E6-5530. Prospective Grant of an Exclusive License: Therapeutics for the Treatment of Neurodegenerative Disorders

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), announces that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in: 1. E-177-1990/2-US-01, “Activity-dependent Neurotrophic Factor” by Douglas E. Brenneman and Illana Gozes, patent number 5,767,240 (issue date June 16, 1998); 2. E-177-1990/3-US-01, “Activity-dependent Neurotrophic Factor” by Douglas E. Brenneman and Illana Gozes, patent number 6,174,862 (issue date January 16, 2001); 3. E-177-1990/1-PCT-01, “Activity-dependent Neurotrophic Factor” by Douglas E. Brenneman and Illana Gozes, patent application number PCT/US92/03109 (filing date April 22, 1992) and all related foreign patent applications; 4. E-177-1990/3-PCT-02, “Activity-dependent Neurotrophic Factor” by Douglas E. Brenneman and Illana Gozes, patent application number PCT/US95/12929 (issue date October 16, 1995) and all related foreign patent applications; 5. E-209-2001/0-US-01, “Neurotrophic Components of the ADNF I Complex” by Brenneman et al., patent application number 60/322,760 (filing date September 12, 2001); 6. E-209-2001/2-US-01, “Neurotrophic Components of the ADNF I Complex” by Brenneman et al., patent application number 60/371,961 (filing date April 10, 2002); 7. E-209-2001/1-PCT-01, “Neurotrophic Components of the ADNF I Complex” by Brenneman et al., patent application number PCT/US02/29146 (filing date September 12, 2002); 8. E-209-2001/1-US-02, “Neurotrophic Components of the ADNF I Complex” by Brenneman et al., patent application number 10/489,515 (filing date March 11, 2004); to Allon Therapeutics, having a place of business in Vancouver, BC, Canada. 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 therapeutics for the treatment of human neurodegenerative diseases.

DATES:

Only written comments and/or license applications which are received by the National Institutes of Health on or before June 13, 2006 will be considered.

ADDRESSES:

Requests for copies of the patent and/or patent applications, inquiries, comments and other materials relating to the contemplated exclusive license should be directed to: John Stansberrry, PhD., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone]; Facsimile: [phone]; E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Neuronal cell death has been associated with a variety of diseases and conditions, including Alzheimer's, AIDS-related dementia, Huntington's disease, and Parkinson's disease to name a few. Neuronal cell death has also been associated with developmental retardation and learning impairments that have lifelong effects on individuals diagnosed with these conditions.

This invention discloses pharmaceutical compositions and methods of using Activity Dependent Neurotrophic Factor I (ADNF I) complex polypeptides which have been shown to prevent neuronal cell death. ADNF polypeptides are secreted by astroglial cells in the presence of vasoactive intestinal peptide (VIP). These new ADNF I complex polypeptides are effective for reducing neuronal cell death, for reducing oxidative stress, for reducing condition(s) associated with fetal alcohol syndrome in a subject, for enhancing learning and memory, both pre- and post-natally, and for other conditions.

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 establish 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: April 6, 2006.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.