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Prospective Grant of Exclusive License: Development of Diagnostic Tests for Plasmodium falciparum

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National Institutes of Health, Public Health Service, DHHS.




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, is contemplating the grant of an exclusive license concerning the inventions embodied in:

USSN 5,130,416 (USPA 07/518,299, filed 05/03/90) issued July 14, 1992

USSN 5,296,382 (USPA 07/791,392, filed 11/14/91) issued March 22, 1994

USSN 5,476,785 (USPA 08/161,406, filed 12/06/93) issued December 19, 1995

all entitled “Recombinant DNA clone containing a genomic fragment of PfHRP-II gene from Plasmodium falciparum” and invented by Thomas E. Wellems and Russell J. Howard, to Akers Laboratories, Inc., a diagnostic company having a place of business in Thorofare, N.J. The United States of America is an assignee to the patent rights of these inventions.

The contemplated exclusive license may be limited to the development of diagnostic tests for Plasmodium falciparum-caused Malaria for sales in the United States. A nonexclusive license of the present inventions to make and use in the United States but to sell in territories outside of the United States is available to other licensees.


Only written comments and/or applications for a license, which are received by the NIH Office of Technology Transfer on or before March 25, 2002, will be considered.


Requests for a copy of the patents, inquiries or comments relating to the contemplated license should be directed to: Uri Reichman, Ph.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 496-7056, ext. 240; Facsimile: (301) 402-0220; e-mail:

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The inventions included in the prospective license relates to the isolation of clones of DNA from the malaria-causing parasite Plasmodium falciparum (P. falciparum) that encode a histidine-rich protein (designated name PfHRP-II) from this organism. PfHRP-II is expressed on P. falciparum-infected erythrocytes, and released from the infected host erythrocytes into the body fluids. The inventions describe the cloning procedure and the characterization of the coding sequence as well as that of the encoded protein and the antibodies made against it. The inventions can be utilized in the development of diagnostic tests for malaria as contemplated by the Start Printed Page 2897prospective licensee, or for vaccine development against malaria.

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.

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.

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Dated: January 14, 2002.

Jack Spiegel,

Director, Division of Technology Development and Transfer, Office of Technology Transfer.

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[FR Doc. 02-1438 Filed 1-18-02; 8:45 am]