exclusive, exclusive, or partially exclusive: American Red Cross,

[Federal Register: April 27, 1998 (Volume 63, Number 80)]

[Notices]

[Page 20640-20641]

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

[DOCID:fr27ap98-86]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Prospective Grant of Exclusive License: Use of Long WAP Promoter in Mammary Tissue of Transgenic Animals

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 Application Serial No. 07/943,246, filedSeptember 10, 1992, entitled ``Expression of Active Protein C in Mammary Tissue of Transgenic Animals Using a Long WAP Promoter'' to the American Red Cross having a place of business in Rockville, Maryland. The patent rights in these inventions have been assigned to the United States of America.

The field of use will be the use of the invention for the production in transgenic animals of factor VIII, factor IX, fibrinogen, Protein C, and von Willebrand factor.

DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before June 26, 1998 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: Leopold J. Luberecki, Jr., J.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Box 13, Rockville, MD 20852-3804; Telephone: (301) 496-7735, ext. 223; Facsimile: (301) 402- 0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent application.

SUPPLEMENTARY INFORMATION: The patent application claims a transgenic, non-human mammal containing an exogenous DNA sequence that has the 5' 4.2 kb promoter fragment of the mouse whey acid protein (WAP) gene, or a variant thereof, operably linked to a DNA sequence encoding an active polypeptide and a signal peptide, such that the WAP promoter is specifically active in mammary cells and the signal peptide is effective in directing the secretion of the polypeptide into the milk of the transgenic animal. The invention goes on to describe a process for the production of the polypeptide by using the promoter and the signal peptide to produce the desired polypeptide in the milk of the transgenic animal, collecting the milk, and isolating the polypeptide therefrom.

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 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.

[[Page 20641]]

Dated: April 17, 1998. Jack Spiegel, Director, Division of Technology, Development and Transfer, Office of Technology Transfer.

[FR Doc. 98-11112Filed4-24-98; 8:45 am]

BILLING CODE 4140-01-M