[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