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

###### National Institutes of Health

# AGENCY:

National Institutes of Health, Public Health Service, HHS.

# ACTION:

Notice.

      ( print page 6212)    

# 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 (HHS), is contemplating the grant of a an exclusive license to practice the following invention as embodied in the following patent applications:

                        (1) E-120-2001/0, Whitehead                         *et al.,*                         “Development of Mutations Useful for Attenuating Dengue Viruses and Chimeric Dengue Viruses”—European Patent Application Number 02739358.6, filed May 22, 2002; United States Patent Application Number 10/719,547, filed November 21, 2003, now U.S. Patent Number 7,226,602, issued June 5, 2007; Canadian Patent Application Number 2448329, filed May 22, 2002; Australian Patent Application Number 2002312011, filed May 22, 2002, now Australian Patent Number 2002312011, issued August 8, 2007; Brazilian Patent Application Number PI0209943.8, filed May 22, 2002; Indian Patent Application Number 2184/DELNP/2003, filed May 22, 2002, now Indian Patent Number 218306, issued March 31, 2007; Indian Patent Application Number 165/DELNP/2008, filed May 22, 2002; United States Patent Application Number 11/446,050, filed June 2, 2006, now U.S. Patent Number 7,560,118, issued July 14, 2009; Australian Patent Application Number 2008203275, filed May 22, 2002; Indian Patent Application Number 204/DELNP/2005, filed May 22, 2002; and United States Patent Application Number 12/396,376, filed March 2, 2009                    

                        (2) E-089-2002/0,1, Whitehead                         *et al.,*                         “Dengue Tetravalent Vaccine Containing a Common 30 Nucleotide Deletion in the 3′-UTR of Dengue Types 1,2,3, and 4, or Antigenic Chimeric Dengue Viruses 1,2,3, and 4”—United States Patent Application Number 10/970,640, filed October 21, 2004, now United States Patent Number 7,517,531, issued April 14, 2009; Canadian Patent Application Number 2483653, filed April 25, 2003; European Patent Application Number 03724319.3, filed April 25, 2003; Japanese Patent Application Number 2004-50077, filed April 25, 2003; Indian Patent Application Number 3450/DELNP/2004, filed April 25, 2003, now Indian Patent Number 3450/DELNP, issued May 29, 2006; Australian Patent Application 2003231185, filed April 25, 2003, now Australian Patent Number 2003231185, issued January 10, 2008; United States Patent Application Number 12/398,043, filed March 4, 2009; and Brazilian Patent Application PI0309631-9, filed April 25, 2003                    

                        (3) E-139-2006/0, Whitehead                         *et al.,*                         “Development of Dengue Vaccine Components”—Australian Patent Application 2007285929, filed August 15, 2007; Canadian Patent Application Number 2661296, filed August 15, 2007; Chinese Patent Application Number 200780031489.4, filed August 15, 2007; European Patent Application Number 07840969.5, filed August 15, 2007; Indian Patent Application Number 1608/DELNP/2009, filed August 15, 2007; United States Patent Application Number 12/376,756, filed February 6, 2009; and Brazilian Patent Application TBA, filed August 15, 2007 to GlaxoSmithKline Biologicals, having a place of business in Rixensart, Belgium. The patent rights in this invention have been assigned to 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 March 10, 2010 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: Peter Soukas, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; E-mail:                         *ps193c@nih.gov;*                         Telephone: (301) 435-4646; Facsimile: (301) 402-0220.                    

# SUPPLEMENTARY INFORMATION:

The global prevalence of dengue has grown dramatically in recent decades. The disease is now endemic in more than 100 countries in Africa, North and South America, the Eastern Mediterranean, Southeast Asia and the Western Pacific. Southeast Asia and the Western Pacific are most seriously affected. Before 1970 only nine countries had experienced Dengue Hemorrhagic Fever (DHF) epidemics, a number that had increased more than four-fold by 1995. WHO currently estimates there may be 50 million cases of dengue infection worldwide every year.

                    The methods and compositions of this invention provide a means for prevention of dengue infection and dengue hemorrhagic fever (DHF) by immunization with attenuated, immunogenic viral vaccines against dengue. The vaccine is further described in Blaney JE                     *et al.,*                     “Mutations which enhance the replication of dengue virus type 4 and an antigenic chimeric dengue virus type 2/4  vaccine candidate in Vero cells.” Vaccine. 2003 Oct 1;21(27-30):4317-27 and Whitehead SS                     *et al.,*                     “A live, attenuated dengue virus type 1 vaccine candidate with a 30-nucleotide deletion in the 3′ untranslated region is highly attenuated and immunogenic in monkeys.”                     *J. Virol.*                     2003 Jan;77(2):1653-7.                

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 404.7. The prospective exclusive license may be granted unless, within thirty (30) 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 purified inactivated vaccines against dengue infections in humans.

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: January 28, 2010.

Richard U. Rodriguez,

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

[FR Doc. 2010-2697 Filed 2-5-10; 8:45 am]

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