[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1097 Introduced in Senate (IS)]
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119th CONGRESS
1st Session
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
March 24, 2025
Mr. Durbin (for himself, Mr. Tillis, Mr. Grassley, Mr. Coons, and Mr.
Welch) 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 Administration 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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Interagency Patent Coordination and
Improvement Act of 2025''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) Decisions by the United States Patent and Trademark
Office relating to patents may implicate, or have relevance to,
information housed at or involving other Federal agencies.
(2) Entities submitting patent applications to the United
States Patent and Trademark Office may also submit information
to, or share information with, other Federal agencies,
necessitating accuracy and consistency in those
representations.
(3) Research has shown that patent examiners may benefit
from additional information that is housed at, or is available
to, Federal agencies other than the United States Patent and
Trademark Office in order to assess prior art and the state of
science and technology.
(4) The Under Secretary of Commerce for Intellectual
Property and Director of the United States Patent and Trademark
Office is encouraged to work with other Federal agencies.
SEC. 3. REPORT BY UNITED STATES PATENT AND TRADEMARK OFFICE.
Not later than 4 years after the date of enactment of this Act, the
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office shall submit to the
Committee on the Judiciary of the Senate and the Committee on the
Judiciary of the House of Representatives a report that contains--
(1) a description of the frequency with which--
(A) information is provided by the Food and Drug
Administration to the United States Patent and
Trademark Office through the Interagency Task Force on
Patents established under section 15 of title 35,
United States Code, as added by section 4(a) of this
Act, or under processes established by that Task Force;
and
(B) the information described in subparagraph (A)
is used in patent examinations;
(2) an identification of which methods of providing
information, as described in paragraph (1)(A), and types of
information so shared, are most useful to patent examiners;
(3) any recommendations for changes to be made by Congress
to the mandate, funding, or operations of the Task Force
described in paragraph (1)(A); and
(4) an identification of other Federal agencies with which
the Under Secretary of Commerce for Intellectual Property and
Director of the United States Patent and Trademark Office
should explore opportunities for coordination that are similar
to those undertaken with the Food and Drug Administration
through the activities of the Task Force described in paragraph
(1)(A).
SEC. 4. INTERAGENCY TASK FORCE ON PATENTS.
(a) In General.--Chapter 1 of title 35, United States Code, is
amended--
(1) in section 2(c), by adding at the end the following:
``(6)(A) In exercising the Director's powers and duties under this
section relating to patents, and decisions or actions involving
patents, for human drugs and biological products, the Director shall,
through the Interagency Task Force on Patents established under section
15, consult with the Commissioner of Food and Drugs in the manner
described in that section.
``(B) For purposes of subparagraph (A), the term `decisions or
actions involving patents' means decisions or actions taken with
respect to patents under this title.''; and
(2) by adding at the end the following:
``Sec. 15. Interagency Task Force on Patents
``(a) Establishment.--There is established an interagency task
force, to be known as the Interagency Task Force on Patents (referred
to in this section as the `task force'), to coordinate efforts between
the Director and the Commissioner of Food and Drugs (referred to in
this section as the `Commissioner') regarding communication about,
evaluation of, and effective implementation of the activities of the
Office and the Food and Drug Administration with respect to patents,
and decisions or actions involving patents (as defined in section
2(c)(6)(B)), for human drugs and biological products.
``(b) Memorandum of Understanding.--The Director and the
Commissioner shall enter into a memorandum of understanding, or update
an existing memorandum of understanding, for the purposes of
implementing and carrying out the duties of the task force.
``(c) Membership.--The task force shall be comprised of employees
of the Office, who shall be appointed by the Director, and employees of
the Food and Drug Administration, who shall be appointed by the
Commissioner, who have appropriate expertise and decision-making
authority regarding operational, administrative, technical, medical,
pharmacological, clinical, and scientific matters to carry out the
functions of the task force.
``(d) Activities.--The task force shall carry out the following
functions regarding interagency coordination to promote reciprocal
access of information:
``(1) Sharing information on the general processes of the
Office and the Food and Drug Administration, what each such
agency considers in its respective review of applications, and
how each such agency evaluates those applications, which may be
undertaken through routine and ongoing meetings, workshops, and
training sessions.
``(2) Sharing information on new approvals of patents,
human drugs and biological products, new technologies and prior
art (as appropriate on a case-by-case basis), and scientific
trends and developments.
``(3) Establishing a process that requires--
``(A) the Director to request from the Commissioner
(and the Commissioner to provide to the Director, upon
receiving such a request)--
``(i) appropriate information for use by
employees of the Office with responsibility to
examine patent applications under section 131
(referred to in this section as `patent
examiners') regarding when certain information
relating to a human drug or biological product
approval, which may include updates to a label
or newly approved indications, is made publicly
available, including when such information is
posted online; and
``(ii) appropriate access for patent
examiners to relevant sources of product
application, approval, patent, and labeling
information or communications between the Food
and Drug Administration and the human drug or
biological product sponsors that may not
currently be subject to public disclosure, as
appropriate and only to the extent necessary
for the Office to carry out the
responsibilities of the Office, such as
ensuring accurate representations and access to
information on whether the claimed invention
that would be the subject of the patent was on
sale before the effective filing date of the
claimed invention, as described in section
102(a)(1); and
``(B) the Office to assist the Food and Drug
Administration in its ministerial role of listing
patents.
``(4) Establishing a process to ensure that, in appropriate
circumstances, at the request of the Director, the Commissioner
shall consult with or otherwise furnish specific, available
information to the Office with respect to certain applications,
responses, or affidavits after rejections in order to assist
patent examiners in carrying out the duties of those patent
examiners.
``(e) Rule of Construction.--Nothing in subsection (d)(3)(B) shall
be construed as--
``(1) directing the Office to interfere with, delay, or
supersede the ministerial function of the Food and Drug
Administration of listing patents;
``(2) indicating the position of the Office regarding the
ability to assert a patent in infringement litigation; or
``(3) changing the ministerial function of the Food and
Drug Administration of listing patents.
``(f) Confidentiality.--
``(1) In general.--With respect to any record or other
information of the Food and Drug Administration or the Office
that is confidential, either such agency may share any such
information with the other agency in furtherance of the
activities described in this section, which shall remain
subject to such protections as if the information were held by
the Food and Drug Administration.
``(2) Protocols.--
``(A) In general.--The task force shall establish
appropriate protocols to safeguard confidentiality and
prevent the inappropriate disclosure of information
when sharing information between the Office and the
Food and Drug Administration.
``(B) Contents.--The protocols established under
subparagraph (A) shall provide that--
``(i) before sharing any information
described in paragraph (1), the sponsor of the
human drug or biological product to which that
information relates shall be provided notice of
that sharing by the applicable agency and with
a period of 30 days to consult with the agency
sharing that information; and
``(ii) the Director shall, in order to
protect against the inadvertent disclosure of
information, maintain any information shared
with the Director by the Commissioner separate
from pending patent applications and establish
procedures for the identification of
confidential information.
``(C) Potential remedies.--In establishing
protocols under this paragraph, the task force shall
identify appropriate remedies for any potential injury
suffered when confidential information is made
available, including inadvertently, through the sharing
of information described in this subsection.
``(3) Rule of construction.--Nothing in this subsection may
be construed as superseding any other remedy available for the
unauthorized disclosure of confidential information.''.
(b) Technical and Conforming Amendment.--The table of sections for
chapter 1 of title 35, United States Code, is amended by adding at the
end the following:
``15. Interagency Task Force on Patents.''.
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