```

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4430 Reported in Senate (RS)]

<DOC>

                                                       Calendar No. 463
117th CONGRESS
  2d Session
                                S. 4430

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

                             June 16, 2022

   Mr. Durbin (for himself, Mr. Tillis, Mr. Grassley, Mr. Leahy, Mr. 
 Coons, and Mr. Cornyn) introduced the following bill; which was read 
          twice and referred to the Committee on the Judiciary

                             August 2, 2022

               Reported by Mr. Durbin, with an amendment
 [Strike out all after the enacting clause and insert the part 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,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Interagency Patent 
Coordination and Improvement Act of 2022''.</DELETED>

<DELETED>SEC. 2. FINDINGS.</DELETED>

<DELETED>    Congress finds the following:</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>

<DELETED>SEC. 3. REPORT BY UNITED STATES PATENT AND TRADEMARK 
              OFFICE.</DELETED>

<DELETED>    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--
</DELETED>
        <DELETED>    (1) a description of the frequency with which--
        </DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (B) the information described in 
                subparagraph (A) is used in patent 
                examinations;</DELETED>
        <DELETED>    (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;</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (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).</DELETED>

<DELETED>SEC. 4. INTERAGENCY TASK FORCE ON PATENTS.</DELETED>

<DELETED>    (a) In General.--Chapter 1 of title 35, United States 
Code, is amended--</DELETED>
        <DELETED>    (1) in section 2(c), by adding at the end the 
        following:</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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</DELETED>
        <DELETED>    (2) by adding at the end the following:</DELETED>
<DELETED>``Sec. 15. Interagency Task Force on Patents</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(d) Activities.--The task force shall carry out the 
following functions regarding interagency coordination to promote 
reciprocal access of information:</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(3) Establishing a process that requires--
        </DELETED>
                <DELETED>    ``(A) the Director to request from the 
                Commissioner (and the Commissioner to provide to the 
                Director, upon receiving such a request)--</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(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 prescription 
                        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, including 
                        ensuring accurate representations and the 
                        enforcement of the limitation on granting a 
                        patent because 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</DELETED>
                <DELETED>    ``(B) the Office to assist the Food and 
                Drug Administration in its ministerial role of listing 
                appropriate and accurate descriptions of 
                patents.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(e) Rule of Construction.--Nothing in subsection 
(d)(3)(B) shall be construed as--</DELETED>
        <DELETED>    ``(1) directing the Office to interfere with or 
        delay the ministerial function of the Food and Drug 
        Administration of listing patents; or</DELETED>
        <DELETED>    ``(2) indicating the position of the Office 
        regarding the ability to assert a patent in infringement 
        litigation.</DELETED>
<DELETED>    ``(f) Confidentiality.--</DELETED>
        <DELETED>    ``(1) 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.</DELETED>
        <DELETED>    ``(2) Potential remedies.--In establishing 
        protocols under paragraph (1), 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 
        that paragraph.''.</DELETED>
<DELETED>    (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:</DELETED>

<DELETED>``15. Interagency Task Force on Patents.''.
<DELETED>    (c) Authorization of Appropriations.--There are authorized 
to be appropriated to the Under Secretary of Commerce for Intellectual 
Property and Director of the United States Patent and Trademark Office 
and the Commissioner of Food and Drugs such sums as may be necessary 
for the purposes of carrying out the functions of the Interagency Task 
Force on Patents established under section 15 of title 35, United 
States Code, as added by subsection (a).</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Interagency Patent Coordination and 
Improvement Act of 2022''.

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 
                appropriate and accurate descriptions of 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; or
            ``(2) indicating the position of the Office regarding the 
        ability to assert a patent in infringement litigation.
    ``(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.''.
    (c) Authorization of Appropriations.--There are authorized to be 
appropriated to the Under Secretary of Commerce for Intellectual 
Property and Director of the United States Patent and Trademark Office 
and the Commissioner of Food and Drugs such sums as may be necessary 
for the purposes of carrying out the functions of the Interagency Task 
Force on Patents established under section 15 of title 35, United 
States Code, as added by subsection (a).
                                                       Calendar No. 463

117th CONGRESS

  2d Session

                                S. 4430

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                             August 2, 2022

                       Reported with an amendment
```