exclusive, exclusive, or partially exclusive: Ash Stevens, Inc.,

[Federal Register: July 2, 1999 (Volume 64, Number 127)]

[Notices]

[Page 36029]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr02jy99-79]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Prospective Grant of Co-Exclusive License: Prodrug Forms of the Anti-Cancer Agent 9-‹greek-b›-D-Arabinofuranosyl-2-Fluoroadenine as Therapeutics for the Treatment of Cancers and Leukemia

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 a worldwide co-exclusive license to practice the invention embodied in U.S. Patent 4,357,324, issued November 2, 1982 and entitled ``Prodrug Derivatives 9-‹greek-b›-D-arabinofuranosyl-2-fluoroadenine'', to Ash Stevens, Inc., having a place of business in Detroit, Michigan. The patent rights in these inventions have been assigned to the United States of America.

A co-exlusive license had been granted to Schering AG and its U.S. affiliate, Berlex Laboratories, Inc. in January 1984. PHS intends to grant one additional co-exclusive license to these patent rights.

The field of use may be limited to the development of therapeutics for the treatment of cancers and leukemia.

DATES: Only written comments and/or application for a license which are received by the NIH Office of Technology Transfer on or before August 31, 1999 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: Girish C. Barua, PhD., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 496-7057, ext. 263; Facsimile: (301) 402-0220; E-mail` BaruaG@od.nih.gov.

SUPPLEMENTARY INFORMATION: This invention involves the preparation of the 5'-formate and the 5'-phosphate derivatives of 9-‹greek-b›-D- arabinofuranosyl-2-fluoroadenine as prodrug forms of the anti-cancer agent 9-‹greek-b›-D-arabinofuranosyl-2-fluoroadenine, known as F-ara-A. These derivatives are quite water soluble whereas F-ara-A itself is sparingly soluble in water or in any organic solvents. Delivery of these prodrug forms to mice with L1210 leukemia results in the formation of higher levels of the triphosphate of F-ara-A, the active form of the drug, in the target L1210 leukemia cells. These prodrug forms are much more active chemotherapeutically than 9-‹greek-b›-D- arabinofuranosyl, known as ara-A, and equivalent in activity to the combination of ara-A and 2-deoxycoformycin, known as 2'-dCF, an effective in vivo inhibitor of adenosine deaminase, a ubiquitous enzyme that destroys ara-A in vivo.

The prospective co-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 co-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 filedcompeting applications for a license filedin 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: June 25, 1999. Jack Spiegel, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

[FR Doc. 99-16895Filed7-1-99; 8:45 am]

BILLING CODE 4140-01-M