[Federal Register Volume 81, Number 34 (Monday, February 22, 2016)]
[Notices]
[Pages 8728-8729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03486]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Production of Attenuated
Respiratory Syncytial Virus Vaccines
AGENCY: National Institutes of Health.
ACTION: Notice.
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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 Institute of Allergy and
Infectious Diseases (NIAID), 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-194-1999/0,
Collins et al., ``Production of Attenuated Respiratory Syncytial Virus
Vaccines Involving Modification of M2 ORF2'', U.S. Provisional Patent
Application Number 60/143,097, filed July 9, 1999, PCT Patent
Application Number PCT/US2000/18534, filed July 7, 2000, U.S. Patent
Application Number 09/611,829 (now U.S. Patent Number 6,713,066), and
U.S. Patent Application Number 11/011,502 (now U.S. Patent Number
7,485,440), (2) E-135-2010/0, Collins et al., ``Genetically Stable Live
Attenuated Vaccine for Respiratory Syncytial Virus (RSV) with an
Attenuation and Temperature Sensitive Phenotype Conferred by an Amino
Acid Deletion'', U.S. Provisional Patent Application Number 61/624,010,
filed April 13, 2012, PCT Patent Application Number PCT/US2013/030836,
filed March 13, 2013, United States Patent Application Number 14/
394,226, filed October 13, 2014, European Patent Application Number
13712641.3, filed March 13, 2013, (3) E-216-2014/0, Collins et al.,
``Versions of Respiratory Syncytial Virus (RSV) Vaccine Candidate LID
Delta M2-2 with Increased Attenuation'', U.S. Provisional Patent
Application Number 62/266,199, filed December 11, 2015, (4) E-241-2014/
0, Collins et al., ``Improved RSV F Protein for Expression from a
Heterologous Vector'', U.S. Provisional Patent Application Number 62/
105,667, filed January 20, 2015, PCT Patent Application Number PCT/
US2016/014154, filed January 20, 2016, and (5) E-037-2016/0, Collins et
al., ``Attenuated RSV Vaccine Strains in which the NS1 and/or NS2 Genes
have been Shifted to Promoter-Distal Positions'', U.S. Provisional
Patent Application Number 62/266,206, filed December 11, 2015, to
Sanofi Pasteur, Inc., having a place of business in Swiftwater,
Pennsylvania, U.S.A. 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 National Institute of Allergy and Infectious Diseases,
Technology Transfer and Intellectual Property Office on or before March
8, 2016. 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, Senior Technology Licensing
Specialist, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases, 5601 Fishers
Lane, Suite 6D, Rockville, MD 20852-9804, Tel: (301) 594-8730 or email:
[email protected].
SUPPLEMENTARY INFORMATION: Respiratory syncytial virus (RSV) is the
most important cause of viral acute lower respiratory infection (ALRI)
in infants and children worldwide and is responsible for over 30
million new ALRI episodes worldwide and up to 199,000 deaths in
children under five (5) years old. In the United States, the virus
infects nearly all children at least once by the age of two (2) and is
the most common cause of bronchiolitis and infant pneumonia, causing up
to 125,000 hospitalizations of children each year. RSV disease burden
is less understood in the developing world, but available data
indicates that the virus causes a significant proportion of childhood
ALRI in these parts of the world, particularly in the first months of
life. The drug palivizumab (Synagis) can help prevent RSV disease in
high risk infants, but it cannot treat or cure already-serious RSV
infection. No vaccine exists today to prevent RSV due to an incomplete
understanding of the body's immune response to the virus, which has
challenged and delayed RSV vaccine development efforts.
The methods and compositions of this invention provide a means for
[[Page 8729]]
prevention of RSV and/or parainfluenza virus (PIV) infection by
immunization with live attenuated, immunogenic viral vaccines against
RSV and/or PIV.
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 part
404. The prospective exclusive license may be granted unless, within
fifteen (15) 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 part 404.
The field of use may be limited to live attenuated vaccines against
respiratory syncytial virus (RSV) and/or parainfluenza virus (PIV)
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: February 16, 2016.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office,
NIAID.
[FR Doc. 2016-03486 Filed 2-19-16; 8:45 am]
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