[Federal Register Volume 88, Number 201 (Thursday, October 19, 2023)]
[Notices]
[Pages 72088-72089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23030]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent Commercialization License: 
Human Monoclonal Antibodies That Broadly Target Coronaviruses

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 patent 
license to Leyden Laboratories B.V., located at Emmy Noetherweg 2, 2333 
BK Leiden, the Netherlands to practice the inventions embodied in the 
patent applications listed in the SUPPLEMENTARY INFORMATION section of 
this notice.

DATES: Only written comments and/or applications for a license which 
are received by the Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases on or 
before November 3, 2023 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated exclusive patent license 
should be directed to: Dawn Taylor-Mulneix, Technology Transfer and 
Patent Specialist, Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases, 5601 
Fishers Lane, Suite 2G, MSC 9804, Rockville, MD 20852-9804, phone 
number 301-767-5189, or [email protected].

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement: U.S. 
provisional application (63/308,898), filed on February 19, 2022, and 
the PCT application (PCT/US2023/062324), filed on February 9, 2023, 
entitled ``Human Monoclonal Antibodies that Broadly Target 
Coronaviruses'' (HHS Reference No. E-047-2022). All rights in these 
inventions have been assigned to the Government of the United States of 
America.
    The prospective exclusive patent commercialization license 
territory may be worldwide, and the field of use may be limited to: 
Prevention and treatment of coronavirus infection, illness, and 
transmission through mucosal delivery

[[Page 72089]]

to the respiratory tract of products, comprised of COV44-62 (fusion 
peptide), COV44-79 (fusion peptide), COV89-22 (stem helix), and/or 
COV72-37 (stem helix), including products that may be obtained from the 
genetic sequence of the same and derivatives thereof. The prospective 
exclusive patent commercialization license may include two products 
(preventative and therapeutic) in the field of use.
    An abstract for this invention was published in the Federal 
Register on June 10, 2022. The family of coronaviruses cause upper 
respiratory tract disease in humans and have caused three major disease 
outbreaks in recent history: the 2003 SARS outbreak, the 2012 MERS 
outbreak, and the current SARS-CoV-2 pandemic. There is an urgent need 
for strategies that broadly target coronaviruses, both to deal with new 
SARS-CoV-2 variants and future coronavirus outbreaks.
    Scientists at NIAID have developed several novel human monoclonal 
antibodies that bind to conserved parts of the SARS-CoV-2 spike 
protein. These antibodies can neutralize SARS- CoV-2 variants of 
concern including Omicron BA.1 and BA.2, as well as neutralize at least 
one other betacoronavirus. Further, these antibodies limit disease in 
animal models. Broadly reactive antibodies against coronaviruses are 
useful tools to identify conserved sites on the coronavirus spike 
protein, which could be investigated for the development of broad 
coronavirus vaccines that aim to prevent future pandemics. Potent 
neutralizers that target these sites could also be useful for 
prevention of disease caused by diverse coronaviruses, including those 
that may emerge in the future.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive patent commercialization license 
will be royalty bearing, and 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. 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. 522.

Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2023-23030 Filed 10-18-23; 8:45 am]
BILLING CODE 4140-01-P