2012-10636. Prospective Grant of Exclusive License: Development of Ocular Therapeutics Utilizing the Peptide C16Y and Related Peptides

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to ODIN Biotech, a Texas corporation, having a place of business in Dallas, Texas, to practice the inventions embodied in the patents and patent applications belonging to the patent family having HHS Reference Number E-008-2004/0. The exclusive license is one which qualifies under the Start-Up License Agreement program which is in place from October 1, 2011 through September 30, 2012. Specific details regarding the individual patents or patent applications which belong to this patent family are set forth in the table below:

Patent application number	Country	Filing date or international filing date	Status	Publication or patent number
PCT/US2004/04142	PCT	02/12/2004	Expired	WO 2005/087250
10/588,884	US	08/09/2006	Issued	8,039,585 B2
2004317159	AU	02/12/2004	Issued	2004317159 B2
2,555,792	CA	2/12/2004	Pending	2555792 A1
04 710659.6	EP	2/12/2004	Pending	1737479 A1

The patent rights in these inventions have been assigned to the United States of America.

The prospective exclusive license territory may be “worldwide”, and the field of use may be limited to “use of C16Y and related peptides in the treatment of ocular disease.”

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before May 18, 2012 will be considered.

FOR FURTHER INFORMATION CONTACT:

Requests for copies of the patent application(s), inquiries, AND comments relating to the contemplated exclusive license should be directed to: Susan S. Rucker, JD, CLP, Senior Advisor for Intellectual Property Transactions, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone]; Facsimile: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

The technology encompassed by the patents and/or patent applications (IP) to be included in this exclusive license relates to a protein designated C16Y and variations thereof. C16Y is an engineered peptide derived from laminin gamma 1 chain having anti-angiogenic properties. The C16Y peptide is at least 5-fold more potent than the previously described C16S peptide and has been shown to inhibit choroidal neovascularization (CNV) in vivo and inhibit angiogenesis in a tumor bearing mouse model (see Ponce, et al Cancer Research 63: 5060-64 (2003)). The IP covers various C16Y compositions and uses thereof, particularly its use in treating ocular diseases.

The prospective start up exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective start up exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the NIH 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 404.7.

Only applications for a license in the field of use set forth in this notice and filed in response to this notice will be treated as objections to the grant of the contemplated start up exclusive license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

Dated: April 27, 2012.

Richard U. Rodriguez,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.