[Federal Register Volume 70, Number 250 (Friday, December 30, 2005)]
[Notices]
[Pages 77420-77421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-8120]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Implants for Sustained 
Ocular Therapeutic Agent Delivery

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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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 Sj[ouml]gren'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: (301) 435-
5019; Facsimile: (301) 402-0220; E-mail: [email protected]. 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.


[[Page 77421]]


    Dated: December 21, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E5-8120 Filed 12-29-05; 8:45 am]
BILLING CODE 4140-01-P