Loading chat...
NY S03203
Bill
Status
5/20/2025
Primary Sponsor
Nathalia Fernandez
Click for details
AI Summary
-
Presumes patent settlement agreements between brand-name drug companies and generic/biosimilar manufacturers are anticompetitive when the generic company receives value in exchange for delaying market entry of their competing product
-
Allows parties to rebut the anticompetitive presumption only by demonstrating with clear and convincing evidence that compensation was for legitimate goods/services or that procompetitive benefits outweigh anticompetitive effects
-
Excludes from "anything of value" certain settlement terms including early market entry rights, covenants not to sue, reasonable litigation expense reimbursement (capped at $7.5 million or 5% of projected revenue), and forgiveness of at-risk launch damages
-
Authorizes civil penalties of up to three times the value received from the violation or $20 million, whichever is greater, recoverable only by the state attorney general
-
Establishes a six-year statute of limitations for enforcement actions and takes effect 60 days after enactment
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
2/24/2026