Us Congress 2025-2026 Regular Session

Us Congress Senate Bill SB43 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	II
2	2	119THCONGRESS
3	3	1
4	4	STSESSION S. 43
5	5	To amend title 35, United States Code, to provide for a safe harbor from
6	6	infringement of a method of use patent relating to drugs or biological
7	7	products.
8	8	IN THE SENATE OF THE UNITED STATES
9	9	JANUARY9, 2025
10	10	Mr. H
11	11	ICKENLOOPER(for himself, Mr. WELCH, Mr. COTTON, and Ms. COL-
12	12	LINS) introduced the following bill; which was read twice and referred to
13	13	the Committee on the Judiciary
14	14	A BILL
15	15	To amend title 35, United States Code, to provide for a
16	16	safe harbor from infringement of a method of use patent
17	17	relating to drugs or biological products.
18	18	Be it enacted by the Senate and House of Representa-1
19	19	tives of the United States of America in Congress assembled, 2
20	20	SECTION 1. SHORT TITLE. 3
21	21	This Act may be cited as the ‘‘Skinny Labels, Big 4
22	22	Savings Act’’. 5
23	23	SEC. 2. SAFE HARBOR FROM INFRINGEMENT OF A METHOD 6
24	24	OF USE PATENT. 7
25	25	(a) I
26	26	NGENERAL.—Section 271 of title 35, United 8
27	27	States Code, is amended— 9
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30	30	•S 43 IS
31	31	(1) by redesignating subsections (h) and (i) as 1
32	32	subsections (k) and (l), respectively; and 2
33	33	(2) by inserting after subsection (g) the fol-3
34	34	lowing: 4
35	35	‘‘(h)(1) The following shall not be acts of direct, in-5
36	36	duced, or contributory infringement of a method of use 6
37	37	claim in a patent included in the list described in section 7
38	38	505(j)(7) or section 512(n)(4) of the Federal Food, Drug, 8
39	39	and Cosmetic Act (21 U.S.C. 355(j)(7), 360b(n)(4)) in an 9
40	40	action or counterclaim under this section: 10
41	41	‘‘(A) Submitting or seeking approval of an ap-11
42	42	plication under section 505(j) or section 512(b)(2) of 12
43	43	the Federal Food, Drug, and Cosmetic Act (21 13
44	44	U.S.C. 355(j), 360b(b)(2)), or submitting or seeking 14
45	45	approval of an application described in section 15
46	46	505(b)(2) of such Act (21 U.S.C. 355(b)(2)), pro-16
47	47	vided that such application includes a statement 17
48	48	under, as applicable, section 505(j)(2)(A)(viii), sec-18
49	49	tion 512(n)(1)(I), or section 505(b)(2)(B) of such 19
50	50	Act (21 U.S.C. 355(j)(2)(A)(viii), 360b(n)(1)(I), 20
51	51	355(b)(2)(B)) for the method of use claims in the 21
52	52	patent with the labeling proposed in such applica-22
53	53	tion. 23
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57	57	‘‘(B) Promoting or commercially marketing a 1
58	58	drug product with the labeling approved in an appli-2
59	59	cation described in subparagraph (A). 3
60	60	‘‘(C) Describing a drug product approved in an 4
61	61	application submitted under section 505(j) or section 5
62	62	512(b)(2) of such Act (21 U.S.C. 355(j), 6
63	63	360b(b)(2)) or approved in an application described 7
64	64	in section 505(b)(2) of such Act (21 U.S.C. 8
65	65	355(b)(2)) as a generic of, or therapeutically equiva-9
66	66	lent to, the listed drug referenced in such applica-10
67	67	tion, as applicable. 11
68	68	‘‘(2) Subparagraphs (A) through (C) of paragraph 12
69	69	(1) shall apply only if the labeling, promotion, or commer-13
70	70	cial marketing does not reference the condition or condi-14
71	71	tions of use claimed in the patent that was identified by 15
72	72	the patent owner or assignee to the Secretary under sec-16
73	73	tion 314.53 of title 21, Code of Federal Regulations (or 17
74	74	a successor regulation) and that was subject to the state-18
75	75	ment under section 505(j)(2)(A)(viii), section 19
76	76	512(n)(1)(I), or section 505(b)(2)(B) of the Federal Food, 20
77	77	Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(A)(viii), 21
78	78	360b(n)(1)(I), 355(b)(2)(B)), as applicable. 22
79	79	‘‘(i)(1) The following shall not be acts of direct, in-23
80	80	duced, or contributory infringement of a patent claim cov-24
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84	84	ering a method of using the reference product in an action 1
85	85	or counterclaim under this section: 2
86	86	‘‘(A) Submitting or seeking approval of an ap-3
87	87	plication under section 351(k) of the Public Health 4
88	88	Service Act (42 U.S.C. 262(k)). 5
89	89	‘‘(B) Describing a biological product approved 6
90	90	in an application described in subparagraph (A) as 7
91	91	biosimilar to, or interchangeable with, the reference 8
92	92	product, as applicable, with the labeling approved in 9
93	93	such application, when the biological product has not 10
94	94	been approved for the patented condition or condi-11
95	95	tions of use. 12
96	96	‘‘(C) Promoting or commercially marketing a 13
97	97	biological product with the labeling approved in an 14
98	98	application described in subparagraph (A). 15
99	99	‘‘(2) Subparagraphs (A) through (C) of paragraph 16
100	100	(1) shall apply only if the labeling, promotion, or commer-17
101	101	cial marketing does not reference the condition or condi-18
102	102	tions of use claimed in the patent and specifically reflected 19
103	103	in the prescribing information. 20
104	104	‘‘(j) As used in this section: 21
105	105	‘‘(1) The terms ‘biological product’, ‘biosimilar’, 22
106	106	‘interchangeable’, and ‘reference product’ have the 23
107	107	meanings given such terms in section 351(i) of the 24
108	108	Public Health Service Act (42 U.S.C. 262(i)). 25
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112	112	‘‘(2) The term ‘commercial marketing’ has the 1
113	113	meaning given such term in section 314.3 of title 21, 2
114	114	Code of Federal Regulations (or a successor regula-3
115	115	tion). 4
116	116	‘‘(3) The term ‘labeling’ has the meaning given 5
117	117	such term in section 201(m) of the Federal Food, 6
118	118	Drug, and Cosmetic Act (21 U.S.C. 321(m)). 7
119	119	‘‘(4) The term ‘promoting’— 8
120	120	‘‘(A) is within the meaning of the term 9
121	121	used in section 202.1 of title 21, Code of Fed-10
122	122	eral Regulations (or a successor regulation); 11
123	123	and 12
124	124	‘‘(B) includes the use of promotional label-13
125	125	ing and advertising, as described in paragraphs 14
126	126	(1) and (2) of section 202.1(l) of title 21, Code 15
127	127	of Federal Regulations (or successor regula-16
128	128	tions).’’. 17
129	129	(b) A
130	130	PPLICATION.—This Act and the amendments 18
131	131	made by this Act shall apply to— 19
132	132	(1) conduct that occurs before, on, or after the 20
133	133	date of enactment of this Act; and 21
134	134	(2) all judicial or other proceedings pending as 22
135	135	of such date of enactment. 23
136	136	Æ
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