[Federal Register Volume 74, Number 86 (Wednesday, May 6, 2009)]
[Notices]
[Pages 20959-20960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10410]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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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. 207 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.

ADDRESSES: 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.

Method of Detecting and Quantifying Contaminants in Heparin 
Preparations

    Description of Technology: Heparin is a naturally occurring acidic 
carbohydrate produced commercially from extracts of animal tissues 
(such as bovine lung or porcine intestine) and is used in the treatment 
of a wide range of diseases in addition to their classic anticoagulant 
activity. Heparin is also used to coat many medical devices, such as 
catheters, syringes, stents and filters. Recently, certain lots of 
heparin were associated with serious side effects and adverse events. 
Recalls were issued in multiple countries and it became evident that 
there was an extensive problem with heparin manufacture.
    Traditional tests may not be able to determine the presence of 
contaminant(s) without lyophilizing and concentrating each sample and 
may not be suitable for testing finished medical devices. Therefore, 
there is a demonstrated need to develop other assay methods for 
detecting contaminating oversulfated compounds of any source in heparin 
and heparin-derived products.
    This technology relates to methods for detecting and/or quantifying 
oversulfated glycosaminoglycans based on inhibition of nucleic acid 
polymerases and resistance to enzymatic degradation. It also relates to 
the use of these methods to screen and quantify pharmaceutical 
preparations such as heparin preparations for oversulfated 
contaminants.
    Potential Applications: Robust, simple and effective method for 
detecting and optionally quantifying oversulfated contaminants in 
heparin preparations.
    Development Status: The method has been developed and qualified for 
sensitivity and identity, but full validation and commercialization 
have not been undertaken.
    Inventor: Daniela Verthelyi et al. (FDA).
    Publication: C Tami, M Puig, JC Reepmeyer, H Ye, DA D'Avignon, L 
Buhse, D Verthelyi. Inhibition of Taq polymerase as a method for 
screening heparin for oversulfated contaminants. Biomaterials 2008 
Dec;29(36):4808-4814.
    Patent Status: U.S. Provisional Application No. 61/095,562 filed 09 
Sep 2008 (HHS Reference No. E-227-2008/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Fatima Sayyid, M.H.P.M.; 301-435-4521; 
[email protected].
    Collaborative Research Opportunity: The FDA, Division of 
Therapeutic Proteins, Laboratory of Immunology, is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize this high 
throughput screening test for oversulfated glycosamineglycan 
contaminants in heparin. Please contact Daniela Verthelyi at 
[email protected] or Alice Welch at [email protected] 
for more information.

Immunogenic West Nile Virus-Like Particles

    Description of Technology: Currently, no specific vaccine or 
therapy for West Nile Virus (WNV) is available for human use; a killed-
virus vaccine and booster is in use for horses (efficacy not yet 
reported). Virus-like particles (VLPs) are an exciting new strategy, as 
it combines the safety of killed-virus and DNA-based vaccines with the 
potential for immunogenicity of live-attenuated virus. VLPs have been 
used in approved vaccine for humans, including human papilloma virus 
(HPV). Generating VLPs for West Nile Virus, however, has proven 
difficult.
    The inventors have successfully generated West Nile VLPs in insect 
cells by using recombinant baculoviruses expressing the WNV structural 
proteins prME or CprME. Mice immunized with purified West Nile VLPs 
developed antibodies specific to WNV with potent neutralizing 
activities; moreover, the mice showed no morbidity or mortality after a 
subsequent challenge with live WNV and showed no evidence of viremia or 
viral RNA in the spleen or brain.
    The patent application covers applications ranging from 
pharmaceutical/vaccine preparations for WNV-LPs to methods for making 
and using them.
    Applications: Antiviral therapies, vaccines, and diagnostic kits 
based on West Nile VLPs.
    Advantages:
     Demonstrated efficacy in mice.
     Noninfectious.
     Manufacture using insect cells is simple and inexpensive.
     Vaccines or therapeutics are a preferable means to control 
infection versus the current method (reduce mosquito populations using 
toxic pesticides).
     First successful generation of West Nile VLPs.
    Development Status: Successful completion of proof-of-principle 
tests in mice.
    Market: For the last few years, the CDC has reported between 2,000-
3,000 human cases of WNV in the United States each year, typically with 
a mortality rate of about 5-6% (cumulatively since 1999, 27,000 cases 
and approaching 2,000 deaths). People over age 50 are at greatest risk 
for severe illness. Birds and horses are also vulnerable, with up to 
about 15,000 horse cases reported per year.
    Inventors: T. Jake Liang (NIDDK) et al.
    Relevant Publication: M Qiao et al. Induction of sterilizing 
immunity against West Nile Virus (WNV), by immunization with WNV-like 
particles produced in insect cells. J Infect Dis. 2004 Dec 
15;190(12):2104-2108.
    Patent Status: HHS Reference No. E-352-2003/0--U.S. Patent 
Application No. 11/579,459 (2008/0118528) and European Patent 
Application 05746277.2, both filed 03 Nov 2006 (from PCT publication WO 
2005/018560) and claiming priority to 4 May 2004.
    Licensing Status: Available for licensing.
    Licensing Contact: Bruce Goldstein, J.D., M.S.; 301-435-5470; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Diabetes and Digestive and Kidney Diseases, Liver Diseases Branch, is 
seeking parties

[[Page 20960]]

interested in collaborative research directed toward molecular 
strategies for vaccine and antiviral development, and animal models of 
viral hepatitis C. For more information, please contact Dr. T. Jake 
Liang at 301-496-1721, [email protected], or Ms. Patricia Lake at 301-594-
6762, [email protected].

    Dated: April 29, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-10410 Filed 5-5-09; 8:45 am]
BILLING CODE 4140-01-P