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Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act

USA117th CongressHR-2884| House 
| Updated: 9/30/2021
Henry C. "Hank" Johnson

Henry C. "Hank" Johnson

Democratic Representative

Georgia

Cosponsors (2)
Sheila Jackson Lee (Democratic)Darrell Issa (Republican)

Judiciary Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act This bill limits in certain instances the number of patents that the manufacturer of a biologic drug can assert in a lawsuit against a company seeking to sell a biosimilar version of that drug. (A biologic drug is produced through natural processes or isolated from natural sources. A biosimilar version is substantially similar to the original biologic, which is the reference product, and is often marketed as a less expensive alternative.) The bill's provisions apply to an existing framework that gives the biosimilar manufacturer an abbreviated path to Food and Drug Administration approval to sell the biosimilar. Specifically, if the biosimilar manufacturer completes certain actions under the framework, such as sharing certain information about its product with the reference product manufacturer, the bill limits the number of certain patents that the reference product manufacturer may assert in a lawsuit, such as patents that were filed more than four years after the reference product received market approval. The limit shall not apply to patents claiming certain methods for using the biologic drug. The court in which the infringement lawsuit is filed may increase the limit if justice so requires or if there is good cause for the increase.
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Timeline

Bill from Previous Congress

HR 116-3991
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019
Apr 28, 2021
Introduced in House
Apr 28, 2021
Referred to the House Committee on the Judiciary.
Sep 30, 2021
Ordered to be Reported in the Nature of a Substitute by Voice Vote.
Sep 30, 2021
Committee Consideration and Mark-up Session Held.
  • Bill from Previous Congress

    HR 116-3991
    Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019


  • April 28, 2021
    Introduced in House


  • April 28, 2021
    Referred to the House Committee on the Judiciary.


  • September 30, 2021
    Ordered to be Reported in the Nature of a Substitute by Voice Vote.


  • September 30, 2021
    Committee Consideration and Mark-up Session Held.

Commerce

Related Bills

  • HR 117-5260: Reduced Costs and Continued Cures Act
  • HR 117-5237: Reduced Costs and Continued Cures Act of 2021
  • S 117-1435: Affordable Prescriptions for Patients Act of 2021
Competition and antitrustHealth care costs and insuranceInflation and pricesIntellectual propertyJudicial review and appealsPrescription drugs

Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act

USA117th CongressHR-2884| House 
| Updated: 9/30/2021
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act This bill limits in certain instances the number of patents that the manufacturer of a biologic drug can assert in a lawsuit against a company seeking to sell a biosimilar version of that drug. (A biologic drug is produced through natural processes or isolated from natural sources. A biosimilar version is substantially similar to the original biologic, which is the reference product, and is often marketed as a less expensive alternative.) The bill's provisions apply to an existing framework that gives the biosimilar manufacturer an abbreviated path to Food and Drug Administration approval to sell the biosimilar. Specifically, if the biosimilar manufacturer completes certain actions under the framework, such as sharing certain information about its product with the reference product manufacturer, the bill limits the number of certain patents that the reference product manufacturer may assert in a lawsuit, such as patents that were filed more than four years after the reference product received market approval. The limit shall not apply to patents claiming certain methods for using the biologic drug. The court in which the infringement lawsuit is filed may increase the limit if justice so requires or if there is good cause for the increase.
View Full Text

Suggested Questions

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

Timeline

Bill from Previous Congress

HR 116-3991
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019
Apr 28, 2021
Introduced in House
Apr 28, 2021
Referred to the House Committee on the Judiciary.
Sep 30, 2021
Ordered to be Reported in the Nature of a Substitute by Voice Vote.
Sep 30, 2021
Committee Consideration and Mark-up Session Held.
  • Bill from Previous Congress

    HR 116-3991
    Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019


  • April 28, 2021
    Introduced in House


  • April 28, 2021
    Referred to the House Committee on the Judiciary.


  • September 30, 2021
    Ordered to be Reported in the Nature of a Substitute by Voice Vote.


  • September 30, 2021
    Committee Consideration and Mark-up Session Held.
Henry C. "Hank" Johnson

Henry C. "Hank" Johnson

Democratic Representative

Georgia

Cosponsors (2)
Sheila Jackson Lee (Democratic)Darrell Issa (Republican)

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
  • S 117-1435: Affordable Prescriptions for Patients Act of 2021
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Competition and antitrustHealth care costs and insuranceInflation and pricesIntellectual propertyJudicial review and appealsPrescription drugs