[Federal Register Volume 72, Number 59 (Wednesday, March 28, 2007)]
[Notices]
[Pages 14601-14602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5672]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Catalytic Moiety of 
the Glucose-6-Phosphatase System: The Gene and Protein and Related 
Mutations

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

ACTION: Notice.

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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 (NIH), 
Department of Health and Human Services, is contemplating the grant of 
an exclusive license worldwide to practice the invention embodied in 
U.S. Patent Number 5,460,942 issued October 24, 1995 entitled, ``The 
Catalytic Moiety of the Glucose-6-Phosphatase System: the Gene and 
Protein and Related Mutations'' (HHS Ref. No. E-179-1993/0-US-01) to 
GlyGenix, Inc., having a place of business in Cheshire, CT 06410. The 
contemplated exclusive license may be limited to the following field of 
use: an FDA-approvable human therapeutic for Glycogen Storage Disease 
Type Ia. The United States of America is the assignee of the patent 
rights in this invention.

DATES: Only written comments and/or application for a license which are 
received by the NIH Office of Technology Transfer on or before May 29, 
2007 will be considered.

ADDRESSES: Requests for a copy of the patent, inquiries, comments, and 
other materials relating to the contemplated license should be directed 
to: Tara L. Kirby, PhD, Technology Licensing Specialist, Office of 
Technology Transfer, National Institutes of Health, 6011 Executive 
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: 301-435-
4426; Facsimile: 301-402-0220; E-mail: [email protected].

SUPPLEMENTARY INFORMATION: Glycogen storage diseases result from at 
least 10 different genetic defects in proteins required by glycogen 
metabolism. Glycogen storage disease Type Ia (GSD, also known as von 
Gierke disease) is defined as the deficiency of glucose-6-phosphatase 
(G-6-Pase) which is normally present in liver, kidney, and intestine. 
Glycogen storage disease Type la is inherited by one per 100,000 people 
as an autosomal recessive trait and is usually manifested during the 
first twelve months of life by symptomatic hypoglycemia, or by the 
recognition of hepatomegaly. In

[[Page 14602]]

addition, GSD type Ia can cause growth retardation, delayed 
adolescence, lacticacidemia, hyperlipidemia, hyperuricemia, and in 
adults, hepatic adenomas.
    The invention discloses nucleic acid sequences and vectors useful 
for producing recombinant G-6-Pase proteins, as well as nucleic acid 
sequences and kits for detecting a mutation in the G-6-Pase gene.
    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 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.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. Comments and objections submitted in response 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: March 20, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-5672 Filed 3-27-07; 8:45 am]
BILLING CODE 4140-01-P