[Federal Register Volume 63, Number 80 (Monday, April 27, 1998)]
[Notices]
[Page 20642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11114]


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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 
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, longer acting tissue plasminogen 
activator, myelin basic protein, pro-insulin, prolactin, tissue 
plasminogen activator, soluble CD4 HIV receptor, 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 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 hte 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. 98-11114 Filed 4-24-98; 8:45 am]
BILLING CODE 4140-01-M