[Federal Register Volume 69, Number 118 (Monday, June 21, 2004)]
[Notices]
[Pages 34381-34382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-13891]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Human-Bovine Reassortant 
Rotavirus Vaccine

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 
an exclusive license in the U.S., Europe, and Canada only to practice 
the invention embodied in U.S. Serial Number 60/094,425, filed July 28, 
1998, PCT filed (PCT/US99/

[[Page 34382]]

17036) on July 27, 1999, and National Stage filed in China, India, 
Korea, Australia, Canada, Europe, Japan, Brazil and the U.S., entitled 
``Multivalent Human-Bovine Rotavirus Vaccine'' (DHHS ref. E-015-1998/0) 
to Aridis, LLC, having a place of business in Portola Valley, 
California. The patent rights in these inventions have been assigned to 
the United States of America.
    This Notice replaces a Federal Register document previously 
published on Tuesday, June 8, 2004, 69 FR 32036.

DATES: Only written comments and/or application for a license which are 
received by the NIH Office of Technology Transfer on or before 
September 20, 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; Email: [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 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.
    This technology describes multivalent immunogenic compositions 
comprising at least four human-bovine reassortant rotaviruses, where 
the gene encoding VP7 protein from G1, G2, G3, or G4 human rotavirus 
strain is inserted into a bovine rotavirus backbone. These VP7 
serotypes represent the clinically most important human rotavirus 
serotypes, which depends on VP4 and VP7 proteins, both found in the 
viral capsid and both of which independently induce neutralizing 
antibodies. Additionally, human-bovine reassortants for VP7 serotypes 
G5 and G9 and a bovine-bovine reassortant for VP7 G10 serotype are 
mentioned. Each of these reassortants is monovalent, and administered 
as a multivalent mixture. Compared to other human-bovine rotavirus 
reassortants, the compositions described in this technology induce an 
immunological response at significantly lower dosage than other human-
bovine rotavirus reassortants (which required 10-100 times the dose of 
human-rhesus reassortants) and does not result in a low-grade, 
transient fever.
    The field of use may be limited to development of human-bovine 
reassortant rotavirus vaccines.
    The licensed territory will be exclusive in the U.S., Canada, and 
Europe.
    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.

    June 14, 2004.
Mark L. Rohrbaugh,
Director, Office of Technology Transfer, National Institutes of Health.
[FR Doc. 04-13891 Filed 6-18-04; 8:45 am]
BILLING CODE 4140-01-P