[Federal Register Volume 73, Number 150 (Monday, August 4, 2008)]
[Notices]
[Page 45231]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17817]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Development of Human 
Therapeutics for the Treatment of Depression

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

ACTION: Notice.

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SUMMARY: This 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 11/137,114 entitled ``Scopolamine For The Treatment 
Of Depression And Anxiety'' [HHS Ref. E-175-2004/0-US-01], PCT 
Application PCT/US2006/019335 [HHS Ref. E-175-2004/0-PCT-02] and all 
continuing applications and foreign counterparts (Europe, Australia and 
Canada), to Transcept Pharmaceuticals, Inc., which has offices in Pt. 
Richmond, CA. The patent rights in these inventions have been assigned 
to and/or exclusively licensed to the Government of the United States 
of America.
    The prospective exclusive license territory may be worldwide, and 
the field of use may be limited to:

    A worldwide exclusive license for the use of scopolamine for 
treatment of depression, including major depressive disorders (MDD), 
wherein the administration of scopolamine is intravenous, through 
the buccal membrane, intranasal, intramuscular or through a skin 
patch.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
October 3, 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: David A. Lambertson, Ph.D., Technology 
Licensing Specialist, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
MD 20852-3804; Telephone: (301) 435-4632; Facsimile: (301) 402-0220; E-
mail: [email protected].

SUPPLEMENTARY INFORMATION: The invention concerns the use of 
scopolamine for the treatment of depression, including major depressive 
disorders (MDD). Although scopolamine has been employed in the 
treatment of nausea and motion sickness, the suitability of scopolamine 
for treating MDD was unrecognized prior to this invention. Current MDD 
treatments can be ineffective in large percentage of patients and 
typically do not take effect until 4 weeks after administration. In 
contrast, treatment with scopolamine has a wide-ranging and rapid 
effect, suggesting it can be effective either as a stand alone 
treatment or as a treatment for patients who are unresponsive to 
currently available drugs.
    A Cooperative Research and Development Agreement (CRADA) is 
simultaneously being negotiated to accompany the exclusive license 
agreement. The CRADA will involve the further development of the 
licensed technology between the National Institute of Mental Health and 
Transcept.
    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. Applicants may also contact the 
National Institute of Mental Health regarding the CRADA opportunity. 
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: July 29, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E8-17817 Filed 8-1-08; 8:45 am]
BILLING CODE 4140-01-P