This notice was published in the Federal Register on Tuesday, November 25, 1997, pp. 62781-62782 [62 FR 62781].
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
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 A 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 A 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 A 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 A 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 A DNA Clones for the Expression of Pigment Epithelium Derived Factor and Related Proteins@ filed January 25, 1995 by Fintan R. Steele, Gerald J. Chader, Joyce Tombran-Tink, Sofia P. Becerra and Ignacio R. Rodriquez
6. USSN 08/520,373 entitled A Retinal Pigmented Epithelium Derived Neurotrophic Factor@ filed August 29, 1995 by Gerald J. Chader, Joyce Tombran-Tink, Sofia P. Becerra, Ignacio R. Rodriquez and Fintan R. Steele
DATE: Only written comments and/or applications for a license which are received by NIH on or before January 26, 1998 will be considered.
ADDRESS: 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 form 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.