[Federal Register Volume 63, Number 80 (Monday, April 27, 1998)]
[Notices]
[Pages 20641-20642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11113]


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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.

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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. 07/943,246, filed September 10, 
1992, entitled ``Expression of Active Protein C in Mammary Tissue of 
Transgenic Animals Using a Long WAP Promoter'' to Genzyme Transgenics 
Corporation, having a place of business in Framingham, Massachusetts. 
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 alpha interferon, alpha-1 
proteinase inhibitor, angiogenin, antithrombin III, beta interferon, 
calf intestine alkaline phosphatase, cystic fibrosis transmembrane 
regulator, Factor X, glutamic acid decarboxylase, human growth hormone, 
human serum albumin, insulin, lactoferrin, longer acting tissue 
plasminogen activator, myelin basic protein, pro-insulin, prolactin, 
soluble CD4 HIV receptor, tissue plasminogen activator, the recombinant 
monoclonal antibody against Lewis Y antigen designated BR96, and the 
monoclonal antibody designated CTLA4 Ig.

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 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

[[Page 20642]]

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 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. 98-11113 Filed 4-24-98; 8:45 am]
BILLING CODE 4140-01-M