[Federal Register Volume 83, Number 215 (Tuesday, November 6, 2018)]
[Notices]
[Pages 55556-55557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24225]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Therapeutics for 
Insulin Resistance and Non-Alcoholic Fatty Liver Disease/Non-Alcoholic 
Steatohepatitis (NASH/NAFLD)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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[[Page 55557]]

SUMMARY: The National Heart, Lung and Blood Institute (NHLBI), National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an exclusive commercialization patent 
license to Ovensa, Inc. headquartered in Ontario, Canada, to practice 
the inventions embodied in the patent application(s) listed in the 
Supplementary Information section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the NHLBI Office of Technology Transfer and Development 
November 21, 2018 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated exclusive patent license 
should be directed to: Michael Shmilovich, Esq., 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 following and all continuing U.S. and 
foreign patents/patent applications thereof are the intellectual 
properties to be licensed under the prospective agreement to Ovensa: 
HHS Ref. No. E-103-2013-0, U.S. Provisional Patent Application 61/
839,239, ``Glucan-Encapsulated siRNA For Treating Type 2 Diabetes 
Mellitus,'' filed June 25, 2013, International Patent Application PCT/
2014/043924 filed June 24, 2014, European Patent Application 14818342.9 
filed June 24, 2018, and US Patent 10,077,446 filed June 24, 2014 and 
issued September 18, 2018. The patent rights in this invention have 
been assigned to the Government of the United States of America. The 
prospective license would be granted worldwide and in a field of use 
not broader than therapeutics for preventing or treating insulin 
resistance and non-alcoholic fatty liver disease/non-alcoholic 
steatohepatitis. The scope of any proposed licensed may also be limited 
to products sold that include therapeutic siRNAs encapsulated in 
nanoparticles made from either glucan based biopolymers and/or Ovensa's 
TRIOZANTM (N,N,N-Trimethyl Chitosan) proprietary biopolymer.
    The invention pertains to the use of glucan encapsulated non-
immunostimulatory small interfering RNAs (siRNAs) to treat type-2 
diabetes. Endocannabinoids (EC) are lipid signaling molecules that act 
on the same cannabinoid receptors that recognize and mediate the 
effects of endo- and phytocannabanoids. EC receptor CB1R activation is 
implicated in the development of obesity and its metabolic 
consequences, including insulin resistance and type 2 diabetes. Beta-
cell loss has been demonstrated in a Zucker diabetic fatty (ZDF) rat 
model of type-2 diabetes through CB1R-mediated activation of a 
macrophage-mediated inflammatory response. Conversely, rats treated 
with a peripheral CB1R antagonist restores normoglycemia and preserves 
beta-cell function. Similar results are seen following selective in 
vivo knockdown of macrophage CB1R by daily treatment of ZDF rats with 
the instant D-glucan-encapsulated CB1R small interfering RNA (siRNA). 
Knock-down of CB1R using glucan encapsulated siRNA represent new 
methods of treating type-2 diabetes or preventing the progression of 
insulin resistance to overt diabetes.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive patent license will be royalty 
bearing and may be granted unless within fifteen (15) days from the 
date of this published notice, the NHLBI 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 timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive patent 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: October 24, 2018.
Michael A. Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2018-24225 Filed 11-5-18; 8:45 am]
 BILLING CODE 4140-01-P