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

# 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 Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 60/689,746, filed June 10, 2005, now abandoned [HHS Ref. No. E-089-2005/0-US-01]; PCT Patent Application No. PCT/US2006/22401, filed June 7, 2006, now abandoned [HHS Ref. No. E-089-2005/0-US-02]; U.S. Patent Application No. 11/917,036, filed December 10, 2007 [HHS Ref. No. E-089-2005/0-US-03]; European Patent Application No. 06772641.4, filed December 7, 2007, which published as 1888064 on February 20, 2008 [HHS Ref. No. E-089-2005/0-EP-04]; Australian Patent Application No. 2006258035, filed November 30, 2007 [HHS Ref. No. E-089-2005/0-AU-05]; Japanese Patent Application No. 2008-515947, filed December 7, 2007 [HHS Ref. No. E-089-2005/0-JP-06]; and Canadian Patent Application No. 2609577, filed November 23, 2007 [HHS Ref. No. E-089-2005/0-CA-07], all of which are entitled “Benztropinamine Analogs as Dopamine Uptake Inhibitors” (Inventors: Amy Newman and Jonathan Katz, NIDA) to Shire LLC, having an office in at least Basingstoke, United Kingdom. The patent rights in these inventions have been assigned to the United States of America. 

                        The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of benztropinamine analogs,                               ( print page 55860)                            specifically, compounds derived from Formula I, wherein B is NR 4                         and wherein R 4                         is not CH3                         (methyl group) to treat psychiatric and neurological disorders.                     

# DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before November 25, 2008 will be considered. 

# ADDRESSES:

                        Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: Charlene A. Sydnor, Ph.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-4689; Facsimile: (301) 402-0220; e-mail:                         *sydnorc@mail.nih.gov*.                     

# SUPPLEMENTARY INFORMATION:

This technology relates to the synthesis of novel dopamine transport inhibitors and their use to treat mental disorders. The inventors developed benztropinamine analogs by replacing the benzhydrylether moiety of benztropine and its analogs with the isosteric benzhydrylamine system in order to produce more stable compounds with increased solubility and bioavailability for improved therapeutic formulation and utility. These compounds have a high affinity for the dopamine transporter and inhibit dopamine uptake, but do not produce a significant stimulation of locomotor activity or cocaine-like subjective effects in a drug discrimination model. These compounds are useful for the treatment of mental disorders such as conduct disorders, alcohol addiction, tobacco addiction, nicotine addiction, drug addiction, sleep disorders, inhalation disorders, Parkinsonism including Parkinson's disease, female and male orgasmic disorders, female and male sexual arousal disorders, hypoactive sexual desire disorders, and anxiety and/or depression disorders. These compounds are also useful as imaging probes for detecting cocaine binding sites, as well as monitoring or diagnosing Parkinson's 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 Part 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 establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR Part 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 17, 2008. 

Richard U. Rodriguez, 

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

[FR Doc. E8-22611 Filed 9-25-08; 8:45 am] 

BILLING CODE 4140-01-P