Notice: Prospective Grant of an Exclusive License: Therapeutics Based on 
Histone Deacetylase (HDAC) Inhibitors for the Prevention and Treatment 
of Central Nervous System (CNS) Metastases of Extra-CNS Origin Cancers

Federal Register: September 30, 2008 (Volume 73, Number 190)               
                  Page 56852

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

ACTION: Notice.

SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 
Part 404.7(a)(1)(i), announces that the Department of Health and Human 
Services is contemplating the grant of an exclusive license to practice 
the inventions embodied in U.S. Provisional Application 60/891,856 
filed February 27, 2007 (E-084-2007/0-US-01) and International 
Application PCT/US2008/055149 filed February 27, 2008 (E-084-2007/0-
PCT-02), entitled ``Use of Histone Deacetylase Inhibitors for the 
Treatment of Central Nervous System Metastases,'' to Waypharm S.A.S. 
The patent rights in these inventions have been assigned to the United 
States of America.
    The prospective exclusive license territory may be the United 
States and Europe, and the field of use may be limited to therapeutics 
based on CNS metastases of extra-CNS origin cancers.

DATES: Only written comments and/or license applications which are 
received by the National Institutes of Health on or before December 1, 
2008 will be considered.

ADDRESSES: Requests for copies of the patent and/or patent 
applications, inquiries, comments and other materials relating to the 
contemplated exclusive license should be directed to: Whitney A. 
Hastings, M.S., Technology Licensing Specialist, Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804. Telephone: (301) 451-7337; 
Facsimile: (301) 402-0220; E-mail: hastingw@mail.nih.gov.

SUPPLEMENTARY INFORMATION: The invention provides a method of treating 
CNS metastasis of cancers of extra-CNS origin. More specifically, the 
method comprises treating CNS metastasis of extra-CNS origin 
originating in one or more organs such as lung, breast, liver, colon, 
and prostate with a histone deacetylase (HDAC) inhibitor. The HDAC 
inhibitor can be any HDAC inhibitor that is capable of crossing the 
blood-brain barrier (BBB) such as vorinostat.
    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, the NIH receives 
written evidence and argument that establish that the grant of the 
license would not be consistent with the requirements of 35 U.S.C. 209 
and 37 CFR 404.7.
    Applications for a license in the field of use filed in response to 
this notice will be treated as objections to the grant of the 
contemplated 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: September 18, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-22893 Filed 9-29-08; 8:45 am]

BILLING CODE 4140-01-P