[Federal Register Volume 80, Number 243 (Friday, December 18, 2015)]
[Notices]
[Page 79052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31831]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Development of a Small
Molecule Farnesoid X Receptor Inhibitor
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: This notice, in accordance with 35 U.S.C. 209 and 37 CFR part
404, that the National Cancer Institute (NCI), 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 following U.S. Patents and Patent Applications to
Heliome Biotech, Inc. (``Heliome'') located in New York, NY, USA.
Intellectual Property:
1. United States Provisional Patent Application No. 61/861,109, filed
August 1, 2013 ``Inhibitors of the Farnesoid X Receptor and Use Thereof
in the Prevention of Weight Gain'' [HHS Reference No. E-508-2013/0-US-
01];
2. United States Provisional Patent Application No. 62/004,436, filed
May 29, 2014, entitled ``Methods of Treating or Preventing Obesity,
Insulin Resistance and Non-Alcoholic Fatty Liver Disease'' [HHS
Reference No. E-508-2013/1-US-01]; and
3. PCT Patent Application No. PCT/US2014/49460 filed August 1, 2014
``Inhibitors of the Farnesoid X Receptor and Uses in Medicine'' [HHS
Reference No. E-508-2013/2-PCT-01].
The patent rights in these inventions have been assigned 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 use of the Licensed Patent
Rights to make or have made, use and sell a small molecule farnesoid X
receptor inhibitor for all metabolic diseases.
DATES: Only written comments and/or applications for a license which
are received by the NCI Technology Transfer Center on or before January
4, 2016 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
and comments relating to the contemplated exclusive license should be
directed to: Thomas Clouse, J.D., Senior 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: Remodeling the gut microbiota using specific
compounds can affect high fat diet-induced obesity through signal
transduction mediated by the nuclear receptor farnesoid X receptor
(FXR). FXR is inhibited due to the altered gut microbiota as a result
of lack of metabolism (bile salt hydrolase activity) of a potent FXR
antagonist tauro-[beta]-muracholic acid (T[beta]MCA) that is produced
in the liver and secreted to the intestine. The technology identifies a
class of compounds that specifically decrease levels of Lactobacillus-
associated bile salt hydrolase activity resulting in accumulation of
intestinal T[beta]MCA which is now identified as an antagonist of FXR.
The technology has the potential of being developed into a therapeutic
for various metabolic disorders associated with inhibition of the
farnesoid X receptor pathway, including Non-Alcoholic Fatty Liver
Disease (NAFLD), Type 2 Diabetes, and non-alcoholic steatohepatitis
(NASH).
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 part
404. The prospective exclusive license may be granted unless within
fifteen (15) days from the date of this published notice, the NCI
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.
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: December 15, 2015.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2015-31831 Filed 12-17-15; 8:45 am]
BILLING CODE 4140-01-P