Notice2023-23030
Prospective Grant of Exclusive Patent Commercialization License: Human Monoclonal Antibodies That Broadly Target Coronaviruses
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 19, 2023
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 201 (Thursday, October 19, 2023)</title>
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[Federal Register Volume 88, Number 201 (Thursday, October 19, 2023)]
[Notices]
[Pages 72088-72089]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="/cdn-cgi/l/email-protection#640005130a4a10051d080b16490911080a010d1c240a0d0c4a030b12"><span class="__cf_email__" data-cfemail="bfdbdec8d191cbdec6d3d0cd92d2cad3d1dad6c7ffd1d6d791d8d0c9">[email protected]</span></a>.
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
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