II
Calendar No. 41
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
PRIL10, 2025
Reported by Mr. G
RASSLEY, with amendments
[Omit the parts struck through and insert the parts printed in italic] 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
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SECTION 1. SHORT TITLE. 1
This Act may be cited as the ‘‘Interagency Patent 2
Coordination and Improvement Act of 2025’’. 3
SEC. 2. FINDINGS. 4
Congress finds the following: 5
(1) Decisions by the United States Patent and 6
Trademark Office relating to patents may implicate, 7
or have relevance to, information housed at or in-8
volving other Federal agencies. 9
(2) Entities submitting patent applications to 10
the United States Patent and Trademark Office may 11
also submit information to, or share information 12
with, other Federal agencies, necessitating accuracy 13
and consistency in those representations. 14
(3) Research has shown that patent examiners 15
may benefit from additional information that is 16
housed at, or is available to, Federal agencies other 17
than the United States Patent and Trademark Of-18
fice in order to assess prior art and the state of 19
science and technology. 20
(4) The Under Secretary of Commerce for In-21
tellectual Property and Director of the United States 22
Patent and Trademark Office is encouraged to work 23
with other Federal agencies. 24
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SEC. 3. REPORT BY UNITED STATES PATENT AND TRADE-1
MARK OFFICE. 2
Not later than 4 years after the date of enactment 3
of this Act, the Under Secretary of Commerce for Intellec-4
tual Property and Director of the United States Patent 5
and Trademark Office shall submit to the Committee on 6
the Judiciary of the Senate and the Committee on the Ju-7
diciary of the House of Representatives a report that con-8
tains— 9
(1) a description of the frequency with which— 10
(A) information is provided by the Food 11
and Drug Administration to the United States 12
Patent and Trademark Office through the 13
Interagency Task Force on Patents established 14
under section 1514 of title 35, United States 15
Code, as added by section 4(a) of this Act, or 16
under processes established by that Task Force; 17
and 18
(B) the information described in subpara-19
graph (A) is used in patent examinations; 20
(2) an identification of which methods of pro-21
viding information, as described in paragraph 22
(1)(A), and types of information so shared, are most 23
useful to patent examiners; 24
(3) any recommendations for changes to be 25
made by Congress to the mandate, funding, or oper-26
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ations of the Task Force described in paragraph 1
(1)(A); and 2
(4) an identification of other Federal agencies 3
with which the Under Secretary of Commerce for In-4
tellectual Property and Director of the United States 5
Patent and Trademark Office should explore oppor-6
tunities for coordination that are similar to those 7
undertaken with the Food and Drug Administration 8
through the activities of the Task Force described in 9
paragraph (1)(A). 10
SEC. 4. INTERAGENCY TASK FORCE ON PATENTS. 11
(a) I
NGENERAL.—Chapter 1 of title 35, United 12
States Code, is amended— 13
(1) in section 2(c), by adding at the end the fol-14
lowing: 15
‘‘(6)(A) In exercising the Director’s powers and du-16
ties under this section relating to patents, and decisions 17
or actions involving patents, for human drugs and biologi-18
cal products, the Director shall, through the Interagency 19
Task Force on Patents established under section
1514, 20
consult with the Commissioner of Food and Drugs in the 21
manner described in that section. 22
‘‘(B) For purposes of subparagraph (A), the term 23
‘decisions or actions involving patents’ means decisions or 24
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actions taken with respect to patents under this title.’’; 1
and 2
(2) by adding at the end the following: 3
‘‘§
1514. Interagency Task Force on Patents 4
‘‘(a) E
STABLISHMENT.—There is established an 5
interagency task force, to be known as the Interagency 6
Task Force on Patents (referred to in this section as the 7
‘task force’), to coordinate efforts between the Director 8
and the Commissioner of Food and Drugs (referred to in 9
this section as the ‘Commissioner’) regarding communica-10
tion about, evaluation of, and effective implementation of 11
the activities of the Office and the Food and Drug Admin-12
istration with respect to patents, and decisions or actions 13
involving patents (as defined in section 2(c)(6)(B)), for 14
human drugs and biological products. 15
‘‘(b) M
EMORANDUM OF UNDERSTANDING.—The Di-16
rector and the Commissioner shall enter into a memo-17
randum of understanding, or update an existing memo-18
randum of understanding, for the purposes of imple-19
menting and carrying out the duties of the task force. 20
‘‘(c) M
EMBERSHIP.—The task force shall be com-21
prised of employees of the Office, who shall be appointed 22
by the Director, and employees of the Food and Drug Ad-23
ministration, who shall be appointed by the Commissioner, 24
who have appropriate expertise and decision-making au-25
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thority regarding operational, administrative, technical, 1
medical, pharmacological, clinical, and scientific matters 2
to carry out the functions of the task force. 3
‘‘(d) A
CTIVITIES.—The task force shall carry out the 4
following functions regarding interagency coordination to 5
promote reciprocal access of information: 6
‘‘(1) Sharing information on the general proc-7
esses of the Office and the Food and Drug Adminis-8
tration, what each such agency considers in its re-9
spective review of applications, and how each such 10
agency evaluates those applications, which may be 11
undertaken through routine and ongoing meetings, 12
workshops, and training sessions. 13
‘‘(2) Sharing information on new approvals of 14
patents, human drugs and biological products, new 15
technologies and prior art (as appropriate on a case- 16
by-case basis), and scientific trends and develop-17
ments. 18
‘‘(3) Establishing a process that requires— 19
‘‘(A) the Director to request from the 20
Commissioner (and the Commissioner to pro-21
vide to the Director, upon receiving such a re-22
quest)— 23
‘‘(i) appropriate information for use 24
by employees of the Office with responsi-25
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bility to examine patent applications under 1
section 131 (referred to in this section as 2
‘patent examiners’) regarding when certain 3
information relating to a human drug or 4
biological product approval, which may in-5
clude updates to a label or newly approved 6
indications, is made publicly available, in-7
cluding when such information is posted 8
online; and 9
‘‘(ii) appropriate access for patent ex-10
aminers to relevant sources of product ap-11
plication, approval, patent, and labeling in-12
formation or communications between the 13
Food and Drug Administration and the 14
human drug or biological product sponsors 15
that may not currently be subject to public 16
disclosure, as appropriate and only to the 17
extent necessary for the Office to carry out 18
the responsibilities of the Office, such as 19
ensuring accurate representations and ac-20
cess to information on whether the claimed 21
invention that would be the subject of the 22
patent was on sale before the effective fil-23
ing date of the claimed invention, as de-24
scribed in section 102(a)(1); and 25
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‘‘(B) the Office to assist the Food and 1
Drug Administration in its ministerial role of 2
listing patents. 3
‘‘(4) Establishing a process to ensure that, in 4
appropriate circumstances, at the request of the Di-5
rector, the Commissioner shall consult with or other-6
wise furnish specific, available information to the Of-7
fice with respect to certain applications, responses, 8
or affidavits after rejections in order to assist patent 9
examiners in carrying out the duties of those patent 10
examiners. 11
‘‘(e) R
ULE OFCONSTRUCTION.—Nothing in sub-12
section (d)(3)(B) shall be construed as— 13
‘‘(1) directing the Office to interfere with, 14
delay, or supersede the ministerial function of the 15
Food and Drug Administration of listing patents; 16
‘‘(2) indicating the position of the Office re-17
garding the ability to assert a patent in infringement 18
litigation; or 19
‘‘(3) changing the ministerial function of the 20
Food and Drug Administration of listing patents. 21
‘‘(f) C
ONFIDENTIALITY.— 22
‘‘(1) I
N GENERAL.—With respect to any record 23
or other information of the Food and Drug Adminis-24
tration or the Office that is confidential, either such 25
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agency may share any such information with the 1
other agency in furtherance of the activities de-2
scribed in this section, which shall remain subject to 3
such protections as if the information were held by 4
the Food and Drug Administration. 5
‘‘(2) P
ROTOCOLS.— 6
‘‘(A) I
N GENERAL.—The task force shall 7
establish appropriate protocols to safeguard 8
confidentiality and prevent the inappropriate 9
disclosure of information when sharing informa-10
tion between the Office and the Food and Drug 11
Administration. 12
‘‘(B) C
ONTENTS.—The protocols estab-13
lished under subparagraph (A) shall provide 14
that— 15
‘‘(i) before sharing any information 16
described in paragraph (1), the sponsor of 17
the human drug or biological product to 18
which that information relates shall be pro-19
vided notice of that sharing by the applica-20
ble agency and with a period of 30 days to 21
consult with the agency sharing that infor-22
mation; and 23
‘‘(ii) the Director shall, in order to 24
protect against the inadvertent disclosure 25
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of information, maintain any information 1
shared with the Director by the Commis-2
sioner separate from pending patent appli-3
cations and establish procedures for the 4
identification of confidential information. 5
‘‘(C) P
OTENTIAL REMEDIES .—In estab-6
lishing protocols under this paragraph, the task 7
force shall identify appropriate remedies for any 8
potential injury suffered when confidential in-9
formation is made available, including inadvert-10
ently, through the sharing of information de-11
scribed in this subsection. 12
‘‘(3) R
ULE OF CONSTRUCTION .—Nothing in 13
this subsection may be construed as superseding any 14
other remedy available for the unauthorized disclo-15
sure of confidential information.’’. 16
(b) T
ECHNICAL AND CONFORMINGAMENDMENT.— 17
The table of sections for chapter 1 of title 35, United 18
States Code, is amended by adding at the end the fol-19
lowing: 20
‘‘
1514. Interagency Task Force on Patents.’’.
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41
119
TH
CONGRESS
1
ST
S
ESSION
S. 1097 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 Administration for purposes of
sharing information and providing technical as-
sistance with respect to patents, and for other
purposes.
A
PRIL
10, 2025
Reported with amendments
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