02-10928. 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.

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 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: [phone] ext 245; fax: [phone]. 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.