[Federal Register Volume 86, Number 14 (Monday, January 25, 2021)]
[Notices]
[Pages 6892-6893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-01488]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development and
Commercialization of Certain Fusion Proteins and Their Use for the
Treatment of Humans With Short Stature
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The Eunice Kennedy Shriver National Institute of Child Health
and Human Development and the National Cancer Institute, both
institutes of the National Institutes of Health, Department of Health
and Human Services, are contemplating the grant of an Exclusive Patent
License to practice the inventions embodied in the Patents and Patent
Applications listed in the Supplementary Information section of this
Notice to EpifiZa Inc. of Montreal, QC (Canada).
DATES: Only written comments and/or applications for a license which
are received by the National Cancer Institute's Technology Transfer
Center on or before February 9, 2021 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: Richard T. Girards, Jr., Esq., MBA, Senior
Technology Transfer Manager, National Institutes of Health, NCI
Technology Transfer Center by email ([email protected]) or phone
(240-276-6825).
SUPPLEMENTARY INFORMATION:
Intellectual Property
E-003-2014: Agents That Specifically Bind Matrilin-3 and Their Use/
Cartilage Targeting Agents and Their Use
1. United States Provisional Patent Application No. 61/927,904,
filed 15 January 2014 (HHS Reference No. E-003-2014-0-US-01);
2. United States Patent No. 10,323,083, issued 18 June 2019 (HHS
Reference No. E-003-2014-0-US-06);
3. United States Patent Application No. 16/391,101, filed 22 April
2019
[[Page 6893]]
(HHS Reference No. E-003-2014-0-US-07);
4. International Patent Application No. PCT/US2015/011433, filed 14
January 2015 (HHS Reference No. E-003-2014-0-PCT-02);
5. Australia Patent No. 2015206515, issued 26 March 2020 (HHS
Reference No. E-003-2014-0-AU-03);
6. Canada Patent Application No. 2931005, filed 14 January 2015
(HHS Reference No. E-003-2014-0-CA-04);
7. European Patent No. 3 094 350 B1, issued 04 March 2020 (HHS
Reference No. E-003-2014-0-EP-05) and all of its national validations;
8. European Patent Application No. 19219282.1, filed 14 January
2015 (HHS Reference No. E-003-2014-0-EP-11); and
9. any and all other U.S. and ex-U.S. patents and patent
applications claiming priority to any one of the foregoing, now or in
the future.
The patent and patent application rights in these inventions have
been assigned and/or exclusively licensed to the government of the
United States of America.
The prospective exclusive license territory may be worldwide and
the fields of use may be limited to the following: The development,
manufacture, distribution, sale and use of one or more fusion proteins
for the treatment of humans with short stature associated with one or
more genetic conditions.
These technologies disclose, e.g., monoclonal antibodies and
antibody fragments that specifically bind to matrilin-3, conjugates
including these molecules, and nucleic acid molecules encoding the
antibodies, antigen binding fragments and conjugates. Also disclosed
are compositions including the disclosed antibodies, antigen binding
fragments, conjugates, and nucleic acid molecules. Methods of treating
or inhibiting a cartilage disorder in a subject, as well as methods of
increasing chondrogenesis in cartilage tissue are further provided. The
methods can be used, for example, for treating or inhibiting a growth
plate disorder in a subject, such as a skeletal dysplasia or short
stature.
This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR
404. The prospective exclusive license will be royalty bearing, and the
prospective exclusive license may be granted unless within fifteen (15)
days from the date of this published Notice, the National Cancer
Institute 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 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.
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: January 11, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2021-01488 Filed 1-22-21; 8:45 am]
BILLING CODE 4140-01-P