[Federal Register Volume 68, Number 228 (Wednesday, November 26, 2003)]
[Notices]
[Page 66472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-29491]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Adenovirus-based Vaccines 
Against Ebola, Marburg, and/or Lassa

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

ACTION: Notice.

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SUMMARY: This is 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 
world-wide exclusive license to practice the invention embodied in: (1) 
U.S. Serial Number 60/326,476, filed October 1, 2001, entitled 
``Development of a Preventive Vaccine for Filovirus Infection in 
Primate''; PCT filed (PCT/US02/30251) on September 24, 2002; (2) U.S. 
Serial Number 60/068,655, filed December 23, 1997, entitled 
``Immunization For Ebola Virus Infection'', PCT filed (PCT/US98/27364) 
on December 23, 1998, and U.S. Serial Number 09/913,909, filed August 
17, 2001; (3) U.S. Serial Number 60/395,876, filed July 12, 2002, 
entitled ``Assays for Assembly of Ebola Virus Nucleocapsids Inhibitors 
of Viral Infection'', PCT filed on July 12, 2003 (PCT/US03/21757); and 
(4) U.S. Serial Number 60/491,933, filed August 1, 2003, entitled 
``Accelerated Vaccination'', to Crucell Holland B.V., having a place of 
business in Leiden, The Netherlands. The patent rights in these 
inventions have been assigned to the United States of America.

DATES: Only written comments and/or application for a license which are 
received by the NIH Office of Technology Transfer on or before January 
26, 2004, will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Susan Ano, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; E-mail: [email protected]; Telephone: (301) 
435-5515; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: 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 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.
    The above referenced technologies describe development of vaccines 
for Ebola, Marburg, and/or Lassa viruses using naked DNA constructs, 
DNA prime/adenovirus boost regimens, and one-dose administration of 
adenovirus vectors encoding the Ebola glycoprotein or nucleoprotein. 
Also described are assays for identification of compounds that inhibit 
the assembly of the nucleoprotein (NP) and virion associated proteins 
(VP) 35 and 24, all of which are required for Ebola nucleocapsid (or 
virion-like particle (VLP)) formation, or which inhibit glycosylation 
of NP, which is also necessary for nucleocapsid formation.
    The field of use may be limited to development of Ebola, Marburg, 
and/or Lassa vaccines comprising at least an adenovirus-based 
component.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. Comments and objections submitted in response 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: November 19, 2003.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 03-29491 Filed 11-25-03; 8:45 am]
BILLING CODE 4140-01-P