Prospective Grant of Exclusive Patent License: Oral Treatment of Hemophilia, 57868 [2013-22875]
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Federal Register / Vol. 78, No. 183 / Friday, September 20, 2013 / Notices
Special Emphasis Panel, PAR–11–043 NIDDK
Program Project: Responses to Bariatric
Surgery.
Date: December 11, 2013.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Ann A. Jerkins, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 759, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, 301–594–2242,
jerkinsa@niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: September 13, 2013.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–22891 Filed 9–19–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
License: Oral Treatment of Hemophilia
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR 404, that
the National Institutes of Health (NIH),
Department of Health and Human
Services (HHS), is contemplating the
grant of an Exclusive Patent License to
ProGenetics, LLC, a company having its
headquarters in Blacksburg, Virginia, to
practice the inventions embodied in
U.S. Patent No. 7,220,718, issued 27
February 2007 (HHS Ref. No. E–281–
2001/0–US–03]), European Patent
Application No. 02756904.5 (HHS Ref.
No. E281–2001/0–EP–04), filed August
2, 2002, and U.S. Patent No. 7,867,974,
issued 11 January 2011 (HHS Ref. No.
E–281–2001/0–US–05), entitled
respectively, ‘‘Oral Treatment of
Hemophilia’’ and ‘‘Induction of
Tolerance by Oral administration of
Factor VIII and Treatment of
Hemophilia’’. The patent rights in these
inventions have been assigned to or
exclusively licensed to the Government
of the United States of America. The
prospective Exclusive Patent License
territory may be ‘‘worldwide’’, and the
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:24 Sep 19, 2013
Jkt 229001
field of use may be limited to:
‘‘Treatment of Hemophilia A and B and
immunotolerization using oral delivery
methods’’.
DATES: Only written comments and/or
applications for a license received by
the NIH Office of Technology Transfer
on or before October 21, 2013 will be
considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments
and other materials relating to the
contemplated Exclusive Patent License
should be directed to: Vince Contreras,
Ph.D., Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Telephone:
(301) 435–4711; Facsimile: (301) 402–
0220; Email: vince.contreras@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: This
technology relates to therapeutic
methods of arresting bleeding episodes
in a subject having hemophilia A or B,
by orally administering an effective
amount of the appropriate clotting
factor, sufficient to induce oral tolerance
and supply exogenous clotting factor to
the subject. Roughly 20,000 people in
the U.S. have hemophilia with over 200
new patients born every year. Currently
there is no cure for hemophilia and
treatment generally involves
intravenous infusion of missing clotting
factors derived from concentrated
preparations of donated blood plasma
which can be expensive and result in
generating inhibitory antibodies. The
current technology provides a rapid,
inexpensive oral treatment for
individuals suffering from hemophilia A
or B by utilizing a high quantity source
of clotting factors produced in milk.
The prospective worldwide 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
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
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
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: September 16, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2013–22875 Filed 9–19–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Nominations to the Report on
Carcinogens; Request for Information
National Toxicology Program
(NTP) Office of the Report on
Carcinogens (ORoC) requests
information on 20 substances, mixtures,
and exposure circumstances
(collectively referred to as ‘‘substances’’)
nominated for possible review for future
editions of the Report on Carcinogens
(RoC).
DATES: The deadline for receipt of
information is October 18, 2013.
ADDRESSES: Information can be
submitted electronically on the ORoC
nomination page (https://
ntp.niehs.nih.gov/go/rocnom) or to
lunn@niehs.nih.gov.
FOR FURTHER INFORMATION CONTACT: Dr.
Ruth Lunn, Director, ORoC, DNTP,
NIEHS, P.O. Box 12233, MD K2–14,
Research Triangle Park, NC 27709;
telephone (919) 316–4637; FAX: (301)
480–2970; lunn@niehs.nih.gov. Courier
address: NIEHS, Room 2138, 530 Davis
Drive, Morrisville, NC 27560.
SUPPLEMENTARY INFORMATION:
Request for Information: The NTP
requests information on the 20
substances listed below that have been
nominated for possible review for future
editions of the RoC (for more
information, see https://
ntp.niehs.nih.gov/go/rocnom).
Specifically, the NTP requests
information on each substance for the
following topics: (1) data on current
production, use patterns, and human
exposure; (2) information about
published, ongoing, or planned studies
related to evaluating carcinogenicity; (3)
scientific issues important for assessing
carcinogenicity of the substance; and (4)
names of scientists with expertise or
knowledge about the substance. Please
include any available bibliographic
citations for the information. The NTP
will use this information for identifying
SUMMARY:
E:\FR\FM\20SEN1.SGM
20SEN1
]]>Agencies
[Federal Register Volume 78, Number 183 (Friday, September 20, 2013)]
[Notices]
[Page 57868]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22875]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Oral Treatment of
Hemophilia
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR
404, that the National Institutes of Health (NIH), Department of Health
and Human Services (HHS), is contemplating the grant of an Exclusive
Patent License to ProGenetics, LLC, a company having its headquarters
in Blacksburg, Virginia, to practice the inventions embodied in U.S.
Patent No. 7,220,718, issued 27 February 2007 (HHS Ref. No. E-281-2001/
0-US-03]), European Patent Application No. 02756904.5 (HHS Ref. No.
E281-2001/0-EP-04), filed August 2, 2002, and U.S. Patent No.
7,867,974, issued 11 January 2011 (HHS Ref. No. E-281-2001/0-US-05),
entitled respectively, ``Oral Treatment of Hemophilia'' and ``Induction
of Tolerance by Oral administration of Factor VIII and Treatment of
Hemophilia''. The patent rights in these inventions have been assigned
to or exclusively licensed to the Government of the United States of
America. The prospective Exclusive Patent License territory may be
``worldwide'', and the field of use may be limited to: ``Treatment of
Hemophilia A and B and immunotolerization using oral delivery
methods''.
DATES: Only written comments and/or applications for a license received
by the NIH Office of Technology Transfer on or before October 21, 2013
will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments and other materials relating to the contemplated Exclusive
Patent License should be directed to: Vince Contreras, Ph.D., Office of
Technology Transfer, National Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-
4711; Facsimile: (301) 402-0220; Email: vince.contreras@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: This technology relates to therapeutic
methods of arresting bleeding episodes in a subject having hemophilia A
or B, by orally administering an effective amount of the appropriate
clotting factor, sufficient to induce oral tolerance and supply
exogenous clotting factor to the subject. Roughly 20,000 people in the
U.S. have hemophilia with over 200 new patients born every year.
Currently there is no cure for hemophilia and treatment generally
involves intravenous infusion of missing clotting factors derived from
concentrated preparations of donated blood plasma which can be
expensive and result in generating inhibitory antibodies. The current
technology provides a rapid, inexpensive oral treatment for individuals
suffering from hemophilia A or B by utilizing a high quantity source of
clotting factors produced in milk.
The prospective worldwide 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 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: September 16, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-22875 Filed 9-19-13; 8:45 am]
BILLING CODE 4140-01-P
