[Federal Register Volume 84, Number 86 (Friday, May 3, 2019)]
[Notices]
[Pages 19090-19091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09099]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Scopolamine 
Therapeutics for Depression and Bipolar Disorder

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Institute of Mental Health (NIMH), National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an exclusive patent license to Repurposed 
Therapeutics, Inc. (``Repurposed Therapeutics'') located in Tampa, 
Florida, to practice the inventions embodied in the patent application 
listed in the Supplementary Information section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the NIMH Technology Transfer Office May 20, 2019 will 
be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated exclusive patent license 
should be directed to: Jennifer Wong, MS, Technology Development 
Coordinator, NIMH Technology Transfer Office, 35A Convent Drive, GE-
400, Bethesda, MD 20892, phone number 301-480-4821, or 
[email protected].

SUPPLEMENTARY INFORMATION: The following patents/patent applications 
are the intellectual properties to be licensed under the prospective 
agreement to Repurposed Therapeutics: U.S. Patent 8,859,585, issued 
October 14, 2014, entitled ``Scopolamine for the Treatment of 
Depression and Anxiety'' [HHS Ref. No. E-175-2004-0-US-01]; Patent 
Cooperation Treaty (PCT) Application PCT/US2006/019335 filed May 18, 
2006, entitled ``Scopolamine for the Treatment of Depression and 
Anxiety'' [HHS Ref. No. E-175-2004-0-PCT-02]; European Patent 1896025, 
issued December 28, 2011 entitled ``Scopolamine for the Treatment of 
Depression and Anxiety'' [HHS Ref. No. E-175-2004-0-EP-03]; Canadian 
Patent 2610025, issued July 22, 2014, entitled ``Scopolamine for the 
Treatment of Depression and Anxiety'' [HHS Ref. No. E-175-2004-0-CA-
04]; German Patent 602006026717.7, issued December 28, 2011, entitled 
``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. 
No. E-175-2004-0-DE-07]; French Patent 1896025, issued December 28, 
2011, entitled ``Scopolamine for the Treatment of Depression and 
Anxiety'' [HHS Ref. No. E-175-2004-0-FR-08]; UK Patent 1896025, issued 
December 28, 2011, entitled ``Scopolamine for the Treatment of 
Depression and Anxiety'' [HHS Ref. No. E-175-2004-0-GB-09], and US 
Patent No. Patent 9,707,220, issued July 18, 2017, entitled 
``Scopolamine for the Treatment of Depression and Anxiety''

[[Page 19091]]

[HHS Ref. No. E-175-2004-0-US-10]. The patent rights in these 
inventions have been assigned to the Government of the United States of 
America.
    The prospective patent license may be worldwide, and the field of 
use may be limited to intranasal and intravenous scopolamine 
therapeutics for depression and bipolar disorder.
    The invention pertains to the use of scopolamine for the treatment 
of depression and other indications associated with depression, such as 
the depressive phase of bipolar disorder. Although scopolamine has been 
employed in the treatment of nausea and motion sickness, the 
suitability of scopolamine for treating depression was unrecognized 
prior to this invention. Current depression treatments can be 
ineffective in large percentage of patients and typically do not take 
effect until four weeks after administration. In contrast, treatment 
with scopolamine suggests it may be effective either as a stand-alone 
treatment or as a treatment for patients who are unresponsive to 
currently available drugs.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive patent license will be royalty 
bearing and may be granted unless within fifteen (15) days from the 
date of this published notice, the NIMH 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.
    Complete applications for a license in the prospective field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive patent 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.

Jennifer S. Wong,
Technology Development Coordinator, Technology Transfer Office, 
National Institute of Mental Health.
[FR Doc. 2019-09099 Filed 5-2-19; 8:45 am]
BILLING CODE 4140-01-P