[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)]
[Notices]
[Pages 19984-19985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07864]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License for 
Commercialization: Boron Neutron Capture Therapy for Skin Cancer

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), 
Department of Health and Human Services, is contemplating the grant of 
a worldwide exclusive license to practice the inventions embodied in: 
HHS Ref. No. E-135-2015/0, U.S. Provisional Patent Application No. 62/
155,085, filed April 30, 2015, entitled ``Boron Mimics Of Amino Acids 
And Uses Thereof,'' to Beijing Lanyears Communication Technology, Ltd., 
a company formed under the laws of the People's Republic of China and 
having its principle place of business in Beijing, China.
    The contemplated exclusive license may be limited to boron neutron 
capture therapy for skin cancer.

DATES: Only written comments and/or applications for a license that are 
received by NIH at the address indicated below on or before April 21, 
2016 will be considered.

ADDRESSES: Requests for a copy of any unpublished patent application, 
inquiries, objections to this notice, comments and other requests 
relating to the contemplated license should be directed to: Michael 
Shmilovich, Esq., CLP, Senior Licensing and Patent Manager, 31 Center 
Drive, Room 4A29, MSC2479, Bethesda, MD 20892-2479, phone number 301-
435-5019, or [email protected].

SUPPLEMENTARY INFORMATION: The invention pertains to boramino acid 
compounds that can be used as imaging agents for positron emission 
tomography of cancer or for boron neutron capture therapy. Mimetics 
created by substituting the carboxylate group (-COO-) of an amino acid 
with trifluoroborate (-BF3-) are metabolically stable and allow for the 
use of fluorine-18 (\18\F) as the radiolabel (e.g., trifluoroborate 
phenylalanine (B-Phe)). Using boramino acid for \18\F-labeling allows 
for integrating the \18\F radiolabel into the core molecular backbone 
rather than the side-chains thus increasing the agent's target 
specificity. There is a direct relationship between amino acid uptake 
and cancer cell replication, where the uptake is extensively 
upregulated in most cancer cells. This uptake increases as cancer 
progresses, leading to greater uptake in high-grade tumors and 
metastases. Amino acids act as signaling molecules for proliferation 
and may also reprogram metabolic networks in the buildup of biomass. 
This invention provides for an unmet need for traceable amino acid 
mimics, including those based on naturally-occurring amino acids, which 
may be non-invasively detected by imaging technology, including for 
clinical diagnosis or BNCT. Boron neutron capture therapy (BNCT) is 
based on the nuclear capture and fission reactions that occur when non-
radioactive boron-10 (\10\B, approximately 20% of natural elemental 
boron), is irradiated and thus activated with neutrons of the 
appropriate energy to yield excited boron-11 (\11\B*). This isotope 
turn

[[Page 19985]]

decays into high energy alpha particles (``stripped'' down \4\He 
nuclei) and high energy lithium-7 (\7\Li) nuclei. Both the emitted 
alpha particles and the lithium ions are close proximity reactions, 
i.e., at a range of approximately 5-9 [micro]m; the diameter of a 
target cell. The energies produced in this ionization and radio-decay 
is cytotoxic and thus exploited as the basis for cancer radiotherapy. 
The success of BNCT is dependent on the selective delivery of 
sufficient amounts of \10\B to the tumor site with only small amounts 
localized in the surrounding normal tissues thus sparing normal tissue 
from the nuclear capture and fission reactions.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. 
The prospective exclusive license may be granted unless, within fifteen 
(15) days from the date of this published notice, 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 404.7.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. Comments and objections submitted in response 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: April 1, 2016.
Michael Shmilovich,
Senior Licensing and Patent Manager, Office of Technology Transfer and 
Development, National Heart, Lung, and Blood Institute.
[FR Doc. 2016-07864 Filed 4-5-16; 8:45 am]
 BILLING CODE 4140-01-P