[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Notices]
[Pages 58007-58008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26540]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: N-Acetyl 
Mannosamine as a Therapeutic Agent

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Human Genome Research 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 
Leadiant Biosciences, Inc, located in Gaithersburg, Maryland, USA.

DATES: Only written comments and/or applications for a license which 
are received by the National Human Genome Research Institute's 
Technology Transfer Office on or before December 26, 2017 will be 
considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Eggerton Campbell, Ph.D., Senior 
Licensing and Patenting Manager, Technology Transfer Office (TTO), 
National Human Genome Research Institute (NHGRI), National Institutes 
of Health (NIH), 5635 Fishers Lane, Suite 3058, MSC 9307, Bethesda, MD 
20892-9307. Telephone: 301-402-1648. Fax: 301-402-9722. email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Intellectual Property

    U.S. Provisional Patent Application No.: 60/932,451, [HHS Ref. No.: 
E-217-2007/0-US-01], Filed May 31, 2007; PCT Patent Application No.: 
PCT/US2008/006895, [HHS Ref. No.: E-217-2007/0-PCT-02], Filed: May 30, 
2008; CA Patent Application 2680842, [HHS Ref. No.: E-217-2007/0-CA-
03], Filed: May 30, 2008; EP Patent Application No.: 08767999.9, [HHS 
Ref. No.: E-217-2007/0-EP-04], Filed: September 14, 2009; IL Patent 
Application No.: 200872, [HHS Ref. No.: E-217-2007/0-IL-05], Filed: May 
30, 2008; JP Patent Application No.: 2010-510363, [HHS Ref. No.: E-217-
2007/0-JP-06, Filed: May 30, 2008; U.S. Patent Application No.: 12/
530,433, [HHS Ref. No.: E-217-2007/0-US-07], Filed: Sept 8, 2009; U.S. 
Patent Application No.: 13/791,576, [HHS Ref. No.: E-217-2007/0-US-08], 
Filed: March 8, 2013; JP Patent Application No.: 2014-208695, [HHS Ref. 
No.: E-217-2007/0-JP-09], Filed: May 30, 2008; U.S. Patent Application 
No.: 14/754,304, [HHS Ref. No.: E-217-2007/0-US-10], Filed: June 29, 
2015; CA Patent Application No.: 2903133, [HHS Ref. No.: E-217-2007/0-
CA-11], Filed: May 30, 2008; IL Patent Application No.: 245026, [HHS 
Ref. No.: E-217-2007/0-IL-12], Filed: March 8, 2013; JP Patent 
Application No.: 2016-159061, [HHS Ref. No.: E-217-2007/0-JP-13], 
Filed: August 15, 2016; EP Patent Application No.: 16196935.7, [HHS 
Ref. No.: E-217-2007/0-EP-14], Filed: March 8, 2013; U.S. Patent 
Application No.: 15/702,529, [HHS Ref. No.: E-217-2007/0-US-08], Filed: 
September 12, 2017; and all continuing applications and foreign 
counterparts.

[[Page 58008]]

    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 use of Licensed Patent Rights 
for the following: ``Treating GNE Myopathy (also referred to as distal 
myopathy with rimmed vacuoles (DMRV), Nonaka myopathy, muscular 
dystrophy hereditary inclusion body myopathy (HIBM) or inclusion body 
myopathy type 2 (IBM2)) and kidney disorders due to hyposialylation of 
the glomerulae or sialic acid deficiency including but not limited to 
minimal change disease glomerulopathy, focal segmental 
glomerulosclerosis and membranous nephropathy, in humans with oral 
formulations of N-acetyl mannosamine (ManNAc) or derivative.''
    N-Acetyl Mannosamine is a precursor for the synthesis of sugar 
molecules known as sialic acids which play an important role in 
specific biological processes such as cellular adhesion, cellular 
communication and signal transduction. Lack of sialic acids also play 
an important role in disease processes such as cancer, inflammation and 
immunity.
    This invention relates to methods of administering ManNAc or its 
derivative (to produce sialic acid in patients who are deficient in the 
sugar molecule) to treat GNE Myopathy (also referred to as distal 
myopathy with rimmed vacuoles (DMRV), Nonaka myopathy, muscular 
dystrophy hereditary inclusion body myopathy (HIBM) or inclusion body 
myopathy type 2 (IBM2)), and kidney disorders due to hyposialylation of 
the glomerulae or sialic acid deficiency may be treated by this method 
as well.
    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 
Human Genome Research 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.
    In response to this Notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
license application, will not be treated confidentially, and may be 
made publicly available.
    License applications submitted in response to this Notice will be 
presumed to contain business confidential information and any release 
of information in these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.

    Dated: November 30, 2017.
Claire T. Driscoll,
Director, NHGRI Technology Transfer Office.
[FR Doc. 2017-26540 Filed 12-7-17; 8:45 am]
 BILLING CODE 4140-01-P