Senate Bill S4513

2023-2024 Legislative Session

Preserves access to affordable drugs

download bill text pdf

Sponsored By

Current Bill Status - In Senate Committee Finance Committee


  • Introduced
    • In Committee Assembly
    • In Committee Senate
    • On Floor Calendar Assembly
    • On Floor Calendar Senate
    • Passed Assembly
    • Passed Senate
  • Delivered to Governor
  • Signed By Governor

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2023-S4513 (ACTIVE) - Details

See Assembly Version of this Bill:
A7465
Current Committee:
Senate Finance
Law Section:
Public Health Law
Laws Affected:
Add Art 2-A Title IV §§282 & 283, Pub Health L
Versions Introduced in 2021-2022 Legislative Session:
S4370, A7245

2023-S4513 (ACTIVE) - 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.

2023-S4513 (ACTIVE) - Sponsor Memo

2023-S4513 (ACTIVE) - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   4513
 
                        2023-2024 Regular Sessions
 
                             I N  S E N A T E
 
                             February 9, 2023
                                ___________
 
 Introduced by Sen. FERNANDEZ -- 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:

   Section 1. Article 2-A of the public health law is amended by adding a
 new title IV to read as follows:
                                 TITLE IV
                   PRESERVING ACCESS TO AFFORDABLE DRUGS
 SECTION 282. DEFINITIONS.
         283. PRESERVING ACCESS TO AFFORDABLE DRUGS.
   §  282.  DEFINITIONS.  FOR  THE  PURPOSES OF THIS TITLE, THE FOLLOWING
 TERMS SHALL HAVE THE FOLLOWING MEANINGS:
   1. "ANDA" SHALL MEAN ABBREVIATED NEW DRUG APPLICATION AS DESCRIBED  BY
 505(J) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT, 21 U.S.C. 335(J).
   2. "ANDA FILER" SHALL MEAN A PARTY THAT OWNS OR CONTROLS AN ANDA FILED
 WITH  THE  FEDERAL  FOOD  AND  DRUG  ADMINISTRATION OR HAS THE EXCLUSIVE
 RIGHTS UNDER THAT ANDA TO DISTRIBUTE THE ANDA PRODUCT.
   3. "AGREEMENT" SHALL MEAN ANYTHING THAT WOULD CONSTITUTE AN  AGREEMENT
 UNDER STATE LAW.
   4.  "AGREEMENT  RESOLVING  OR  SETTLING  A  PATENT INFRINGEMENT CLAIM"
 INCLUDES ANY AGREEMENT THAT IS ENTERED INTO WITHIN THIRTY  DAYS  OF  THE
 RESOLUTION  OR  THE SETTLEMENT OF THE CLAIM, OR ANY OTHER AGREEMENT THAT
 IS CONTINGENT UPON, PROVIDES A CONTINGENT CONDITION FOR, OR IS OTHERWISE
 RELATED TO THE  RESOLUTION  OR  SETTLEMENT  OF  THE  CLAIM.  THIS  SHALL
 INCLUDE, BUT IS NOT LIMITED TO, THE FOLLOWING:
   (A) ANY AGREEMENT REQUIRED TO BE PROVIDED TO THE FEDERAL TRADE COMMIS-
 SION  OR  THE  ANTITRUST  DIVISION  OF  THE  UNITED STATES DEPARTMENT OF
 JUSTICE UNDER THE MEDICARE PRESCRIPTION DRUG, IMPROVEMENT,  AND  MODERN-
 IZATION ACT OF 2003, PUB. L. NO. 108-173;
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD09108-01-3
              

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