Preserve Access to Affordable Generics and Biosimilars Act

Summary

Preserve Access to Affordable Generics and Biosimilars Act This bill authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar. An agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects. When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC concerning the agreement contains the complete agreement and any agreements related to that main agreement, including descriptions of any oral agreements or representations. The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.

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Timeline

1. 9 January 2019

   Introduced

   Read twice and referred to the Committee on the Judiciary.

   Source: IntroReferral

2. 9 January 2019

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 9 January 2019 · Download file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 9 January 2019

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 9 January 2019

  ViewDownloadOpen at official source

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• Introduced in Senate

  summary · EN · 9 January 2019

  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. Klobuchar, Amy [D-MN] · D · Sponsor
• Sen. Grassley, Chuck [R-IA] · R · Sponsor
• Sen. Leahy, Patrick J. [D-VT] · D · Cosponsor
• Sen. Ernst, Joni [R-IA] · R · Cosponsor
• Sen. Cramer, Kevin [R-ND] · R · Cosponsor
• Sen. Durbin, Richard J. [D-IL] · D · Cosponsor
• Sen. Van Hollen, Chris [D-MD] · D · Cosponsor
• Sen. Collins, Susan M. [R-ME] · R · Cosponsor
• · ssju00 · Standing

Related records

• related to → Preserve Access to Affordable Generics and Biosimilars Act
• related to ← Competitive DRUGS Act of 2019
• related to ← Preserve Access to Affordable Generics and Biosimilars Act
• related to ← Affordable Medications Act
• related to ← Lowering Prescription Drug Prices for America’s Seniors and Families Act of 2020