[Federal Register Volume 87, Number 80 (Tuesday, April 26, 2022)]
[Notices]
[Pages 24570-24571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08795]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Engineered 
Tumor Infiltrating Lymphocytes for Cancer Therapy

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 Iovance 
Biotherapeutics, Inc. (``Iovance''), headquartered in San Carlos, CA.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before May 11, 2022 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: Andrew Burke, Ph.D., Senior Technology Transfer 
Manager, NCI Technology Transfer Center, Telephone: (240)-276-5484; 
Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

E-170-2009: Inducible Interleukin-12

    1. US Provisional Patent Application 61/174,046, filed April 30, 
2009 (E-170-2009-0-US-01);
    2. International Patent Application PCT/US2010/031988, filed April 
22, 2010 (E-170-2009-0-PCT-02);

[[Page 24571]]

    3. Australian Patent 2010241864, issued June 5, 2014 (E-170-2009-0-
AU-03);
    4. Canadian Patent 2,760,446, issued January 2, 2018 (E-170-2009-0-
CA-04).
    5. European Patent 2424887, issued September 30, 2015 (E-170-2009-
0-EP-05); and a. Validated in DE, FR and GB
    6. United States Patent 8,556,882, issued October 15, 2013 (E-170-
2009-0-US-06).
    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 field of use may be limited to the following:
    ``The use of the Licensed Patent Rights to develop, manufacture, 
distribute, sell, and use autologous tumor infiltrating lymphocyte 
(TIL) adoptive cell therapy products for the treatment of cancer. 
Specifically excluded from this Licensed Field of Use are adoptive cell 
therapy products genetically engineered to express a chimeric antigen 
receptor and/or T cell receptor.''
    E-170-2009 is primarily directed to recombinant constructs for the 
inducible expression of Interleukin-12 (IL-12). IL-12 has been reported 
to be an important immunostimulatory cytokine; however, its clinical 
utility has been constrained, in part, by dose-limiting toxicity 
following systemic administration. The subject invention potentially 
addresses this limitation by operatively associating a nuclear factor 
of activated T cells (NFAT) promoter with the coding sequence for IL-
12. TIL engineered to express these constructs produce and secrete IL-
12 at the site of antigen binding (exempli gratia, in the tumor 
microenvironment).
    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 establishing 
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 Freedom of Information Act, 5 
U.S.C. 552.

    Dated: April 20, 2022.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2022-08795 Filed 4-25-22; 8:45 am]
BILLING CODE 4140-01-P