2014-00126. Prospective Grant of Exclusive License: The Development of a Veterinary Rabies Vaccine Based on the ERAg3m Virus Strain

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Provisional Patent Application No. 60/727,038, entitled “Method of Sequencing Whole Viral Genomes, Related Compositions, and Genome Sequences”, filed October 14, 2005 (HHS Ref. No. E-326-2013/0-US-01); PCT Patent Application No. PCT/US2006/040134, entitled “Rabies Virus Compositions and Methods”, filed October 13, 2006, (E-326-2013/0-PCT-02); and Chinese Patent Application No. 200680038314.4, entitled “Rabies Virus Compositions and Methods”, filed October 13, 2006 (HHS Ref. No. E-326-2013/0-CN-06). The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive license territory is China, and the field of use may be limited to “Rabies vaccines based on the ERAg3m virus strain for veterinary use only.”

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before February 10, 2014 will be considered.

ADDRESSES:

Requests for copies of the patent application(s), inquiries, and comments relating to the contemplated exclusive license should be directed to: Whitney Blair, J.D., M.P.H., Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone]; Facsimile: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

This license specifically concerns a highly attenuated rabies virus, ERAg3m, with a mutation in the glycoprotein (G) gene and a switch of the G gene with the matrix protein gene in the viral genome. After a one-dose intramuscular vaccination, the ERAg3m virus protected 100% of mice and hamsters from lethal challenge. ERAg3m also may offer better protection than traditional inactivated vaccinations, as demonstrated in co-infection studies. This technology is capable of being developed into a one-dose rabies vaccine for human or veterinary use.

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 part 404. The prospective exclusive license may be granted unless within thirty (30) days from the date of the published notice, the 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 part 404.

Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted 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: January 2, 2014.

Richard U. Rodriguez,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.