[Federal Register Volume 62, Number 227 (Tuesday, November 25, 1997)]
[Notices]
[Pages 62781-62782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30924]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Pigment Epithelium 
Derived Growth Factor

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

ACTION: Notice.

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SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 
404.7(a)(1)(I), announces that the National Institutes of Health is 
contemplating the grant of an exclusive world-wide license to GenVec, 
Inc., a Delaware corporation headquartered in Rockville, Maryland to 
practice the inventions embodied in the U.S. Patent Applications listed 
below (and corresponding foreign patent applications) in the field of 
ocular gene therapy. These inventions are owned by the Government of 
the United States of America as represented by the Department of Health 
and Human Services.
    1. USSN 07/952,796 entitled ``DNA Clones for the Expression of 
Pigment Epithelium Derived Growth Factor and Related Proteins'' filed 
September 24, 1992 by Fintan R. Steele, Gerald J. Chader, Joyce 
Tombran-Tink and Sofia P. Becerra.
    2. USSN 08/257,963 entitled ``Pigment Epithelium Derived Factor: 
Characterizations of Its Biological Activity and Sequences Encoding and 
Expressing the Protein'' filed June 7, 1994 by Gerald J. Chader, Sofia 
P. Becerra, Joan P. Schwartz, Takayuki Taniwaki and Yukihera Sugita.
    3. USSN 08/279,979 entitled ``Retinal Pigmented Epithelium Derived 
Neurotrophic Factor'' filed July 25, 1994 by Fintan R. Steele, Gerald 
J. Chader, Joyce Tombran-Tink, Sofia P. Becerra and Ignacio R. 
Rodriquez and Lincoln Johnson.
    4. USSN 08/367,841 entitled ``Pigment Epithelium Derived Factor: 
Characterization, Genomic Organization and Sequence of the PEDF Gene'' 
filed December 30, 1994 by Gerald J. Chader, Joyce Tombran-Tink, Sofia 
P. Becerra, Ignacio R. Rodriquez and Fintan R. Steele and Lincoln 
Johnson.
    5. USSN 08/377,710 entitled ``DNA Clones for the Expression of 
Pigment Epithelium Derived Factor and Related Proteins'' filed January 
25, 1995 by Fintan R. Steele, Gerald L. Chader, Joyce Tombran-Tink, 
Sofia P. Becerra and Ignacio R. Rodriquez.
    6. USSN 08/520,373 entitled ``Retinal Pigmented Epithelium Derived

[[Page 62782]]

Neurotrophic Factor'' filed August 29, 1995 by Gerald J. Chader, Joyce 
Tombran-Tink, Sofia P. Becerra, Ignacio R. Rodriquez and Fintan R. 
Steele.

DATES: Only written comments and/or applications for a license which 
are received by NIH on or before January 26, 1998 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
comments and other materials relating to the contemplated licenses 
should be directed to: Jaconda Wagner, Esq., Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-
3804; Telephone: (301) 496-7735 ext. 284; Facsimile: (301) 402-0220. A 
signed Confidentiality Agreement will be required to receive copies of 
the patent applications.

SUPPLEMENTARY INFORMATION: Cultured retinal pigment epithelium (RPE) 
cells secrete pigment epithelium-derived factor (PEDF) into the 
photoreceptor matrix. This protein, with a molecular weight of 
approximately 50 kD, has trophic activity which induces neuronal cell 
differentiation, survival of mature neurons and a gliastatic effect. 
This technology can be used to develop therapeutics for the treatment 
of inflammatory, vascular, degenerative and dystrophic diseases of the 
retina and central nervous system (CNS) as well as to treat cancers of 
the CNS and conditions resulting from the activity of serine proteases.
    The various patent applications encompassing this invention contain 
claims to a recombinant DNA molecule comprising a gene encoding the 
PEDF; an organism transformed with the recombinant DNA molecule; a 
method of treating tumors ocular diseases, nerve injuries and 
conditions resulting from the activity of serine proteases using the 
PEDF; the PEDF protein and its biological activity, specifically a 
method of enhancing neuron cell survival and inhibiting glial cell 
proliferation; purified antibodies to PEDF; a method for purifying the 
PEDF; and immunoassay for detecting the level of PEDF in a sample.
    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 sixty 
(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.
    Applications for a license in the field of use filed in response to 
this notice will be treated as objections to the grant of the 
contemplated licenses. Comments and objections submitted 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: November 14, 1997.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 97-30924 Filed 11-24-97; 8:45 am]
BILLING CODE 4140-01-M