[Federal Register Volume 87, Number 154 (Thursday, August 11, 2022)]
[Notices]
[Page 49599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17214]



[[Page 49599]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License, Inter-Institutional 
Agreement-Institution Lead: Multivalent Vaccines for Rabies Virus and 
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, 
sublicensable patent license to Thomas Jefferson University, located in 
Philadelphia, Pennsylvania 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 August 26, 2022 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: Wade Green, Ph.D., Lead Technology Transfer and 
Patent Specialist, Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases (NIAID), 
5601 Fishers Lane, Suite 6D, MSC9804, Rockville, MD 20852-9804, phone 
number 301-761-7505, or [email protected].

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement: US Provisional 
Patent Application Number 62/318,087, filed 04 April 2016, titled 
``Multivalent vaccines for rabies virus and coronaviruses'' (HHS 
Reference No. E-128-2016-0-US-01); PCT Application Number PCT/US17/
25623, filed 31 March 2017, titled ``Multivalent vaccines for rabies 
virus and coronaviruses'' (HHS Reference No. E-128-2016-0-PCT-02); US 
Patent 11,041,170, issued 22 June 2021, titled ``Multivalent vaccines 
for rabies virus and coronaviruses'' (HHS Reference No. E-128-2016-0-
US-05); US Patent Application Number 17/307,066, filed 04 May 2021, 
titled ``Multivalent vaccines for rabies virus and coronaviruses'' (HHS 
Reference No. E-128-2016-0-US-06); EPO Patent Application Number 
2017718216.9, filed 31 March 2017, titled ``Multivalent vaccines for 
rabies virus and coronaviruses'' (HHS Reference No. E-128-2016-0-EP-
03); and Saudi Arabian Patent Application Number 518400172, filed 04 
October 2018, titled ``Multivalent vaccines for rabies virus and 
coronaviruses'' (HHS Reference No. E-128-2016-0-SA-04). All rights in 
these inventions have been assigned to Thomas Jefferson University, 
University of Maryland, Baltimore, and the Government of the United 
States of America as represented by the Secretary, Department of Health 
& Human Services.
    The prospective patent license will be for the purpose of 
consolidating the patent rights to Thomas Jefferson University, one of 
the co-owners of said rights, for commercial development and marketing.
    Consolidation of these co-owned rights is intended to expedite 
development of the invention, consistent with the goals of the Bayh-
Dole Act codified as 35 U.S.C. 200-212.
    The prospective interinstitutional agreement will include an 
exclusive license for NIAID's rights in these jointly owned patents. It 
will be sublicensable, and any sublicenses granted by Thomas Jefferson 
University will be subject to the provisions of 37 CFR part 401 and 
404.
    The subject patent rights are related to novel recombinant vaccine 
constructs based on a genetically modified, attenuated rabies virus 
vaccine vector expressing one or more coronavirus immunogenic 
polypeptides. These constructs elicit strong bi-valent immunogenic 
responses against both rabies virus and the respective coronavirus in 
animal models. The novel rabies virus vector used in these constructs 
was developed by Thomas Jefferson University prior to the co-
development of the subject patent rights by Thomas Jefferson 
University, the University of Maryland, Baltimore, and NIAID.
    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 may be granted unless within fifteen (15) days from the date of 
this published notice, the National Insitute 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.
    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.
    Complete 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: August 5, 2022.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2022-17214 Filed 8-10-22; 8:45 am]
BILLING CODE 4140-01-P