[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