[Federal Register Volume 85, Number 151 (Wednesday, August 5, 2020)]
[Notices]
[Page 47394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17098]


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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 Therapies To Treat IGF-1 Deficiency and 
Achondroplasia

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute and the Eunice Kennedy Shriver 
National Institute of Child Health and Human Development, 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 PreciThera, 
Inc, located in Montreal, 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 August 20, 2020 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated an Exclusive Patent License 
should be directed to: Martha T. Lubet, Ph.D., Licensing and Patenting 
Manager, NCI Technology Transfer Center, Telephone: (240) 276-5530 or 
Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    (United States Provisional) Patent Application No. 61/927904, filed 
January 15, 2014 and entitled: ``Cartilage Targeting Agents and Their 
Use'' [HHS Reference No. E-003-2014/0-US-01]; (PCT) Patent Application 
PCT/US2015/011433, filed January 14, 2015 and entitled ``Cartilage 
Targeting Agents and Their Use'' [HHS Reference No. E-003-2014/0-PCT-
02]; (and U.S. and foreign patent applications claiming priority to the 
aforementioned applications).
    The patent 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 field of use may be limited to the following:
    (A) A fusion protein comprising one of the anti-matrilin 3 binding 
agents and insulin-like growth factor 1 (IGF-1) for the treatment of 
short stature of humans with primary IGF-1 deficiency and
    (B) a fusion protein comprising one of anti-matrilin 3 binding 
agents and C-type natriuretic protein for the treatment of humans with 
achondroplasia.
    This technology discloses antigen binding antibody fragments that 
bind to matrilin-3. These agents were selected from a yeast display 
antibody library for the ability to bind to human or mouse matrilin-3. 
Matrilin-3 is strongly expressed in the epiphyseal growth plate of 
bones. In some embodiments, the antibody fragments are linked to an 
effector molecule (e.g. growth hormone, IGF-1, or C-type natriuretic 
protein). Methods of using the anti-Matrilin-3 binding agents to treat 
skeletal dysplasia, short stature and osteoarthritis are also 
disclosed.
    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 the prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the National 
Cancer Institute and the Eunice Kennedy Shriver National Institute of 
Child Health and Human Development receive 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.
    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: July 28, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2020-17098 Filed 8-4-20; 8:45 am]
BILLING CODE 4140-01-P