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###### Department of Health and Human Services

###### National Institutes of Health 

# 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