Daily Rules, Proposed Rules, and Notices of the Federal Government


National Institutes of Health

Prospective Grant of Exclusive License: Human Monoclonal Antibodies, Their Fragments and Derivatives as Biotherapeutics for the Treatment of HIV Infections

AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the inventions embodied in: U.S. Provisional Patent Application S/N 60/378,408, filed May 6, 2002 (E-144-2002/0-US-01), PCT Application, PCT/US03/14292, filed May 6, 2003, (E-144-2002/0-PCT-02), converted into 03736557.4 (E-144-2002/0-EP-04) filed in Europe on December 3, 2004, and 2003237187 (E-144-2002/0-AU-05) filed in Australia on November 3, 2004, 10/513,725 (E-144-2002/0-US-03) filed in USA on November 5, 2004, as well as 2,484,930 (E-144-2002/0-CA-06) filed in Canada on November 5, 2004, entitled "Novel broadly cross-reactive HIV neutralizing human monoclonal antibodies selected from Fab phage display libraries using a novel strategy based on alternative antigen panning," Inventors: Dimiter S. Dimitrov (NCI) and Mei-Yun Zhang (SAIC), to Profectus Biosciences, Inc., having a place of business in Baltimore, Maryland. The patent rights in these inventions have been assigned to the United States of America.
DATES: Only written comments and/or application for a license, which are received by the NIH Office of Technology Transfer on or before August 1, 2006 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: Sally Hu, Ph.D., M.B.A., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804;;Telephone: (301) 435-5606; Facsimile: (301) 402-0220.

The subject invention (E-144-2002/0) identifies four antibodies, designed 4B1-4, 4B1-10, 4H4, and 5H22 (M12, M14, M16, and M18). These four antibodies were isolated from a human Fab phage display library using alternating antigen panning (AAP). All four antibodies bind to recombinant HIV envelope glycoproteins (Env) gp12089.6, gp120JR-FLand gp120IIIBwith high affinity. Moreover, 4B1-10 binding to gp 120 or gp 140 is significantly enhanced in the presence of the receptor CD4.

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 404.7. The prospective exclusive license may be granted unless, within 60 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 404.7.

The field of use may be limited to the development of human monoclonal antibodies for use as a therapeutic or preventative in HIV infection either alone or in combination with other compounds.

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: May 25, 2006. David R. Sadowski, Acting Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.