Senate Bill S488A

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  488--A
     Cal. No. 204
 
                        2025-2026 Regular Sessions
 
                             I N  S E N A T E
 
                                (PREFILED)
 
                              January 8, 2025
                                ___________
 
 Introduced  by  Sens. FERNANDEZ, ADDABBO, WEBB -- read twice and ordered
   printed, and when printed to be committed to the Committee on Consumer
   Protection -- reported favorably from said committee, ordered to first
   and second report, ordered to a third reading, passed  by  Senate  and
   delivered  to  the  Assembly, recalled, vote reconsidered, restored to
   third reading, amended and ordered reprinted, retaining its  place  in
   the order of third reading
 
 AN  ACT  to  amend  the  general  business law, in relation to requiring
   prescription drug manufacturers to  notify  the  attorney  general  of
   arrangements  between  pharmaceutical  manufacturers  resulting in the
   delay of the introduction of generic drugs
 
   THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section  1.  This act shall be known and may be cited as the "manufac-
 turer disclosure and transparency act".
   § 2. The general business law is amended by adding a new section  396-
 rrr to read as follows:
   §  396-RRR.  DELAY  OF  INTRODUCTION  OF GENERIC MEDICATIONS. 1.   FOR
 PURPOSES OF THIS SECTION, THE FOLLOWING TERMS SHALL HAVE  THE  FOLLOWING
 MEANINGS:
   (A)  "AGREEMENT"  MEANS  ANYTHING  THAT  WOULD CONSTITUTE AN AGREEMENT
 UNDER STATE LAW.
   (B) "ATTORNEY GENERAL" MEANS THE OFFICE OF THE NEW YORK STATE ATTORNEY
 GENERAL.
   (C) "PATENT SETTLEMENT AGREEMENT" MEANS ANY AGREEMENT THAT IS  ENTERED
 INTO  WITHIN  SIXTY  DAYS  OF THE RESOLUTION OR THE SETTLEMENT OF PATENT
 LITIGATION, OR ANY OTHER AGREEMENT THAT IS CONTINGENT UPON,  PROVIDES  A
 CONTINGENT  CONDITION  FOR, OR IS OTHERWISE RELATED TO THE RESOLUTION OR
 SETTLEMENT OF PATENT LITIGATION, INCLUDING, WITHOUT LIMITATION:

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

                                                            LBD00774-04-5
 S. 488--A                           2
 
   (I) 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;
   (II)  ANY  AGREEMENT  BETWEEN  A BIOSIMILAR OR INTERCHANGEABLE PRODUCT
 APPLICANT AND A BIOLOGICAL PRODUCT DEEMED A  REFERENCE  PRODUCT  SPONSOR
 UNDER  THE  BIOLOGICS PRICE COMPETITION AND INNOVATION ACT OF 2009, PUB.
 L. NO. 111-148, THAT RESOLVES PATENT CLAIMS BETWEEN  THE  APPLICANT  AND
 SPONSOR; OR
   (III)  ANY  AGREEMENT BETWEEN PARTIES TO A PATENT SETTLEMENT AGREEMENT
 EXECUTED SIXTY DAYS BEFORE  OR  AFTER  FINAL  EXECUTION  OF  THE  PATENT
 SETTLEMENT  AGREEMENT AND WHICH EITHER: (A) IS INTENDED TO RELATE TO THE
 PATENT SETTLEMENT AGREEMENT, SUCH AS  INCLUDING  ACTIVITIES  OR  ACTIONS
 CONTEMPLATED  UNDER  THE PATENT SETTLEMENT AGREEMENT; (B) REFERENCES THE
 PATENT SETTLEMENT AGREEMENT OR ANY OBLIGATION ARISING OUT OF THE  PATENT
 SETTLEMENT  AGREEMENT,  OR IS OTHERWISE RELATED TO THE PATENT SETTLEMENT
 AGREEMENT; OR (C) IDENTIFIES, REFERENCES OR REFERS TO ANY DRUG OR ACTIVE
 PHARMACEUTICAL INGREDIENT THAT WAS THE SUBJECT MATTER OR  REFERENCED  BY
 THE LITIGATION THAT RESULTED IN THE PATENT SETTLEMENT AGREEMENT.
   (D) "BIOLOGICAL PRODUCT," "BIOSIMILAR," "INTERCHANGEABLE PRODUCT," AND
 "REFERENCE  PRODUCT  SPONSOR"  SHALL  HAVE  THE SAME MEANINGS AS DEFINED
 UNDER SECTION THREE HUNDRED FIFTY-ONE OF THE PUBLIC HEALTH SERVICE  ACT,
 42  U.S.C. 262 ET SEQ., FOR LICENSURE OF A BIOLOGICAL PRODUCT, INCLUDING
 AS BIOSIMILAR TO, OR INTERCHANGEABLE WITH, A REFERENCE BIOLOGICAL  PROD-
 UCT.
   (E)  "DRUG"  MEANS A DRUG AS DEFINED BY 21 U.S.C. 321(G), AND APPROVED
 FOR SALE IN THE UNITED STATES PURSUANT TO SECTION FIVE HUNDRED  FIVE  OF
 THE FEDERAL FOOD, DRUG AND COSMETICS ACT, 21 U.S.C 355 ET SEQ.
   (F)  "PATENT  INFRINGEMENT  CLAIM"  SHALL  MEAN  A  CLAIM  FOR  PATENT
 INFRINGEMENT MADE UNDER 35 U.S.C. 271.
   (G) "PHARMACEUTICAL MANUFACTURER" SHALL MEAN ANY ENTITY THAT  MANUFAC-
 TURES,  EITHER ITSELF OR THROUGH OTHER ENTITIES, SUCH AS BY CONTRACT, OR
 SEEKS TO MANUFACTURE EITHER A DRUG OR BIOLOGICAL PRODUCT.
   2. (A) ANY PHARMACEUTICAL MANUFACTURER DOING BUSINESS  IN  THIS  STATE
 THAT  ENTERS  INTO A PATENT SETTLEMENT AGREEMENT RESOLVING OR SETTLING A
 PATENT INFRINGEMENT CLAIM WITH ANOTHER PHARMACEUTICAL MANUFACTURER WHICH
 IN ANY WAY SETS OR OTHERWISE AFFECTS THE DATE OF COMMERCIAL LAUNCH OF  A
 DRUG  OR  BIOLOGICAL  PRODUCT  BY  OR ON BEHALF OF EITHER PHARMACEUTICAL
 MANUFACTURER, SHALL, NO LATER THAN THIRTY DAYS AFTER ENTERING  INTO  THE
 PATENT  SETTLEMENT  AGREEMENT, SEND NOTICE AND THE FULL TEXT, ALONG WITH
 ANY ATTACHMENTS AND EXHIBITS, OF THE PATENT SETTLEMENT AGREEMENT TO  THE
 ATTORNEY GENERAL.
   (B) WITHIN SIXTY DAYS OF RECEIVING NOTICE PURSUANT TO PARAGRAPH (A) OF
 THIS  SUBDIVISION,  THE  ATTORNEY GENERAL SHALL POST ON ITS WEBSITE SUCH
 NOTICE IN A FORMAT AND MANNER DEVELOPED BY THE ATTORNEY GENERAL THAT  IS
 SEARCHABLE  BY  DRUG, COST, DISEASE, AND MANUFACTURER BOTH FOR THE BRAND
 AND GENERIC DRUG FOR PUBLIC REVIEW. SUCH  NOTICES  SHALL  BE  CONSIDERED
 PUBLIC  RECORDS  FOR  THE PURPOSES OF ARTICLE SIX OF THE PUBLIC OFFICERS
 LAW.
   3. FAILURE TO SUBMIT THE REQUIRED NOTICE TO THE ATTORNEY GENERAL WITH-
 IN THIRTY DAYS AFTER ENTERING INTO A PATENT SETTLEMENT AGREEMENT  PURSU-
 ANT  TO  SUBDIVISION  TWO  OF THIS SECTION SHALL RESULT IN A FINE OF TEN
 THOUSAND DOLLARS PER DAY FOR EACH DAY OF NONCOMPLIANCE.
   § 3. If any clause, sentence, paragraph, subdivision, section, or part
 of this act shall be adjudged by any court of competent jurisdiction  to
 be  invalid or unenforceable, such judgment shall not affect, impair, or
 S. 488--A                           3
 
 invalidate the remainder thereof, but shall be confined in its operation
 to the clause, sentence, paragraph, subdivision, section or part thereof
 directly involved in the controversy in which such judgment  shall  have
 been rendered. It is hereby declared to be the intent of the legislature
 that  this  act  would have been enacted even if such invalid provisions
 had not been included herein.
   § 4. This act shall take effect on the one hundred eightieth day after
 it shall have become a law.