2010-22833. Prospective Grant of Exclusive License: Development of AAV5 Based Therapeutics To Treat Human Diseases

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 Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the invention embodied in U.S. Patent 6, 984, 517, entitled “AAV5 and Uses Thereof,” U.S. Patent 7, 479, 554, entitled “AAV5 Nucleic Acids” and PCT Application Serial No. PCT/US99/11958 and foreign equivalents thereof, entitled “AAV5 and Uses Thereof” [HHS Ref. No. E-127-1998/0]; and U.S. Patent 6, 855, 314 entitled “AAV5 Vector for Transducing Brain Cells and Lung Cells” [HHS Ref. No. E-072-2000/0] to Amsterdam Molecular Therapeutics, which is located in Amsterdam, The Netherlands. The Government of the United States of America has the right to license these patent rights.

The prospective exclusive license territory may be worldwide, and the field of use may be limited to the development and sale of AAV5 based therapeutic products to be delivered to the brain, eyes and liver for treatment of diseases originated from these organs, as claimed in the Licensed Patent Rights.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before October 14, 2010 will be considered.

ADDRESSES:

Requests for copy of the patent, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: Betty B. Tong, PhD., Senior Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone]; Facsimile: [phone]; E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The technology describes an adeno-associated virus 5 (AAV5), vectors and particles derived from the virus; as well as methods of delivering nucleic acids to a cell by using the AAV5 vectors and particles. More specifically, the technology provides the methods of delivering nucleic acids to cells of specific regions, tissues and cell types of the central nervous system (CNS); as well as to cells of the lung, by using AAV5 vectors and particles. The specific brain cells that are targeted by AAV5 belong to both non-neuronal/glial cells and neuronal cells, such as cerebellar cells and ependymal cells. The specific lung cells targeted by AAV5 are the apical surfaces of the airway such as alveolar cells.

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. The prospective exclusive license may be granted unless within thirty (30) days from the date of this published notice, the 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 in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

Dated: September 7, 2010.

Richard U. Rodriguez,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.