Prospective Grant of Exclusive License: The Development of Human Therapeutics for the Treatment of Depression, 45231 [E8-17817]
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Federal Register / Vol. 73, No. 150 / Monday, August 4, 2008 / Notices
Licensing Contact
Surekha Vathyam, Ph.D.; 301–435–
4076; vathyams@mail.nih.gov.
Dated: July 28, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–17812 Filed 8–1–08; 8:45 am]
BILLING CODE 4140–01–P
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
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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.
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,
pwalker on PROD1PC71 with NOTICES
DATES:
VerDate Aug<31>2005
16:50 Aug 01, 2008
Jkt 214001
45231
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:
lambertsond@od.nih.gov.
DEPARTMENT OF HOMELAND
SECURITY
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.
National Preparedness for Response
Exercise Program
SUPPLEMENTARY INFORMATION:
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
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
Coast Guard
[Docket No. USCG–2008–0521]
Coast Guard, DHS.
Notice; request for public
comment.
AGENCY:
ACTION:
SUMMARY: The Coast Guard, the Pipeline
and Hazardous Materials Safety
Administration, the Environmental
Protection Agency, and the Minerals
Management Service, in concert with
representatives from various State
governments, industry, environmental
interest groups, and the general public,
developed the National Preparedness for
Response Exercise Program (PREP)
Guidelines to reflect the consensus
agreement of the entire oil spill
response community. This notice
announces the PREP 5-year exercise
cycle, 2009 through 2013, and requests
comments from the public, and requests
volunteers from industry to participate
in the scheduled PREP Area exercises.
The new schedule adjustment from 3
years to 5 years was created to align
with the Department of Homeland
Security’s National Exercise 5-year
Schedule.
Comments and related material
must reach the Docket Management
Facility on or before October 3, 2008.
ADDRESSES: You may submit comments
identified by Coast Guard docket
number USCG–2008–0521 to the Docket
Management Facility at the U.S.
Department of Transportation. To avoid
duplication, please use only one of the
following methods:
(1) Online: https://
www.regulations.gov.
(2) Mail: Docket Management Facility
(M–30), U.S. Department of
Transportation, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue, SE., Washington, DC 20590–
0001.
(3) Hand delivery: Same as mail
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: 202–493–2251.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this notice, or
need general information regarding the
PREP or the 5-year exercise schedule,
contact Lieutenant Shawn Essert, Office
of Contingency Exercises (CG–535), U.S.
Coast Guard, telephone 202–372–2149,
or e-mail shawn.g.essert@uscg.mil. If
DATES:
E:\FR\FM\04AUN1.SGM
04AUN1
]]>Agencies
[Federal Register Volume 73, Number 150 (Monday, August 4, 2008)]
[Notices]
[Page 45231]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17817]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: lambertsond@od.nih.gov.
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
