[Federal Register Volume 80, Number 13 (Wednesday, January 21, 2015)]
[Notices]
[Pages 2951-2952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-00811]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Start-up Exclusive License: Scopolamine for 
the Treatment of Depression and Anxiety

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Institutes of Health (NIH), Department of 
Health and Human Services, is contemplating the grant of a Start-Up 
Exclusive Patent License to Biohaven Pharmaceuticals Holding Company 
having its principal place of business in New Haven, Connecticut. The 
contemplated license would be for the inventions claimed in U.S. 
Utility Patent Number 8,859,585, issued October 14, 2014 (filed May 25, 
2005), PCT Patent Application Number PCT/US2006/19335, filed May 18, 
2006, U.S. Patent Application Number 14/478,442, filed September 5, 
2014, European Patent Number 1896025, issued December 28, 2011 (and 
validated in Germany, France, and the United Kingdom), and Canadian 
Patent Number 2610025, issued July 22, 2014 (filed May 28, 2006). In 
addition, inventions claimed in any future applications claiming 
priority to or benefit of these patents and patent applications would 
also be subject to any license granted pursuant to this Notice.
    The patent rights in this invention have been assigned to the 
Government of the United States of America. The territory of the 
prospective Start-Up Exclusive Patent License Agreement may be 
worldwide and the field of use may be limited to use of scopolamine

[[Page 2952]]

for treatment of neuropsychiatric indications.

DATES: Only written comments and/or applications for a license that are 
received by the NIH Office of Technology Transfer on or before February 
5, 2015 will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated Start-Up 
Exclusive license should be directed to: Susan Ano, Ph.D., Branch 
Chief, Office of Technology Transfer, National Institutes of Health, 
6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; 
Telephone: (301) 435-5515; Facsimile: (301) 402-0220; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: 
    The subject invention describes the use of scopolamine for the 
treatment of depression, including major depressive disorder. 
Scopolamine is a known compound that has been employed in the treatment 
of nausea and motion sickness, as well as in conjunction with 
analgesics but the suitability of scopolamine for treating depression 
was unrecognized prior to this invention.
    An important feature of scopolamine, as a treatment for depression, 
is its fast-acting nature. Currently available treatments can be 
ineffective in certain depression patients and typically do not show an 
effect in any patient until four weeks after first administration. 
However, preclinical data suggests that scopolamine has a rapid, wide-
ranging and long lasting effect. This feature makes scopolamine highly 
desirable as a new treatment for depression.
    The prospective Start-Up Exclusive License Agreement is being 
considered under the small business initiative launched on October 1, 
2011 and complies with the terms and conditions of 35 U.S.C. 209 and 37 
CFR 404. The prospective exclusive license may be granted unless within 
fifteen (15) 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 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 Start-Up 
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: January 13, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-00811 Filed 1-20-15; 8:45 am]
BILLING CODE 4140-01-P