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NY A08576
Bill
Status
5/21/2025
Primary Sponsor
Anna Kelles
Click for details
AI Summary
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Prohibits "pay-for-delay" pharmaceutical patent settlement agreements where brand-name drug companies pay generic or biosimilar drug makers to delay bringing cheaper versions to market, presuming such agreements have anticompetitive effects
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Defines illegal agreements as those where a generic/biosimilar drug filer receives anything of value from a brand company asserting patent infringement and agrees to limit or forego research, development, manufacturing, marketing, or sales of their competing product
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Allows exceptions for legitimate settlement terms including early market entry rights, covenants not to sue, reasonable litigation expense compensation (capped at $7.5 million or 5% of projected 3-year revenue), and forgiveness of damages from at-risk product launches
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Requires parties claiming procompetitive benefits to prove by clear and convincing evidence that any value received was fair compensation for other goods/services or that procompetitive benefits outweigh anticompetitive effects
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Establishes civil penalties of up to three times the value received from violations or $20 million (whichever is greater), enforceable by the Attorney General, with a six-year statute of limitations
Legislative Description
Relates to preserving access to affordable drugs; provides that an agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a pharmaceutical product, shall be presumed to have anticompetitive effects if a nonreference drug filer receives anything of value from another company asserting patent infringement and if the nonreference drug filer agrees to limit or forego research, development, manufacturing, marketing, or sales of the nonreference drug filer's product for any period of time.
Last Action
referred to health
1/7/2026