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Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019

USA116th CongressHR-3991| House 
| Updated: 11/21/2019
Henry C. "Hank" Johnson

Henry C. "Hank" Johnson

Democratic Representative

Georgia

Cosponsors (1)
Martha Roby (Republican)

Courts, Intellectual Property, Artificial Intelligence, and the Internet Subcommittee, Judiciary Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 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
Jul 25, 2019
Introduced in House
Jul 25, 2019
Referred to the House Committee on the Judiciary.
Aug 28, 2019
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
Nov 19, 2019
Subcommittee on Courts, Intellectual Property, and the Internet Discharged.
Nov 21, 2019
Ordered to be Reported (Amended).
Nov 21, 2019
Committee Consideration and Mark-up Session Held.
  • July 25, 2019
    Introduced in House


  • July 25, 2019
    Referred to the House Committee on the Judiciary.


  • August 28, 2019
    Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.


  • November 19, 2019
    Subcommittee on Courts, Intellectual Property, and the Internet Discharged.


  • November 21, 2019
    Ordered to be Reported (Amended).


  • November 21, 2019
    Committee Consideration and Mark-up Session Held.

Commerce

Related Bills

  • S 116-1416: Affordable Prescriptions for Patients Act of 2019
  • HR 116-2486: FUTURE Act
Competition and antitrustHealth care costs and insuranceInflation and pricesIntellectual propertyJudicial review and appealsPrescription drugs

Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019

USA116th CongressHR-3991| House 
| Updated: 11/21/2019
Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 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
Jul 25, 2019
Introduced in House
Jul 25, 2019
Referred to the House Committee on the Judiciary.
Aug 28, 2019
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
Nov 19, 2019
Subcommittee on Courts, Intellectual Property, and the Internet Discharged.
Nov 21, 2019
Ordered to be Reported (Amended).
Nov 21, 2019
Committee Consideration and Mark-up Session Held.
  • July 25, 2019
    Introduced in House


  • July 25, 2019
    Referred to the House Committee on the Judiciary.


  • August 28, 2019
    Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.


  • November 19, 2019
    Subcommittee on Courts, Intellectual Property, and the Internet Discharged.


  • November 21, 2019
    Ordered to be Reported (Amended).


  • November 21, 2019
    Committee Consideration and Mark-up Session Held.
Henry C. "Hank" Johnson

Henry C. "Hank" Johnson

Democratic Representative

Georgia

Cosponsors (1)
Martha Roby (Republican)

Courts, Intellectual Property, Artificial Intelligence, and the Internet Subcommittee, Judiciary Committee

Commerce

Related Bills

  • S 116-1416: Affordable Prescriptions for Patients Act of 2019
  • HR 116-2486: FUTURE Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Competition and antitrustHealth care costs and insuranceInflation and pricesIntellectual propertyJudicial review and appealsPrescription drugs