[Federal Register Volume 86, Number 59 (Tuesday, March 30, 2021)]
[Notices]
[Page 16602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06474]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Chimeric Antigen 
Receptors Targeting CD56

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute (NCI), National Institutes of 
Health, Department of Health and Human Services, is contemplating the 
grant of an exclusive, sublicensable patent license to Memorial Sloan 
Kettering Cancer Center, (``MSKCC''), a non-profit research center 
located in New York, in its rights to the inventions and patents listed 
in the SUPPLEMENTARY INFORMATION section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the NCI Technology Transfer Center April 14, 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: Rose M. Freel, Ph.D., Senior Licensing and 
Patenting Manager at Telephone: (301) 624-8775 or Email: 
[email protected].

SUPPLEMENTARY INFORMATION: The following and all continuing U.S. and 
foreign patents/patent applications thereof are the intellectual 
properties to be licensed under the prospective agreement to MSKCC: 
U.S. Provisional Patent Application No. 62/199,775, filed July 31, 2015 
entitled ``Antigen-Binding Proteins Targeting CD56 And Uses Thereof,'' 
(HHS Ref. No. E-142-2014-0-US-01); PCT Application No. PCT/US16/045027, 
filed August 2, 2016 entitled ``Antigen-binding proteins targeting CD56 
and uses thereof'' (HHS Ref. No. E-142-2014-0-PCT-02); U.S. Patent No. 
10,730,941, granted on August 4, 20201, corresponding to U.S. Patent 
Application No. 15/884,608, filed January 31, 2018, entitled ``Antigen-
binding proteins targeting CD56 and uses thereof'' (HHS Ref. No. E-142-
2014-0-US-03); Canadian Patent Application No. 2994412, filed January 
31, 2018, entitled ``Antigen-binding proteins targeting CD56 and uses 
thereof'' (HHS Ref. No. E-142-2014-0-CA-04); Australian Patent 
Application No. 16833684.0, filed January 31, 2018, entitled ``Antigen-
binding proteins targeting CD56 and uses thereof'' (HHS Ref. No. E-142-
2014-0-AU-05); U.S. Patent Application No. 16/912,291, filed June 25, 
2020, entitled ``Methods of treatments using antigen-binding proteins 
targeting CD56'' (HHS Ref. No. E-142-2014-0-US-06).
    The patent rights in these inventions have been assigned to the 
Government of the United States of America and Memorial Sloan Kettering 
Cancer Center. The prospective patent license will be for the purpose 
of consolidating the patent rights to MSKCC, one of the co-owners of 
said rights, for commercial development and marketing. Consolidation of 
these co-owned rights is intended to expedite development of the 
invention, consistent with the goals of the Bayh-Dole Act codified as 
35 U.S.C. 200-212.
    The prospective patent license will be worldwide, exclusive, and 
may be limited to those fields of use commensurate in scope with the 
patent rights. It will be sublicensable, and any sublicenses granted by 
MSKCC will be subject to the provisions of 37 CFR part 401 and 404.
    The invention pertains to novel antibody binders and chimeric 
antigen receptors (CARs) that target CD56 or NCAM, a glycoprotein that 
is highly expressed in a variety of cancerous cells. Based on current 
available data, the intended use for the invention is anti-CD56 CARs 
for the treatment of CD56 positive cancers such as multiple myeloma.
    This notice is made pursuant to 35 U.S.C. 209 and 37 CFR part 404. 
The prospective exclusive patent license will include terms for the 
sharing of royalty income with NCI from commercial sublicenses of the 
patent rights and may be granted unless within fifteen (15) days from 
the date of this published notice the NCI 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.
    Complete applications for a license that are timely filed in 
response to this notice will be treated as objections to the grant of 
the contemplated exclusive patent license. 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 Freedom of Information Act, 5 
U.S.C Sec.  552.

    Dated; March 10, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2021-06474 Filed 3-29-21; 8:45 am]
BILLING CODE 4140-01-P