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Preserve Access to Affordable Generics and Biosimilars Act

USA116th CongressS-64| Senate 
| Updated: 1/9/2019
Amy Klobuchar

Amy Klobuchar

Democratic Senator

Minnesota

Cosponsors (7)
Joni Ernst (Republican)Patrick J. Leahy (Democratic)Richard J. Durbin (Democratic)Chris Van Hollen (Democratic)Kevin Cramer (Republican)Susan M. Collins (Republican)Chuck Grassley (Republican)

Judiciary 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.
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Timeline
Jan 9, 2019
Introduced in Senate
Jan 9, 2019
Read twice and referred to the Committee on the Judiciary.
Dec 24, 2020

Latest Companion Bill Action

HR 116-2375
Placed on the Union Calendar, Calendar No. 576.
  • January 9, 2019
    Introduced in Senate


  • January 9, 2019
    Read twice and referred to the Committee on the Judiciary.


  • December 24, 2020

    Latest Companion Bill Action

    HR 116-2375
    Placed on the Union Calendar, Calendar No. 576.

Health

Related Bills

  • S 116-1801: Affordable Medications Act
  • HR 116-2375: Preserve Access to Affordable Generics and Biosimilars Act
  • S 116-3384: Lowering Prescription Drug Prices for America’s Seniors and Families Act of 2020
  • HR 116-1344: Competitive DRUGS Act of 2019
Administrative law and regulatory proceduresCivil actions and liabilityCompetition and antitrustContracts and agencyFederal Trade Commission (FTC)Intellectual propertyJudicial review and appealsLicensing and registrationsManufacturingMarketing and advertisingPrescription drugs

Preserve Access to Affordable Generics and Biosimilars Act

USA116th CongressS-64| Senate 
| Updated: 1/9/2019
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.
View Full Text

Suggested Questions

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

Timeline
Jan 9, 2019
Introduced in Senate
Jan 9, 2019
Read twice and referred to the Committee on the Judiciary.
Dec 24, 2020

Latest Companion Bill Action

HR 116-2375
Placed on the Union Calendar, Calendar No. 576.
  • January 9, 2019
    Introduced in Senate


  • January 9, 2019
    Read twice and referred to the Committee on the Judiciary.


  • December 24, 2020

    Latest Companion Bill Action

    HR 116-2375
    Placed on the Union Calendar, Calendar No. 576.
Amy Klobuchar

Amy Klobuchar

Democratic Senator

Minnesota

Cosponsors (7)
Joni Ernst (Republican)Patrick J. Leahy (Democratic)Richard J. Durbin (Democratic)Chris Van Hollen (Democratic)Kevin Cramer (Republican)Susan M. Collins (Republican)Chuck Grassley (Republican)

Judiciary Committee

Health

Related Bills

  • S 116-1801: Affordable Medications Act
  • HR 116-2375: Preserve Access to Affordable Generics and Biosimilars Act
  • S 116-3384: Lowering Prescription Drug Prices for America’s Seniors and Families Act of 2020
  • HR 116-1344: Competitive DRUGS Act of 2019
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresCivil actions and liabilityCompetition and antitrustContracts and agencyFederal Trade Commission (FTC)Intellectual propertyJudicial review and appealsLicensing and registrationsManufacturingMarketing and advertisingPrescription drugs