[Federal Register Volume 85, Number 205 (Thursday, October 22, 2020)]
[Notices]
[Page 67360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23386]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Development of 
a Direct Ocular Administered Formulation of Metformin for Use in 
Therapeutic Treatment of Retinal Degenerative Diseases in Humans

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Eye Institute, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Patent License to practice 
certain of the inventions embodied in the Patents and Patent 
Applications listed in the SUPPLEMENTARY INFORMATION section of this 
notice to Connectyx Technologies Holdings Group located in Boca Raton, 
Florida.

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 November 6, 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: Tedd Fenn, Senior Technology Transfer Manager, 
NCI Technology Transfer Center at Telephone: (240) 276-5530 or Email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Intellectual Property

    U.S. provisional patent application No. 62/899,899 and entitled, 
``Druggable Targets to Treat Retinal Degeneration'' filed September 13, 
2019 (E-227-2017-US-01); International Patent Application No.: PCT/
US2020/050540 and entitled, ``Druggable Targets to Treat Retinal 
Degeneration'' filed September 11, 2020 (E-227-2017-PCT-02); and U.S. 
and foreign patent applications claiming priority to the aforementioned 
applications.
    The patent rights in these inventions have been assigned 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 rights to develop, make use and 
sell, a direct ocular-administered formulation of metformin for use as 
therapeutics to treat retinal degenerative diseases in human.
    Metformin administration to Retinal Pigment Epithelium (``RPE'') 
cells derived from age-related macular degeneration patients and to RPE 
cells derived from Stargart's-patients shows reduced accumulations of 
disease associated retinal deposits, suggesting clinical treatment 
value for metformin in retinal degenerative diseases. Metformin is FDA 
approved for the treatment of diabetes. No formulation of metformin is 
available for direct ocular use. Development of a direct ocular 
delivery metformin formulation could provide improved treatment effects 
for retinal degenerative diseases, without major systemic side effects.
    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 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.
    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: October 15, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2020-23386 Filed 10-21-20; 8:45 am]
BILLING CODE 4140-01-P