Loading chat...
NY S04370
Bill
Status
2/3/2021
Primary Sponsor
Alessandra Biaggi
Click for details
AI Summary
-
Adds Title IV to Public Health Law establishing prohibited "pay-for-delay" agreements where generic or biosimilar drug makers receive compensation from brand-name drug makers in exchange for delaying market entry of cheaper alternative drugs.
-
Presumes anticompetitive effects and violation when a nonreference drug filer receives value from a reference drug holder and agrees to limit or forego research, development, manufacturing, marketing, or sales of their product.
-
Permits certain settlements without violation, including right to market before patent expiration, covenants not to sue, litigation cost compensation (capped at $7.5 million or 5% of projected three-year revenue), and forgiveness of at-risk launch damages.
-
Authorizes New York Attorney General to pursue civil penalties up to three times the value received by violators or $20 million, whichever is greater, with causes of action surviving six years after accrual.
-
Preserves all existing state and federal antitrust remedies and unfair competition claims while establishing a severability clause and effective date 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
COMMITTED TO RULES
6/3/2022