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Preserve Access to Affordable Generics and Biosimilars Act

USA118th CongressS-142| Senate 
| Updated: 3/1/2023
Amy Klobuchar

Amy Klobuchar

Democratic Senator

Minnesota

Cosponsors (10)
Joni Ernst (Republican)Jon Ossoff (Democratic)Richard J. Durbin (Democratic)Chris Van Hollen (Democratic)Kevin Cramer (Republican)Cory A. Booker (Democratic)Peter Welch (Democratic)Chuck Grassley (Republican)Richard Blumenthal (Democratic)Mark Kelly (Democratic)

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 and secure final approval for 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

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2 versions available

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Timeline

Bill from Previous Congress

S 117-1428
Preserve Access to Affordable Generics and Biosimilars Act

Bill from Previous Congress

S 116-64
Preserve Access to Affordable Generics and Biosimilars Act
Jan 30, 2023
Introduced in Senate
Jan 30, 2023
Read twice and referred to the Committee on the Judiciary.
Feb 9, 2023
Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
Mar 1, 2023
Committee on the Judiciary. Reported by Senator Durbin with an amendment in the nature of a substitute. Without written report.
Mar 1, 2023
Placed on Senate Legislative Calendar under General Orders. Calendar No. 20.
  • Bill from Previous Congress

    S 117-1428
    Preserve Access to Affordable Generics and Biosimilars Act


  • Bill from Previous Congress

    S 116-64
    Preserve Access to Affordable Generics and Biosimilars Act


  • January 30, 2023
    Introduced in Senate


  • January 30, 2023
    Read twice and referred to the Committee on the Judiciary.


  • February 9, 2023
    Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.


  • March 1, 2023
    Committee on the Judiciary. Reported by Senator Durbin with an amendment in the nature of a substitute. Without written report.


  • March 1, 2023
    Placed on Senate Legislative Calendar under General Orders. Calendar No. 20.

Health

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

USA118th CongressS-142| Senate 
| Updated: 3/1/2023
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 and secure final approval for 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

Bill from Previous Congress

S 117-1428
Preserve Access to Affordable Generics and Biosimilars Act

Bill from Previous Congress

S 116-64
Preserve Access to Affordable Generics and Biosimilars Act
Jan 30, 2023
Introduced in Senate
Jan 30, 2023
Read twice and referred to the Committee on the Judiciary.
Feb 9, 2023
Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
Mar 1, 2023
Committee on the Judiciary. Reported by Senator Durbin with an amendment in the nature of a substitute. Without written report.
Mar 1, 2023
Placed on Senate Legislative Calendar under General Orders. Calendar No. 20.
  • Bill from Previous Congress

    S 117-1428
    Preserve Access to Affordable Generics and Biosimilars Act


  • Bill from Previous Congress

    S 116-64
    Preserve Access to Affordable Generics and Biosimilars Act


  • January 30, 2023
    Introduced in Senate


  • January 30, 2023
    Read twice and referred to the Committee on the Judiciary.


  • February 9, 2023
    Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.


  • March 1, 2023
    Committee on the Judiciary. Reported by Senator Durbin with an amendment in the nature of a substitute. Without written report.


  • March 1, 2023
    Placed on Senate Legislative Calendar under General Orders. Calendar No. 20.
Amy Klobuchar

Amy Klobuchar

Democratic Senator

Minnesota

Cosponsors (10)
Joni Ernst (Republican)Jon Ossoff (Democratic)Richard J. Durbin (Democratic)Chris Van Hollen (Democratic)Kevin Cramer (Republican)Cory A. Booker (Democratic)Peter Welch (Democratic)Chuck Grassley (Republican)Richard Blumenthal (Democratic)Mark Kelly (Democratic)

Judiciary Committee

Health

  • 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