[Federal Register Volume 86, Number 146 (Tuesday, August 3, 2021)]
[Notices]
[Page 41855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16462]



[[Page 41855]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Improved Live-
Attenuated Vaccine for Respiratory Syncytial Virus

AGENCY: National Institutes of Health.

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 Codagenix, Inc. (Codagenix), having a place 
of business in Farmingdale, New York, U.S.A.

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 August 18, 2021 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; Email: [email protected]; Telephone: (301) 496-2644; 
Facsimile: (240) 627-3117.

SUPPLEMENTARY INFORMATION:

Intellectual Property

    U.S. Provisional Patent Application Number 63/023,949, filed May 
13, 2020 and PCT Patent Application Number PCT/US2021/32305, filed May 
13, 2021, entitled ``Improved Live-Attenuated Vaccine for Respiratory 
Syncytial Virus (RSV) Bearing Codon-Pair Deoptimized NS1, NS2, N, P, M 
and SH Genes and Additional Point Mutations in the P Gene,'' [HHS 
Reference No. E-104-2020-0]; 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-attenuated codon-deoptimized 
human respiratory syncytial virus vaccine.''
    RSV is the most important viral agent of severe respiratory disease 
in infants and young children worldwide and also causes substantial 
morbidity and mortality in older adults. RSV is estimated to cause more 
than 33 million lower respiratory tract illnesses, three million 
hospitalizations, and nearly 200,000 childhood deaths worldwide 
annually, with many deaths occurring in developing countries. However, 
despite the prevalence of RSV and the dangers associated with 
infection, no RSV vaccine has been successfully developed to date. 
Accordingly, there is a public health need for RSV vaccines. This 
vaccine candidate comprises live RSV that was attenuated by subjecting 
the protein-coding sequences of the viral NS1, NS2, N, P, M, and SH 
genes to codon-pair deoptimization, which resulted in many nucleotide 
substitutions that were silent at the amino acid level but conferred 
attenuation. In addition, specific amino acid substitutions were 
identified and introduced into the P protein that improved attenuation 
and genetic stability. Genetic stability was confirmed in vitro, and 
attenuation was confirmed in experimental animals.
    This live-attenuated RSV vaccine is designed to be administered 
intranasally by drops or spray to infants and young children. Based on 
experience with other live-attenuated RSV vaccine candidates, the 
present candidates are anticipated to be well tolerated in humans and 
are available for clinical evaluation. The National Institute of 
Allergy and Infectious Diseases has extensive experience and capability 
in evaluating live-attenuated RSV vaccine candidates in pediatric 
clinical studies.
    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.

Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-16462 Filed 8-2-21; 8:45 am]
BILLING CODE 4140-01-P