Legis Daily

Affordable Prescriptions for Patients Act

USA119th CongressS-1041| Senate 
| Updated: 4/10/2025
John Cornyn

John Cornyn

Republican Senator

Texas

Cosponsors (3)
Richard J. Durbin (Democratic)Chuck Grassley (Republican)Richard Blumenthal (Democratic)

Judiciary Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
The "Affordable Prescriptions for Patients Act" proposes significant amendments to patent law concerning biological products, aiming to clarify and streamline infringement proceedings. It expands the definition of patent infringement under title 35, United States Code, to explicitly cover patents claiming the biological product itself, its methods of use, or any method or product integral to its manufacture. A central provision introduces a limit on the number of patents a reference product sponsor can assert against an applicant for a biosimilar product, capping it at 20 patents in an infringement action. This limit is contingent upon the biosimilar applicant fulfilling all required information exchange obligations under the Public Health Service Act. While courts may increase this limit for good cause, such as a biosimilar applicant's failure to provide necessary information, patents claiming methods of use for therapy or diagnosis are specifically exempt from this numerical restriction. These changes are designed to influence the landscape of biosimilar patent litigation.

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 116-1416
Affordable Prescriptions for Patients Act of 2019

Bill from Previous Congress

S 117-1435
Affordable Prescriptions for Patients Act of 2021

Bill from Previous Congress

S 118-150
Affordable Prescriptions for Patients Act of 2023
Mar 13, 2025
Introduced in Senate
Mar 13, 2025
Read twice and referred to the Committee on the Judiciary.
Apr 3, 2025
Committee on the Judiciary. Ordered to be reported with amendments favorably.
Apr 10, 2025
Committee on the Judiciary. Reported by Senator Grassley with amendments. Without written report.
Apr 10, 2025
Placed on Senate Legislative Calendar under General Orders. Calendar No. 44.
  • Bill from Previous Congress

    S 116-1416
    Affordable Prescriptions for Patients Act of 2019


  • Bill from Previous Congress

    S 117-1435
    Affordable Prescriptions for Patients Act of 2021


  • Bill from Previous Congress

    S 118-150
    Affordable Prescriptions for Patients Act of 2023


  • March 13, 2025
    Introduced in Senate


  • March 13, 2025
    Read twice and referred to the Committee on the Judiciary.


  • April 3, 2025
    Committee on the Judiciary. Ordered to be reported with amendments favorably.


  • April 10, 2025
    Committee on the Judiciary. Reported by Senator Grassley with amendments. Without written report.


  • April 10, 2025
    Placed on Senate Legislative Calendar under General Orders. Calendar No. 44.

Commerce

Related Bills

  • S 119-891: Bipartisan Health Care Act
  • HR 119-1768: Lower Costs for Everyday Americans Act
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

USA119th CongressS-1041| Senate 
| Updated: 4/10/2025
The "Affordable Prescriptions for Patients Act" proposes significant amendments to patent law concerning biological products, aiming to clarify and streamline infringement proceedings. It expands the definition of patent infringement under title 35, United States Code, to explicitly cover patents claiming the biological product itself, its methods of use, or any method or product integral to its manufacture. A central provision introduces a limit on the number of patents a reference product sponsor can assert against an applicant for a biosimilar product, capping it at 20 patents in an infringement action. This limit is contingent upon the biosimilar applicant fulfilling all required information exchange obligations under the Public Health Service Act. While courts may increase this limit for good cause, such as a biosimilar applicant's failure to provide necessary information, patents claiming methods of use for therapy or diagnosis are specifically exempt from this numerical restriction. These changes are designed to influence the landscape of biosimilar patent litigation.

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 116-1416
Affordable Prescriptions for Patients Act of 2019

Bill from Previous Congress

S 117-1435
Affordable Prescriptions for Patients Act of 2021

Bill from Previous Congress

S 118-150
Affordable Prescriptions for Patients Act of 2023
Mar 13, 2025
Introduced in Senate
Mar 13, 2025
Read twice and referred to the Committee on the Judiciary.
Apr 3, 2025
Committee on the Judiciary. Ordered to be reported with amendments favorably.
Apr 10, 2025
Committee on the Judiciary. Reported by Senator Grassley with amendments. Without written report.
Apr 10, 2025
Placed on Senate Legislative Calendar under General Orders. Calendar No. 44.
  • Bill from Previous Congress

    S 116-1416
    Affordable Prescriptions for Patients Act of 2019


  • Bill from Previous Congress

    S 117-1435
    Affordable Prescriptions for Patients Act of 2021


  • Bill from Previous Congress

    S 118-150
    Affordable Prescriptions for Patients Act of 2023


  • March 13, 2025
    Introduced in Senate


  • March 13, 2025
    Read twice and referred to the Committee on the Judiciary.


  • April 3, 2025
    Committee on the Judiciary. Ordered to be reported with amendments favorably.


  • April 10, 2025
    Committee on the Judiciary. Reported by Senator Grassley with amendments. Without written report.


  • April 10, 2025
    Placed on Senate Legislative Calendar under General Orders. Calendar No. 44.
John Cornyn

John Cornyn

Republican Senator

Texas

Cosponsors (3)
Richard J. Durbin (Democratic)Chuck Grassley (Republican)Richard Blumenthal (Democratic)

Judiciary Committee

Commerce

Related Bills

  • S 119-891: Bipartisan Health Care Act
  • HR 119-1768: Lower Costs for Everyday Americans Act
  • 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