Us Congress 2025-2026 Regular Session

Us Congress Senate Bill SB1097 Compare Versions

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11 II
2-Calendar No. 41
32 119THCONGRESS
43 1
54 STSESSION S. 1097
65 To amend title 35, United States Code, to establish an interagency task
76 force between the United States Patent and Trademark Office and the
87 Food and Drug Administration for purposes of sharing information and
98 providing technical assistance with respect to patents, and for other
109 purposes.
1110 IN THE SENATE OF THE UNITED STATES
1211 MARCH24, 2025
1312 Mr. D
1413 URBIN(for himself, Mr. TILLIS, Mr. GRASSLEY, Mr. COONS, and Mr.
1514 W
1615 ELCH) introduced the following bill; which was read twice and referred
1716 to the Committee on the Judiciary
18-A
19-PRIL10, 2025
20-Reported by Mr. G
21-RASSLEY, with amendments
22-[Omit the parts struck through and insert the parts printed in italic] A BILL
17+A BILL
2318 To amend title 35, United States Code, to establish an
2419 interagency task force between the United States Patent
2520 and Trademark Office and the Food and Drug Adminis-
2621 tration for purposes of sharing information and providing
2722 technical assistance with respect to patents, and for other
2823 purposes.
2924 Be it enacted by the Senate and House of Representa-1
3025 tives of the United States of America in Congress assembled, 2
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26+SECTION 1. SHORT TITLE. 3
27+This Act may be cited as the ‘‘Interagency Patent 4
28+Coordination and Improvement Act of 2025’’. 5
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33-•S 1097 RS
34-SECTION 1. SHORT TITLE. 1
35-This Act may be cited as the ‘‘Interagency Patent 2
36-Coordination and Improvement Act of 2025’’. 3
37-SEC. 2. FINDINGS. 4
38-Congress finds the following: 5
39-(1) Decisions by the United States Patent and 6
40-Trademark Office relating to patents may implicate, 7
41-or have relevance to, information housed at or in-8
42-volving other Federal agencies. 9
43-(2) Entities submitting patent applications to 10
44-the United States Patent and Trademark Office may 11
45-also submit information to, or share information 12
46-with, other Federal agencies, necessitating accuracy 13
47-and consistency in those representations. 14
48-(3) Research has shown that patent examiners 15
49-may benefit from additional information that is 16
50-housed at, or is available to, Federal agencies other 17
51-than the United States Patent and Trademark Of-18
52-fice in order to assess prior art and the state of 19
53-science and technology. 20
54-(4) The Under Secretary of Commerce for In-21
55-tellectual Property and Director of the United States 22
56-Patent and Trademark Office is encouraged to work 23
57-with other Federal agencies. 24
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31+•S 1097 IS
32+SEC. 2. FINDINGS. 1
33+Congress finds the following: 2
34+(1) Decisions by the United States Patent and 3
35+Trademark Office relating to patents may implicate, 4
36+or have relevance to, information housed at or in-5
37+volving other Federal agencies. 6
38+(2) Entities submitting patent applications to 7
39+the United States Patent and Trademark Office may 8
40+also submit information to, or share information 9
41+with, other Federal agencies, necessitating accuracy 10
42+and consistency in those representations. 11
43+(3) Research has shown that patent examiners 12
44+may benefit from additional information that is 13
45+housed at, or is available to, Federal agencies other 14
46+than the United States Patent and Trademark Of-15
47+fice in order to assess prior art and the state of 16
48+science and technology. 17
49+(4) The Under Secretary of Commerce for In-18
50+tellectual Property and Director of the United States 19
51+Patent and Trademark Office is encouraged to work 20
52+with other Federal agencies. 21
53+SEC. 3. REPORT BY UNITED STATES PATENT AND TRADE-22
54+MARK OFFICE. 23
55+Not later than 4 years after the date of enactment 24
56+of this Act, the Under Secretary of Commerce for Intellec-25
57+tual Property and Director of the United States Patent 26
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61-SEC. 3. REPORT BY UNITED STATES PATENT AND TRADE-1
62-MARK OFFICE. 2
63-Not later than 4 years after the date of enactment 3
64-of this Act, the Under Secretary of Commerce for Intellec-4
65-tual Property and Director of the United States Patent 5
66-and Trademark Office shall submit to the Committee on 6
67-the Judiciary of the Senate and the Committee on the Ju-7
68-diciary of the House of Representatives a report that con-8
69-tains— 9
70-(1) a description of the frequency with which— 10
71-(A) information is provided by the Food 11
72-and Drug Administration to the United States 12
73-Patent and Trademark Office through the 13
74-Interagency Task Force on Patents established 14
75-under section 1514 of title 35, United States 15
76-Code, as added by section 4(a) of this Act, or 16
77-under processes established by that Task Force; 17
78-and 18
79-(B) the information described in subpara-19
80-graph (A) is used in patent examinations; 20
81-(2) an identification of which methods of pro-21
82-viding information, as described in paragraph 22
83-(1)(A), and types of information so shared, are most 23
84-useful to patent examiners; 24
85-(3) any recommendations for changes to be 25
86-made by Congress to the mandate, funding, or oper-26
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61+and Trademark Office shall submit to the Committee on 1
62+the Judiciary of the Senate and the Committee on the Ju-2
63+diciary of the House of Representatives a report that con-3
64+tains— 4
65+(1) a description of the frequency with which— 5
66+(A) information is provided by the Food 6
67+and Drug Administration to the United States 7
68+Patent and Trademark Office through the 8
69+Interagency Task Force on Patents established 9
70+under section 15 of title 35, United States 10
71+Code, as added by section 4(a) of this Act, or 11
72+under processes established by that Task Force; 12
73+and 13
74+(B) the information described in subpara-14
75+graph (A) is used in patent examinations; 15
76+(2) an identification of which methods of pro-16
77+viding information, as described in paragraph 17
78+(1)(A), and types of information so shared, are most 18
79+useful to patent examiners; 19
80+(3) any recommendations for changes to be 20
81+made by Congress to the mandate, funding, or oper-21
82+ations of the Task Force described in paragraph 22
83+(1)(A); and 23
84+(4) an identification of other Federal agencies 24
85+with which the Under Secretary of Commerce for In-25
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90-ations of the Task Force described in paragraph 1
91-(1)(A); and 2
92-(4) an identification of other Federal agencies 3
93-with which the Under Secretary of Commerce for In-4
94-tellectual Property and Director of the United States 5
95-Patent and Trademark Office should explore oppor-6
96-tunities for coordination that are similar to those 7
97-undertaken with the Food and Drug Administration 8
98-through the activities of the Task Force described in 9
99-paragraph (1)(A). 10
100-SEC. 4. INTERAGENCY TASK FORCE ON PATENTS. 11
88+•S 1097 IS
89+tellectual Property and Director of the United States 1
90+Patent and Trademark Office should explore oppor-2
91+tunities for coordination that are similar to those 3
92+undertaken with the Food and Drug Administration 4
93+through the activities of the Task Force described in 5
94+paragraph (1)(A). 6
95+SEC. 4. INTERAGENCY TASK FORCE ON PATENTS. 7
10196 (a) I
102-NGENERAL.—Chapter 1 of title 35, United 12
103-States Code, is amended— 13
104-(1) in section 2(c), by adding at the end the fol-14
105-lowing: 15
106-‘‘(6)(A) In exercising the Director’s powers and du-16
107-ties under this section relating to patents, and decisions 17
108-or actions involving patents, for human drugs and biologi-18
109-cal products, the Director shall, through the Interagency 19
110-Task Force on Patents established under section
111-1514, 20
112-consult with the Commissioner of Food and Drugs in the 21
113-manner described in that section. 22
114-‘‘(B) For purposes of subparagraph (A), the term 23
115-‘decisions or actions involving patents’ means decisions or 24
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97+NGENERAL.—Chapter 1 of title 35, United 8
98+States Code, is amended— 9
99+(1) in section 2(c), by adding at the end the fol-10
100+lowing: 11
101+‘‘(6)(A) In exercising the Director’s powers and du-12
102+ties under this section relating to patents, and decisions 13
103+or actions involving patents, for human drugs and biologi-14
104+cal products, the Director shall, through the Interagency 15
105+Task Force on Patents established under section 15, con-16
106+sult with the Commissioner of Food and Drugs in the 17
107+manner described in that section. 18
108+‘‘(B) For purposes of subparagraph (A), the term 19
109+‘decisions or actions involving patents’ means decisions or 20
110+actions taken with respect to patents under this title.’’; 21
111+and 22
112+(2) by adding at the end the following: 23
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119-actions taken with respect to patents under this title.’’; 1
120-and 2
121-(2) by adding at the end the following: 3
122-‘‘§
123-1514. Interagency Task Force on Patents 4
115+•S 1097 IS
116+‘‘§ 15. Interagency Task Force on Patents 1
124117 ‘‘(a) E
125-STABLISHMENT.—There is established an 5
126-interagency task force, to be known as the Interagency 6
127-Task Force on Patents (referred to in this section as the 7
128-‘task force’), to coordinate efforts between the Director 8
129-and the Commissioner of Food and Drugs (referred to in 9
130-this section as the ‘Commissioner’) regarding communica-10
131-tion about, evaluation of, and effective implementation of 11
132-the activities of the Office and the Food and Drug Admin-12
133-istration with respect to patents, and decisions or actions 13
134-involving patents (as defined in section 2(c)(6)(B)), for 14
135-human drugs and biological products. 15
118+STABLISHMENT.—There is established an 2
119+interagency task force, to be known as the Interagency 3
120+Task Force on Patents (referred to in this section as the 4
121+‘task force’), to coordinate efforts between the Director 5
122+and the Commissioner of Food and Drugs (referred to in 6
123+this section as the ‘Commissioner’) regarding communica-7
124+tion about, evaluation of, and effective implementation of 8
125+the activities of the Office and the Food and Drug Admin-9
126+istration with respect to patents, and decisions or actions 10
127+involving patents (as defined in section 2(c)(6)(B)), for 11
128+human drugs and biological products. 12
136129 ‘‘(b) M
137-EMORANDUM OF UNDERSTANDING.—The Di-16
138-rector and the Commissioner shall enter into a memo-17
139-randum of understanding, or update an existing memo-18
140-randum of understanding, for the purposes of imple-19
141-menting and carrying out the duties of the task force. 20
130+EMORANDUM OF UNDERSTANDING.—The Di-13
131+rector and the Commissioner shall enter into a memo-14
132+randum of understanding, or update an existing memo-15
133+randum of understanding, for the purposes of imple-16
134+menting and carrying out the duties of the task force. 17
142135 ‘‘(c) M
143-EMBERSHIP.—The task force shall be com-21
144-prised of employees of the Office, who shall be appointed 22
145-by the Director, and employees of the Food and Drug Ad-23
146-ministration, who shall be appointed by the Commissioner, 24
147-who have appropriate expertise and decision-making au-25
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136+EMBERSHIP.—The task force shall be com-18
137+prised of employees of the Office, who shall be appointed 19
138+by the Director, and employees of the Food and Drug Ad-20
139+ministration, who shall be appointed by the Commissioner, 21
140+who have appropriate expertise and decision-making au-22
141+thority regarding operational, administrative, technical, 23
142+medical, pharmacological, clinical, and scientific matters 24
143+to carry out the functions of the task force. 25
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151-thority regarding operational, administrative, technical, 1
152-medical, pharmacological, clinical, and scientific matters 2
153-to carry out the functions of the task force. 3
154-‘‘(d) A
155-CTIVITIES.—The task force shall carry out the 4
156-following functions regarding interagency coordination to 5
157-promote reciprocal access of information: 6
158-‘‘(1) Sharing information on the general proc-7
159-esses of the Office and the Food and Drug Adminis-8
160-tration, what each such agency considers in its re-9
161-spective review of applications, and how each such 10
162-agency evaluates those applications, which may be 11
163-undertaken through routine and ongoing meetings, 12
164-workshops, and training sessions. 13
165-‘‘(2) Sharing information on new approvals of 14
166-patents, human drugs and biological products, new 15
167-technologies and prior art (as appropriate on a case- 16
168-by-case basis), and scientific trends and develop-17
169-ments. 18
170-‘‘(3) Establishing a process that requires— 19
171-‘‘(A) the Director to request from the 20
172-Commissioner (and the Commissioner to pro-21
173-vide to the Director, upon receiving such a re-22
174-quest)— 23
175-‘‘(i) appropriate information for use 24
176-by employees of the Office with responsi-25
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147+‘‘(d) ACTIVITIES.—The task force shall carry out the 1
148+following functions regarding interagency coordination to 2
149+promote reciprocal access of information: 3
150+‘‘(1) Sharing information on the general proc-4
151+esses of the Office and the Food and Drug Adminis-5
152+tration, what each such agency considers in its re-6
153+spective review of applications, and how each such 7
154+agency evaluates those applications, which may be 8
155+undertaken through routine and ongoing meetings, 9
156+workshops, and training sessions. 10
157+‘‘(2) Sharing information on new approvals of 11
158+patents, human drugs and biological products, new 12
159+technologies and prior art (as appropriate on a case- 13
160+by-case basis), and scientific trends and develop-14
161+ments. 15
162+‘‘(3) Establishing a process that requires— 16
163+‘‘(A) the Director to request from the 17
164+Commissioner (and the Commissioner to pro-18
165+vide to the Director, upon receiving such a re-19
166+quest)— 20
167+‘‘(i) appropriate information for use 21
168+by employees of the Office with responsi-22
169+bility to examine patent applications under 23
170+section 131 (referred to in this section as 24
171+‘patent examiners’) regarding when certain 25
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180-bility to examine patent applications under 1
181-section 131 (referred to in this section as 2
182-‘patent examiners’) regarding when certain 3
183-information relating to a human drug or 4
184-biological product approval, which may in-5
185-clude updates to a label or newly approved 6
186-indications, is made publicly available, in-7
187-cluding when such information is posted 8
188-online; and 9
189-‘‘(ii) appropriate access for patent ex-10
190-aminers to relevant sources of product ap-11
191-plication, approval, patent, and labeling in-12
192-formation or communications between the 13
193-Food and Drug Administration and the 14
194-human drug or biological product sponsors 15
195-that may not currently be subject to public 16
196-disclosure, as appropriate and only to the 17
197-extent necessary for the Office to carry out 18
198-the responsibilities of the Office, such as 19
199-ensuring accurate representations and ac-20
200-cess to information on whether the claimed 21
201-invention that would be the subject of the 22
202-patent was on sale before the effective fil-23
203-ing date of the claimed invention, as de-24
204-scribed in section 102(a)(1); and 25
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174+•S 1097 IS
175+information relating to a human drug or 1
176+biological product approval, which may in-2
177+clude updates to a label or newly approved 3
178+indications, is made publicly available, in-4
179+cluding when such information is posted 5
180+online; and 6
181+‘‘(ii) appropriate access for patent ex-7
182+aminers to relevant sources of product ap-8
183+plication, approval, patent, and labeling in-9
184+formation or communications between the 10
185+Food and Drug Administration and the 11
186+human drug or biological product sponsors 12
187+that may not currently be subject to public 13
188+disclosure, as appropriate and only to the 14
189+extent necessary for the Office to carry out 15
190+the responsibilities of the Office, such as 16
191+ensuring accurate representations and ac-17
192+cess to information on whether the claimed 18
193+invention that would be the subject of the 19
194+patent was on sale before the effective fil-20
195+ing date of the claimed invention, as de-21
196+scribed in section 102(a)(1); and 22
197+‘‘(B) the Office to assist the Food and 23
198+Drug Administration in its ministerial role of 24
199+listing patents. 25
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208-‘‘(B) the Office to assist the Food and 1
209-Drug Administration in its ministerial role of 2
210-listing patents. 3
211-‘‘(4) Establishing a process to ensure that, in 4
212-appropriate circumstances, at the request of the Di-5
213-rector, the Commissioner shall consult with or other-6
214-wise furnish specific, available information to the Of-7
215-fice with respect to certain applications, responses, 8
216-or affidavits after rejections in order to assist patent 9
217-examiners in carrying out the duties of those patent 10
218-examiners. 11
202+•S 1097 IS
203+‘‘(4) Establishing a process to ensure that, in 1
204+appropriate circumstances, at the request of the Di-2
205+rector, the Commissioner shall consult with or other-3
206+wise furnish specific, available information to the Of-4
207+fice with respect to certain applications, responses, 5
208+or affidavits after rejections in order to assist patent 6
209+examiners in carrying out the duties of those patent 7
210+examiners. 8
219211 ‘‘(e) R
220-ULE OFCONSTRUCTION.—Nothing in sub-12
221-section (d)(3)(B) shall be construed as— 13
222-‘‘(1) directing the Office to interfere with, 14
223-delay, or supersede the ministerial function of the 15
224-Food and Drug Administration of listing patents; 16
225-‘‘(2) indicating the position of the Office re-17
226-garding the ability to assert a patent in infringement 18
227-litigation; or 19
228-‘‘(3) changing the ministerial function of the 20
229-Food and Drug Administration of listing patents. 21
212+ULE OFCONSTRUCTION.—Nothing in sub-9
213+section (d)(3)(B) shall be construed as— 10
214+‘‘(1) directing the Office to interfere with, 11
215+delay, or supersede the ministerial function of the 12
216+Food and Drug Administration of listing patents; 13
217+‘‘(2) indicating the position of the Office re-14
218+garding the ability to assert a patent in infringement 15
219+litigation; or 16
220+‘‘(3) changing the ministerial function of the 17
221+Food and Drug Administration of listing patents. 18
230222 ‘‘(f) C
231-ONFIDENTIALITY.— 22
223+ONFIDENTIALITY.— 19
232224 ‘‘(1) I
233-N GENERAL.—With respect to any record 23
234-or other information of the Food and Drug Adminis-24
235-tration or the Office that is confidential, either such 25
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225+N GENERAL.—With respect to any record 20
226+or other information of the Food and Drug Adminis-21
227+tration or the Office that is confidential, either such 22
228+agency may share any such information with the 23
229+other agency in furtherance of the activities de-24
230+scribed in this section, which shall remain subject to 25
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239-agency may share any such information with the 1
240-other agency in furtherance of the activities de-2
241-scribed in this section, which shall remain subject to 3
242-such protections as if the information were held by 4
243-the Food and Drug Administration. 5
233+•S 1097 IS
234+such protections as if the information were held by 1
235+the Food and Drug Administration. 2
244236 ‘‘(2) P
245-ROTOCOLS.— 6
237+ROTOCOLS.— 3
246238 ‘‘(A) I
247-N GENERAL.—The task force shall 7
248-establish appropriate protocols to safeguard 8
249-confidentiality and prevent the inappropriate 9
250-disclosure of information when sharing informa-10
251-tion between the Office and the Food and Drug 11
252-Administration. 12
239+N GENERAL.—The task force shall 4
240+establish appropriate protocols to safeguard 5
241+confidentiality and prevent the inappropriate 6
242+disclosure of information when sharing informa-7
243+tion between the Office and the Food and Drug 8
244+Administration. 9
253245 ‘‘(B) C
254-ONTENTS.—The protocols estab-13
255-lished under subparagraph (A) shall provide 14
256-that— 15
257-‘‘(i) before sharing any information 16
258-described in paragraph (1), the sponsor of 17
259-the human drug or biological product to 18
260-which that information relates shall be pro-19
261-vided notice of that sharing by the applica-20
262-ble agency and with a period of 30 days to 21
263-consult with the agency sharing that infor-22
264-mation; and 23
265-‘‘(ii) the Director shall, in order to 24
266-protect against the inadvertent disclosure 25
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246+ONTENTS.—The protocols estab-10
247+lished under subparagraph (A) shall provide 11
248+that— 12
249+‘‘(i) before sharing any information 13
250+described in paragraph (1), the sponsor of 14
251+the human drug or biological product to 15
252+which that information relates shall be pro-16
253+vided notice of that sharing by the applica-17
254+ble agency and with a period of 30 days to 18
255+consult with the agency sharing that infor-19
256+mation; and 20
257+‘‘(ii) the Director shall, in order to 21
258+protect against the inadvertent disclosure 22
259+of information, maintain any information 23
260+shared with the Director by the Commis-24
261+sioner separate from pending patent appli-25
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270-of information, maintain any information 1
271-shared with the Director by the Commis-2
272-sioner separate from pending patent appli-3
273-cations and establish procedures for the 4
274-identification of confidential information. 5
264+•S 1097 IS
265+cations and establish procedures for the 1
266+identification of confidential information. 2
275267 ‘‘(C) P
276-OTENTIAL REMEDIES .—In estab-6
277-lishing protocols under this paragraph, the task 7
278-force shall identify appropriate remedies for any 8
279-potential injury suffered when confidential in-9
280-formation is made available, including inadvert-10
281-ently, through the sharing of information de-11
282-scribed in this subsection. 12
268+OTENTIAL REMEDIES .—In estab-3
269+lishing protocols under this paragraph, the task 4
270+force shall identify appropriate remedies for any 5
271+potential injury suffered when confidential in-6
272+formation is made available, including inadvert-7
273+ently, through the sharing of information de-8
274+scribed in this subsection. 9
283275 ‘‘(3) R
284-ULE OF CONSTRUCTION .—Nothing in 13
285-this subsection may be construed as superseding any 14
286-other remedy available for the unauthorized disclo-15
287-sure of confidential information.’’. 16
276+ULE OF CONSTRUCTION .—Nothing in 10
277+this subsection may be construed as superseding any 11
278+other remedy available for the unauthorized disclo-12
279+sure of confidential information.’’. 13
288280 (b) T
289-ECHNICAL AND CONFORMINGAMENDMENT.— 17
290-The table of sections for chapter 1 of title 35, United 18
291-States Code, is amended by adding at the end the fol-19
292-lowing: 20
293-‘‘
294-1514. Interagency Task Force on Patents.’’.
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298-41
299-119
300-TH
301-CONGRESS
302-1
303-ST
304-S
305-ESSION
306-
307-S. 1097 A BILL
308-To amend title 35, United States Code, to establish
309-an interagency task force between the United
310-States Patent and Trademark Office and the
311-Food and Drug Administration for purposes of
312-sharing information and providing technical as-
313-sistance with respect to patents, and for other
314-purposes.
315-A
316-PRIL
317-10, 2025
318-Reported with amendments
319-VerDate Sep 11 2014 19:15 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00012 Fmt 6651 Sfmt 6651 E:\BILLS\S1097.RS S1097
281+ECHNICAL AND CONFORMINGAMENDMENT.— 14
282+The table of sections for chapter 1 of title 35, United 15
283+States Code, is amended by adding at the end the fol-16
284+lowing: 17
285+‘‘15. Interagency Task Force on Patents.’’.
286+Æ
287+VerDate Sep 11 2014 00:10 Mar 29, 2025 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6301 E:\BILLS\S1097.IS S1097
320288 ssavage on LAPJG3WLY3PROD with BILLS