Connecticut 2023 Regular Session

Connecticut House Bill HB06619 Compare Versions

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Version 2 (New)

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7		-	General Assembly ~~Substitute~~ Bill No. 6619
	5	+	General Assembly Raised Bill No. 6619
8	6		January Session, 2023
	7	+	LCO No. 3052
	8	+
	9	+
	10	+	Referred to Committee on INSURANCE AND REAL ESTATE
	11	+
	12	+
	13	+	Introduced by:
	14	+	(INS)
9	15
10	16
11	17
12		-	AN ACT CONCERNING PROHIBITING PAY FOR DELAY .
	18	+
	19	+	AN ACT CONCERNING BANNING PAY FOR DELAY.
13	20		Be it enacted by the Senate and House of Representatives in General
14	21		Assembly convened:
15	22
16	23		Section 1. (NEW) (Effective October 1, 2023) For purposes of this 1
17	24		section and section 2 of this act: 2
18	25		(1) "AB-rated generic" means a drug product determined by the 3
19	26		federal Food and Drug Administration to be pharmaceutically and 4
20	27		therapeutically bioequivalent to a reference drug product. 5
21	28		(2) "ANDA" means abbreviated new drug application. 6
22		-	(3) "ANDA filer" means a party that owns or controls an ANDA 7
23		-	~~filed~~ with the federal Food and Drug Administration or has the 8
24		-	~~exclusive~~ rights under such ANDA to distribute the ANDA product. 9
	29	+	(3) "ANDA filer" means a party that owns or controls an ANDA filed 7
	30	+	with the federal Food and Drug Administration or has the exclusive 8
	31	+	rights under such ANDA to distribute the ANDA product. 9
25	32		(4) "Agreement resolving or settling a patent infringement claim" 10
26	33		includes any agreement that is entered into not later than thirty days 11
27	34		after the resolution or the settlement of the claim, or any other 12
28		-	agreement that is contingent upon, provides a contingent condition 13
29		-	for, or is otherwise related to the resolution or settlement of the claim. 14
30		-	"Agreement resolving or settling a patent infringement claim" 15
31		-	includes, but is not limited to, the following: 16
32		-	(A) Any agreement required to be provided to the Federal Trade 17
33		-	Commission or the Antitrust Division of the United States Department 18 Substitute Bill No. 6619
	35	+	agreement that is contingent upon, provides a contingent condition for, 13
	36	+	or is otherwise related to the resolution or settlement of the claim. 14 Raised Bill No. 6619
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	42	+	"Agreement resolving or settling a patent infringement claim" includes, 15
	43	+	but is not limited to, the following: 16
	44	+	(A) Any agreement required to be provided to the Federal Trade 17
	45	+	Commission or the Antitrust Division of the United States Department 18
40	46		of Justice under the Medicare Prescription Drug, Improvement, and 19
41	47		Modernization Act of 2003; and 20
42	48		(B) Any agreement between a biosimilar or interchangeable 21
43	49		biological product applicant and a reference drug product sponsor that 22
44	50		resolves patent claims between the applicant and sponsor. 23
45	51		(5) "At-risk launch" means launching a nonreference drug product 24
46	52		before the resolution of a nonappealable court decision or patent 25
47	53		expiration involving such generic drug product. 26
48		-	(6) "Biosimilar biological product application filer" means a party 27
49		-	~~that~~ owns or controls a biosimilar biological product application filed 28
50		-	~~with~~ the federal Food and Drug Administration under ~~Section 351~~(k) 29
51		-	of the Public Health Service Act, 42 USC 262, for licensure of a 30
52		-	biological product as biosimilar to, or interchangeable with, a ~~reference~~ 31
53		-	drug product or that has the exclusive rights under the ~~application to~~ 32
54		-	distribute the biosimilar biological product. 33
	54	+	(6) "Biosimilar biological product application filer" means a party that 27
	55	+	owns or controls a biosimilar biological product application filed with 28
	56	+	the federal Food and Drug Administration under subsection (k) of 29
	57	+	section 351 of the Public Health Service Act, 42 USC 262, for licensure of 30
	58	+	a biological product as biosimilar to, or interchangeable with, a 31
	59	+	reference drug product or that has the exclusive rights under the 32
	60	+	application to distribute the biosimilar biological product. 33
55	61		(7) "NDA" means new drug application. 34
56	62		(8) "Nonreference drug filer" means (A) an ANDA filer, or (B) a 35
57	63		biosimilar biological product application filer. 36
58	64		(9) "Nonreference drug product" means the product to be 37
59	65		manufactured under an ANDA that is the subject of the patent 38
60	66		infringement claim, a biosimilar biological product that is the product 39
61	67		to be manufactured under the biosimilar biological product application 40
62	68		that is the subject of the patent infringement claim, or both. 41
63	69		(10) "Patent infringement" means infringement of any patent or of 42
64	70		any filed patent application, extension, reissue, renewal, division, 43
65		-	continuation, continuation in part, reexamination, patent term 44
	71	+	continuation, continuation in part, reexamination, patent term 44 Raised Bill No. 6619
	72	+
	73	+
	74	+
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	76	+
66	77		restoration, patents of addition and extensions thereof. 45
67	78		(11) "Patent infringement claim" means any allegation made to a 46
68		-	nonreference drug filer, whether or not included in a complaint filed 47 Substitute Bill No. 6619
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	79	+	nonreference drug filer, whether or not included in a complaint filed 47
75	80		with a court of law, that such nonreference drug filer's nonreference 48
76		-	drug product or application infringes any patent held by, or 49
77		-	~~exclusively~~ licensed to, the reference drug holder. 50
	81	+	drug product or application infringes any patent held by, or exclusively 49
	82	+	licensed to, the reference drug holder. 50
78	83		(12) "Procompetitive benefit" means the favorable competitive 51
79	84		consequences resulting from the agreement resolving or settling a 52
80	85		patent infringement claim. 53
81	86		(13) "Reference drug holder" means: 54
82	87		(A) A brand holder that is any of the following: 55
83	88		(i) The holder of an approved NDA for a drug product application 56
84		-	filed under Section 505~~(b)~~ of the federal Food, Drug and ~~Cosmetic Act,~~ 57
85		-	21 USC 355; 58
	89	+	filed under subsection (b) of section 505 of the federal Food, Drug and 57
	90	+	Cosmetic Act, 21 USC 355; 58
86	91		(ii) A person owning or controlling enforcement of the patent listed 59
87	92		in the Approved Drug Products With Therapeutic Equiva lence 60
88		-	Evaluations, commonly known as the "FDA Orange Book" in 61
89		-	~~connection~~ with the NDA; or 62
	93	+	Evaluations, commonly known as the "FDA Orange Book" in connection 61
	94	+	with the NDA; or 62
90	95		(iii) The predecessors, subsidiaries, divisions, groups and affiliates 63
91	96		controlled by, controlling or under common control with, any of the 64
92		-	entities described in this subdivision, with control to be presumed by 65
93		-	direct or indirect share ownership of fifty per cent or greater, as well as 66
94		-	the licensees, licensors, successors and assigns of each such entity; or 67
95		-	(B) A biological product license holder, that includes any of the 68
96		-	following: 69
97		-	(i) The holder of an approved biological product license application 70
98		-	for a biological drug product under Section 351(a) of the Public Health 71
99		-	Service Act, 42 USC 262; 72
100		-	(ii) A person owning or controlling enforcement of any patents that 73
101		-	claim the biological product that is the subject of the approved 74
102		-	biological patent license application; or 75 Substitute Bill No. 6619
	97	+	entities described in this subparagraph or subparagraph (B) of this 65
	98	+	subdivision, with control to be presumed by direct or indirect share 66
	99	+	ownership of fifty per cent or greater, as well as the licensees, licensors, 67
	100	+	successors and assigns of each such entity; or 68
	101	+	(B) A biological product license holder, that includes any of the 69
	102	+	following: 70
	103	+	(i) The holder of an approved biological product license application 71
	104	+	for a biological drug product under subsection (a) of section 351 of the 72
	105	+	Public Health Service Act, 42 USC 262; 73 Raised Bill No. 6619
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109		-	(iii) The predecessors, subsidiaries, divisions, groups and affiliates 76
110		-	controlled by, controlling or under common control with, any of the 77
111		-	entities described in this subdivision, with such control to be 78
112		-	presumed by direct or indirect share ownership of fifty per cent or 79
113		-	greater, as well as the licensees, licensors, successors and assigns of 80
114		-	each such entity. 81
115		-	(14) "Reference drug product" means the product to be 82
116		-	manufactured by the reference drug holder and includes branded 83
117		-	drugs of the NDA holder and the biological drug product of the 84
118		-	biological product license applicant. 85
119		-	(15) "Statutory exclusivity" means prohibitions on the approval of 86
120		-	drug applications under Section 505(c), 527 or 505A of the federal 87
121		-	Food, Drug and Cosmetic Act, 21 USC 355, 360cc and 355a, or on the 88
122		-	licensing of biological product applications under Section 262(k) or (m) 89
123		-	of the Public Health Service Act, 42 USC 262. 90
124		-	Sec. 2. (NEW) (Effective October 1, 2023) (a) (1) Except as provided in 91
125		-	subdivision (3) of this subsection, an agreement resolving or settling, 92
126		-	on a final or interim basis, a patent infringement claim shall be 93
127		-	presumed to have anticompetitive effects and shall be a violation of 94
128		-	this section if both of the following apply: 95
129		-	(A) A nonreference drug filer receives anything of value from 96
130		-	another company asserting patent infringement, including, but not 97
131		-	limited to, an exclusive license or a promise that the brand company 98
132		-	will not launch an authorized generic version of such brand company's 99
133		-	brand drug; and 100
134		-	(B) The nonreference drug filer agrees to limit or forego research, 101
135		-	development, manufacturing, marketing or sales of the nonreference 102
136		-	drug filer's product for any period of time. 103
137		-	(2) As used in subparagraph (A) of subdivision (1) of this 104
138		-	subsection, "anything of value" does not include a settlement of a 105
139		-	patent infringement claim in which the consideration granted by the 106 Substitute Bill No. 6619
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	110	+
	111	+	(ii) A person owning or controlling enforcement of any patents that 74
	112	+	claim the biological product that is the subject of the approved biological 75
	113	+	patent license application; or 76
	114	+	(iii) The predecessors, subsidiaries, divisions, groups and affiliates 77
	115	+	controlled by, controlling or under common control with, any of the 78
	116	+	entities described in this subparagraph or subparagraph (A) of this 79
	117	+	subdivision, with such control to be presumed by direct or indirect share 80
	118	+	ownership of fifty per cent or greater, as well as the licensees, licensors, 81
	119	+	successors and assigns of each such entity. 82
	120	+	(14) "Reference drug product" means the product to be manufactured 83
	121	+	by the reference drug holder and includes branded drugs of the NDA 84
	122	+	holder and the biological drug product of the biological product license 85
	123	+	applicant. 86
	124	+	(15) "Statutory exclusivity" means prohibitions on the approval of 87
	125	+	drug applications under subsection (c) of section 505, section 527 or 88
	126	+	505A of the federal Food, Drug and Cosmetic Act, 21 USC 355, 360cc and 89
	127	+	355a, or on the licensing of biological product applications under 90
	128	+	subsection (k) or (m) of section 262 of the Public Health Service Act, 42 91
	129	+	USC 262. 92
	130	+	Sec. 2. (NEW) (Effective October 1, 2023) (a) (1) Except as provided in 93
	131	+	subdivision (3) of this subsection, an agreement resolving or settling, on 94
	132	+	a final or interim basis, a patent infringement claim, shall be presumed 95
	133	+	to have anticompetitive effects and shall be a violation of this section if 96
	134	+	both of the following apply: 97
	135	+	(A) A nonreference drug filer receives anything of value from another 98
	136	+	company asserting patent infringement, including, but not limited to, 99
	137	+	an exclusive license or a promise that the brand company will not 100
	138	+	launch an authorized generic version of such brand company's brand 101
	139	+	drug; and 102
	140	+	(B) The nonreference drug filer agrees to limit or forego research, 103
	141	+	development, manufacturing, marketing or sales of the nonreference 104 Raised Bill No. 6619
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146		-	brand or reference drug filer to the nonreference drug filer as part of 107
147		-	the resolution or settlement consists of one or more of the following: 108
148		-	(A) The right to market the competing product in the United States 109
149		-	before the expiration of either: 110
150		-	(i) A patent that is the basis for the patent infringement claim; or 111
151		-	(ii) A patent right or other statutory exclusivity that would prevent 112
152		-	the marketing of the drug; 113
153		-	(B) A covenant not to sue on a claim that the nonreference drug 114
154		-	product infringes a United States patent; 115
155		-	(C) Compensation for saved reasonable future litigation expenses of 116
156		-	the reference drug holder, but only if both of the following are true: 117
157		-	(i) The total compensation for saved litigation expenses is reflected 118
158		-	in budgets that the reference drug holder documented and adopted 119
159		-	not less than six months before the settlement; and 120
160		-	(ii) The compensation does not exceed the lesser of the following: 121
161		-	(I) Seven million five hundred thousand dollars, or 122
162		-	(II) Five per cent of the revenue that the nonreference drug holder 123
163		-	projected or forecasted such nonreference drug holder would receive 124
164		-	in the first three years of sales of such nonreference drug holder's 125
165		-	version of the reference drug documented not less than twelve months 126
166		-	before the settlement. If no such projections or forecasts are available, 127
167		-	the compensation shall not exceed two hundred fifty thousand dollars; 128
168		-	(D) An agreement resolving or settling a patent infringement claim 129
169		-	that permits a nonreference drug filer to begin selling, offering for sale 130
170		-	or distributing the nonreference drug product if the reference drug 131
171		-	holder seeks approval to launch, obtains approval to launch or 132
172		-	launches a different dosage, strength or form of the reference drug 133
173		-	having the same active ingredient before the date set by the agreement 134 Substitute Bill No. 6619
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	146	+
	147	+	drug filer's product for any period of time. 105
	148	+	(2) As used in subparagraph (A) of subdivision (1) of this subsection, 106
	149	+	"anything of value" does not include a settlement of a patent 107
	150	+	infringement claim in which the consideration granted by the brand or 108
	151	+	reference drug filer to the nonreference drug filer as part of the 109
	152	+	resolution or settlement consists of one or more of the following: 110
	153	+	(A) The right to market the competing product in the United States 111
	154	+	before the expiration of either: 112
	155	+	(i) A patent that is the basis for the patent infringement claim; or 113
	156	+	(ii) A patent right or other statutory exclusivity that would prevent 114
	157	+	the marketing of the drug; 115
	158	+	(B) A covenant not to sue on a claim that the nonreference drug 116
	159	+	product infringes a United States patent; 117
	160	+	(C) Compensation for saved reasonable future litigation expenses of 118
	161	+	the reference drug holder, but only if both of the following are true: 119
	162	+	(i) The total compensation for saved litigation expenses is reflected in 120
	163	+	budgets that the reference drug holder documented and adopted not 121
	164	+	less than six months before the settlement; and 122
	165	+	(ii) The compensation does not exceed the lesser of the following: 123
	166	+	(I) Seven million five hundred thousand dollars, or 124
	167	+	(II) Five per cent of the revenue that the nonreference drug holder 125
	168	+	projected or forecasted such nonreference drug holder would receive in 126
	169	+	the first three years of sales of its version of the reference drug 127
	170	+	documented not less than twelve months before the settlement. If no 128
	171	+	such projections or forecasts are available, the compensation shall not 129
	172	+	exceed two hundred fifty thousand dollars; 130
	173	+	(D) An agreement resolving or settling a patent infringement claim 131
	174	+	that permits a nonreference drug filer to begin selling, offering for sale 132 Raised Bill No. 6619
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180		-	for entry of the nonreference drug filer. A different form of the 135
181		-	reference drug does not include an authorized generic version of the 136
182		-	reference drug; 137
183		-	(E) An agreement by the reference drug holder not to interfere with 138
184		-	the nonreference drug filer's ability to secure and maintain regulatory 139
185		-	approval to market the nonreference drug product or an agreement to 140
186		-	facilitate the nonreference drug filer's ability to secure and maintain 141
187		-	regulatory approval to market the nonreference drug product; or 142
188		-	(F) An agreement resolving a patent infringement claim in which 143
189		-	the reference drug holder forgives the potential damages accrued by a 144
190		-	nonreference drug holder for an at-risk launch of the nonreference 145
191		-	drug product that is the subject of such patent infringement claim. 146
192		-	(3) Parties to an agreement are not in violation of subdivision (1) of 147
193		-	this subsection if they can demonstrate by a preponderance of the 148
194		-	evidence that either of the following are met: 149
195		-	(A) The value received by the nonreference drug filer described in 150
196		-	subparagraph (A) of subdivision (1) of this subsection is a fair and 151
197		-	reasonable compensation solely for other goods or services that the 152
198		-	nonreference drug filer has promised to provide; or 153
199		-	(B) The agreement has directly generated procompetitive benefits 154
200		-	and the procompetitive benefits of the agreement outweigh the 155
201		-	anticompetitive effects of the agreement. 156
202		-	(b) (1) In determining whether the parties to the agreement have 157
203		-	met their burden under subdivision (3) of subsection (a) of this section, 158
204		-	the factfinder in any action brought by the state to enforce the 159
205		-	provisions of this section shall not presume any of the following: 160
206		-	(A) That entry into the marketplace could not have occurred until 161
207		-	the expiration of the relevant patent exclusivity or that the agreement's 162
208		-	provision for entry of the nonreference drug product before the 163
209		-	expiration of any patent exclusivity means that the agreement is 164 Substitute Bill No. 6619
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	179	+
	180	+	or distributing the nonreference drug product if the reference drug 133
	181	+	holder seeks approval to launch, obtains approval to launch or launches 134
	182	+	a different dosage, strength or form of the reference drug having the 135
	183	+	same active ingredient before the date set by the agreement for entry of 136
	184	+	the nonreference drug filer. A different form of the reference drug does 137
	185	+	not include an authorized generic version of the reference drug; 138
	186	+	(E) An agreement by the reference drug holder not to interfere with 139
	187	+	the nonreference drug filer's ability to secure and maintain regulatory 140
	188	+	approval to market the nonreference drug product or an agreement to 141
	189	+	facilitate the nonreference drug filer's ability to secure and maintain 142
	190	+	regulatory approval to market the nonreference drug product; or 143
	191	+	(F) An agreement resolving a patent infringement claim in which the 144
	192	+	reference drug holder forgives the potential damages accrued by a 145
	193	+	nonreference drug holder for an at-risk launch of the nonreference drug 146
	194	+	product that is the subject of such patent infringement claim. 147
	195	+	(3) Parties to an agreement are not in violation of subdivision (1) of 148
	196	+	this subsection if they can demonstrate by a preponderance of the 149
	197	+	evidence that either of the following are met: 150
	198	+	(A) The value received by the nonreference drug filer described in 151
	199	+	subparagraph (A) of subdivision (1) of this subsection is a fair and 152
	200	+	reasonable compensation solely for other goods or services that the 153
	201	+	nonreference drug filer has promised to provide; or 154
	202	+	(B) The agreement has directly generated procompetitive benefits 155
	203	+	and the procompetitive benefits of the agreement outweigh the 156
	204	+	anticompetitive effects of the agreement. 157
	205	+	(b) (1) In determining whether the parties to the agreement have met 158
	206	+	their burden under subdivision (3) of subsection (a) of this section, the 159
	207	+	factfinder in any action brought by the state to enforce the provisions of 160
	208	+	this section shall not presume any of the following: 161
	209	+	(A) That entry into the marketplace could not have occurred until the 162 Raised Bill No. 6619
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216		-	procompetitive within the meaning of subparagraph (B) of subdivision 165
217		-	(3) of subsection (a) of this section; 166
218		-	(B) That any patent is enforceable and infringed by the nonreference 167
219		-	drug filer in the absence of a final adjudication binding on the filer of 168
220		-	such issues; 169
221		-	(C) That the agreement caused no delay in entry of the nonreference 170
222		-	drug filer's drug product because of the lack of federal Food and Drug 171
223		-	Administration approval of such drug product or of another 172
224		-	nonreference drug product; or 173
225		-	(D) That the agreement caused no harm or delay due to the 174
226		-	possibility that the nonreference drug filer's drug product may infringe 175
227		-	some patent that has not been asserted against the nonreference drug 176
228		-	filer or that is not subject to a final and binding adjudication on such 177
229		-	nonreference drug filer as to the patent's scope, enforceability and 178
230		-	infringement. 179
231		-	(2) This subsection shall not be construed to preclude a party from 180
232		-	introducing evidence regarding subparagraphs (A) to (D), inclusive, of 181
233		-	this subdivision and shall not be construed to preclude the factfinder 182
234		-	from making a determination regarding said subparagraphs based on 183
235		-	the full scope of the evidence. 184
236		-	(c) In determining whether the parties to the agreement have met 185
237		-	their burden under subdivision (3) of subsection (a) of this section, the 186
238		-	factfinder in any action brought by the state to enforce the provisions 187
239		-	of this section shall presume that the relevant product market is such 188
240		-	product market consisting of the brand or reference drug of the 189
241		-	company alleging patent infringement and the drug product of the 190
242		-	nonreference company accused of infringement and any other 191
243		-	biological product that is licensed as biosimilar or is an AB-rated 192
244		-	generic to the reference product. 193
245		-	(d) (1) The provisions of this section shall not modify, impair, limit 194
246		-	or supersede the right of any drug company applicant to assert claims 195 Substitute Bill No. 6619
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	214	+
	215	+	expiration of the relevant patent exclusivity or that the agreement's 163
	216	+	provision for entry of the nonreference drug product before the 164
	217	+	expiration of any patent exclusivity means that the agreement is 165
	218	+	procompetitive within the meaning of subparagraph (B) of subdivision 166
	219	+	(3) of subsection (a) of this section; 167
	220	+	(B) That any patent is enforceable and infringed by the nonreference 168
	221	+	drug filer in the absence of a final adjudication binding on the filer of 169
	222	+	such issues; 170
	223	+	(C) That the agreement caused no delay in entry of the nonreference 171
	224	+	drug filer's drug product because of the lack of federal Food and Drug 172
	225	+	Administration approval of such drug product or of another 173
	226	+	nonreference drug product; or 174
	227	+	(D) That the agreement caused no harm or delay due to the possibility 175
	228	+	that the nonreference drug filer's drug product may infringe some 176
	229	+	patent that has not been asserted against the nonreference drug filer or 177
	230	+	that is not subject to a final and binding adjudication on such 178
	231	+	nonreference drug filer as to the patent's scope, enforceability and 179
	232	+	infringement. 180
	233	+	(2) This subsection shall not be construed to preclude a party from 181
	234	+	introducing evidence regarding subparagraphs (A) to (D), inclusive, of 182
	235	+	this subdivision and shall not be construed to preclude the factfinder 183
	236	+	from making a determination regarding said subparagraphs based on 184
	237	+	the full scope of the evidence. 185
	238	+	(c) In determining whether the parties to the agreement have met 186
	239	+	their burden under subdivision (3) of subsection (a) of this section, the 187
	240	+	factfinder in any action brought by the state to enforce the provisions of 188
	241	+	this section shall presume that the relevant product market is such 189
	242	+	product market consisting of the brand or reference drug of the 190
	243	+	company alleging patent infringement and the drug product of the 191
	244	+	nonreference company accused of infringement and any other 192
	245	+	biological product that is licensed as biosimilar or is an AB-rated generic 193
	246	+	to the reference product. 194 Raised Bill No. 6619
247	247
248	248
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250		-	HB.docx }
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252	249
253		-	or counterclaims against any person under the antitrust laws or other 196
254		-	laws relating to unfair competition of the federal antitrust law or state 197
255		-	law. 198
256		-	(2) If any provision of this section, an amendment made to this 199
257		-	section or the application of any provision or amendment to any 200
258		-	person or circumstance is held to be unconstitutional, the remainder of 201
259		-	this section, the amendments made to this section and the application 202
260		-	of the provisions of this section or amendments to any person or 203
261		-	circumstance shall not be affected. 204
	250	+	LCO No. 3052 8 of 9
	251	+
	252	+	(d) (1) The provisions of this section shall not modify, impair, limit or 195
	253	+	supersede the right of any drug company applicant to assert claims or 196
	254	+	counterclaims against any person under the antitrust laws or other laws 197
	255	+	relating to unfair competition of the federal antitrust law or state law. 198
	256	+	(2) If any provision of this section, an amendment made to this section 199
	257	+	or the application of any provision or amendment to any person or 200
	258	+	circumstance is held to be unconstitutional, the remainder of this 201
	259	+	section, the amendments made to this section and the application of the 202
	260	+	provisions of this section or amendments to any person or circumstance 203
	261	+	shall not be affected. 204
262	262		(e) (1) (A) Each person that violates or assists in a violation of this 205
263		-	section shall forfeit and pay to the state a civil penalty sufficient to 206
264		-	~~deter~~ violations of this section, as follows: 207
	263	+	section shall forfeit and pay to the state a civil penalty sufficient to deter 206
	264	+	violations of this section, as follows: 207
265	265		(i) If the person who violated this section received any value due to 208
266	266		such violation, an amount up to three times the value received by the 209
267	267		party that is reasonably attributable to the violation of this section, or 210
268	268		twenty million dollars, whichever is greater; or 211
269	269		(ii) If the violator has not received anything of value as described in 212
270		-	subparagraph (A)(i) of this subdivision, an amount up to three times 213
271		-	~~the~~ value given to other parties to the agreement reasonably 214
272		-	~~attributable to~~ the violation of this section, or twenty million dollars, 215
273		-	~~whichever is~~ greater. 216
274		-	For purposes of this subparagraph, "reasonably attributable to ~~the~~ 217
275		-	violation" shall be determined by the effect on the state's share of the 218
	270	+	subparagraph (A)(i) of this subdivision, an amount up to three times the 213
	271	+	value given to other parties to the agreement reasonably attributable to 214
	272	+	the violation of this section, or twenty million dollars, whichever is 215
	273	+	greater. 216
	274	+	(iii) For purposes of this subparagraph, "reasonably attributable to 217
	275	+	the violation" shall be determined by the effect on the state's share of the 218
276	276		market for the brand drug at issue in the agreement. 219
277	277		(B) Any penalty described in subparagraph (A) of this subdivision 220
278	278		shall accrue only to the state and shall be recovered in a civil action 221
279		-	brought by the Attorney General against any party to an agreement 222
280		-	that violates this section. 223
281		-	(2) Each party that violates or assists in the violation of this section 224
282		-	shall be liable for any damages, penalties, costs, fees, injunctions or 225 Substitute Bill No. 6619
	279	+	brought by the Attorney General against any party to an agreement that 222
	280	+	violates this section. 223
	281	+	(2) Each party that violates or assists in the violation of this section 224 Raised Bill No. 6619
283	282
284	283
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288	284
	285	+	LCO No. 3052 9 of 9
	286	+
	287	+	shall be liable for any damages, penalties, costs, fees, injunctions, or 225
289	288		other remedies that may be just and reasonable, as determined by the 226
290	289		court. 227
291	290		(3) If the state is awarded penalties under subparagraph (A) of 228
292	291		subdivision (1) of this subsection, the state may not recover penalties 229
293		-	pursuant to subdivision (2) of this subsection, provided this 230
294		-	subdivision shall not be construed to foreclose the state's ability to 231
295		-	claim any other relief or damages available in subdivision (2) of this 232
296		-	subsection. 233
297		-	(4) An action to enforce a cause of action for a violation of this 234
298		-	section shall be commenced not later than four years after the cause of 235
299		-	action accrued. 236
	292	+	pursuant to subdivision (2) of this subsection, provided this subdivision 230
	293	+	shall not be construed to foreclose the state's ability to claim any other 231
	294	+	relief or damages available in subdivision (2) of this subsection. 232
	295	+	(4) An action to enforce a cause of action for a violation of this section 233
	296	+	shall be commenced not later than four years after the cause of action 234
	297	+	accrued. 235
300	298		This act shall take effect as follows and shall amend the following
301	299		sections:
302	300
303	301		Section 1 October 1, 2023 New section
304	302		Sec. 2 October 1, 2023 New section
305	303
306		-	Statement of ~~Legislative Commissioners~~:
307		-	~~In Section 2(a)(2)(C)(ii)(II), "its" was changed~~ to ~~"such nonreference~~
308		-	~~drug holder's" for clarity~~, ~~and the title was changed.~~
309		-
310		-	~~INS Joint Favorable Subst. -LCO~~
	304	+	Statement of Purpose:
	305	+	To preserve consumer access to affordable generic drugs.
	306	+	[Proposed deletions are enclosed in brackets. Proposed additions are indicated by underline, except
	307	+	that when the entire text of a bill or resolution or a section of a bill or resolution is new, it is not
	308	+	underlined.]
311	309