[Federal Register Volume 65, Number 39 (Monday, February 28, 2000)]
[Notices]
[Page 10505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4553]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Use of Thymosin [4 for 
Wound Healing Applications

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: This is notice in accordance with 15 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 world-wide license to practice the inventions embodied in 
any domestic or foreign applications corresponding to PCT Patent 
Application PCT/US99/17282 and USSN 60/094,960, both entitled 
``Thymosin 4 Promotes Wound Repair'' to Alpha1 Biomedicals, 
Inc., of Bethesda, Maryland. The patent rights in this invention have 
been assigned to the United States of America and Alpha1 Biomedicals, 
Inc. The prospective exclusive license may be limited to the 
development of therapeutic applications, including compositions and 
methods, to be used in the treatment of wounds and tissue repair.

DATES: Only written comments and/or license applications which are 
received by the National Institutes of Health on or before May 30, 2000 
will be considered.

ADDRESSES: Requests for a copy of these patent applications, inquiries, 
comment and other materials relating to the contemplated license should 
be directed to Susan S. Rucker, J.D., Patent and Licensing Specialist, 
Office of Technology Transfer, National Institutes of Health, 6011 
Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; 
telephone: 301/496-7056 ext 245; fax: 301/402-0220. A signed 
Confidentiality Agreement will be required to receive copies of the 
patent applications.

SUPPLEMENTARY INFORMATION: The patent applications describe the use of 
the compound thymosin 4, isoforms of thymosin 4 
(T4 \ala\, T9, T11, T12, 
T13, T14, or T15) or a peptide derived 
therefrom, LKKTET, (aa residues 17-22) as an agent for promoting wound 
healing. Thymosin 4 is a small, 43 mer, 4.9 kDa, peptide which 
can be produced by chemical synthesis or recombinantly. Studies using a 
punch model for wounds in rats have shown that providing thymosin 
4 either by systemic delivery (intraperitoneal) or topical 
delivery accelerates wound healing and that extracellular matrix 
deposition occurs in the wound bed. In addition, Thymosin 4 
has been shown previously to promote endothelial cell migration and to 
promote angiogenesis.
    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. 
This prospective exclusive license may be granted unless within ninety 
(90) 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.
    Applications for a license (i.e., a completed ``Application for 
License to Public Health Service Inventions'') in the indicated 
exclusive field of use filed in response to this notice will be treated 
as objections to the grant of the contemplated license. Comments and 
objections will not be made available for public inspection and, to the 
extent permitted by law, will not be subject to disclosure under the 
Freedom of Information Act 35 U.S.C. 552.

    Dated: February 16, 2000.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 00-4553 Filed 2-25-00; 8:45 am]
BILLING CODE 4140-01-P