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Biologic Patent Transparency Act

USA116th CongressS-659| Senate 
| Updated: 3/5/2019
Susan M. Collins

Susan M. Collins

Republican Senator

Maine

Cosponsors (8)
Jeanne Shaheen (Democratic)Mike Braun (Republican)Rand Paul (Republican)Tim Kaine (Democratic)Debbie Stabenow (Democratic)Josh Hawley (Republican)Rob Portman (Republican)Lisa Murkowski (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Biologic Patent Transparency Act This bill requires the holder of a license to market a biologic drug to disclose all patents believed to be covering that drug. The bill also directs the Department of Health and Human Services (HHS) to make such information publicly available. (Biologics are drugs produced through natural processes or isolated from natural sources.) The holder of a market approval license for a biologic product shall submit a list to HHS of all patents that the holder reasonably believes would be infringed by an unauthorized person making, using, offering to sell, selling, or importing that product. The license holder shall update HHS as to any relevant patents granted after the initial submission and as to listed patents that were later invalidated or rendered unenforceable. If a patent that should have been listed was not timely disclosed to HHS, the patent holder may not sue for infringement of that patent. HHS shall publish an easily searchable list of all biologics that have received market approval or for which an application for approval has been filed. The list shall contain information including (1) the official and proprietary name of the product, (2) the patents the license holder has listed under this bill, (3) whether various market exclusivity periods apply to the product, and (4) information about whether the product is interchangeable with another biologic product.
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Timeline
Mar 5, 2019
Introduced in Senate
Mar 5, 2019
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Dec 18, 2019

Latest Companion Bill Action

HR 116-4850
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
  • March 5, 2019
    Introduced in Senate


  • March 5, 2019
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • December 18, 2019

    Latest Companion Bill Action

    HR 116-4850
    Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.

Commerce

Related Bills

  • HR 116-4850: Biologic Patent Transparency Act
  • S 116-4796: Fair Care Act of 2020
  • S 116-1895: Lower Health Care Costs Act
  • HR 116-8527: Fair Care Act of 2020
Biological and life sciencesGeneticsGovernment information and archivesIntellectual propertyLicensing and registrations

Biologic Patent Transparency Act

USA116th CongressS-659| Senate 
| Updated: 3/5/2019
Biologic Patent Transparency Act This bill requires the holder of a license to market a biologic drug to disclose all patents believed to be covering that drug. The bill also directs the Department of Health and Human Services (HHS) to make such information publicly available. (Biologics are drugs produced through natural processes or isolated from natural sources.) The holder of a market approval license for a biologic product shall submit a list to HHS of all patents that the holder reasonably believes would be infringed by an unauthorized person making, using, offering to sell, selling, or importing that product. The license holder shall update HHS as to any relevant patents granted after the initial submission and as to listed patents that were later invalidated or rendered unenforceable. If a patent that should have been listed was not timely disclosed to HHS, the patent holder may not sue for infringement of that patent. HHS shall publish an easily searchable list of all biologics that have received market approval or for which an application for approval has been filed. The list shall contain information including (1) the official and proprietary name of the product, (2) the patents the license holder has listed under this bill, (3) whether various market exclusivity periods apply to the product, and (4) information about whether the product is interchangeable with another biologic product.
View Full Text

Suggested Questions

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

Timeline
Mar 5, 2019
Introduced in Senate
Mar 5, 2019
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Dec 18, 2019

Latest Companion Bill Action

HR 116-4850
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
  • March 5, 2019
    Introduced in Senate


  • March 5, 2019
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • December 18, 2019

    Latest Companion Bill Action

    HR 116-4850
    Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
Susan M. Collins

Susan M. Collins

Republican Senator

Maine

Cosponsors (8)
Jeanne Shaheen (Democratic)Mike Braun (Republican)Rand Paul (Republican)Tim Kaine (Democratic)Debbie Stabenow (Democratic)Josh Hawley (Republican)Rob Portman (Republican)Lisa Murkowski (Republican)

Health, Education, Labor, and Pensions Committee

Commerce

Related Bills

  • HR 116-4850: Biologic Patent Transparency Act
  • S 116-4796: Fair Care Act of 2020
  • S 116-1895: Lower Health Care Costs Act
  • HR 116-8527: Fair Care Act of 2020
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Biological and life sciencesGeneticsGovernment information and archivesIntellectual propertyLicensing and registrations