New York A 8576: Preserves access to affordable drugs

Bill Text

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A08576 Summary:

BILL NOA08576 

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SAME ASSAME AS S03203

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SPONSORKelles

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COSPNSRRivera, Davila, Burdick, Simon, Epstein, Rosenthal, Lupardo, Gonzalez-Rojas, Paulin, Bichotte
 Hermelyn, Steck, Stirpe, Smith, Reyes, Forrest, Lavine, Jackson, Hevesi, Dinowitz, Mamdani, Glick,
 Santabarbara, Stern, Levenberg, Septimo, Griffin

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MLTSPNSR

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Add Art 2-A Title IV 282 & 283, Pub Health L

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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.

Go to top A08576 Actions:

BILL NOA08576 

&nbsp

05/21/2025referred to health

01/07/2026referred to health

Go to topA08576 Committee&nbspVotes:

Go to topA08576 Floor&nbspVotes:

There are no Assembly votes for this bill in this legislative session.

Go to topA08576 Text:

 STATE OF NEW YORK
 ________________________________________________________________________

 8576

 2025-2026 Regular Sessions

 IN ASSEMBLY

 May 21, 2025
 ___________

 Introduced by M. of A. KELLES, RIVERA, DAVILA, BURDICK, SIMON, EPSTEIN,
 ROSENTHAL, LUPARDO, GONZALEZ-ROJAS, PAULIN, BICHOTTE HERMELYN, STECK,
 STIRPE, SMITH, REYES, FORREST, LAVINE, JACKSON, HEVESI, DINOWITZ,
 MAMDANI, GLICK, SANTABARBARA, STERN, LEVENBERG, SEPTIMO -- read once
 and referred to the Committee on Health

 AN ACT to amend the public health law, in relation to preserving access
 to affordable drugs

 The People of the State of New York, represented in Senate and Assem-
 bly, do enact as follows:

 1 Section 1. Article 2-A of the public health law is amended by adding a
 2 new title IV to read as follows:
 3 TITLE IV
 4 PRESERVING ACCESS TO AFFORDABLE DRUGS
 5 Section 282. Definitions.
 6 283. Preserving access to affordable drugs.
 7 § 282. Definitions. For the purposes of this title, the following
 8 terms shall have the following meanings:
 9 1. "ANDA" shall mean abbreviated new drug application as described by
 10 505(j) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 335(j).
 11 2. "ANDA filer" shall mean a party that owns or controls an ANDA filed
 12 with the federal food and drug administration or has the exclusive
 13 rights under that ANDA to distribute the ANDA product.
 14 3. "Agreement" shall mean anything that would constitute an agreement
 15 under state law.
 16 4. "Agreement resolving or settling a patent infringement claim"
 17 includes any agreement that is entered into within thirty days of the
 18 resolution or the settlement of the claim, or any other agreement that
 19 is contingent upon, provides a contingent condition for, or is otherwise
 20 related to the resolution or settlement of the claim. This shall
 21 include, but is not limited to, the following:

 EXPLANATION--Matter in italics (underscored) is new; matter in brackets
 [ ] is old law to be omitted.
 LBD00058-01-5

 A. 8576 2

 1 (a) Any agreement required to be provided to the federal trade commis-
 2 sion or the antitrust division of the United States Department of
 3 Justice under the Medicare Prescription Drug, Improvement, and Modern-
 4 ization Act of 2003, Pub. L. No. 108-173;
 5 (b) Any agreement between a biosimilar or interchangeable product
 6 applicant and a reference product sponsor under the Biologics Price
 7 Competition and Innovation Act of 2009, Pub. L. No. 111-148, that
 8 resolves patent claims between the applicant and sponsor.
 9 5. "Biosimilar biological product application filer" shall mean a
 10 party that owns or controls a biosimilar biological product application
 11 filed with the federal food and drug administration pursuant to section
 12 351(k) of the Public Health Service Act, 42 U.S.C. 262(k), for licensure
 13 of a biological product as biosimilar to, or interchangeable with, a
 14 reference product, or that has the exclusive rights under the applica-
 15 tion to distribute the biosimilar biological product.
 16 6. "NDA" shall mean