E5-8120. Prospective Grant of Exclusive License: Implants for Sustained Ocular Therapeutic Agent Delivery

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 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in E-241-1999/0, “Ocular Therapeutic Agent Delivery Devices And Methods For Making And Using Such Devices;” U.S. Patent 6,713,081 issued March 30, 2004 and expires March 15, 2021; U.S. Patent Application 10/471,468 filed September 12, 2004; and European Patent Application 02723446.7 filed March 14, 2002; to Lux Biosciences, a Delaware corporation having a principle place of business in Jersey City, New Jersey. The United States of America is the assignee of the patent rights of the above inventions.

The contemplated exclusive license may be granted in the field of ocular cyclosporine A delivery for the treatment of graft-versus-host-disease-associated dry eye and Sjögren's Syndrome.

DATES:

Only written comments and/or applications for a license received by the NIH Office of Technology Transfer on or before February 28, 2006 will be considered.

ADDRESSES:

Requests for a copy of the patent applications, inquiries, comments and other materials relating to the contemplated license should be directed to: Michael A. Shmilovich, Esq., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone]; Facsimile: [phone]; E-mail: [e-mail]. A signed confidentiality nondisclosure agreement may be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION:

The patent applications intended for licensure disclose and/or cover the following: E-241-1999/0, “Ocular Therapeutic Agent Delivery Devices And Methods For Making And Using Such Devices.” The invention is a method and apparatus for delivering a precisely controlled amount of drug to the eye on a sustained basis using an implantable polymer cylinder containing a drug pellet. In this method, the thickness of the polymer around the drug pellet is precisely controlled to provide a predictable release rate of the drug to the eye. Drug pellets made using a modified press are placed in a teflon tube having a silicone base, the top of the tube is filled with wet silicone and the pellet is spun down and centered in the teflon tubing. The teflon tubing is removed and the top and bottom ends of the silicone cylinder surrounding the pellet are trimmed. Thus, an annulus of uniform thickness surrounds the drug pellet, resulting in a uniform and predictable release rate. The invention also comprises a method, apparatus and implant design developed for surgical subconjunctival implantation to deliver an initial bolus of drug to the eye compartments followed by slow release of drug from the polymer matrix of the implant. A pellet of drug (e.g., cyclosporine) is imbedded between two saucer or disk shaped polyvinyl alcohol (PVA) components, forming a “wafer” shaped implant. The drug is also mixed into the matrix of the PVA itself at a nominal 10% concentration. Soon after implantation, a high level of drug is delivered to the eye for the first month and, thereafter, the embedded pellet sustains a continuous release of the drug.

The invention has also been described along with preclinical data in a recent publication by Kim et al. (2005) IOVS 46(2):655-662, “Preclinical Evaluation of a Novel Episcleral Cyclosporine Implant for Ocular Graft-Versus-Host Disease.”

The prospective 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 exclusive license may be granted unless, within sixty (60) days from the date of this published notice, 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.

Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response 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: December 21, 2005.

Steven M. Ferguson,

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