02-15147. Prospective Grant of Exclusive License: Activity Dependent Neurotrophic Factor (ADNF) III

AGENCY:

National Institutes of Health, Public Health Services, 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 license to practice the inventions embodied in U.S. provisional patent application 60/037,404 filed February 7, 1997 and entitled “Activity Dependent Neurotrophic Factor (ANDF) III,” PCT application PCT/US98/02485 filed on February 6, 1998 and entitled “Activity Dependent Neurotrophic Factor (ANDF) III,” U.S. Continuation-in-Part application 09/187,330 filed on November 6, 1999 and entitled “Activity Dependent Neurotrophic Factor III (ANDF III),” PCT application PCT/US99/26213 filed February 4, 1999 and entitled “Activity Dependent Neurotrophic Factor (ANDF) III,” U.S. provisional patent application 60/208,944 filed on May 31, 2000 and entitled “Use of Activity-Dependent Neurotrophic Factor-Derived Polypeptides for Enhancing Learning and Memory,” U.S. provisional patent application 60/267,805 filed on February 8, 2001 and entitled “Prenatal Treatment with ADNF Polypeptides to Improve Learning and Memory,” PCT application PCT/US01/17758 filed on May 31, 2001 and entitled “Use of Activity Dependent Neurotrophic Factor Derived Polypeptide for Enhancing Learning and Memory: Pre- and Post-Natal Administration.” U.S. patent application 09/267,511 filed on March 12, 1999, PCT application PCT/US00/06364 filed on March 10, 2000 and entitled “Prevention of Fetal Alcohol Syndrome and Neuronal Cell Death with ADNF Polypeptides,” U.S. provisional patent application 60/149,956 filed on August 18, 1999, and PCT application PCT/US00/22861 filed on August 17, 2000, and entitled “Orally Active Peptides that Prevent Cell Damage and Death,” to Allon Therapeutics, of San Diego California. The patent rights in these inventions have been assigned to the United States of America.

The prospective exclusive license territory will be worldwide. The field of use will be all neurodegenerative diseases, but may be limited to Alzheimer's disease and stroke.

DATES:

Only written comments and/or license applications which are received by the National Institutes of Health on or before August 16, 2002, will be considered.

ADDRESSES:

Requests for copies of the patent(s)/patent application(s), inquiries, comments and other materials relating to the contemplated exclusive license should be directed to: Jonathan V. Dixon, Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone], x270; Facsimile 301.402.0220; email [e-mail].

SUPPLEMENTARY INFORMATION:

The above-referenced patent(s)/patent application(s) relate to Activity Dependent Neurotrophic factor III (ADNF III) and a specific eight amino acid peptide denoted as NAP (NAPVSIQ) derived from the cloned ADNF III. NAP has been discovered to have potent neuroprotective properties in vitro and in vivo. NAP has been shown to significantly reduce the number of apoptotic cells and to protect neurons against numerous toxins and cellular stresses including in vitro exictotoxicity, oxidative stress, and glucose deprivation. NAP also exhibits neuroprotective activity in a variety of animal models including a learning deficient apolipoprotein E knockout mice (a model related to Alzheimer's disease), mouse paradigms of traumatic head injury (associated with an inflammatory response) and fetal alcohol syndrome (oxidative stress), and a rat model of cholinotoxicity.

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: May 28, 2002.

Jack Spiegel,

Director, Division of Technology Development and Transfer, Office of Technology Transfer.