition and antitrustCongressional oversightContracts and agencyFederal Trade Commission (FTC)Intellectual propertyJudicial review and appealsLicensing and registrationsMarketing and advertisingPrescription drugs

Preserve Access to Affordable Generics and Biosimilars Act

USA116th CongressHR-2375| House 
| Updated: 12/24/2020
Preserve Access to Affordable Generics and Biosimilars Act This bill authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar. An agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects. When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC concerning the agreement contains the complete agreement and any agreements related to that main agreement, including descriptions of any oral agreements or representations. The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.

Bill Text Versions

View Text
2 versions available

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Jan 9, 2019

Latest Companion Bill Action

S 116-64
Introduced in Senate
Apr 29, 2019
Introduced in House
Apr 29, 2019
Referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce, 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.
Apr 30, 2019
Referred to the Subcommittee on Health.
Apr 30, 2019
Committee Consideration and Mark-up Session Held.
Apr 30, 2019
Ordered to be Reported by Voice Vote.
Dec 24, 2020
Placed on the Union Calendar, Calendar No. 576.
Dec 24, 2020
Reported by the Committee on Judiciary. H. Rept. 116-693, Part I.
Dec 24, 2020
Committee on Energy and Commerce discharged.
  • January 9, 2019

    Latest Companion Bill Action

    S 116-64
    Introduced in Senate


  • April 29, 2019
    Introduced in House


  • April 29, 2019
    Referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce, 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.


  • April 30, 2019
    Referred to the Subcommittee on Health.


  • April 30, 2019
    Committee Consideration and Mark-up Session Held.


  • April 30, 2019
    Ordered to be Reported by Voice Vote.


  • December 24, 2020
    Placed on the Union Calendar, Calendar No. 576.


  • December 24, 2020
    Reported by the Committee on Judiciary. H. Rept. 116-693, Part I.


  • December 24, 2020
    Committee on Energy and Commerce discharged.
Jerrold Nadler

Jerrold Nadler

Democratic Representative

New York

Cosponsors (4)
Mark Meadows (Republican)David N. Cicilline (Democratic)Steve Cohen (Democratic)Doug Collins (Republican)

Health Subcommittee, Judiciary Committee, Energy and Commerce Committee

Health

Related Bills

  • HR 116-1344: Competitive DRUGS Act of 2019
  • S 116-64: Preserve Access to Affordable Generics and Biosimilars Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresCivil actions and liabilityCompetition and antitrustCongressional oversightContracts and agencyFederal Trade Commission (FTC)Intellectual propertyJudicial review and appealsLicensing and registrationsMarketing and advertisingPrescription drugs