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MN HF3744
Bill
Status
2/24/2020
Primary Sponsor
Raymond Dehn
Click for details
AI Summary
H.F. No. 3744 - Preserving Access to Affordable Drugs Act
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Establishes presumption that patent settlement agreements between brand drug companies and generic/biosimilar drug filers are anticompetitive violations if the generic filer receives anything of value (exclusive licenses, promises not to launch authorized generics) and agrees to limit or forego research, development, manufacturing, marketing, or sales.
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Carves out specific types of consideration that do not constitute "anything of value": marketing rights before patent expiration, covenants not to sue, documented litigation cost compensation up to $7.5 million or 5% of projected three-year revenue, entry triggers based on new drug dosages, and forgiveness of damages from at-risk launches.
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Allows parties to rebut the anticompetitive presumption by proving the value received is fair compensation for other goods/services or that procompetitive benefits outweigh anticompetitive effects, but prohibits presuming patent validity, FDA approval delays, or market entry delays without evidence.
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Imposes civil penalties of up to 3 times the value received or $20 million (whichever is greater) enforceable by the Minnesota attorney general, plus liability for other damages under state antitrust law.
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Establishes four-year statute of limitations for enforcement actions and preserves existing antitrust remedies under Minnesota law.
Legislative Description
Affordable drug access preserved.
Last Action
Introduction and first reading, referred to Commerce
2/24/2020