Enacts the manufacturer disclosure and transparency act requiring prescription drug manufacturers to notify the attorney general of arrangements between pharmaceutical manufacturers resulting in the delay of the introduction of generic medications.
STATE OF NEW YORK
________________________________________________________________________
2289--A
2025-2026 Regular Sessions
IN ASSEMBLY
January 16, 2025
___________
Introduced by M. of A. GALLAGHER, STIRPE, FORREST, MAMDANI, STERN,
GONZALEZ-ROJAS, SIMON, SHIMSKY, COLTON, REYES, SIMONE, RAGA, SHRESTHA,
SEAWRIGHT, RAMOS, ROSENTHAL, DAVILA, CLARK, LUPARDO, K. BROWN,
EPSTEIN, SANTABARBARA, ROMERO, KELLES, JACOBSON -- read once and
referred to the Committee on Consumer Affairs and Protection --
committee discharged, bill amended, ordered reprinted as amended and
recommitted to said committee
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:
1 Section 1. This act shall be known and may be cited as the "manufac-
2 turer disclosure and transparency act".
3 § 2. The general business law is amended by adding a new section 396-
4 rrr to read as follows:
5 § 396-rrr. Delay of introduction of generic medications. 1. For
6 purposes of this section, the following terms shall have the following
7 meanings:
8 (a) "Agreement" means anything that would constitute an agreement
9 under state law.
10 (b) "Attorney general" means the office of the New York state attorney
11 general.
12 (c) "Patent settlement agreement" means any agreement that is entered
13 into within sixty days of the resolution or the settlement of patent
14 litigation, or any other agreement that is contingent upon, provides a
15 contingent condition for, or is otherwise related to the resolution or
16 settlement of patent litigation, including, without limitation:
17 (i) any agreement required to be provided to the federal trade commis-
18 sion or the antitrust division of the United States department of
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD00774-05-5
A. 2289--A 2
1 justice under the Medicare Prescription Drug, Improvement, and Modern-
2 ization Act of 2003, Pub. L. No. 108-173;
3 (ii) any agreement between a biosimilar or interchangeable product
4 applicant and a biological product deemed a reference product sponsor
5 under the Biologics Price Competition and Innovation Act of 2009, Pub.
6 L. No. 111-148, that resolves patent claims between the applicant and
7 sponsor; or
8 (iii) any agreement between parties to a patent settlement agreement
9 executed sixty days before or after final execution of the patent
10 settlement agreement and which either: (A) is intended to relate to the
11 patent settlement agreement, such as including activities or actions
12 contemplated under the patent settlement agreement; (B) references the
13 patent settlement agreement or any obligation arising out of the patent
14 settlement agreement, or is otherwise related to the patent settlement
15 agreement; or (C) identifies, references or refers to any drug or active
16 pharmaceutical ingredient that was the subject matter or referenced by
17 the litigation that resulted in the patent settlement agreement.
18 (d) "Biological product," "biosimilar," "interchangeable product," and
19 "reference product sponsor" shall have the same meanings as defined
20 under section three hundred fifty-one of the public health service act,
21 42 U.S.C. 262 et seq., for licensure of a biological product, including
22 as biosimilar to, or interchangeable with, a reference biological prod-
23 uct.
24 (e) "Drug" means a drug as defined by 21 U.S.C. 321(g), and approved
25 for sale in the United States pursuant to section five hundred five of
26 the federal food, drug and cosmetics Act, 21 U.S.C 355 et seq.
27 (f) "Patent infringement claim" shall mean a claim for patent
28 infringement made under 35 U.S.C. 271.
29 (g) "Pharmaceutical manufacturer" shall mean any entity that manufac-
30 tures, either itself or through other entities, such as by contract, or
31 seeks to manufacture either a drug or biological product.
32 2. (a) Any pharmaceutical manufacturer doing business in this state
33 that enters into a patent settlement agreement resolving or settling a
34 patent infringement claim with another pharmaceutical manufacturer which
35 in any way sets or otherwise affects the date of commercial launch of a
36 drug or biological product by or on behalf of either pharmaceutical
37 manufacturer, shall, no later than thirty days after entering into the
38 patent settlement agreement, send notice and the full text, along with
39 any attachments and exhibits, of the patent settlement agreement to the
40 attorney general.
41 (b) Within sixty days of receiving notice pursuant to paragraph (a) of
42 this subdivision, the attorney general shall post on its website such
43 notice in a format and manner developed by the attorney general that is
44 searchable by drug, cost, disease, and manufacturer both for the brand
45 and generic drug for public review. Such notices shall be considered
46 public records for the purposes of article six of the public officers
47 law.
48 3. Failure to submit the required notice to the attorney general with-
49 in thirty days after entering into a patent settlement agreement pursu-
50 ant to subdivision two of this section shall result in a fine of ten
51 thousand dollars per day for each day of noncompliance.
52 § 3. If any clause, sentence, paragraph, subdivision, section, or part
53 of this act shall be adjudged by any court of competent jurisdiction to
54 be invalid or unenforceable, such judgment shall not affect, impair, or
55 invalidate the remainder thereof, but shall be confined in its operation
56 to the clause, sentence, paragraph, subdivision, section or part thereof
A. 2289--A 3
1 directly involved in the controversy in which such judgment shall have
2 been rendered. It is hereby declared to be the intent of the legislature
3 that this act would have been enacted even if such invalid provisions
4 had not been included herein.
5 § 4. This act shall take effect on the one hundred eightieth day after
6 it shall have become a law.
