II
119THCONGRESS
1
STSESSION S. 1097
To amend title 35, United States Code, to establish an interagency task
force between the United States Patent and Trademark Office and the
Food and Drug Administration for purposes of sharing information and
providing technical assistance with respect to patents, and for other
purposes.
IN THE SENATE OF THE UNITED STATES
MARCH24, 2025
Mr. D
URBIN(for himself, Mr. TILLIS, Mr. GRASSLEY, Mr. COONS, and Mr.
W
ELCH) introduced the following bill; which was read twice and referred
to the Committee on the Judiciary
A BILL
To amend title 35, United States Code, to establish an
interagency task force between the United States Patent
and Trademark Office and the Food and Drug Adminis-
tration for purposes of sharing information and providing
technical assistance with respect to patents, and for other
purposes.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Interagency Patent 4
Coordination and Improvement Act of 2025’’. 5
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SEC. 2. FINDINGS. 1
Congress finds the following: 2
(1) Decisions by the United States Patent and 3
Trademark Office relating to patents may implicate, 4
or have relevance to, information housed at or in-5
volving other Federal agencies. 6
(2) Entities submitting patent applications to 7
the United States Patent and Trademark Office may 8
also submit information to, or share information 9
with, other Federal agencies, necessitating accuracy 10
and consistency in those representations. 11
(3) Research has shown that patent examiners 12
may benefit from additional information that is 13
housed at, or is available to, Federal agencies other 14
than the United States Patent and Trademark Of-15
fice in order to assess prior art and the state of 16
science and technology. 17
(4) The Under Secretary of Commerce for In-18
tellectual Property and Director of the United States 19
Patent and Trademark Office is encouraged to work 20
with other Federal agencies. 21
SEC. 3. REPORT BY UNITED STATES PATENT AND TRADE-22
MARK OFFICE. 23
Not later than 4 years after the date of enactment 24
of this Act, the Under Secretary of Commerce for Intellec-25
tual Property and Director of the United States Patent 26
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and Trademark Office shall submit to the Committee on 1
the Judiciary of the Senate and the Committee on the Ju-2
diciary of the House of Representatives a report that con-3
tains— 4
(1) a description of the frequency with which— 5
(A) information is provided by the Food 6
and Drug Administration to the United States 7
Patent and Trademark Office through the 8
Interagency Task Force on Patents established 9
under section 15 of title 35, United States 10
Code, as added by section 4(a) of this Act, or 11
under processes established by that Task Force; 12
and 13
(B) the information described in subpara-14
graph (A) is used in patent examinations; 15
(2) an identification of which methods of pro-16
viding information, as described in paragraph 17
(1)(A), and types of information so shared, are most 18
useful to patent examiners; 19
(3) any recommendations for changes to be 20
made by Congress to the mandate, funding, or oper-21
ations of the Task Force described in paragraph 22
(1)(A); and 23
(4) an identification of other Federal agencies 24
with which the Under Secretary of Commerce for In-25
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tellectual Property and Director of the United States 1
Patent and Trademark Office should explore oppor-2
tunities for coordination that are similar to those 3
undertaken with the Food and Drug Administration 4
through the activities of the Task Force described in 5
paragraph (1)(A). 6
SEC. 4. INTERAGENCY TASK FORCE ON PATENTS. 7
(a) I
NGENERAL.—Chapter 1 of title 35, United 8
States Code, is amended— 9
(1) in section 2(c), by adding at the end the fol-10
lowing: 11
‘‘(6)(A) In exercising the Director’s powers and du-12
ties under this section relating to patents, and decisions 13
or actions involving patents, for human drugs and biologi-14
cal products, the Director shall, through the Interagency 15
Task Force on Patents established under section 15, con-16
sult with the Commissioner of Food and Drugs in the 17
manner described in that section. 18
‘‘(B) For purposes of subparagraph (A), the term 19
‘decisions or actions involving patents’ means decisions or 20
actions taken with respect to patents under this title.’’; 21
and 22
(2) by adding at the end the following: 23
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‘‘§ 15. Interagency Task Force on Patents 1
‘‘(a) E
STABLISHMENT.—There is established an 2
interagency task force, to be known as the Interagency 3
Task Force on Patents (referred to in this section as the 4
‘task force’), to coordinate efforts between the Director 5
and the Commissioner of Food and Drugs (referred to in 6
this section as the ‘Commissioner’) regarding communica-7
tion about, evaluation of, and effective implementation of 8
the activities of the Office and the Food and Drug Admin-9
istration with respect to patents, and decisions or actions 10
involving patents (as defined in section 2(c)(6)(B)), for 11
human drugs and biological products. 12
‘‘(b) M
EMORANDUM OF UNDERSTANDING.—The Di-13
rector and the Commissioner shall enter into a memo-14
randum of understanding, or update an existing memo-15
randum of understanding, for the purposes of imple-16
menting and carrying out the duties of the task force. 17
‘‘(c) M
EMBERSHIP.—The task force shall be com-18
prised of employees of the Office, who shall be appointed 19
by the Director, and employees of the Food and Drug Ad-20
ministration, who shall be appointed by the Commissioner, 21
who have appropriate expertise and decision-making au-22
thority regarding operational, administrative, technical, 23
medical, pharmacological, clinical, and scientific matters 24
to carry out the functions of the task force. 25
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‘‘(d) ACTIVITIES.—The task force shall carry out the 1
following functions regarding interagency coordination to 2
promote reciprocal access of information: 3
‘‘(1) Sharing information on the general proc-4
esses of the Office and the Food and Drug Adminis-5
tration, what each such agency considers in its re-6
spective review of applications, and how each such 7
agency evaluates those applications, which may be 8
undertaken through routine and ongoing meetings, 9
workshops, and training sessions. 10
‘‘(2) Sharing information on new approvals of 11
patents, human drugs and biological products, new 12
technologies and prior art (as appropriate on a case- 13
by-case basis), and scientific trends and develop-14
ments. 15
‘‘(3) Establishing a process that requires— 16
‘‘(A) the Director to request from the 17
Commissioner (and the Commissioner to pro-18
vide to the Director, upon receiving such a re-19
quest)— 20
‘‘(i) appropriate information for use 21
by employees of the Office with responsi-22
bility to examine patent applications under 23
section 131 (referred to in this section as 24
‘patent examiners’) regarding when certain 25
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information relating to a human drug or 1
biological product approval, which may in-2
clude updates to a label or newly approved 3
indications, is made publicly available, in-4
cluding when such information is posted 5
online; and 6
‘‘(ii) appropriate access for patent ex-7
aminers to relevant sources of product ap-8
plication, approval, patent, and labeling in-9
formation or communications between the 10
Food and Drug Administration and the 11
human drug or biological product sponsors 12
that may not currently be subject to public 13
disclosure, as appropriate and only to the 14
extent necessary for the Office to carry out 15
the responsibilities of the Office, such as 16
ensuring accurate representations and ac-17
cess to information on whether the claimed 18
invention that would be the subject of the 19
patent was on sale before the effective fil-20
ing date of the claimed invention, as de-21
scribed in section 102(a)(1); and 22
‘‘(B) the Office to assist the Food and 23
Drug Administration in its ministerial role of 24
listing patents. 25
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‘‘(4) Establishing a process to ensure that, in 1
appropriate circumstances, at the request of the Di-2
rector, the Commissioner shall consult with or other-3
wise furnish specific, available information to the Of-4
fice with respect to certain applications, responses, 5
or affidavits after rejections in order to assist patent 6
examiners in carrying out the duties of those patent 7
examiners. 8
‘‘(e) R
ULE OFCONSTRUCTION.—Nothing in sub-9
section (d)(3)(B) shall be construed as— 10
‘‘(1) directing the Office to interfere with, 11
delay, or supersede the ministerial function of the 12
Food and Drug Administration of listing patents; 13
‘‘(2) indicating the position of the Office re-14
garding the ability to assert a patent in infringement 15
litigation; or 16
‘‘(3) changing the ministerial function of the 17
Food and Drug Administration of listing patents. 18
‘‘(f) C
ONFIDENTIALITY.— 19
‘‘(1) I
N GENERAL.—With respect to any record 20
or other information of the Food and Drug Adminis-21
tration or the Office that is confidential, either such 22
agency may share any such information with the 23
other agency in furtherance of the activities de-24
scribed in this section, which shall remain subject to 25
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such protections as if the information were held by 1
the Food and Drug Administration. 2
‘‘(2) P
ROTOCOLS.— 3
‘‘(A) I
N GENERAL.—The task force shall 4
establish appropriate protocols to safeguard 5
confidentiality and prevent the inappropriate 6
disclosure of information when sharing informa-7
tion between the Office and the Food and Drug 8
Administration. 9
‘‘(B) C
ONTENTS.—The protocols estab-10
lished under subparagraph (A) shall provide 11
that— 12
‘‘(i) before sharing any information 13
described in paragraph (1), the sponsor of 14
the human drug or biological product to 15
which that information relates shall be pro-16
vided notice of that sharing by the applica-17
ble agency and with a period of 30 days to 18
consult with the agency sharing that infor-19
mation; and 20
‘‘(ii) the Director shall, in order to 21
protect against the inadvertent disclosure 22
of information, maintain any information 23
shared with the Director by the Commis-24
sioner separate from pending patent appli-25
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cations and establish procedures for the 1
identification of confidential information. 2
‘‘(C) P
OTENTIAL REMEDIES .—In estab-3
lishing protocols under this paragraph, the task 4
force shall identify appropriate remedies for any 5
potential injury suffered when confidential in-6
formation is made available, including inadvert-7
ently, through the sharing of information de-8
scribed in this subsection. 9
‘‘(3) R
ULE OF CONSTRUCTION .—Nothing in 10
this subsection may be construed as superseding any 11
other remedy available for the unauthorized disclo-12
sure of confidential information.’’. 13
(b) T
ECHNICAL AND CONFORMINGAMENDMENT.— 14
The table of sections for chapter 1 of title 35, United 15
States Code, is amended by adding at the end the fol-16
lowing: 17
‘‘15. Interagency Task Force on Patents.’’.
Æ
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