2020-23386. 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.

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: [phone] or Email: [e-mail].

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.