[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]
 BILLING CODE 4140-01-P