119-s1097

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1097 Reported in Senate

    (RS) ]

<DOC>

 Calendar No. 41
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

 April 10, 2025

 Reported by Mr. Grassley, 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 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 14 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 14, 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. 1514. 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:

``1514. Interagency Task Force on Patents.''.
 Calendar No. 41

119th CONGRESS

 1st Session

 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 assistance with respect to patents, and for other 
 purposes.

_______________________________________________________________________

 April 10, 2025

 Reported with amendments