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Affordable Prescriptions for Patients Act of 2021

USA117th CongressS-1435| Senate 
| Updated: 7/29/2021
John Cornyn

John Cornyn

Republican Senator

Texas

Cosponsors (16)
Joni Ernst (Republican)Mike Braun (Republican)Jon Ossoff (Democratic)Patrick J. Leahy (Democratic)Richard J. Durbin (Democratic)Angus S. King (Independent)Amy Klobuchar (Democratic)Ted Cruz (Republican)Patty Murray (Democratic)Tina Smith (Democratic)Josh Hawley (Republican)Cory A. Booker (Democratic)Chuck Grassley (Republican)Gary C. Peters (Democratic)Richard Blumenthal (Democratic)Mark Kelly (Democratic)

Judiciary Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Affordable Prescriptions for Patients Act of 2021 This bill prohibits product hopping by drug manufacturers, authorizes the Federal Trade Commission to enforce this prohibition, and imposes limits on patent litigation involving biological products. Generally, product-hopping describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a follow-on product is a modified version of the reference drug that shares an indication (what the drug is used for) with the reference drug. The bill presumes product hopping has occurred when a reference drug manufacturer, after receiving notice that the Food and Drug Administration (FDA) has received an application to market a competing generic (or biosimilar) version, takes certain actions such as withdrawing the reference drug from the market and selling a follow-on product. A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition. The bill also limits in certain instances the number of patents that a reference biological product manufacturer can assert in a patent infringement lawsuit against a company seeking to sell a biosimilar version. Specifically, if the biosimilar manufacturer completes certain actions as part of an abbreviated pathway to get FDA market approval, the bill limits, subject to exceptions and waivers, the number of certain types of patents that the reference product manufacturer may assert, such as patents filed more than four years after the reference product received market approval.
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Timeline

Bill from Previous Congress

S 116-1416
Affordable Prescriptions for Patients Act of 2019
Apr 28, 2021
Introduced in Senate
Apr 28, 2021
Read twice and referred to the Committee on the Judiciary.
Jul 29, 2021
Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
  • Bill from Previous Congress

    S 116-1416
    Affordable Prescriptions for Patients Act of 2019


  • April 28, 2021
    Introduced in Senate


  • April 28, 2021
    Read twice and referred to the Committee on the Judiciary.


  • July 29, 2021
    Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.

Commerce

Related Bills

  • HR 117-5260: Reduced Costs and Continued Cures Act
  • HR 117-5237: Reduced Costs and Continued Cures Act of 2021
  • HR 117-2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
  • HR 117-2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Administrative remediesCivil actions and liabilityCompetition and antitrustConsumer affairsDrug safety, medical device, and laboratory regulationFederal Trade Commission (FTC)Health care costs and insuranceInflation and pricesIntellectual propertyJudicial review and appealsManufacturingPrescription drugs

Affordable Prescriptions for Patients Act of 2021

USA117th CongressS-1435| Senate 
| Updated: 7/29/2021
Affordable Prescriptions for Patients Act of 2021 This bill prohibits product hopping by drug manufacturers, authorizes the Federal Trade Commission to enforce this prohibition, and imposes limits on patent litigation involving biological products. Generally, product-hopping describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a follow-on product is a modified version of the reference drug that shares an indication (what the drug is used for) with the reference drug. The bill presumes product hopping has occurred when a reference drug manufacturer, after receiving notice that the Food and Drug Administration (FDA) has received an application to market a competing generic (or biosimilar) version, takes certain actions such as withdrawing the reference drug from the market and selling a follow-on product. A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition. The bill also limits in certain instances the number of patents that a reference biological product manufacturer can assert in a patent infringement lawsuit against a company seeking to sell a biosimilar version. Specifically, if the biosimilar manufacturer completes certain actions as part of an abbreviated pathway to get FDA market approval, the bill limits, subject to exceptions and waivers, the number of certain types of patents that the reference product manufacturer may assert, such as patents filed more than four years after the reference product received market approval.
View Full Text

Suggested Questions

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

Timeline

Bill from Previous Congress

S 116-1416
Affordable Prescriptions for Patients Act of 2019
Apr 28, 2021
Introduced in Senate
Apr 28, 2021
Read twice and referred to the Committee on the Judiciary.
Jul 29, 2021
Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
  • Bill from Previous Congress

    S 116-1416
    Affordable Prescriptions for Patients Act of 2019


  • April 28, 2021
    Introduced in Senate


  • April 28, 2021
    Read twice and referred to the Committee on the Judiciary.


  • July 29, 2021
    Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
John Cornyn

John Cornyn

Republican Senator

Texas

Cosponsors (16)
Joni Ernst (Republican)Mike Braun (Republican)Jon Ossoff (Democratic)Patrick J. Leahy (Democratic)Richard J. Durbin (Democratic)Angus S. King (Independent)Amy Klobuchar (Democratic)Ted Cruz (Republican)Patty Murray (Democratic)Tina Smith (Democratic)Josh Hawley (Republican)Cory A. Booker (Democratic)Chuck Grassley (Republican)Gary C. Peters (Democratic)Richard Blumenthal (Democratic)Mark Kelly (Democratic)

Judiciary Committee

Commerce

Related Bills

  • HR 117-5260: Reduced Costs and Continued Cures Act
  • HR 117-5237: Reduced Costs and Continued Cures Act of 2021
  • HR 117-2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
  • HR 117-2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative remediesCivil actions and liabilityCompetition and antitrustConsumer affairsDrug safety, medical device, and laboratory regulationFederal Trade Commission (FTC)Health care costs and insuranceInflation and pricesIntellectual propertyJudicial review and appealsManufacturingPrescription drugs