01-22794. Prospective Grant of Exclusive License: Adeno-Associated Virus with Inverted Terminal Repeat Sequence as Promoter

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 U.S. patents 5,587,308 (12/24/1996); 5,989,540 (11/23/1999); 5,866,696 (02/02/1999), and 6,165,781 (12/26/2000) or foreign applications corresponding to PCT Patent Application PCT/US93/05310, entitled “Modified Adeno-Associated Virus Vector Capable of Expression from a Novel Promoter” published as WO 93/24641 (12/09/1993) to Targeted Genetics Corporation of Seattle, Washington. The prospective exclusive license may be limited to the development of compositions and methods utilizing Adeno-Associated Viral Vectors which are useful in the treatment and prophylaxis of human and animal diseases.

DATES:

Only written comments and/or applications for a license which are received by NIH on or before November 13, 2001, 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, J.D., Patent and Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: [phone] ext 245; fax: [phone]. A signed Confidentiality Agreement will be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION:

The patents describe and claim compositions and methods utilizing adeno-associated viral (AAV) vectors. In particular, these vectors utilize the AAV Inverted Terminal Repeat (ITR) as the promoter element to control expression of the nucleic acid encoding the heterologous protein to be delivered to the patient. The ability of these vectors to utilize the AAV ITR as the promoter increases the capacity of the AAV vector with respect to the size of the heterologous protein which can be encoded and delivered via the vector. The methods of the patent can be used to deliver and produce therapeutic or prophylactic products which are particularly useful in the field of gene therapy.

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 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: September 5, 2001.

Jack Spiegel,

Director, Division of Technology Development and Transfer, Office of Technology Transfer.