[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Notices]
[Pages 36563-36564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14702]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: 
Oligonucleotides Analogues Targeting Human LMNA ``lamin A'' Gene

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Human Genome Research Institute (NHGRI), 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 consolidate co-owned rights to the 
inventions and the Patents and Patent Applications listed in the 
Supplementary Information section of this notice to The Progeria 
Research Foundation (``PRF''), having a place of business in 200 Lake 
Street, Unit 102, Peabody, MA 01960.

DATES: Only written comments and/or applications for a license that are 
received by the NHGRI Office of Technology Transfer Office on or before 
July 27, 2021 will be considered.

ADDRESSES: Requests for a copy of the patent application(s), inquiries, 
and comments relating to the contemplated license should be directed 
to: Eggerton Campbell, License and Patent Manager, NHGRI Technology 
Transfer Office, Telephone: 301-402-1648; email: 
<a href="/cdn-cgi/l/email-protection#3a5f5d5d5f484e555414595b574a585f56567a545352145d554c"><span class="__cf_email__" data-cfemail="82e7e5e5e7f0f6edecace1e3eff2e0e7eeeec2ecebeaace5edf4">[email protected]</span></a>.

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:

----------------------------------------------------------------------------------------------------------------
         Country                              Title                          Application No.        Patent No.
----------------------------------------------------------------------------------------------------------------
United States...........  Methods For Treating Progeroid Laminopathies  61/568,590..............
                           Using Oligonucleotide Analogues Targeting
                           Human LMNA NIH E-044-2013-0-US-01.
WIPO....................  Methods For Treating Progeroid Laminopathies  PCT/US12/068609.........
                           Using Oligonucleotide Analogues Targeting    WO 2013/086444..........
                           Human LMNA NIH E-044-2013-0-PCT-03.
United Kingdom..........  Methods For Treating Progeroid Laminopathies  12806796.4..............         2788488
                           Using Oligonucleotide Analogues Targeting
                           Human LMNA NIH E-044-2013-0-GB-12.
United States...........  Methods For Treating Progeroid Laminopathies  13/708,709..............       9,326,992
                           Using Oligonucleotide Analogues Targeting
                           Human LMNA NIH E-044-2013-0-US-02.
United States...........  Methods For Treating Progeroid Laminopathies  15/084,255..............       9,833,468
                           Using Oligonucleotide Analogues Targeting
                           Human LMNA NIH E-044-2013-0-US-06.
United States...........  Methods For Treating Progeroid Laminopathies  15/727,483 CON..........      10,398,721
                           Using Oligonucleotide Analogues Targeting
                           Human LMNA NIH E-044-2013-0-US-07.
Europe..................  Methods For Treating Progeroid Laminopathies  12806796.4..............         2788488
                           Using Oligonucleotide Analogues Targeting
                           Human LMNA NIH E-044-2013-0-EP-04.
Japan...................  Methods For Treating Progeroid Laminopathies  2019-109410.............
                           Using Oligonucleotide Analogues Targeting
                           Human LMNA NIH E-044-2013-0-JP-15.
France..................  Methods For Treating Progeroid Laminopathies  12806796.4..............         2788488
                           Using Oligonucleotide Analogues Targeting
                           Human LMNA NIH E-044-2013-0-FR-11.
Germany.................  Methods For Treating Progeroid Laminopathies  12806796.4..............         2788488
                           Using Oligonucleotide Analogues Targeting
                           Human LMNA NIH E-044-2013-0-DE-10.
Ireland.................  Methods For Treating Progeroid Laminopathies  12806796.4..............         2788488
                           Using Oligonucleotide Analogues Targeting
                           Human LMNA NIH E-044-2013-0-IE-13.
Japan...................  Methods For Treating Progeroid Laminopathies  2014-546152.............         6132849
                           Using Oligonucleotide Analogues Targeting
                           Human LMNA NIH E-044-2013-0-JP-05.
Japan...................  Methods For Treating Progeroid Laminopathies  2017-41744..............
                           Using Oligonucleotide Analogues Targeting
                           Human LMNA NIH E-044-2013-0-JP-08.
Netherlands.............  Methods For Treating Progeroid Laminopathies  12806796.4..............         2788488
                           Using Oligonucleotide Analogues Targeting
                           Human LMNA NIH E-044-2013-0-NL-14.
Switzerland.............  Methods For Treating Progeroid Laminopathies  12806796.4..............         2788488
                           Using Oligonucleotide Analogues Targeting
                           Human LMNA NIH E-044-2013-0-CH-09.
United States...........  Oligonucleotide Analogues Targeting Human     62/330,027..............
                           LMNA NIH E-044-2013-1-US-01.
WIPO....................  Oligonucleotide Analogues Targeting Human     PCT/US17/30174..........
                           LMNA NIH E-044-2013-1-PCT-02.                WO 2017/190041..........

[[Page 36564]]

 
United States...........  Oligonucleotide Analogues Targeting Human     16/096,524 (371-national      10,822,608
                           LMNA NIH E-044-2013-1-US-16.                  phase).
United States...........  Oligonucleotide Analogues Targeting Human     17/024,100..............
                           LMNA.
Australia...............  Oligonucleotide Analogues Targeting Human     2017258642..............
                           LMNA NIH E-044-2013-1-AU-03.
Brazil..................  Oligonucleotide Analogues Targeting Human     BR1120180722790.........
                           LMNA NIH E-044-2013-1-BR-04.
Canada..................  Oligonucleotide Analogues Targeting Human     3,022,303...............
                           LMNA NIH E-044-2013-1-CA-05.
China...................  Oligonucleotide Analogues Targeting Human     201780040785.7..........
                           LMNA NIH E-044-2013-1-CN-06.
Colombia................  Oligonucleotide Analogues Targeting Human     NC2018/0012783..........
                           LMNA NIH E-044-2013-1-CO-07.
Eurasia.................  Oligonucleotide Analogues Targeting Human     201892467...............
                           LMNA NIH E-044-2013-1-EA-08.
Europe..................  Oligonucleotide Analogues Targeting Human     17735676.3..............
                           LMNA NIH E-044-2013-1-EP-09.
Hong Kong...............  Methods For Treating Progeroid Laminopathies  19126894.5..............
                           Using Oligonucleotide Analogues Targeting
                           Human LMNA NIH E-044-2013-1-HK-17.
India...................  Oligonucleotide Analogues Targeting Human     201847043433............
                           LMNA NIH E-044-2013-1-IN-10.
Japan...................  Oligonucleotide Analogues Targeting Human     2019-508165.............
                           LMNA NIH E-044-2013-1-JP-11.
Korea (South)...........  Oligonucleotide Analogues Targeting Human     10-2018-7034615.........
                           LMNA NIH E-044-2013-1-KR-12.
Mexico..................  Oligonucleotide Analogues Targeting Human     MX/A/2018/013157........
                           LMNA NIH E-044-2013-1-MX-13.
New Zealand.............  Oligonucleotide Analogues Targeting Human     747685..................
                           LMNA NIH E-044-2013-1-NZ-14.
Singapore...............  Oligonucleotide Analogues Targeting Human     11201809468X............
                           LMNA NIH E-044-2013-1-SG-15.
----------------------------------------------------------------------------------------------------------------

    The patent rights in these inventions have been assigned to the 
Government of the United States of America, the University of Maryland, 
Sarepta Therapeutics, Inc, and the Progeria Research Foundation (PRF), 
co-owners of said rights, for commercial development and marketing. The 
rights to be granted by NHGRI are controlled by NHGRI by virtue of co-
ownership and a license received to the listed intellectual property. 
The prospective patent license will be for the purpose of consolidating 
the patent rights to PRF. 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, may be limited 
to those fields of use commensurate in scope with the patent rights, 
and will be sublicensable.
    The subject technology pertains to modified oligonucleotides 
(called phosphorodiamidate morpholino oligonucleotides or PMOs) 
targeted to pre-mRNA of human LMNA Lamin A gene. These PMOs can be used 
to correct aberrant splicing of LMNA gene known to be involved in 
Hutchinson-Gilford Progeria Syndrome (HGPS), and could be used in 
treating this ultra-rare disease and related laminopathies.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective Exclusive Patent License will be royalty 
bearing and may be granted unless, within fifteen (15) days from the 
date of this published notice, the NHGRI Technology Transfer Office 
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 this 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.

    Dated: June 29, 2021.
Claire T. Driscoll,
Director, Technology Transfer Office, National Human Genome Research 
Institute, National Institutes of Health.
[FR Doc. 2021-14702 Filed 7-9-21; 8:45 am]
BILLING CODE 4140-01-P


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