Notice: Prospective Grant of Exclusive License: Use of N-Acetyl-
Mannosamine and Derivatives Thereof to Treat Muscle Wasting Diseases 
and Kidney Diseases Related to Hyposialylation

Federal Register: June 3, 2009 (Volume 74, Number 105)            
                  Page 26714-26715

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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, Department 
of Health and Human Services, is contemplating the grant of an 
exclusive patent license to practice the inventions embodied in U.S. 
Patent Application No. 60/932,451, filed May 31, 2007, now abandoned, 
[HHS Ref. No. E-217-2007/0-US-01]; PCT Patent Application No. PCT/
US2008/006895, filed May 30, 2008, [HHS Ref. No. E-217-2007/0-PCT-02], 
both of which are entitled, ``N-Acetyl-Mannosamine as a Therapeutic 
Agent'' (Inventors: Drs. Marjan Huizing, William A. Gahl, Irini Manoli, 
and Enriko Klootwijk, NHGRI) to New Zealand Pharmaceuticals, Ltd., 
having an office in at Palmerston North, New Zealand. The patent rights 
in these inventions have been assigned to 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 N-Acetyl-Mannosamine or 
derivatives thereof for the treatment of muscle wasting diseases and 
kidney diseases related to hyposialylation.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
August 3, 2009 will be considered.

[[Page 26715]]


ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Steven Standley, PhD, Licensing and 
Patenting Manager, Office of Technology Transfer, National Institutes 
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-4074; Facsimile: (301) 402-0220; E-mail: 
sstand@od.nih.gov.

SUPPLEMENTARY INFORMATION: 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 N-Acetyl 
Mannosamine or its derivative (to produce sialic acid in patients who 
are deficient in the sugar molecule) to treat muscular atrophy 
including hereditary inclusion body myopathy (HIBM) and distal myopathy 
with rimmed vacuoles (DMRV, or Nonaka myopathy). Certain kidney 
conditions such as those arising from hyposialytion of kidney membranes 
may be treated by this method as well.
    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 sixty 
(60) days from the date of this published notice, the 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.
    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: May 27, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-12858 Filed 6-2-09; 8:45 am]

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