[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Notices]
[Pages 26772-26773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-10836]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Ocular Therapeutics Agent 
Delivery Devices and Methods for Making and Using Such Devices

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 patent license to practice the inventions embodied in 
Patent Applications USSN 09/808,149, filed Mar 15, 2001, issued Mar 30, 
2004; PCT/US02/07836, filed Mar 14, 2002, designated EP, 02723446,7 and 
US 10/471,468, issued Feb 9, 2010; USSN 11/739,540, filed Apr 29, 2007; 
and USSN 12/647,980, filed Dec 28, 2009; entitled ``Ocular Therapeutic 
Agent Delivery Devices and Methods For Making and Using Such Devices'', 
by Michael R. Robinson et al (NEI, CC, and NIBIB) (E-241-1999/0), to 
ODIN Biotech having a place of business in 4000 Hanover Street, Dallas, 
TX. The patent rights in this invention have been assigned to the 
United States of America. The exclusive patent license is one which 
qualifies under the Start-up Exclusive Patent License Agreement 
program, which is in place from October 1, 2011 through September 30, 
2012.

DATES: Only written comments and/or application for a license that are 
received by the NIH Office of Technology Transfer on or before May 22, 
2012 will be considered.

[[Page 26773]]


FOR FURTHER INFORMATION CONTACT: Requests for a copy of the patent 
application, inquiries, and comments relating to the contemplated 
license should be directed to: Susan Ano, Ph.D., Branch Chief, IDME, 
Office of Technology Transfer, National Institutes of Health, 6011 
Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Email: 
[email protected]; Telephone: 301-435-5515; Facsimile: 301-402-0220.

SUPPLEMENTARY INFORMATION: The invention relates to a drug delivery 
system, compositions of, methods of making the drug delivery system, 
and methods of use as a drug delivery platform. Ocular therapeutics 
that require repeated intravitreal injections are associated with eye 
infections, retinal detachment, hemorrhaging, endophthalmitis, and/or 
cataracts, while topical solutions that require daily application are 
associated with patient non-compliance. This technology describes a 
drug delivery platform that can be designed to deliver therapeutics to 
the eye over months to years. Therefore, this technology can be used to 
design a therapeutic implant that reduces or eliminates patient non-
compliance and/or improve patient safety. The therapeutic implant has 
the following advantages: (a) It is bioerodible which makes it more 
noninvasive than repeated intravitreal injections and non-bioerodible 
implants; (b) has a dual release system that allows the release of two 
distinct therapeutics or a single therapeutic at different rates; (c) 
prolongs the therapeutic dose of an agent across the surface of the eye 
compared to topical solutions; (d) reduces the risk of additional eye 
damage compared to repeated intravitreal injections; (e) dispenses a 
therapeutic agent over a long period of time resulting in increase 
patient compliance and patient health; and (f) is associated with 
reduced systemic drug side-effects compared to drugs applied 
systemically. Data are available for rodents, rabbits, dogs, and 
horses.
    The field of use may be limited to ``Episcleral Therapeutic Implant 
for Ophthalmic Diseases''.
    The prospective worldwide 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 fifteen (15) 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: May 1, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-10836 Filed 5-4-12; 8:45 am]
BILLING CODE 4140-01-P