Us Congress 2023-2024 Regular Session

Us Congress Senate Bill SB79 Compare Versions

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11 II
2-Calendar No. 18
32 118THCONGRESS
43 1
54 STSESSION S. 79
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 JANUARY25, 2023
1312 Mr. D
14-URBIN(for himself, Mr. TILLIS, Mr. GRASSLEY, Mr. COONS, Mr.
15-W
16-ELCH, and Mrs. FEINSTEIN) introduced the following bill; which was
17-read twice and referred to the Committee on the Judiciary
18-M
19-ARCH1, 2023
20-Reported by Mr. D
21-URBIN, without amendment A BILL
13+URBIN(for himself, Mr. TILLIS, Mr. GRASSLEY, and Mr. COONS) intro-
14+duced the following bill; which was read twice and referred to the Com-
15+mittee on the Judiciary
16+A BILL
2217 To amend title 35, United States Code, to establish an
2318 interagency task force between the United States Patent
2419 and Trademark Office and the Food and Drug Adminis-
2520 tration for purposes of sharing information and providing
2621 technical assistance with respect to patents, and for other
2722 purposes.
2823 Be it enacted by the Senate and House of Representa-1
2924 tives of the United States of America in Congress assembled, 2
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25+SECTION 1. SHORT TITLE. 3
26+This Act may be cited as the ‘‘Interagency Patent 4
27+Coordination and Improvement Act of 2023’’. 5
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32-•S 79 RS
33-SECTION 1. SHORT TITLE. 1
34-This Act may be cited as the ‘‘Interagency Patent 2
35-Coordination and Improvement Act of 2023’’. 3
36-SEC. 2. FINDINGS. 4
37-Congress finds the following: 5
38-(1) Decisions by the United States Patent and 6
39-Trademark Office relating to patents may implicate, 7
40-or have relevance to, information housed at or in-8
41-volving other Federal agencies. 9
42-(2) Entities submitting patent applications to 10
43-the United States Patent and Trademark Office may 11
44-also submit information to, or share information 12
45-with, other Federal agencies, necessitating accuracy 13
46-and consistency in those representations. 14
47-(3) Research has shown that patent examiners 15
48-may benefit from additional information that is 16
49-housed at, or is available to, Federal agencies other 17
50-than the United States Patent and Trademark Of-18
51-fice in order to assess prior art and the state of 19
52-science and technology. 20
53-(4) The Under Secretary of Commerce for In-21
54-tellectual Property and Director of the United States 22
55-Patent and Trademark Office is encouraged to work 23
56-with other Federal agencies. 24
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30+•S 79 IS
31+SEC. 2. FINDINGS. 1
32+Congress finds the following: 2
33+(1) Decisions by the United States Patent and 3
34+Trademark Office relating to patents may implicate, 4
35+or have relevance to, information housed at or in-5
36+volving other Federal agencies. 6
37+(2) Entities submitting patent applications to 7
38+the United States Patent and Trademark Office may 8
39+also submit information to, or share information 9
40+with, other Federal agencies, necessitating accuracy 10
41+and consistency in those representations. 11
42+(3) Research has shown that patent examiners 12
43+may benefit from additional information that is 13
44+housed at, or is available to, Federal agencies other 14
45+than the United States Patent and Trademark Of-15
46+fice in order to assess prior art and the state of 16
47+science and technology. 17
48+(4) The Under Secretary of Commerce for In-18
49+tellectual Property and Director of the United States 19
50+Patent and Trademark Office is encouraged to work 20
51+with other Federal agencies. 21
52+SEC. 3. REPORT BY UNITED STATES PATENT AND TRADE-22
53+MARK OFFICE. 23
54+Not later than 4 years after the date of enactment 24
55+of this Act, the Under Secretary of Commerce for Intellec-25
56+tual Property and Director of the United States Patent 26
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60-SEC. 3. REPORT BY UNITED STATES PATENT AND TRADE-1
61-MARK OFFICE. 2
62-Not later than 4 years after the date of enactment 3
63-of this Act, the Under Secretary of Commerce for Intellec-4
64-tual Property and Director of the United States Patent 5
65-and Trademark Office shall submit to the Committee on 6
66-the Judiciary of the Senate and the Committee on the Ju-7
67-diciary of the House of Representatives a report that con-8
68-tains— 9
69-(1) a description of the frequency with which— 10
70-(A) information is provided by the Food 11
71-and Drug Administration to the United States 12
72-Patent and Trademark Office through the 13
73-Interagency Task Force on Patents established 14
74-under section 15 of title 35, United States 15
75-Code, as added by section 4(a) of this Act, or 16
76-under processes established by that Task Force; 17
77-and 18
78-(B) the information described in subpara-19
79-graph (A) is used in patent examinations; 20
80-(2) an identification of which methods of pro-21
81-viding information, as described in paragraph 22
82-(1)(A), and types of information so shared, are most 23
83-useful to patent examiners; 24
84-(3) any recommendations for changes to be 25
85-made by Congress to the mandate, funding, or oper-26
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60+and Trademark Office shall submit to the Committee on 1
61+the Judiciary of the Senate and the Committee on the Ju-2
62+diciary of the House of Representatives a report that con-3
63+tains— 4
64+(1) a description of the frequency with which— 5
65+(A) information is provided by the Food 6
66+and Drug Administration to the United States 7
67+Patent and Trademark Office through the 8
68+Interagency Task Force on Patents established 9
69+under section 15 of title 35, United States 10
70+Code, as added by section 4(a) of this Act, or 11
71+under processes established by that Task Force; 12
72+and 13
73+(B) the information described in subpara-14
74+graph (A) is used in patent examinations; 15
75+(2) an identification of which methods of pro-16
76+viding information, as described in paragraph 17
77+(1)(A), and types of information so shared, are most 18
78+useful to patent examiners; 19
79+(3) any recommendations for changes to be 20
80+made by Congress to the mandate, funding, or oper-21
81+ations of the Task Force described in paragraph 22
82+(1)(A); and 23
83+(4) an identification of other Federal agencies 24
84+with which the Under Secretary of Commerce for In-25
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88-•S 79 RS
89-ations of the Task Force described in paragraph 1
90-(1)(A); and 2
91-(4) an identification of other Federal agencies 3
92-with which the Under Secretary of Commerce for In-4
93-tellectual Property and Director of the United States 5
94-Patent and Trademark Office should explore oppor-6
95-tunities for coordination that are similar to those 7
96-undertaken with the Food and Drug Administration 8
97-through the activities of the Task Force described in 9
98-paragraph (1)(A). 10
99-SEC. 4. INTERAGENCY TASK FORCE ON PATENTS. 11
87+•S 79 IS
88+tellectual Property and Director of the United States 1
89+Patent and Trademark Office should explore oppor-2
90+tunities for coordination that are similar to those 3
91+undertaken with the Food and Drug Administration 4
92+through the activities of the Task Force described in 5
93+paragraph (1)(A). 6
94+SEC. 4. INTERAGENCY TASK FORCE ON PATENTS. 7
10095 (a) I
101-NGENERAL.—Chapter 1 of title 35, United 12
102-States Code, is amended— 13
103-(1) in section 2(c), by adding at the end the fol-14
104-lowing: 15
105-‘‘(6)(A) In exercising the Director’s powers and du-16
106-ties under this section relating to patents, and decisions 17
107-or actions involving patents, for human drugs and biologi-18
108-cal products, the Director shall, through the Interagency 19
109-Task Force on Patents established under section 15, con-20
110-sult with the Commissioner of Food and Drugs in the 21
111-manner described in that section. 22
112-‘‘(B) For purposes of subparagraph (A), the term 23
113-‘decisions or actions involving patents’ means decisions or 24
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96+NGENERAL.—Chapter 1 of title 35, United 8
97+States Code, is amended— 9
98+(1) in section 2(c), by adding at the end the fol-10
99+lowing: 11
100+‘‘(6)(A) In exercising the Director’s powers and du-12
101+ties under this section relating to patents, and decisions 13
102+or actions involving patents, for human drugs and biologi-14
103+cal products, the Director shall, through the Interagency 15
104+Task Force on Patents established under section 15, con-16
105+sult with the Commissioner of Food and Drugs in the 17
106+manner described in that section. 18
107+‘‘(B) For purposes of subparagraph (A), the term 19
108+‘decisions or actions involving patents’ means decisions or 20
109+actions taken with respect to patents under this title.’’; 21
110+and 22
111+(2) by adding at the end the following: 23
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116-•S 79 RS
117-actions taken with respect to patents under this title.’’; 1
118-and 2
119-(2) by adding at the end the following: 3
120-‘‘§ 15. Interagency Task Force on Patents 4
114+•S 79 IS
115+‘‘§ 15. Interagency Task Force on Patents 1
121116 ‘‘(a) E
122-STABLISHMENT.—There is established an 5
123-interagency task force, to be known as the Interagency 6
124-Task Force on Patents (referred to in this section as the 7
125-‘task force’), to coordinate efforts between the Director 8
126-and the Commissioner of Food and Drugs (referred to in 9
127-this section as the ‘Commissioner’) regarding communica-10
128-tion about, evaluation of, and effective implementation of 11
129-the activities of the Office and the Food and Drug Admin-12
130-istration with respect to patents, and decisions or actions 13
131-involving patents (as defined in section 2(c)(6)(B)), for 14
132-human drugs and biological products. 15
117+STABLISHMENT.—There is established an 2
118+interagency task force, to be known as the Interagency 3
119+Task Force on Patents (referred to in this section as the 4
120+‘task force’), to coordinate efforts between the Director 5
121+and the Commissioner of Food and Drugs (referred to in 6
122+this section as the ‘Commissioner’) regarding communica-7
123+tion about, evaluation of, and effective implementation of 8
124+the activities of the Office and the Food and Drug Admin-9
125+istration with respect to patents, and decisions or actions 10
126+involving patents (as defined in section 2(c)(6)(B)), for 11
127+human drugs and biological products. 12
133128 ‘‘(b) M
134-EMORANDUM OF UNDERSTANDING.—The Di-16
135-rector and the Commissioner shall enter into a memo-17
136-randum of understanding, or update an existing memo-18
137-randum of understanding, for the purposes of imple-19
138-menting and carrying out the duties of the task force. 20
129+EMORANDUM OF UNDERSTANDING.—The Di-13
130+rector and the Commissioner shall enter into a memo-14
131+randum of understanding, or update an existing memo-15
132+randum of understanding, for the purposes of imple-16
133+menting and carrying out the duties of the task force. 17
139134 ‘‘(c) M
140-EMBERSHIP.—The task force shall be com-21
141-prised of employees of the Office, who shall be appointed 22
142-by the Director, and employees of the Food and Drug Ad-23
143-ministration, who shall be appointed by the Commissioner, 24
144-who have appropriate expertise and decision-making au-25
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135+EMBERSHIP.—The task force shall be com-18
136+prised of employees of the Office, who shall be appointed 19
137+by the Director, and employees of the Food and Drug Ad-20
138+ministration, who shall be appointed by the Commissioner, 21
139+who have appropriate expertise and decision-making au-22
140+thority regarding operational, administrative, technical, 23
141+medical, pharmacological, clinical, and scientific matters 24
142+to carry out the functions of the task force. 25
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147-•S 79 RS
148-thority regarding operational, administrative, technical, 1
149-medical, pharmacological, clinical, and scientific matters 2
150-to carry out the functions of the task force. 3
151-‘‘(d) A
152-CTIVITIES.—The task force shall carry out the 4
153-following functions regarding interagency coordination to 5
154-promote reciprocal access of information: 6
155-‘‘(1) Sharing information on the general proc-7
156-esses of the Office and the Food and Drug Adminis-8
157-tration, what each such agency considers in its re-9
158-spective review of applications, and how each such 10
159-agency evaluates those applications, which may be 11
160-undertaken through routine and ongoing meetings, 12
161-workshops, and training sessions. 13
162-‘‘(2) Sharing information on new approvals of 14
163-patents, human drugs and biological products, new 15
164-technologies and prior art (as appropriate on a case- 16
165-by-case basis), and scientific trends and develop-17
166-ments. 18
167-‘‘(3) Establishing a process that requires— 19
168-‘‘(A) the Director to request from the 20
169-Commissioner (and the Commissioner to pro-21
170-vide to the Director, upon receiving such a re-22
171-quest)— 23
172-‘‘(i) appropriate information for use 24
173-by employees of the Office with responsi-25
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145+•S 79 IS
146+‘‘(d) ACTIVITIES.—The task force shall carry out the 1
147+following functions regarding interagency coordination to 2
148+promote reciprocal access of information: 3
149+‘‘(1) Sharing information on the general proc-4
150+esses of the Office and the Food and Drug Adminis-5
151+tration, what each such agency considers in its re-6
152+spective review of applications, and how each such 7
153+agency evaluates those applications, which may be 8
154+undertaken through routine and ongoing meetings, 9
155+workshops, and training sessions. 10
156+‘‘(2) Sharing information on new approvals of 11
157+patents, human drugs and biological products, new 12
158+technologies and prior art (as appropriate on a case- 13
159+by-case basis), and scientific trends and develop-14
160+ments. 15
161+‘‘(3) Establishing a process that requires— 16
162+‘‘(A) the Director to request from the 17
163+Commissioner (and the Commissioner to pro-18
164+vide to the Director, upon receiving such a re-19
165+quest)— 20
166+‘‘(i) appropriate information for use 21
167+by employees of the Office with responsi-22
168+bility to examine patent applications under 23
169+section 131 (referred to in this section as 24
170+‘patent examiners’) regarding when certain 25
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176-•S 79 RS
177-bility to examine patent applications under 1
178-section 131 (referred to in this section as 2
179-‘patent examiners’) regarding when certain 3
180-information relating to a human drug or 4
181-biological product approval, which may in-5
182-clude updates to a label or newly approved 6
183-indications, is made publicly available, in-7
184-cluding when such information is posted 8
185-online; and 9
186-‘‘(ii) appropriate access for patent ex-10
187-aminers to relevant sources of product ap-11
188-plication, approval, patent, and labeling in-12
189-formation or communications between the 13
190-Food and Drug Administration and the 14
191-human drug or biological product sponsors 15
192-that may not currently be subject to public 16
193-disclosure, as appropriate and only to the 17
194-extent necessary for the Office to carry out 18
195-the responsibilities of the Office, such as 19
196-ensuring accurate representations and ac-20
197-cess to information on whether the claimed 21
198-invention that would be the subject of the 22
199-patent was on sale before the effective fil-23
200-ing date of the claimed invention, as de-24
201-scribed in section 102(a)(1); and 25
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173+•S 79 IS
174+information relating to a human drug or 1
175+biological product approval, which may in-2
176+clude updates to a label or newly approved 3
177+indications, is made publicly available, in-4
178+cluding when such information is posted 5
179+online; and 6
180+‘‘(ii) appropriate access for patent ex-7
181+aminers to relevant sources of product ap-8
182+plication, approval, patent, and labeling in-9
183+formation or communications between the 10
184+Food and Drug Administration and the 11
185+human drug or biological product sponsors 12
186+that may not currently be subject to public 13
187+disclosure, as appropriate and only to the 14
188+extent necessary for the Office to carry out 15
189+the responsibilities of the Office, such as 16
190+ensuring accurate representations and ac-17
191+cess to information on whether the claimed 18
192+invention that would be the subject of the 19
193+patent was on sale before the effective fil-20
194+ing date of the claimed invention, as de-21
195+scribed in section 102(a)(1); and 22
196+‘‘(B) the Office to assist the Food and 23
197+Drug Administration in its ministerial role of 24
198+listing patents. 25
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204-•S 79 RS
205-‘‘(B) the Office to assist the Food and 1
206-Drug Administration in its ministerial role of 2
207-listing patents. 3
208-‘‘(4) Establishing a process to ensure that, in 4
209-appropriate circumstances, at the request of the Di-5
210-rector, the Commissioner shall consult with or other-6
211-wise furnish specific, available information to the Of-7
212-fice with respect to certain applications, responses, 8
213-or affidavits after rejections in order to assist patent 9
214-examiners in carrying out the duties of those patent 10
215-examiners. 11
201+•S 79 IS
202+‘‘(4) Establishing a process to ensure that, in 1
203+appropriate circumstances, at the request of the Di-2
204+rector, the Commissioner shall consult with or other-3
205+wise furnish specific, available information to the Of-4
206+fice with respect to certain applications, responses, 5
207+or affidavits after rejections in order to assist patent 6
208+examiners in carrying out the duties of those patent 7
209+examiners. 8
216210 ‘‘(e) R
217-ULE OFCONSTRUCTION.—Nothing in sub-12
218-section (d)(3)(B) shall be construed as— 13
219-‘‘(1) directing the Office to interfere with, 14
220-delay, or supersede the ministerial function of the 15
221-Food and Drug Administration of listing patents; 16
222-‘‘(2) indicating the position of the Office re-17
223-garding the ability to assert a patent in infringement 18
224-litigation; or 19
225-‘‘(3) changing the ministerial function of the 20
226-Food and Drug Administration of listing patents. 21
211+ULE OFCONSTRUCTION.—Nothing in sub-9
212+section (d)(3)(B) shall be construed as— 10
213+‘‘(1) directing the Office to interfere with, 11
214+delay, or supersede the ministerial function of the 12
215+Food and Drug Administration of listing patents; 13
216+‘‘(2) indicating the position of the Office re-14
217+garding the ability to assert a patent in infringement 15
218+litigation; or 16
219+‘‘(3) changing the ministerial function of the 17
220+Food and Drug Administration of listing patents. 18
227221 ‘‘(f) C
228-ONFIDENTIALITY.— 22
222+ONFIDENTIALITY.— 19
229223 ‘‘(1) I
230-N GENERAL.—With respect to any record 23
231-or other information of the Food and Drug Adminis-24
232-tration or the Office that is confidential, either such 25
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224+N GENERAL.—With respect to any record 20
225+or other information of the Food and Drug Adminis-21
226+tration or the Office that is confidential, either such 22
227+agency may share any such information with the 23
228+other agency in furtherance of the activities de-24
229+scribed in this section, which shall remain subject to 25
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236-agency may share any such information with the 1
237-other agency in furtherance of the activities de-2
238-scribed in this section, which shall remain subject to 3
239-such protections as if the information were held by 4
240-the Food and Drug Administration. 5
232+•S 79 IS
233+such protections as if the information were held by 1
234+the Food and Drug Administration. 2
241235 ‘‘(2) P
242-ROTOCOLS.— 6
236+ROTOCOLS.— 3
243237 ‘‘(A) I
244-N GENERAL.—The task force shall 7
245-establish appropriate protocols to safeguard 8
246-confidentiality and prevent the inappropriate 9
247-disclosure of information when sharing informa-10
248-tion between the Office and the Food and Drug 11
249-Administration. 12
238+N GENERAL.—The task force shall 4
239+establish appropriate protocols to safeguard 5
240+confidentiality and prevent the inappropriate 6
241+disclosure of information when sharing informa-7
242+tion between the Office and the Food and Drug 8
243+Administration. 9
250244 ‘‘(B) C
251-ONTENTS.—The protocols estab-13
252-lished under subparagraph (A) shall provide 14
253-that— 15
254-‘‘(i) before sharing any information 16
255-described in paragraph (1), the sponsor of 17
256-the human drug or biological product to 18
257-which that information relates shall be pro-19
258-vided notice of that sharing by the applica-20
259-ble agency and with a period of 30 days to 21
260-consult with the agency sharing that infor-22
261-mation; and 23
262-‘‘(ii) the Director shall, in order to 24
263-protect against the inadvertent disclosure 25
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245+ONTENTS.—The protocols estab-10
246+lished under subparagraph (A) shall provide 11
247+that— 12
248+‘‘(i) before sharing any information 13
249+described in paragraph (1), the sponsor of 14
250+the human drug or biological product to 15
251+which that information relates shall be pro-16
252+vided notice of that sharing by the applica-17
253+ble agency and with a period of 30 days to 18
254+consult with the agency sharing that infor-19
255+mation; and 20
256+‘‘(ii) the Director shall, in order to 21
257+protect against the inadvertent disclosure 22
258+of information, maintain any information 23
259+shared with the Director by the Commis-24
260+sioner separate from pending patent appli-25
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266-•S 79 RS
267-of information, maintain any information 1
268-shared with the Director by the Commis-2
269-sioner separate from pending patent appli-3
270-cations and establish procedures for the 4
271-identification of confidential information. 5
263+•S 79 IS
264+cations and establish procedures for the 1
265+identification of confidential information. 2
272266 ‘‘(C) P
273-OTENTIAL REMEDIES .—In estab-6
274-lishing protocols under this paragraph, the task 7
275-force shall identify appropriate remedies for any 8
276-potential injury suffered when confidential in-9
277-formation is made available, including inadvert-10
278-ently, through the sharing of information de-11
279-scribed in this subsection. 12
267+OTENTIAL REMEDIES .—In estab-3
268+lishing protocols under this paragraph, the task 4
269+force shall identify appropriate remedies for any 5
270+potential injury suffered when confidential in-6
271+formation is made available, including inadvert-7
272+ently, through the sharing of information de-8
273+scribed in this subsection. 9
280274 ‘‘(3) R
281-ULE OF CONSTRUCTION .—Nothing in 13
282-this subsection may be construed as superseding any 14
283-other remedy available for the unauthorized disclo-15
284-sure of confidential information.’’. 16
275+ULE OF CONSTRUCTION .—Nothing in 10
276+this subsection may be construed as superseding any 11
277+other remedy available for the unauthorized disclo-12
278+sure of confidential information.’’. 13
285279 (b) T
286-ECHNICAL AND CONFORMINGAMENDMENT.— 17
287-The table of sections for chapter 1 of title 35, United 18
288-States Code, is amended by adding at the end the fol-19
289-lowing: 20
280+ECHNICAL AND CONFORMINGAMENDMENT.— 14
281+The table of sections for chapter 1 of title 35, United 15
282+States Code, is amended by adding at the end the fol-16
283+lowing: 17
290284 ‘‘15. Interagency Task Force on Patents.’’.
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294-18
295-118
296-TH
297-CONGRESS
298-1
299-ST
300-S
301-ESSION
302-
303-S. 79 A BILL
304-To amend title 35, United States Code, to establish
305-an interagency task force between the United
306-States Patent and Trademark Office and the
307-Food and Drug Administration for purposes of
308-sharing information and providing technical as-
309-sistance with respect to patents, and for other
310-purposes.
311-M
312-ARCH
313-1, 2023
314-Reported without amendment
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285+Æ
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316287 pbinns on DSKJLVW7X2PROD with $$_JOB