[Federal Register Volume 78, Number 166 (Tuesday, August 27, 2013)]
[Notices]
[Page 52939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20880]



[[Page 52939]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Use of Scopolamine 
to Treat Depression

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This notice, in accordance with 35 U.S.C. 209 and 37 CFR part 
404, that the National Institutes of Health, Department of Health and 
Human Services, is contemplating the grant of an Exclusive Patent 
License to Antares Pharma Inc., a company having a place of business in 
Ewing, New Jersey, to practice the inventions embodied in the following 
patent applications and patents:
    1. U.S. Patent Application 11/137,114, filed May 25, 2005, titled 
``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. 
No. E-175-2004/0-US-01];
    2. European Patent 1896025, issued December 28, 2011, titled 
``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. 
No. E-175-2004/0-EP-03];
    3. German Patent 1896025, issued December 28, 2011, titled 
``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. 
No. E-175-2004/0-DE-07];
    4. French Patent 1896025, issued December 28, 2011, titled 
``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. 
No. E-175-2004/0-FR-08];
    5. British Patent 1896025, issued December 28, 2011, titled 
``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. 
No. E-175-2004/0-GB-09]; and
    6. Canadian Patent Application 2610025, filed May 18, 2006, titled 
``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. 
No. E-175-2004/0-CA-04.
    The patent rights in these inventions have been assigned to the 
Government of the United States of America. The territory of the 
prospective Exclusive Patent License may be worldwide, and the field of 
use may be limited to: ``The use of scopolamine for treatment of 
depression, including major depressive disorder, wherein the route of 
administration is subcutaneous, intramuscular, or transdermal delivery 
such as through injection or a patch or topical gel-based product''. 
This announcement is the second notice to grant an exclusive license to 
this technology.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
September 26, 2013 will be considered.

ADDRESSES: Requests for copies of the patents, patent applications, 
inquiries, comments, and other materials relating to the contemplated 
Exclusive Patent License should be directed to: Betty B. Tong, Ph.D., 
Senior Licensing and Patenting Manager, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 594-6565; Facsimile: (301) 
402-0220; Email: [email protected]. A signed confidentiality 
nondisclosure agreement will be required to receive copies of any 
patent applications that have not been published or issued by the 
United States Patent and Trademark Office or the World Intellectual 
Property Organization.

SUPPLEMENTARY INFORMATION: The subject invention describes 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 a 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 standalone treatment 
or as a treatment for patients who are unresponsive to currently 
available drugs.
    The prospective Exclusive Patent License will be royalty bearing 
and will comply with the terms and conditions of 35 U.S.C. 209 and 37 
CFR part 404. The prospective Exclusive Patent License may be granted 
unless within thirty (30) days from the date of this published notice, 
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.
    Complete applications for a license in the prospective field of use 
that are filed in response to this notice will be treated as objections 
to the grant of the contemplated Exclusive Patent License. Comments and 
objections submitted in response 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: August 22, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-20880 Filed 8-26-13; 8:45 am]
BILLING CODE 4140-01-P