Prospective Grant of Exclusive License: Nitroxides as Protectors Against Oxidative Stress and the Prophylactic and Therapeutic Treatment Radiation Damage to Normal Tissue

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

SUMMARY:

This 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 Application Serial No. 07/494,532, filed March 16, 1990, entitled “Nitroxides as Protectors Against Oxidative Stress” and U.S. Patent Application Serial No. 60/047,724 filed May 27, 1997 entitled, “The use of Nitroxides in the prophylactic and therapeutic treatment of cancer due to genetic defects” and corresponding foreign patent applications to Varian Biosynergy, Inc., having a place of business in Palo Alto, California. The patent rights in these inventions have been assigned to the United States of America.

The contemplated exclusive license may be limited to use of topical or local tissue application of compounds disclosed and claimed in the invention for the protection of normal tissue against radiation damage caused by radiation therapy of diseased tissue.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before May 8, 2000, 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: (301) 496-7736, ext. 284; Facsimile: (301) 402-0220; E-mail: np59n@nih.gov. A signed Confidential Disclosure Agreement will be required to receive copies of the patent application.

SUPPLEMENTARY INFORMATION:

Effective radioprotective drugs could significantly improve the therapeutic ratio of radiation therapy by protecting normal tissues and allowing greater doses of radiation to be delivered to the tumor. One approach to avoid protecting the tumor is local application of the radioprotective drugs to adjacent health tissue. The patent applications claim a new class of metal independent nitroxide compounds that appear capable of protecting tissue against radiation damage if clinically useful, non-toxic formulations that deliver sufficient local tissue concentrations can be developed.

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 90 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 contemplating 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.