[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33326-33327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13260]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Development and 
Commercialization of Monospecific CD22 Chimeric Antigen Receptor (CAR) 
Therapies for the Treatment of B-Cell Malignancies

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Patent License to practice the 
inventions embodied in the Patents and Patent Applications listed in 
the Supplementary Information section of this Notice to Syncopation 
Life Sciences Inc., (``Syncopation''), located in Palo Alto, 
California.

DATES: Only written comments and/or complete applications for a license 
which are received by the National Cancer Institute's Technology 
Transfer Center on or before July 9, 2021 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Jim Knabb, Senior Technology Transfer Manager, 
at Telephone: (240)-276-7856; or at Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

E-080-2012-0: Human Monoclonal Antibodies Specific for CD22

    1. U.S. Provisional Patent Application 61/042,329, filed April 4, 
2008 (E-080-2008-0-US-01);
    2. International Patent Application PCT/US2009/039,080, Filed April 
1, 2009 (E-080-2008/0-PCT-02);
    3. U.S. Patent Application: 12/934,214, filed September 23, 2010 
(E-080-2008-0-US-03);
    4. U.S. Patent Application 13/959,061, filed August 5, 2015 (E-080-
2008-0-US-04);
    5. U.S. Patent Application 15/012,023, filed February 1, 2016 (E-
080-2008-0-US-05);
    6. U.S. Patent Application 15/424,238, filed February 3, 2017 (E-
080-2008-0-US-06).

E-291-2012-0: M971 Chimeric Antigen Receptors

    1. U.S. Provisional Patent Application 61/717,960, filed October 
24, 2012 (E-291-2012-0-US-01);
    2. International Patent Application PCT/US2013/060332, filed 
September 18, 2013 (E-291-2012-0-PCT-02);
    3. Australia Application No: 2019235926, filed September 2, 2020 
(E-291-2012-0-AU-03);
    4. Brazil Patent Application BR112015009003-6, filed April 22, 2015 
(E-291-2012-0-BR-04);
    5. Canada Application No: 2889055, filed September 18, 2013 (E-291-
2012-0-CA-05);
    6. China Application No: 201380061387.5, filed May 25, 2015 (E-291-
2012-0-CN-06);
    7. European Patent Application No: 13773468.7, filed September 18, 
2013 (E-291-2012-0-EP-07);
    8. India Patent Application No: 2344/CHENP/2015, filed September 
18, 2013 (E-291-2012-0-IN-08);
    9. Japan Application No: 539602/2015, filed April 24, 2015 (E-291-
2012-0-JP-09);
    10. Russia Patent Application: 2015117237, filed May 7, 2015 (E-
291-2012-0-RU-10);
    11. U.S. Patent Application: 14/437,889, filed April 23, 2015 (E-
291-2012-0-US-11);
    12. Hong Kong Patent Application: 16101891.0, filed February 19, 
2016 (E-291-2012-0-HK-12);
    13. Russia Patent Application: 2018116582, filed May 4, 2018 (E-
291-2012-0-RU-13);
    14. Japan Patent Application: 2018-088908, filed May 2, 2018, (E-
291-2012-0-JP-14);
    15. Australia Patent Application: 2018204257, filed June 14, 2018 
(E-291-2012-0-AU-16);
    16. U.S. Patent Application: 16/107,271, filed August 21, 2018 (E-
291-2012-0-US-17);
    17. Germany Patent Application: 13773468.7, filed April 22, 2015 
(E-291-2012-0-DE-18);
    18. Spain Patent Application: 13773468.7, filed April 22, 2015 (E-
291-2012-0-ES-19);
    19. France Patent Application: 13773468.7, filed April 22, 2015 (E-
291-2012-0-FR-20);
    20. Great Britain Patent Application: 13773468.7, filed April 22, 
2015 (E-291-2012-0-GB-21);
    21. Italy Patent Application: 13773468.7, filed April 22, 2015 (E-
291-2012-0-IT-22);
    22. China Patent Application: 201910500128.7, filed June 11, 2019 
(E-291-2012-0-CN-23);
    23. U.S. Patent Application: 16/869,792, filed May 8, 2020 (E-291-
2012-0-US-24).
    The patent rights in these inventions have been assigned and/or 
exclusively licensed to the government of the United States of America.
    The prospective exclusive license territory may be worldwide, and 
the fields of use may be limited to the following:
    ``Development, manufacture and commercialization of chimeric 
antigen receptor T cell (CAR-T) immunotherapies (both autologous and 
allogeneically derived) for the treatment of B cell malignancies that 
express CD22 wherein:
    1. The T cells are engineered to be monospecific for CD22; and
    2. The chimeric antigen receptor is specific for CD22 via the m971 
scFv''.
    This technology discloses CAR therapies that target CD22 by 
utilizing the anti-CD22 binder known as m971. CD22 is expressed on the 
surface of B cells in B cell malignancies and CD22-targeting CAR-T has 
shown early promise in clinical trials for ALL and NHL.
    This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and the prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published Notice, the National 
Cancer Institute receives written evidence and argument that 
establishes that the grant of the license would not be consistent with 
the requirements of 35 U.S.C. 209 and 37 CFR part 404.
    In response to this Notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
license application, will not be treated confidentially, and may be 
made publicly available.
    License applications submitted in response to this Notice will be 
presumed to contain business confidential information and any release 
of information from these license applications will be made only as 
required and upon a request under the

[[Page 33327]]

Freedom of Information Act, 5 U.S.C. 552.

    Dated: June 9, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2021-13260 Filed 6-23-21; 8:45 am]
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