03-29491. 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.

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: [e-mail]; Telephone: [phone]; Facsimile: [phone].

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.