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Bill > S04370


NY S04370

NY S04370
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 no


summary

Introduced
02/03/2021
In Committee
01/05/2022
Crossed Over
Passed
Dead
12/31/2022

Introduced Session

2021-2022 General Assembly

Bill Summary

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.

AI Summary

This bill aims to preserve access to affordable drugs by presuming that certain agreements between pharmaceutical companies that settle patent infringement claims have anticompetitive effects. Specifically, the bill states that such agreements shall be presumed to be anticompetitive if a non-reference drug filer (e.g., a generic or biosimilar drug manufacturer) receives anything of value from the reference drug holder (e.g., the brand-name drug manufacturer) and agrees to limit or forego the research, development, manufacturing, marketing, or sales of its product. The bill provides exceptions where the parties can demonstrate that the agreement has generated procompetitive benefits or that the value received by the non-reference drug filer is fair compensation for other goods or services. The bill also outlines civil penalties for violations and allows the state to seek various legal remedies.

Committee Categories

Health and Social Services

Sponsors (13)

Last Action

COMMITTED TO RULES (on 06/03/2022)

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