[Federal Register Volume 69, Number 185 (Friday, September 24, 2004)]
[Notices]
[Pages 57335-57336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21426]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Partially-Exclusive Licenses: 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 
partially exclusive licenses in (1) India; (2) China; and (3) Brazil to 
practice the invention embodied in U.S. Serial Number 60/094,425, filed 
July 28, 1998, PCT filed (PCT/US99/17036) 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) as follows: (1) Co-
exclusive licenses in India only to Biological E LTD, having a place of 
business in Hyderabad, India, and Bharat Biotech International LTD, 
having a place of business in Hyderabad, India; (2) non-exclusive 
licenses exclusively offered to companies and/or institutions within 
China; and (3) exclusive license in Brazil only to Fundacao Instituto 
Butantan, having a place of business in Sao Paolo, Brazil. The patent 
rights in these inventions have been assigned to the Government of 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 December 
23, 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 technology embodied in the above patent 
rights involves 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

[[Page 57336]]

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 prospective partially exclusive licenses 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 partially exclusive licenses 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 may be limited to development of human-bovine 
reassortant rotavirus vaccines.
    The licensed territory will be exclusive as outlined above and 
excluding U.S., Europe, and Canada.
    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: September 17, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-21426 Filed 9-23-04; 8:45 am]
BILLING CODE 4140-01-P