E7-5672. 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.

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: [phone]; Facsimile: 301-402-0220; E-mail: [e-mail].

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 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.