News Column

Government-Owned Inventions; Availability for Licensing

January 29, 2014



SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

FOR FURTHER INFORMATION CONTACT: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Novel Targets To Prevent Borrelia burgdorferi Infection and Lyme Disease

Description of Technology: B. burgdorferi -infected ticks can cause Lyme disease in mammalian hosts. This technology relates to the use of B. burgdorferi outer surface proteins (BBA64 and BBA66) as Lyme disease vaccine candidates. In vivo animal studies demonstrate these outer surface proteins inhibit tick-to-host B. burgdorferi transmission. Presently, there is no vaccine approved for Lyme disease.

This technology may also be used for creation of antibodies directed against B. burgdorferi. Thus, this innovation may prevent B. burgdorferi infection by passive immunity and provide new diagnostic tools, which will allow early intervention.

Potential Commercial Applications:

* B. burgdorferi /Lyme disease vaccine development

* B. burgdorferi diagnostics

* Prevention of B. burgdorferi infection by passive immunity

* Zoonotic/tick-borne disease surveillance

* Public health vaccination programs against Lyme disease

Competitive Advantages: Currently no approved Lyme disease vaccines

Development Stage:

* Early-stage

* In vitro data available

* In vivo data available (animal)

Inventor: Robert D. Gilmore (CDC)

Publication: Patton TG, et al. Borrelia burgdorferi bba66 gene inactivation results in attenuated mouse infection by tick transmission. Infect Immun. 2013 Jul;81(7):2488-98. [PMID 23630963]

Intellectual Property: HHS Reference No. E-573-2013/0--US Provisional Application No 61/814,741 filed 22 Apr 2013

Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; whitney.blair@nih.gov.

Real-Time RT-PCR Assay for Detection and Quantification of Hepatitis D Virus Infection

Description of Technology: CDC scientists have developed a one-step TaqMan quantitative/real-time reverse transcription-polymerase chain reaction (qRT-PCR) assay for detecting hepatitis D virus (HDV) RNA. Additionally, a quantifiable synthetic RNA control to determine viral load has been created.

HDV is an operatively defective virus that requires hepatitis B virus (HBV) surface antigen (HBsAg) for its assembly. Compared to individuals infected with HBV alone, individuals infected with both HDV and HBV viruses present with more severe hepatitis, progress to liver disease more quickly, and have a higher mortality rate. Currently, there are no regulated tests available for detection and quantification of HDV RNA. This assay directly addresses this unmet need and has been validated with clinical samples of HDV genotypes 1 and 3. It has the potential to detect all eight HDV genotypes.

Potential Commercial Applications:

* Development of a commercial nucleic acid assay for diagnosis of current hepatitis D virus (HDV) infection

* Public health and vaccination programs

* Testing of individuals infected with hepatitis B and/or liver disease

Competitive Advantages:

* Rapid, accurate, inexpensive and stable

* Unique RNA transcript for this assay can be successfully used as a quantitative standard

* Current anti-HDV antibody assay identifies individuals exposed to HDV, but cannot identify current infection

* Easily adapted for inclusion in a hepatitis testing kit, especially when paired with a hepatitis B diagnostic

Development Stage:

* Pre-clinical

* In vitro data available

Inventors: Maja Kodani, Tonya Mixson-Hayden, Saleem Kamili (all of CDC)

Publication: Kodani M, et al. One-step real-time PCR assay for detection and quantitation of hepatitis D virus RNA. J Virol Methods. 2013 Nov;193(2):531-5. [PMID 23896020]

Intellectual Property: HHS Reference No. E-510-2013/0--US Provisional Application No. 61/792,293 filed 15 Mar 2013

Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; whitney.blair@nih.gov.

Reduced Virulence Crimean-Congo Hemorrhagic Fever Virus for Vaccine Development

Description of Technology: This invention relates to a genetically modified hemorrhagic fever virus that can be used as an effective live vaccine agent. Hemorrhagic fever evades the human immune response using the viral ovarian tumor domain (vOTU) protease, which inhibits critical host-immunity functions. The present genetically modified virus has a vOTU protease with decreased ability to remove ubiquitin (Ub) and ISG15 tags from proteins in cells it infects. Thus, the virulence is reduced, creating an immunogenic and non-pathogenic virus for use as a live vaccine against Crimean-Congo hemorrhagic fever (CCHF) virus. Unlike strains with complete ablation of the vOTU protease, the present modified virus retains enough activity for replication in a human cell line, making vaccine production possible. This technology may be used to create vaccines or therapeutics for other nairoviruses, including the Dugbe, Hazara, and Nairobi sheep disease viruses.

Potential Commercial Applications: Development of vaccines or therapeutics for CCHF virus and other nairoviruses, including Dugbe, Hazara and Nairobi sheep disease viruses

Competitive Advantages:

* Increased safety for CCHF laboratory research (Biosafety Level 2)

* Use of human cell lines allows large-scale manufacturing of vaccines

* vOTU domain-disruption may be used to develop vaccines for all nairovirus viruses affecting humans and/or livestock

Development Stage:

* Pre-clinical

* In vitro data available

Inventors: Eric Bergeron (CDC), Stuart T. Nichol (CDC), et al.

Publications:

1. Bergeron E, et al. Crimean-Congo hemorrhagic fever virus-encoded ovarian tumor protease activity is dispensable for virus RNA polymerase function. J Virol. 2010 Jan;84(1):216-26. [PMID 19864393]

2. Capodagli GC, et al. Structural analysis of a viral ovarian tumor domain protease from the Crimean-Congo hemorrhagic fever virus in complex with covalently bonded ubiquitin. J Virol. 2011 Apr;85(7):3621-30. [PMID 21228232]

Intellectual Property: HHS Reference No. E-486-2013/0--

* US Provisional Application No. 61/683,132 filed 14 Aug 2012

* US Patent Application No. 13/829,105 filed 14 Mar 2013

* PCT Application No. PCT/US13/54760 filed 13 Aug 2013

Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; whitney.blair@nih.gov.

Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel

Description of Technology: This invention relates to methods of rapidly detecting influenza, including differentiating between type and subtype. Unlike culture and serological tests requiring 5 to 14 days for completion, CDC researchers developed a rapid, accurate assay, which is easily adapted to kit form. This assay also requires less labor input than immunoassays. These methods can be used to quickly identify a broad variety of influenza types and subtypes, including viruses that may be involved in pandemics (such as H5N1, for example).

Potential Commercial Applications:

* Influenza diagnostic using clinical specimens

* High-throughput screenings

* Influenza surveillance programs

Competitive Advantages:

* Already FDA approved

* Especially useful for H5N1 screening

* Sensitive detection

* Specific discrimination of influenza subtypes

* Easily formatted as kit or array

* Faster than culturing and serological identification methods

* Less laborious and more objective than immunoassays

Development Stage: In vitro data available

Inventors: Stephen Lindstrom, Alexander I. Klimov, Nancy J. Cox, Lamorris Loftin (all of CDC)

Publication: Jernigan DB, et al. Detecting 2009 pandemic influenza A (H1N1) virus infection: availability of diagnostic testing led to rapid pandemic response. Clin Infect Dis. 2011 Jan 1;52 Suppl 1:S36-43. [PMID 21342897]

Intellectual Property: HHS Reference No. E-331-2013/0--

* PCT Application No. PCT/US2007/003646 filed 12 Feb 2007, which published as WO 2007/095155 on 23 Aug 2007

* US Patent No. 8,241,853 issued 14 Aug 2012

* US Patent No. 8,568,981 issued 29 Oct 2013

* US Patent Application No. 14/056,810 filed 17 Oct 2013

--This is a summary of a Federal Register article originally published on the page number listed below--

Notice.

Citation: "79 FR 4730"

Federal Register Page Number: "4730"

"Notices"


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Source: National Institutes of Health Documents & Publications


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