Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act

Summary

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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

1. 28 April 2021

   Introduced

   Referred to the House Committee on the Judiciary.

   Source: IntroReferral

2. 28 April 2021

   Introduced

   Introduced in House

   Source: IntroReferral

3. 28 April 2021

   Introduced

   Introduced in House

   Source: IntroReferral

4. 30 September 2021

   Reported

   Ordered to be Reported in the Nature of a Substitute by Voice Vote.

   Source: Committee

5. 30 September 2021

   Committee

   Committee Consideration and Mark-up Session Held.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 28 April 2021 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 28 April 2021

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 28 April 2021

  ViewDownloadOpen at official source

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  Vertaal document

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• Introduced in House

  summary · EN · 28 April 2021

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Rep. Johnson, Henry C. "Hank" [D-GA-4] · D · Sponsor
• Rep. Issa, Darrell [R-CA-48] · R · Sponsor
• Rep. Jackson Lee, Sheila [D-TX-18] · D · Cosponsor
• · hsju00 · Standing

Related records

• related to → Affordable Prescriptions for Patients Act of 2021
• related to ← Reduced Costs and Continued Cures Act of 2021
• related to ← Reduced Costs and Continued Cures Act
• related to ← Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019