[Federal Register Volume 79, Number 226 (Monday, November 24, 2014)]
[Notices]
[Page 69866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27680]
[[Page 69866]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Development of Autologous
Tumor Infiltrating Lymphocyte Adoptive Cells for the Treatment of
Metastatic Melanoma
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR
part 404, that the National Institutes of Health, Department of Health
and Human Services, is contemplating the grant of an exclusive patent
license to the current licensee, Lion Biotechnologies, Inc., which is
located in Woodland Hills, California to practice the inventions
embodied in the following patent applications and applications claiming
priority to these applications:
1. U.S. Provisional Patent Application No. 61/237,889, filed
August 26, 2009 entitled ``Adoptive cell therapy with young T
cells'' (HHS Ref No. E-273-2009/0-US-01);
2. U.S. Patent No. 8,383,099 issued February 26, 2013 entitled
``Adoptive cell therapy with young T cells'' (HHS Ref No. E-273-
2009/0-US-02);
3. U.S. Patent Application No. 13/742,541 filed January 16, 2013
entitled ``Adoptive cell therapy with young T cells'' (HHS Ref No.
E-273-2009/0-US-03);
4. U.S. Provisional Patent Application No. 61/466,200 filed
March 22, 2011 entitled ``Methods of growing tumor infiltrating
lymphocytes in gas-permeable containers'' (HHS Ref No. E-114-2011/0-
US-01);
5. PCT Application No. PCT/US2012/029744 filed March 20, 2012
entitled ``Methods of growing tumor infiltrating lymphocytes in gas-
permeable containers'' (HHS Ref No. E-114-2011/0-US-01);
6. U.S. Patent Application No. 13/424,646 filed May 20, 2012
entitled ``Methods of growing tumor infiltrating lymphocytes in gas-
permeable containers'' (HHS Ref No. E-114-2011/0-US-01);
The patent rights in these inventions have been assigned to the
United States of America.
The prospective exclusive license territory may be worldwide and
the field of use may be limited to the use of the Licensed Patent
Rights to develop, manufacture, distribute, sell and use autologous
tumor infiltrating lymphocyte adoptive cell therapy products for the
treatment of metastatic melanoma as a stand-alone therapy.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
December 24, 2014 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
license should be directed to: Whitney A. Hastings, Ph.D., Senior
Licensing and Patenting Manager, Office of Technology Transfer,
National Institutes of Health, 6011 Executive Boulevard, Suite 325,
Rockville, MD 20852-3804; Telephone: (301) 451-7337; Facsimile: (301)
402-0220; Email: [email protected].
SUPPLEMENTARY INFORMATION: Isolating cells from the tumor infiltrating
lymphocytes (TIL) of a patient tumor sample provides a suitable initial
lymphocyte culture for further in vitro manipulations. NIH scientists
have discovered that taking the isolated cells through one cycle of
rapid expansion (including exposure to IL-2), rather than multiple
cycles, yields lymphocyte cultures with higher affinity and longer
persistence in patients. In addition, they have found that through the
use of gas permeable (GP) flasks, they could obtain large quantities of
highly reactive TIL from patient tumor samples for anti-cancer
immunotherapy. If an adoptive T cell transfer immunotherapy is to gain
regulatory approval and successfully treat a wide array of patients, it
will need to be rapid, reliable, and technically simple. One of the
most critical factors to this approach is the generation of effective
lymphocyte cultures that will rapidly and repeatedly attack the target
cells when infused into patients.
The prospective exclusive license may be granted unless within
thirty (30) days from the date of this published notice, the NIH
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 in the field of use filed in
response to this notice will be treated as objections to the grant of
the contemplated exclusive license. Comments and objections submitted
to this notice will not be made available for public inspection and, to
the extent permitted by law, will not be released under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: November 17, 2014.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of
Health.
[FR Doc. 2014-27680 Filed 11-21-14; 8:45 am]
BILLING CODE 4140-01-P