[Federal Register Volume 82, Number 34 (Wednesday, February 22, 2017)]
[Notices]
[Pages 11362-11363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03402]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Development of a 
Gene Signature Predictive of Hepatocellular Carcinoma (HCC) Patient 
Response to Transcatheter Arterial Chemoembolization (TACE)

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 3D Medicines 
(``3DMed'') located in Shanghai, China.

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 March 9, 2017 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Jim Knabb, Ph.D., Technology Transfer and Patent 
Specialist, 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: 

Intellectual Property

    United States Provisional Patent Application No. 62/292,789, filed 
February 8, 2016 entitled ``Gene Signature Predictive of Hepatocellular 
Carcinoma Response to Transcatheter Arterial Chemoembolization'' [HHS 
Reference No. E-101-2016/0-US-01]; PCT Patent Application PCT/US2017/
016851, filed February 7, 2017 and entitled ``GENE SIGNATURE PREDICTIVE 
OF HEPATOCELLULAR CARCINOMA RESPONSE TO TRANSCATHETER ARTERIAL 
CHEMOEMBOLIZATION (TACE)'' [HHS Reference No. E-101-2016/0-PCT-02]; 
(and U.S. and foreign patent applications claiming priority to the 
aforementioned applications).
    The patent rights in these inventions have been assigned 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 Development and 
commercialization of the transcatheter arterial chemoembolization 
(TACE) gene signature as a diagnostic device predictive of TACE 
response in patients with hepatocellular carcinoma (HCC). The field of 
use may be further limited to companion diagnostic tests that are sold 
following Premarket Approval by the FDA or equivalent regulatory agency 
in foreign jurisdictions''.
    This technology discloses a gene expression signature that is 
predictive of HCC patient response to TACE. TACE therapy is a procedure 
whereby the tumor is targeted with both local chemotherapy and 
restriction of local blood supply, and is employed in the treatment of 
locally advanced hepatocellular carcinoma (HCC). Patient biopsies are 
analyzed by Next-Generation Sequencing (NGS) and expression analysis of 
the gene signature can be used to stratify patients for TACE therapy. 
Through the commercialization of this gene signature for TACE efficacy, 
HCC patients can be identified as candidates for TACE

[[Page 11363]]

therapy, or as needing alternative treatment strategies.
    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 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 filed in response to this notice will be treated as objections 
to the grant of the contemplated Exclusive Patent License Agreement. 
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: February 15, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2017-03402 Filed 2-21-17; 8:45 am]
 BILLING CODE 4140-01-P