[Federal Register Volume 78, Number 136 (Tuesday, July 16, 2013)]
[Notices]
[Page 42532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16948]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Start-Up Exclusive Evaluation Option 
License: Methods of Treating Giardiasis Using Available Compounds

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 
part 404, that the National Institutes of Health (NIH), Department of 
Health and Human Services, is contemplating the grant of a start-up 
exclusive evaluation option license to practice the inventions embodied 
in U.S. provisional Applications 61/392,096 (E-211-2010/0-US-01) filed 
October 12, 2010 and 61/411,509 filed November 9, 2010 (E-211-2010/1-
US-01); PCT application No. PCT/US2011/055902 filed October 12, 2011 
(E-211-2010/2-PCT-01); US patent application No. 13/878,832 filed April 
11, 2013 (E-211-2010/2-US-06); European patent application No. 
11773158.8 filed May 2, 2013 (E-211-2010/2-EP-04); Canadian application 
No. 2,814,694 filed April 11, 2013 (E-211-2010/2-CA-03); Australia 
application No. 2011316657 filed April 12, 2013 (E-211-2010/2-AU-02); 
and Indian application No. 1137/KOLNP/2013 filed April 22, 2013 (E-211-
2010/2-IN-05); each entitled ``Methods of Treating Giardiasis'' by Wei 
Zheng et al. to BrioMed, Inc., having a place of business at 1743 S. 
Westgate Ave, Los Angeles, CA 90025 USA. The patent rights in this 
invention have been assigned to the United States of America and the 
University of Maryland.

DATES: Only written comments and/or application for a license that are 
received by the NIH Office of Technology Transfer on or before July 31, 
2013 will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Tedd Fenn, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Email: [email protected]; Telephone: 
301-435-5031; Facsimile: 301-402-0220.

SUPPLEMENTARY INFORMATION: The prospective start-up exclusive 
evaluation option 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 start-up exclusive evaluation option license may be granted 
unless, within fifteen (15) 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.
    This technology includes a group of at least twenty-nine, diverse, 
commercially available compounds that are newly identified for activity 
against Giardia lamblia parasites. At least six of the candidate 
compounds, Bortezomib, Decitabine, Hydroxocobalamin, Amlexanox, 
Idarubicin, and Auranofin have preexisting FDA approval for human use 
for other (non-Giardia) conditions. Another three compounds, 
Fumagillin, Nitarsone and Carbadox have preexisting approval for 
veterinary use for non-Giardia conditions. Additional active compounds 
identified include: Acivicin, Riboflavin butyrate, BTO-1, GW9662, 
Dinitroph-dfgp, Deserpidine, Tetramethylthiuram disulsulfide, 
Disulfiram, Mitoxantrone, Ecteinascidin 743, 17-allyaminogeldanamycin, 
Carboquone and Nocodazole. The anti-Giardial activity of these 
compounds presents a cost saving opportunity for the rapid development 
of new, better tolerated treatments for the most prevalent human 
intestinal parasite infection in the United States and the world.
    The proposed field of exclusivity may be limited to therapeutics 
for treatment of Giardia infection in mammals.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated 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: July 9, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 2013-16948 Filed 7-15-13; 8:45 am]
BILLING CODE 4140-01-P