[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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