[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Notices]
[Page 65696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27674]



[[Page 65696]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Production of Live 
Respiratory Syncytial Virus and Parainfluenza Virus Vaccines

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Institute of Allergy and Infectious Diseases, an 
institute of the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of an Exclusive 
Commercialization Patent License to practice the inventions embodied in 
the Patents and Patent Applications listed in the Summary Information 
section of this notice to Medigen Vaccines Biologics Corp. (Medigen), 
having a place of business in Zhubei, Taiwan.

DATES: Only written comments and/or applications for a license which 
are received by the National Institute of Allergy and Infectious 
Diseases' Technology Transfer and Intellectual Property Office on or 
before January 7, 2019 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Commercialization 
Patent License should be directed to: Peter Soukas, Technology Transfer 
and Patent Specialist, Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases, National 
Institutes of Health, 5601 Fishers Lane, Suite 6D, Rockville, MD 20852-
9804; Email: [email protected]; Telephone: (301) 496-2644; Facsimile: 
(240) 627-3117.

SUPPLEMENTARY INFORMATION: 

Intellectual Property

    U.S. Provisional Patent Application Number 62/661,320, filed April 
23, 2018 and entitled ``Chimeric Vaccines,'' [HHS Reference No. E-018-
2018-0]; and U.S. and foreign patent applications claiming priority to 
the aforementioned applications.
    The patent rights in this invention have been assigned to the 
Government of the United States of America.
    The prospective exclusive licensed territory may be worldwide, and 
the field of use may be limited to: ``Live Respiratory Syncytial Virus 
(RSV) and Parainfluenza Virus (PIV) vaccines.''
    Human respiratory syncytial virus (RSV) continues to be the leading 
viral cause of severe acute lower respiratory tract disease in infants 
and children worldwide. A licensed vaccine or antiviral drug suitable 
for routine use remains unavailable. This invention relates to the use 
of murine pneumonia virus (MPV), a virus to which humans normally are 
not exposed and that is not cross-protected with RSV, as a vector to 
express the RSV fusion (F) glycoprotein as an RSV vaccine candidate. 
The RSV F ORF was codon optimized. The RSV F ORF was placed under the 
control of MPV transcription signals and inserted at the first (rMPV-
F1), third (rMPV29 F3), or fourth (rMPV-F4) gene position of a version 
of the MPV genome that contained a codon pair optimized L polymerase 
gene. The recovered viruses replicated in vitro as efficiently as the 
empty vector, with stable expression of RSV F protein. Replication and 
immunogenicity of rMPV-F1 and rMPV-F3 were evaluated in rhesus macaques 
following administration by the combined intranasal and intratracheal 
routes. Both viruses replicated at low levels in the upper and lower 
respiratory tract, maintained stable RSV F expression, and induced 
similar high levels of RSV-neutralizing serum antibodies that reached 
peak titers by fourteen (14) days post-vaccination. rMPV provides a 
highly attenuated yet immunogenic vector for the expression of RSV F 
protein, with potential application in RSV-na[iuml]ve and RSV 
experienced populations. The technology relates to live, chimeric non-
human Mononegavirales vectors that allow a cell to express at least one 
protein from at least one human pathogen as well as compositions 
comprising the vectors, methods and kits for eliciting an immune 
response in a host, and methods of making the vectors.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and the prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the National 
Institute of Allergy and Infectious Diseases 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.
    Complete applications for a license in the prospective field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive patent 
commercialization license. In response to this Notice, the public may 
file comments or objections. Comments and objections, other than those 
in the form of a license application, will not be treated 
confidentially, and may be made publicly available. License 
applications submitted in response to this Notice will be presumed to 
contain business confidential information, and any release of 
information in these license applications will be made only as required 
and upon a request under the Freedom of Information Act, 5 U.S.C. 552.

    Dated: December 11, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-27674 Filed 12-20-18; 8:45 am]
 BILLING CODE 4140-01-P