[Federal Register Volume 78, Number 183 (Friday, September 20, 2013)]
[Notices]
[Page 57868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22875]
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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.
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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: [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: 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