[Federal Register Volume 75, Number 25 (Monday, February 8, 2010)]
[Notices]
[Pages 6211-6212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-2697]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Purified Inactivated 
Dengue Tetravalent Vaccine Containing a Common 30 Nucleotide Deletion 
in the 3'-UTR of Dengue Types 1,2,3, and 4

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

ACTION: Notice.

-----------------------------------------------------------------------

[[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: [email protected]; 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]
BILLING CODE 4140-01-P