[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