[Federal Register Volume 88, Number 27 (Thursday, February 9, 2023)]
[Notices]
[Pages 8440-8441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02772]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Novel Therapeutics 
for the Treatment of Neurodegenerative Disorders

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Institute of Neurological Disorders and Stroke 
(``NINDS''), 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 University College London 
Business, Ltd. (``UCLB''), incorporated in England and Wales under 
company registration number 02776963 whose registered office address is 
University College

[[Page 8441]]

London, Gower Street, London WC1E 6BT, United Kingdom, for NINDS's 
rights to the patent applications listed in the Supplementary 
Information section of this notice. UCLB is the technology transfer 
company of the University College London (``UCL''), a non-profit 
research institution located in London, United Kingdom.

DATES: Only written comments and/or applications for a license which 
are received by the National Institute of Neurological Disorders and 
Stroke Technology Transer Office by February 24, 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: Lola Olufemi, Ph.D., Senior Technology Portfolio 
Manager; NINDS Technology Transfer Office, at Telephone: (301) 451-3748 
or Email: [email protected].

SUPPLEMENTARY INFORMATION: The following and all continuing U.S. and 
foreign patents/patent applications thereof are the intellectual 
properties to be licensed under the prospective agreement to UCLB 
include: PCT patent application number PCT/EP2021/084908, entitled 
``Novel Therapeutics for the treatment of neurodegenerative disorders'' 
(claiming priority to GB 2019418.9, filed December 9, 2020) filed 
December 9, 2021 (HHS Reference E-198-2021) and GB patent application 
number 2117758.9, entitled, ``Therapeutics for the treatment of 
neurodegenerative disorders'' (HHS Reference E-071-2023), filed 
December 9, 2021.
    With respect to the inventions described and claimed in the patent 
applications PCT/EP2021/084908 and GB 2117758.9, each of the inventors 
has assigned their rights to their respective employers or an entity 
which manages the intellectual property for their employer (The United 
States of America, UCL and UCLB). The prospective license will be for 
the purpose of consolidating the patent rights with UCLB, the co-owner 
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 patent license will be worldwide, exclusive, and 
may be limited to those fields of use commensurate in scope with the 
patent rights. It will be sublicensable, and any sublicenses granted by 
UCLB will be subject to the provisions of 37 CFR part 404.
    The technologies describe antisense oligonucleotides (ASOs) that 
are capable of modulating splicing by preventing inclusion of an UNC13A 
cryptic exon into an UNC13A mature mRNA. Guide RNAs including the ASO, 
and viral vectors expressing the ASO are also described. Such ASOs and 
guide RNAs may be used as a medicament, for example, to treat 
neurodegenerative disorders, particularly those associated with TDP-43 
pathology.
    This notice is made pursuant to 35 U.S.C. 209 and 37 CFR part 404. 
The prospective exclusive patent license will include terms for the 
sharing of royalty income with NINDS from commercial sublicenses of the 
patent rights and may be granted unless within fifteen (15) days from 
the date of this published notice the NINDS 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 that are timely filed in 
response to this notice will be treated as objections to the grant of 
the contemplated exclusive patent 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 from these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C 552.

Susan E Ano,
Branch Chief, Technology Transfer Branch, National Institute of 
Neurological Disorders and Stroke.
[FR Doc. 2023-02772 Filed 2-8-23; 8:45 am]
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