Prospective Grant of Exclusive Patent License: Use of Scopolamine to Treat Depression, 52939 [2013-20880]
Download as PDF
<![CDATA[
Federal Register / Vol. 78, No. 166 / Tuesday, August 27, 2013 / Notices
DATES:
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.
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.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:54 Aug 26, 2013
Jkt 229001
52939
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.
Dated: August 22, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
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: tongb@
mail.nih.gov. 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.
[FR Doc. 2013–20880 Filed 8–26–13; 8:45 am]
ADDRESSES:
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.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG–2013–0222]
Collection of Information under Review
by Office of Management and Budget
Coast Guard, DHS.
Thirty-day notice requesting
comments.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an
Information Collection Request (ICR),
abstracted below, to the Office of
Management and Budget (OMB), Office
of Information and Regulatory Affairs
(OIRA), requesting an approval for the
following collection of information:
1625—NEW, U.S. Coast Guard NonAppropriated Fund Employment
Application. Our ICR describes the
information we seek to collect from the
public. Review and comments by OIRA
ensure we only impose paperwork
burdens commensurate with our
performance of duties.
DATES: Comments must reach the Coast
Guard and OIRA on or before September
26, 2013.
ADDRESSES: You may submit comments
identified by Coast Guard docket
number [USCG–2013–0222] to the
Docket Management Facility (DMF) at
the U.S. Department of Transportation
(DOT) and/or to OIRA. To avoid
duplicate submissions, please use only
one of the following means:
(1) Online: (a) To Coast Guard docket
at https://www.regulations.gov. (b) To
OIRA by email via: OIRA-submission@
omb.eop.gov .
(2) Mail: (a) DMF (M–30), DOT, West
Building Ground Floor, Room W12–140,
1200 New Jersey Avenue SE.,
Washington, DC 20590–0001. (b) To
OIRA, 725 17th Street NW.,
Washington, DC 20503, attention Desk
Officer for the Coast Guard.
(3) Hand Delivery: To DMF address
above, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal
holidays. The telephone number is 202–
366–9329.
(4) Fax: (a) To DMF, 202–493–2251.
(b) To OIRA at 202–395–6566. To
SUMMARY:
E:\FR\FM\27AUN1.SGM
27AUN1
]]>Agencies
[Federal Register Volume 78, Number 166 (Tuesday, August 27, 2013)]
[Notices]
[Page 52939]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20880]
[[Page 52939]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: tongb@mail.nih.gov. 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
