[Federal Register Volume 67, Number 85 (Thursday, May 2, 2002)]
[Notices]
[Pages 22101-22102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-10928]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Treatment of Ocular 
Disease With Pigment Epithelium Derived Factor (PEDF) Protein Using 
Non-Gene Therapy Means

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 or all of (a) U.S. patents 5,840,686 (11/24/1998) and 6,319,687 
(11/20/2001), (b) U.S. patent applications 07/894,215 (06/04/1992, now 
abandoned), 07/952,796 (9/24/1992, now abandoned), 08/279,979 (7/25/
1994, now abandoned), 08/377,710 (01/25/1995, now abandoned), 08/
520,373 (8/29/1995) and 09/630,629 (8/1/2000), and (c) foreign 
applications corresponding to PCT Patent Applications (i) PCT/US93/
05358 entitled ``Retinal Pigmented Epithelium Derived Neurotrophic 
Factor'', published as WO 93/24529 (12/9/1993) and (ii) PCT/US95/07201, 
entitled ``Pigment Epithelium-Derived Factor: Characterization, Genomic 
Organization and Sequence of the PEDF Gene'', published as WO 95/33480 
(12/14/95) to EyeTech Pharmaceuticals, Incorporated of New York, New 
York.
    The prospective exclusive license may be limited to the development 
of compositions and methods for the treatment of ocular disease based 
on the

[[Page 22102]]

protein PEDF utilizing delivery methods other than gene therapy. The 
grant of the exclusive license proposed does not supercede that 
previously announced in 62 FR 62781-62782, November 25, 1997.

DATES: Only written comments and/or application for a license which are 
received by the NIH Office of Technology Transfer on or before July 1, 
2002, will be considered.

ADDRESSES: Requests for a copy of these patent applications, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to Susan S. Rucker, J.D., Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-
3821; telephone: 301/496-7056 ext 245; fax: 301/402-0220. A signed 
Confidentiality Agreement (CDA) will be required to receive copies of 
the patent applications.

SUPPLEMENTARY INFORMATION: The patents and patent applications describe 
and claim compositions based on the molecule known as Pigment 
Epithelium Derived Factor (PEDF) and methods for making and using those 
compositions. PEDF is also known as EPC-1 (early population doubling 
level cDNA-1; RJ Pignolo, et al. J Biol Chem. 268(12):8949-57 (Apr 25, 
1993)) and SLED (Bouck, et al. WO 99/04806 (2/4/99)). These methods and 
compositions include the protein, as well as recombinant applications 
thereof based on the amino acid and nucleic acid sequences of PEDF. 
PEDF is a member of the serpin (serine protease inhibitor) superfamily 
of proteins but has not been shown to posses the serine protease 
inhibitory properties. In vitro studies have demonstrated that PEDF has 
properties beneficial to neuronal tissue (neuronal cell survival, 
gliastatic, and neurotrophic activity) and anti-angiogenic properties. 
These properties suggest that PEDF may be useful in compositions and 
methods for the treatment of ocular diseases such as age-related 
macular degeneration and diabetic retinopathy which may be related to 
angiogenesis and neuronal tissue properties or in the treatment of 
cancers.
    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 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 (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. Any objections 
to the grant of the contemplated license must specifically and 
separately, if more than one Notice of Intent to Grant related to these 
patents and patent applications is being responded to, reference the 
particular Notice of Intent to Grant being responded to and address 
only the proposed grant as set forth in the particular Notice of Intent 
to grant (i.e., an objection to the proposed grant as set forth in this 
Notice of Intent to Grant to EyeTech Pharmaceuticals, Incorporated will 
not be considered an objection to the proposed grant as set forth in 
the concurrently published Notice of Intent to Grant to GenVec, 
Incorporated). 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: April 24, 2002.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 02-10928 Filed 5-1-02; 8:45 am]
BILLING CODE 4140-01-P