[Federal Register Volume 81, Number 186 (Monday, September 26, 2016)]
[Notices]
[Page 66048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23048]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Start-Up Exclusive Evaluation Patent 
License: Development of Autologous Tumor-reactive T Cells Isolated From 
Peripheral Blood for the Treatment of Metastatic Follicular Thyroid 
Cancer and Metastatic Soft Tissue Sarcomas

AGENCY: National Institutes of Health.

ACTION: Notice.

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SUMMARY: The National Cancer Institute, National Institutes of Health, 
Department of Health and Human Services, is contemplating the grant of 
a Start-up Exclusive Evaluation Patent License to MedGene Therapeutics, 
Inc. (``MedGene'') located in Bethesda, MD to practice the inventions 
embodied in the patent applications listed Supplementary Information 
section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the NCI Technology Transfer Center on or before October 
11, 2016 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated Start-up Exclusive Evaluation 
Patent License should be directed to: Andrew Burke, Ph.D., Licensing 
and Patenting Manager, NCI Technology Transfer Center, 9609 Medical 
Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business 
mail), Rockville, MD 20850-9702 Telephone: (240) 276-5530; Facsimile: 
(240) 276-5504; Email: [email protected].

SUPPLEMENTARY INFORMATION: United States Provisional Patent Application 
No. 61/771,251 filed March 1, 2013, entitled ``Methods of Producing 
Enriched Populations of Tumor Reactive T Cells from Peripheral Blood'' 
[HHS Reference No. E-085-2013/0-US-01]; and PCT Application No. PCT/
US2013/038813 filed April 30, 2013 entitled ``Methods of Producing 
Enriched Populations of Tumor Reactive T Cells from Peripheral Blood'' 
[HHS Reference No. E-085-2013/0-PCT-02] (and U.S. and foreign patent 
applications claiming priority to the aforementioned applications).
    The patent rights in these inventions have been assigned to the 
government of the United States of America.
    The prospective Start-up Exclusive Evaluation Patent License 
territory may be worldwide and the field of use may be limited to the 
development, manufacture and commercialization of autologous tumor-
reactive peripheral blood T cell therapy products as set forth in the 
Licensed Patent Rights for the treatment of metastatic follicular 
thyroid cancer and metastatic soft tissue sarcomas in humans.
    The present invention describes a method of selecting highly tumor-
reactive T cells from autologous peripheral blood samples based on the 
expression of two specific T cell surface markers: Programmed cell 
death protein 1 (PD-1; CD279) and/or T cell Ig- and mucin-domain-
containing molecule-3 (TIM-3). Following selection, isolated cells may 
be expanded and reinfused into the donor patient as part of an adoptive 
cell transfer therapeutic regimen. The disclosed method may be 
advantageous over existing approaches which rely on the isolation of T 
cells from tumor samples since it eliminates the cost and complications 
associated with tumor resection, as well as provides a T cell product 
for patients without resectable lesions.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective Start-up Exclusive Evaluation Patent License 
will be royalty bearing and the may be granted unless within fifteen 
(15) days from the date of this published notice, the National Cancer 
Institute 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 prospective field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated Start-up Exclusive 
Evaluation Patent 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: September 20, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2016-23048 Filed 9-23-16; 8:45 am]
 BILLING CODE 4140-01-P