[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