[Federal Register Volume 75, Number 177 (Tuesday, September 14, 2010)]
[Pages 55808-55809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22833]



National Institutes of Health

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: (301) 594-6565; Facsimile: (301) 402-0220; E-mail: 
[email protected].

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

[[Page 55809]]

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.
[FR Doc. 2010-22833 Filed 9-13-10; 8:45 am]