Published in the Federal Register on Wednesday, September 10, 1997, pp 47676-
47677 [62 FR 47676]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
DATE: Only written comments and/or applications for a license which are
received by NIH on or before December 9, 1997 will be considered.
ADDRESS: 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 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.