[Congressional Record Volume 169, Number 16 (Wednesday, January 25, 2023)]
[Senate]
[Pages S102-S103]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
By Mr. DURBIN (for himself, Mr. Tillis, Mr. Grassley, and Mr.
Coons):
S. 79. 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; to the Committee on the Judiciary.
Mr. DURBIN. Madam President, I ask unanimous consent that the text of
the bill be printed in the Record.
There being no objection, the text of the bill was ordered to be
printed in the Record, as follows:
S. 79
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 2023''.
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
[[Page S103]]
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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