New York S 3203: Preserves access to affordable drugs

Bill Text

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S03203 Summary:

BILL NOS03203 

&nbsp

SAME ASSAME AS A08576

&nbsp

SPONSORFERNANDEZ

&nbsp

COSPNSRBROUK, CLEARE, JACKSON, LIU, MAY, WEBB

&nbsp

MLTSPNSR

&nbsp

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

&nbsp

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 S03203 Actions:

BILL NOS03203 

&nbsp

01/24/2025REFERRED TO HEALTH

03/04/2025REPORTED AND COMMITTED TO FINANCE

04/29/20251ST REPORT CAL.755

04/30/20252ND REPORT CAL.

05/01/2025ADVANCED TO THIRD READING 

05/20/2025PASSED SENATE

05/20/2025DELIVERED TO ASSEMBLY

05/20/2025referred to health

01/07/2026died in assembly

01/07/2026returned to senate

01/07/2026REFERRED TO HEALTH

02/09/20261ST REPORT CAL.304

02/10/20262ND REPORT CAL.

02/11/2026ADVANCED TO THIRD READING 

02/24/2026PASSED SENATE

02/24/2026DELIVERED TO ASSEMBLY

02/24/2026referred to health

Go to topS03203 Committee&nbspVotes:

Go to topS03203 Floor&nbspVotes:

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

Go to topS03203 Text:

 STATE OF NEW YORK
 ________________________________________________________________________

 3203

 2025-2026 Regular Sessions

 IN SENATE

 January 24, 2025
 ___________

 Introduced by Sens. FERNANDEZ, BROUK, MAY, WEBB -- read twice and
 ordered printed, and when printed to be committed 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:
 22 (a) Any agreement required to be provided to the federal trade commis-
 23 sion or the antitrust division of the United States Department of
 24 Justice under the Medicare Prescription Drug, Improvement, and Modern-
 25 ization Act of 2003, Pub. L. No. 108-173;
 26 (b) Any agreement between a biosimilar or interchangeable product
 27 applicant and a reference product sponsor under the Biologics Price

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

 S. 3203 2

 1 Competition and Innovation Act of 2009, Pub. L. No. 111-148, that
 2 resolves patent claims between the applicant and sponsor.
 3 5. "Biosimilar biological product application filer" shall mean a
 4 party that owns or controls a biosimilar biological product application
 5 filed with the federal food and drug administration pursuant to section
 6 351(k) of the Public Health Service Act, 42 U.S.C. 262(k), for licensure
 7 of a biological product as biosimilar to, or interchangeable with, a
 8 reference product, or that has the exclusive r