Prospective Grant of Exclusive License: Development of Antibody-Based Therapeutics That Specifically Bind the Platelet-Derived Growth Factor Receptor Alpha (CD140A/PDGFR2/PDGFRA)

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

SUMMARY:

This is notice, in accordance with 35 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 5,468,468 (11/21/1995); 5,833,986 (11/10/1998); 5,863,739 (01/26/1999); 5,965,359 (10/12/1999); 6,228,600 (05/08/2001) and 6,660,488 (12/09/2003), (b) U.S. patent applications 07/308,282 (02/09/1989, now abandoned), 07/915,884 (7/20/1992, now abandoned), 08/439,095 (05/11/1995, pending), 10/700,249 (11/03/2003, pending) and (c) foreign applications corresponding to PCT Patent Application PCT/US90/00617 entitled “Type Alpha Platelet Derived Growth Factor Receptor Gene”, published as WO 90/10013 (9/7/1990) to ImClone Systems Incorporated of New York, New York.

The prospective exclusive license may be limited to the development of compositions and methods of utilizing antibody-based products that specifically bind the alpha platelet-derived growth factor receptor (α-PDGFR/CD140a/PDGFRA/PDGF2/PDGFR-α), for the treatment of cancer.

DATES:

Only written comments and/or applications for a license which are received by NIH on or before October 25, 2004 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, Esq., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/435-4478; 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 and methods that incorporate or are derived from the molecule known as alpha platelet derived growth factor receptor (α-PDGFR). α-PDGFR is also known as CD140a/PDGFRA/PDGF2/PDGFR-α. PDGFR-α is a type III receptor tyrosine kinase characterized by an extracellular domain having five IgG-like domains, a transmembrane domain and a catalytic intracellular domain. Research suggests it has autocrine and paracrine signaling capability. PDGFRA expression and signaling have been linked to tumorigenesis and its activity, although not always coupled with over-expression, has been implicated in a number of cancers including lung cancer, ovarian cancer, prostate cancer, glioblastoma and melanoma.

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. Comments and/or objections filed in response to the notices of January 27, 1993 [58 FR 6287] and February 15, 1994 [59 FR 7259] are not considered responsive to this notice and will not be treated as objections thereto. 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 5 U.S.C. 552.