senate Bill S4370B

2021-2022 Legislative Session

Preserves access to affordable drugs

download bill text pdf

Sponsored By

Archive: Last Bill Status - In Senate Committee Rules Committee


  • Introduced
  • In Committee
  • On Floor Calendar
    • Passed Senate
    • Passed Assembly
  • Delivered to Governor
  • Signed/Vetoed by Governor

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Actions

view actions (10)
Assembly Actions - Lowercase
Senate Actions - UPPERCASE
Jun 03, 2022 committed to rules
May 17, 2022 advanced to third reading
May 16, 2022 2nd report cal.
May 11, 2022 1st report cal.1331
May 05, 2022 print number 4370b
May 05, 2022 amend and recommit to health
May 02, 2022 print number 4370a
May 02, 2022 amend and recommit to health
Jan 05, 2022 referred to health
Feb 03, 2021 referred to health

Votes

view votes

May 9, 2022 - Health committee Vote

S4370B
8
5
committee
8
Aye
5
Nay
1
Aye with Reservations
0
Absent
1
Excused
0
Abstained
show Health committee vote details

Health Committee Vote: May 9, 2022

aye wr (1)
excused (1)

Co-Sponsors

view additional co-sponsors

S4370 - Details

See Assembly Version of this Bill:
A7245
Current Committee:
Senate Rules
Law Section:
Public Health Law
Laws Affected:
Add Art 2-A Title IV §§282 & 283, Pub Health L
Versions Introduced in 2023-2024 Legislative Session:
S4513, A7465

S4370 - 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.

S4370 - Sponsor Memo

S4370 - Bill Text download pdf

 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   4370
 
                        2021-2022 Regular Sessions
 
                             I N  S E N A T E
 
                             February 3, 2021
                                ___________
 
 Introduced  by  Sen.  BIAGGI -- 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.
   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.
                                                            LBD04644-01-1

Co-Sponsors

view additional co-sponsors

S4370A - Details

See Assembly Version of this Bill:
A7245
Current Committee:
Senate Rules
Law Section:
Public Health Law
Laws Affected:
Add Art 2-A Title IV §§282 & 283, Pub Health L
Versions Introduced in 2023-2024 Legislative Session:
S4513, A7465

S4370A - 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.

S4370A - Sponsor Memo

S4370A - Bill Text download pdf

 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  4370--A
 
                        2021-2022 Regular Sessions
 
                             I N  S E N A T E
 
                             February 3, 2021
                                ___________
 
 Introduced  by  Sens.  BIAGGI, BROOKS, BROUK, COMRIE, GAUGHRAN, HOYLMAN,
   LIU, MANNION, MAY, MYRIE, RAMOS -- read twice and ordered printed, and
   when printed to be committed to the Committee on Health -- recommitted
   to the Committee on Health in accordance with Senate Rule 6, sec. 8 --
   committee discharged, bill amended, ordered reprinted as  amended  and
   recommitted to said committee
 
 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:
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD04644-02-2

Co-Sponsors

view additional co-sponsors

S4370B (ACTIVE) - Details

See Assembly Version of this Bill:
A7245
Current Committee:
Senate Rules
Law Section:
Public Health Law
Laws Affected:
Add Art 2-A Title IV §§282 & 283, Pub Health L
Versions Introduced in 2023-2024 Legislative Session:
S4513, A7465

S4370B (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.

S4370B (ACTIVE) - Sponsor Memo

S4370B (ACTIVE) - Bill Text download pdf

 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  4370--B
 
                        2021-2022 Regular Sessions
 
                             I N  S E N A T E
 
                             February 3, 2021
                                ___________
 
 Introduced  by  Sens.  BIAGGI, BROOKS, BROUK, COMRIE, GAUGHRAN, HOYLMAN,
   LIU, MANNION, MAY, MYRIE, RAMOS -- read twice and ordered printed, and
   when printed to be committed to the Committee on Health -- recommitted
   to the Committee on Health in accordance with Senate Rule 6, sec. 8 --
   committee discharged, bill amended, ordered reprinted as  amended  and
   recommitted  to  said committee -- committee discharged, bill amended,
   ordered reprinted as amended and recommitted to said committee
 
 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

  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD04644-04-2
 S. 4370--B                          2

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