Prospective Grant of Exclusive License: Dengue Tetravalent Vaccine Containing a Common 30 Nucleotide Deletion in the 3′-UTR of Dengue Types 1,2,3, and 4, 19565 [E9-9853]

Download as PDF Federal Register / Vol. 74, No. 81 / Wednesday, April 29, 2009 / Notices remains the same. The meeting is closed to the public. Dated: April 22, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–9857 Filed 4–28–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. pwalker on PROD1PC71 with NOTICES Name of Committee: National Institute of Mental Health Special Emphasis Panel. SRSP Conflicts. Date: June 11, 2009. Time: 2 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Melrose Hotel, 2430 Pennsylvania Ave., NW., Washington, DC 20037. Contact Person: Marina Broitman, PhD, Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6153, MSC 9608, Bethesda, MD 20892–9608. 301–402–8152. mbroitma@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.242, Mental Health Research Grants; 93.281, Scientist Development Award, Scientist Development Award for Clinicians, and Research Scientist Award; 93.282, Mental Health National Research Service Awards for Research Training, National Institutes of Health, HHS) Dated: April 22, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–9860 Filed 4–28–09; 8:45 am] BILLING CODE 4140–01–P VerDate Nov<24>2008 17:48 Apr 28, 2009 Jkt 217001 19565 Western Pacific are most seriously affected. Before 1970 only nine countries had experienced Dengue National Institutes of Health Hemorrhagic Fever (DHF) epidemics, a number that had increased more than Prospective Grant of Exclusive four-fold by 1995. WHO currently License: Dengue Tetravalent Vaccine estimates there may be 50 million cases Containing a Common 30 Nucleotide Deletion in the 3′-UTR of Dengue Types of dengue infection worldwide every year. 1,2,3, and 4 The methods and compositions of this AGENCY: National Institutes of Health, invention provide a means for Public Health Service, HHS. prevention of dengue infection and ACTION: Notice. dengue hemorrhagic fever (DHF) by immunization with attenuated, SUMMARY: This is notice, in accordance immunogenic viral vaccines against with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National dengue. The vaccine is further described Institutes of Health (NIH), Department in Blaney JE et al., ‘‘Mutations which of Health and Human Services (HHS), is enhance the replication of dengue virus contemplating the grant of a an type 4 and an antigenic chimeric dengue exclusive license to practice the virus type 2/4 vaccine candidate in Vero following invention as embodied in the cells.’’ Vaccine. 2003 Oct 1;21(27– following patent applications: (1) E– 30):4317–27 and Whitehead SS et al., 120–2001/0, Whitehead et al., ‘‘A live, attenuated dengue virus type 1 ‘‘Development of Mutations Useful for vaccine candidate with a 30-nucleotide Attenuating Dengue Viruses and deletion in the 3′ untranslated region is Chimeric Dengue Viruses’’, Brazilian highly attenuated and immunogenic in Patent Application PI0209943.8, filed monkeys.’’ J. Virol. 2003 Jan;77(2):1653– May 22, 2002, (2) E–089–2002/0,1, 7. Whitehead et al., ‘‘Dengue Tetravalent The prospective exclusive license will Vaccine Containing a Common 30 Nucleotide Deletion in the 3′-UTR of be royalty bearing and will comply with Dengue Types 1,2,3, and 4, or Antigenic the terms and conditions of 35 U.S.C. Chimeric Dengue Viruses 1,2,3, and 4’’, 209 and 37 CFR 404.7. The prospective Brazilian Patent Application exclusive license may be granted unless, PI0309631–9, filed April 25, 2003, and within 60 days from the date of this (3) E–139–2006/0, Whitehead et al., published Notice, NIH receives written ‘‘Development of Dengue Vaccine evidence and argument that establishes Components’’, Brazilian Patent that the grant of the license would not Application TBA, filed August 15, 2007 be consistent with the requirements of to Fundacao Butantan, having a place of 35 U.S.C. 209 and 37 CFR 404.7. business in Sao Paulo, Brazil. The The field of use may be limited to live patent rights in this invention have been attenuated vaccines against dengue assigned to the United States of infections in humans. The Licensed America. Territory may be limited to Brazil. DATE: Only written comments and/or Properly filed competing applications application for a license which are for a license filed in response to this received by the NIH Office of notice will be treated as objections to Technology Transfer on or before May 14, 2009 will be considered. the contemplated license. Comments and objections submitted in response to ADDRESSES: Requests for a copy of the patent application, inquiries, comments this notice will not be made available and other materials relating to the for public inspection, and, to the extent contemplated license should be directed permitted by law, will not be released to: Peter Soukas, Office of Technology under the Freedom of Information Act, Transfer, National Institutes of Health, 5 U.S.C. 552. 6011 Executive Boulevard, Suite 325, Dated: April 23, 2009. Rockville, MD 20852–3804; E-mail: ps193c@nih.gov; Telephone: (301) 435– Richard U. Rodriguez, Director, Division of Technology Development 4646; Facsimile: (301) 402–0220. SUPPLEMENTARY INFORMATION: The global and Transfer, Office of Technology Transfer, National Institutes of Health. prevalence of dengue has grown [FR Doc. E9–9853 Filed 4–28–09; 8:45 am] dramatically in recent decades. The BILLING CODE 4140–01–P 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\29APN1.SGM 29APN1

Agencies

[Federal Register Volume 74, Number 81 (Wednesday, April 29, 2009)]
[Notices]
[Page 19565]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9853]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: 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.

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

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'', Brazilian Patent 
Application PI0209943.8, filed May 22, 2002, (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'', Brazilian Patent 
Application PI0309631-9, filed April 25, 2003, and (3) E-139-2006/0, 
Whitehead et al., ``Development of Dengue Vaccine Components'', 
Brazilian Patent Application TBA, filed August 15, 2007 to Fundacao 
Butantan, having a place of business in Sao Paulo, Brazil. The patent 
rights in this invention have been assigned to the United States of 
America.

DATE: Only written comments and/or application for a license which are 
received by the NIH Office of Technology Transfer on or before May 14, 
2009 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 60 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 live attenuated vaccines against 
dengue infections in humans. The Licensed Territory may be limited to 
Brazil.
    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: April 23, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-9853 Filed 4-28-09; 8:45 am]
BILLING CODE 4140-01-P

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