Notice2022-08795
Prospective Grant of an Exclusive Patent License: Engineered Tumor Infiltrating Lymphocytes for Cancer Therapy
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 26, 2022
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
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<title>Federal Register, Volume 87 Issue 80 (Tuesday, April 26, 2022)</title>
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[Federal Register Volume 87, Number 80 (Tuesday, April 26, 2022)]
[Notices]
[Pages 24570-24571]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="/cdn-cgi/l/email-protection#adccc3c9d483cfd8dfc6c8edc3c4c583cac2db"><span class="__cf_email__" data-cfemail="debfb0baa7f0bcabacb5bb9eb0b7b6f0b9b1a8">[email protected]</span></a>.
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
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