[Federal Register Volume 66, Number 176 (Tuesday, September 11, 2001)]
[Notices]
[Pages 47236-47237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22794]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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.

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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 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: 301/496-7056 ext 245; fax: 301/402-0220. 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.

[[Page 47237]]

    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.
[FR Doc. 01-22794 Filed 9-10-01; 8:45 am]
BILLING CODE 4140-01-P