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Us Congress Senate Bill SB1041

Us Congress 2025-2026 Regular Session

Us Congress Senate Bill SB1041 Compare Versions

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11 II
2-Calendar No. 44
32 119THCONGRESS
43 1
54 STSESSION S. 1041
65 To amend title 35, United States Code, to address the infringement of
76 patents that claim biological products, and for other purposes.
87 IN THE SENATE OF THE UNITED STATES
98 MARCH13, 2025
109 Mr. C
1110 ORNYN(for himself, Mr. BLUMENTHAL, Mr. GRASSLEY, and Mr. DUR-
1211 BIN) introduced the following bill; which was read twice and referred to
1312 the Committee on the Judiciary
14-A
15-PRIL10, 2025
16-Reported by Mr. G
17-RASSLEY, with amendments
18-[Omit the parts struck through and insert the parts printed in italic]
1913 A BILL
2014 To amend title 35, United States Code, to address the in-
2115 fringement of patents that claim biological products, and
2216 for other purposes.
2317 Be it enacted by the Senate and House of Representa-1
2418 tives of the United States of America in Congress assembled, 2
2519 SECTION 1. SHORT TITLE. 3
2620 This Act may be cited as the ‘‘Affordable Prescrip-4
2721 tions for Patients Act’’. 5
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22+SEC. 2. PATENT INFRINGEMENT; MEDICARE IMPROVEMENT 6
23+FUND. 7
24+(a) I
25+NGENERAL.—Section 271(e) of title 35, United 8
26+States Code, is amended— 9
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31-SEC. 2. PATENT INFRINGEMENT ;MEDICARE IMPROVEMENT 1
32-FUND. 2
33-(a) I
34-NGENERAL.—Section 271(e) of title 35, United 3
35-States Code, is amended— 4
36-(1) in paragraph (2)
37-(C), in the flush text fol-5
38-lowing clausesubparagraph (C)(ii), by adding at the 6
39-end the following: ‘‘With respect to a submission de-7
40-scribed in clausesubparagraph (C)(ii), the act of in-8
41-fringement shall extend to any patent that claims 9
42-the biological product, a method of using the biologi-10
43-cal product, or a method or product used to manu-11
44-facture the biological product.’’; and 12
45-(2) by adding at the end the following: 13
46-‘‘(7)(A) Subject to subparagraphs (C), (D), and (E), 14
47-if the sponsor of an approved application for a reference 15
48-product, as defined in section 351(i) of the Public Health 16
49-Service Act (42 U.S.C. 262(i)) (referred to in this para-17
50-graph as the ‘reference product sponsor’), brings an action 18
51-for infringement under this section against an applicant 19
52-for approval of a biological product under section 351(k) 20
53-of such Act that references that reference product (re-21
54-ferred to in this paragraph as the ‘subsection (k) appli-22
55-cant’), the reference product sponsor may assert in the 23
56-action a total of not more than 20 patents of the type 24
57-described in subparagraph (B), not more than 10 of which 25
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30+(1) in paragraph (2)(C), in the flush text fol-1
31+lowing clause (ii), by adding at the end the fol-2
32+lowing: ‘‘With respect to a submission described in 3
33+clause (ii), the act of infringement shall extend to 4
34+any patent that claims the biological product, a 5
35+method of using the biological product, or a method 6
36+or product used to manufacture the biological prod-7
37+uct.’’; and 8
38+(2) by adding at the end the following: 9
39+‘‘(7)(A) Subject to subparagraphs (C), (D), and (E), 10
40+if the sponsor of an approved application for a reference 11
41+product, as defined in section 351(i) of the Public Health 12
42+Service Act (42 U.S.C. 262(i)) (referred to in this para-13
43+graph as the ‘reference product sponsor’), brings an action 14
44+for infringement under this section against an applicant 15
45+for approval of a biological product under section 351(k) 16
46+of such Act that references that reference product (re-17
47+ferred to in this paragraph as the ‘subsection (k) appli-18
48+cant’), the reference product sponsor may assert in the 19
49+action a total of not more than 20 patents of the type 20
50+described in subparagraph (B), not more than 10 of which 21
51+shall have issued after the date specified in section 22
52+351(l)(7)(A) of such Act. 23
53+‘‘(B) The patents described in this subparagraph are 24
54+patents that satisfy each of the following requirements: 25
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61-shall have issued after the date specified in section 1
62-351(l)(7)(A) of such Act. 2
63-‘‘(B) The patents described in this subparagraph are 3
64-patents that satisfy each of the following requirements: 4
65-‘‘(i) Patents that claim the biological product 5
66-that is the subject of an application under section 6
67-351(k) of the Public Health Service Act (42 U.S.C. 7
68-262(k)) (or a use of that product) or a method or 8
69-product used in the manufacture of such biological 9
70-product. 10
71-‘‘(ii) Patents that are included on the list of 11
72-patents described in paragraph (3)(A) of section 12
73-351(l) of the Public Health Service Act (42 U.S.C. 13
74-262(l)), including as provided under paragraph (7) 14
75-of such section 351(l). 15
76-‘‘(iii) Patents that— 16
77-‘‘(I) have an actual filing date of more 17
78-than 4 years after the date on which the ref-18
79-erence product is approved; or 19
80-‘‘(II) include a claim to a method in a 20
81-manufacturing process that is not used by the 21
82-reference product sponsor. 22
83-‘‘(C) The court in which an action described in sub-23
84-paragraph (A) is brought may increase the number of pat-24
85-ents limited under that subparagraph— 25
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58+‘‘(i) Patents that claim the biological product 1
59+that is the subject of an application under section 2
60+351(k) of the Public Health Service Act (42 U.S.C. 3
61+262(k)) (or a use of that product) or a method or 4
62+product used in the manufacture of such biological 5
63+product. 6
64+‘‘(ii) Patents that are included on the list of 7
65+patents described in paragraph (3)(A) of section 8
66+351(l) of the Public Health Service Act (42 U.S.C. 9
67+262(l)), including as provided under paragraph (7) 10
68+of such section 351(l). 11
69+‘‘(iii) Patents that— 12
70+‘‘(I) have an actual filing date of more 13
71+than 4 years after the date on which the ref-14
72+erence product is approved; or 15
73+‘‘(II) include a claim to a method in a 16
74+manufacturing process that is not used by the 17
75+reference product sponsor. 18
76+‘‘(C) The court in which an action described in sub-19
77+paragraph (A) is brought may increase the number of pat-20
78+ents limited under that subparagraph— 21
79+‘‘(i) if the request to increase that number is 22
80+made without undue delay; and 23
81+‘‘(ii)(I) if the interest of justice so requires; or 24
82+‘‘(II) for good cause shown, which— 25
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89-‘‘(i) if the request to increase that number is 1
90-made without undue delay; and 2
91-‘‘(ii)(I) if the interest of justice so requires; or 3
92-‘‘(II) for good cause shown, which— 4
93-‘‘(aa) shall be established if the subsection 5
94-(k) applicant fails to provide information re-6
95-quired by section 351(k)(2)(A) of the Public 7
96-Health Service Act (42. U.S.C. 262(k)(2)(A)) 8
97-that would enable the reference product sponsor 9
98-to form a reasonable belief with respect to 10
99-whether a claim of infringement under this sec-11
100-tion could reasonably be asserted; and 12
101-‘‘(bb) may be established— 13
102-‘‘(AA) if there is a material change to 14
103-the biological product (or process with re-15
104-spect to the biological product) of the sub-16
105-section (k) applicant that is the subject of 17
106-the application; 18
107-‘‘(BB) if, with respect to a patent on 19
108-the supplemental list described in section 20
109-351(l)(7) (A) of the Public Health Service 21
110-Act (42 U.S.C. 262(l)(7) (A)), the patent 22
111-would have issued before the date specified 23
112-in such section 351(l)(7)(A) of such Act 24
113-but for the failure of the Office to issue 25
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86+‘‘(aa) shall be established if the subsection 1
87+(k) applicant fails to provide information re-2
88+quired by section 351(k)(2)(A) of the Public 3
89+Health Service Act (42 U.S.C. 262(k)(2)(A)) 4
90+that would enable the reference product sponsor 5
91+to form a reasonable belief with respect to 6
92+whether a claim of infringement under this sec-7
93+tion could reasonably be asserted; and 8
94+‘‘(bb) may be established— 9
95+‘‘(AA) if there is a material change to 10
96+the biological product (or process with re-11
97+spect to the biological product) of the sub-12
98+section (k) applicant that is the subject of 13
99+the application; 14
100+‘‘(BB) if, with respect to a patent on 15
101+the supplemental list described in section 16
102+351(l)(7)(A) of Public Health Service Act 17
103+(42 U.S.C. 262(l)(7)(A)), the patent would 18
104+have issued before the date specified in 19
105+such section 351(l)(7)(A) but for the fail-20
106+ure of the Office to issue the patent or a 21
107+delay in the issuance of the patent, as de-22
108+scribed in paragraph (1) of section 154(b) 23
109+and subject to the limitations under para-24
110+graph (2) of such section 154(b); or 25
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117-the patent or a delay in the issuance of the 1
118-patent, as described in paragraph (1) of 2
119-section 154(b) and subject to the limita-3
120-tions under paragraph (2) of such section 4
121-154(b); or 5
122-‘‘(CC) for another reason that shows 6
123-good cause, as determined appropriate by 7
124-the court. 8
125-‘‘(D) In determining whether good cause has been 9
126-shown for the purposes of subparagraph (C)(ii)(II), a 10
127-court may consider whether the reference product sponsor 11
128-has provided a reasonable description of the identity and 12
129-relevance of any information beyond the subsection (k) ap-13
130-plication that the court believes is necessary to enable the 14
131-court to form a belief with respect to whether a claim of 15
132-infringement under this section could reasonably be as-16
133-serted. 17
134-‘‘(E) The limitation imposed under subparagraph 18
135-(A)— 19
136-‘‘(i) shall apply only if the subsection (k) appli-20
137-cant completes all actions required under paragraphs 21
138-(2)(A), (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of 22
139-section 351(l) of the Public Health Service Act (42 23
140-U.S.C. 262(l)); and 24
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114+‘‘(CC) for another reason that shows 1
115+good cause, as determined appropriate by 2
116+the court. 3
117+‘‘(D) In determining whether good cause has been 4
118+shown for the purposes of subparagraph (C)(ii)(II), a 5
119+court may consider whether the reference product sponsor 6
120+has provided a reasonable description of the identity and 7
121+relevance of any information beyond the subsection (k) ap-8
122+plication that the court believes is necessary to enable the 9
123+court to form a belief with respect to whether a claim of 10
124+infringement under this section could reasonably be as-11
125+serted. 12
126+‘‘(E) The limitation imposed under subparagraph 13
127+(A)— 14
128+‘‘(i) shall apply only if the subsection (k) appli-15
129+cant completes all actions required under paragraphs 16
130+(2)(A), (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of 17
131+section 351(l) of the Public Health Service Act (42 18
132+U.S.C. 262(l)); and 19
133+‘‘(ii) shall not apply with respect to any patent 20
134+that claims, with respect to a biological product, a 21
135+method for using that product in therapy, diagnosis, 22
136+or prophylaxis, such as an indication or method of 23
137+treatment or other condition of use.’’. 24
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144-‘‘(ii) shall not apply with respect to any patent 1
145-that claims, with respect to a biological product, a 2
146-method for using that product in therapy, diagnosis, 3
147-or prophylaxis, such as an indication or method of 4
148-treatment or other condition of use.’’. 5
149-(b) A
150-PPLICABILITY.—The amendments made by sub-6
151-section (a) shall apply with respect to an application sub-7
152-mitted under section 351(k) of the Public Health Service 8
153-Act (42 U.S.C. 262(k)) on or after the date of enactment 9
154-of this Act. 10
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158-44
159-119
160-TH
161-CONGRESS
162-1
163-ST
164-S
165-ESSION
166-
167-S. 1041 A BILL
168-To amend title 35, United States Code, to address
169-the infringement of patents that claim biological
170-products, and for other purposes.
171-A
172-PRIL
173-10, 2025
174-Reported with amendments
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140+•S 1041 IS
141+(b) APPLICABILITY.—The amendments made by sub-1
142+section (a) shall apply with respect to an application sub-2
143+mitted under section 351(k) of the Public Health Service 3
144+Act (42 U.S.C. 262(k)) on or after the date of enactment 4
145+of this Act. 5
146+Æ
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