Affordable Prescriptions for Patients Act of 2021

Summary

Affordable Prescriptions for Patients Act of 2021 This bill prohibits product hopping by drug manufacturers, authorizes the Federal Trade Commission to enforce this prohibition, and imposes limits on patent litigation involving biological products. Generally, product-hopping describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a follow-on product is a modified version of the reference drug that shares an indication (what the drug is used for) with the reference drug. The bill presumes product hopping has occurred when a reference drug manufacturer, after receiving notice that the Food and Drug Administration (FDA) has received an application to market a competing generic (or biosimilar) version, takes certain actions such as withdrawing the reference drug from the market and selling a follow-on product. A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition. The bill also limits in certain instances the number of patents that a reference biological product manufacturer can assert in a patent infringement lawsuit against a company seeking to sell a biosimilar version. Specifically, if the biosimilar manufacturer completes certain actions as part of an abbreviated pathway to get FDA market approval, the bill limits, subject to exceptions and waivers, the number of certain types of patents that the reference product manufacturer may assert, such as patents filed more than four years after the reference product received market approval.

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Timeline

1. 28 April 2021

   Introduced

   Read twice and referred to the Committee on the Judiciary.

   Source: IntroReferral

2. 28 April 2021

   Introduced

   Introduced in Senate

   Source: IntroReferral

3. 29 July 2021

   Reported

   Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 28 April 2021 · Download file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 28 April 2021

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 28 April 2021

  ViewDownloadOpen at official source

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• Introduced in Senate

  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

• Sen. Cornyn, John [R-TX] · R · Sponsor
• Sen. Blumenthal, Richard [D-CT] · D · Sponsor
• Sen. Grassley, Chuck [R-IA] · R · Cosponsor
• Sen. Durbin, Richard J. [D-IL] · D · Cosponsor
• Sen. Klobuchar, Amy [D-MN] · D · Cosponsor
• Sen. Murray, Patty [D-WA] · D · Cosponsor
• Sen. Hawley, Josh [R-MO] · R · Cosponsor
• Sen. Booker, Cory A. [D-NJ] · D · Cosponsor
• Sen. Cruz, Ted [R-TX] · R · Cosponsor
• Sen. Ossoff, Jon [D-GA] · D · Cosponsor
• Sen. Ernst, Joni [R-IA] · R · Cosponsor
• Sen. King, Angus S., Jr. [I-ME] · I · Cosponsor
• Sen. Smith, Tina [D-MN] · D · Cosponsor
• Sen. Peters, Gary C. [D-MI] · D · Cosponsor
• Sen. Leahy, Patrick J. [D-VT] · D · Cosponsor
• Sen. Braun, Mike [R-IN] · R · Cosponsor
• Sen. Kelly, Mark [D-AZ] · D · Cosponsor
• · ssju00 · Standing

Related records

• related to → Affordable Prescriptions for Patients Act of 2023
• related to ← Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
• related to ← Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
• related to ← Reduced Costs and Continued Cures Act of 2021
• related to ← Reduced Costs and Continued Cures Act