02-13017. Prospective Grant of Exclusive License: Treatment of Central Nervous System Disorders With a Combination of Dopaminergic and Adrenergic Antagonists

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

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 Numbers 5,492,907, filed December 9, 1992, issued February 20, 1996 and 5,663,167, filed June 7, 1995, issued September 2, 1997, both entitled “Antipsychotic composition and method of treatment” to Potomac Pharma, Inc., having a place of business in Cabin John, Maryland. The patent rights in these inventions have been assigned to the United States of America.

The contemplated exclusive license may be limited to the use of methods disclosed and claimed in the invention and treatment of human central nervous system disorders.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before July 22, 2002, will be considered.

ADDRESSES:

Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Norbert J. Pontzer, J.D., Ph.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; telephone: [phone], ext. 284; facsimile: [phone], e-mail: [e-mail]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent application.

SUPPLEMENTARY INFORMATION:

A significant number of patients suffering from schizophrenia prove resistant to treatment with typical neuroleptics. Scientists at the NIH discovered that the administration of an alpha₂-adrenergic receptor antagonist unexpectedly enhances the therapeutic effect of typical antipsychotic neuroleptics. The present invention provides an improved treatment for patients suffering from serious psychotic mental illness who have proven resistant to treatments with known typical antipsychotic neuroleptics alone.

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, 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: May 13, 2002.

Jack Spiegel,

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