2012-27896. Prospective Grant of Co-Exclusive License: Veterinary Vaccines for Rift Valley Fever Virus

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice.

SUMMARY:

This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS), is thinking about giving a co-exclusive license in Africa, in the field of use of veterinary vaccines, to practice the inventions listed in the patent applications referred to below to Deltamune Ltd., having a place of business in Centurion, South Africa. The patent rights in these inventions have been assigned to the government of the United States of America. The patent applications(s) to be licensed are:

US Provisional Application 61/016,065, filed 12/21/2007, entitled “Development of Rift Valley Fever Virus Utilizing Reverse Genetics,” US Provisional Application 61/042,987, filed 4/7/2008, entitled “Recombinant Rift Valley Fever (RVF) Viruses and Method of Use,” PCT Application PCT/US2008/087023, filed 12/16/2008, entitled “Recombinant Rift Valley Fever (RVF) Viruses and Method of Use,” US National Stage Application 12/809,561, filed 6/18/2010, entitled “Recombinant Rift Valley Fever (RVF) Viruses and Methods of Use,” and all related continuing and foreign patents/patent applications for the technology family. CDC Technology ID No. I-008-08.

Status: Pending.

Priority Date(s):

61/042,987: 4/7/2008

61/016,065: 12/21/2007

The planned co-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.

Technology: The technology allows for the generation of precisely defined attenuated vaccine constructs that contain complete deletions of critical virulence factors of Rift Valley Fever (RVF) virus. These attenuated vaccines constructs still have the ability to induce robust protective immunity following the administration of a single vaccine dose in a rat model of lethal disease. The vaccines can protect immunized animals against virulent virus challenge. The vaccine candidates also allow for the differentiation of naturally infected and vaccinated animals—a feature that is critical in agricultural settings. This approach will allow for the rapid generation of effective, safe RVF vaccine candidates to control and prevent the spread of wild-type RVF virus in a variety of settings, including preventing the infection of humans or animals during endemic, epidemic or epizootic situations in affected countries, or for prophylactic use among humans in high risk occupational settings, or following intentional release of RVF virus during bioterrorism.

DATES:

Only written comments and/or applications for a license which are received by CDC on or before December 17, 2012 will be considered.

ADDRESSES:

Requests for a copy of these patent applications, inquiries, comments, and other materials relating to the planned license should be directed to Donald Prather, J.D., Ph.D., Technology Licensing and Marketing Specialist, Technology Transfer Office, Centers for Disease Control and Prevention (CDC), 4770 Buford Highway, Mailstop K-79, Atlanta, GA 30341, Telephone: [phone]; Facsimile: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Applications for a license filed in response to this notice will be treated as objections to giving the planned 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 8, 2012.

J. Ronald Campbell,

Director, Division of Executive Secretariat, Centers for Disease Control and Prevention.