[Federal Register Volume 80, Number 100 (Tuesday, May 26, 2015)]
[Notices]
[Pages 30080-30081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12539]


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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 Lung, 
Breast, Bladder, and HPV-Positive Cancers

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 
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:

[[Page 30081]]

    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);
    7. U.S. Provisional Patent Application No. 61/846,161 filed July 
15, 2013 entitled ``Methods of Preparing Anti-human Papillomavirus 
Antigen T Cells'' (HHS Ref No. E-494-2013/0-US-01);
    8. PCT Application No. PCT/US2014/046478 filed July 14, 2014 
entitled ``Methods of Preparing Anti-human Papillomavirus Antigen T 
Cells'' (HHS Ref No. E-494-2013/0-PCT-02);
    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 unselected 
whole autologous tumor infiltrating lymphocyte (TIL) adoptive cell 
therapy products for the treatment of lung, breast, bladder, and HPV-
positive cancers. Specifically excluded from this license are methods 
of generating or using selected subpopulations of TIL and the use of T 
cell receptors isolated from TIL.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before June 
25, 2015 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 scientist 
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: May 19, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-12539 Filed 5-22-15; 8:45 am]
 BILLING CODE 4140-01-P