Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### National Institutes of Health

# 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 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:                         *anos@od.nih.gov*; 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                           ( print 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