[Federal Register Volume 63, Number 80 (Monday, April 27, 1998)]
[Notices]
[Page 20641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11115]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Use of Short WAP Promoter
in Mammary Tissue of Transgenic Animals
AGENCY: National Institutes of Health, Public Health Service, DHHS.
ACTION: Notice.
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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. 08/246,259, filed May 19, 1994,
entitled ``Transgenic Animals Secreting Desired Proteins Into Milk'' 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 applications, 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 a gene that encodes a protein, the gene
being under the transcriptional control of a mammalian milk protein
promoter which does not naturally control the transcription of the
gene, the DNA sequence further including DNA enabling secretion of the
protein. The promoter can be that of a milk serum protein, which
includes the whey acid protein (WAP) or a casein protein. The invention
permits the production of a desired protein in a living domesticated
mammal, which is capable not only of producing the desired protein, but
preferably of passing on the ability to do so to its female offspring.
The present invention specifically includes an exogenous DNA sequence
that has the 5' 2.6 kb promoter fragment of the mouse whey acid protein
(WAP) gene.
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: April 17, 1998.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer.
[FR Doc. 98-11115 Filed 4-24-98; 8:45 am]
BILLING CODE 4140-01-M
