[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