[Federal Register Volume 62, Number 175 (Wednesday, September 10, 1997)]
[Pages 47676-47677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23900]



National Institutes of Health

Prospective Grant of Exclusive License: For Nucleic Acid-Based 
Vaccines and Therapeutics

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.


SUMMARY: This is a 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 
a limited field of use exclusive license in the United States to 
practice the invention embodied in U.S. Patent Application Number 08/
286,730 entitled, ``Liposomal Delivery System for Nucleic Acids,'' and 
its Continuation-In-Part U.S. Patent Application Serial Number 08/
522,246, and all related foreign filings (PCT/US95/09867), invented by 
Alain Thierry formerly of the National Cancer Institute, to Biovector 
Therapeutics, S.A of Labage, France. The patent rights in these 
inventions have been assigned to the United States of America.

DATES: Only written comments and/or applications for a license which 
are received by NIH on or before December 9, 1997 will be considered.

ADDRESSES: Requests for copies of the subject issued patent and pending 
patent applications, inquiries, comments and other materials relating 
to the contemplated license should be directed to: Mr. Larry M. 
Tiffany, Office of Technology Transfer, National Institutes of Health, 
6011 Executive Boulevard, Suite 325, Rockville, MD 20852; Telephone: 
(301) 496-7056, ext. 206; Facsimile: (301) 402-0220. A signed 
Confidentiality Agreement will be required to receive copies of the 
pending patent applications.

SUPPLEMENTARY INFORMATION: The present invention relates to a liposome 
composition comprising a bi- or multi-layered membrane surrounding an 
internal aqueous liposome comprising at least one cationic 
lipopolyamine and at least one neutral lipid provided in a molar ratio 
range, said ratio from about .02:1 to 2:1. In addition to the pending 
composition claims there are also pending rights to methods of 
preparing the liposome composition, pharmaceutical compositions 
including the liposome and methods of introducing nucleic acids into 
cells using the liposome. This invention is advantageous over 
alternative lipid preparations due to its ability to more

[[Page 47677]]

easily form liposomes at physiological temperatures and pH hence making 
it potentially more stable in-vivo.
    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 90 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.
    The field of use would be limited to nucleic acid-based vaccines 
and therapeutics.
    Applications for a license to the field of use described in this 
Notice will be treated as objections to 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, 5 U.S.C. 552.

    Dated: September 2, 1997.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 97-23900 Filed 9-9-97; 8:45 am]