From May 19, 1997 Federal Register
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes Of Health
Prospective Grant Of Exclusive License: Vaccine for Malaria
AGENCY: National Institutes of Health, Public Health Service, DHHS
ACTION: Notice
SUMMARY: This is notice in accordance with 15 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 a limited field of use exclusive world-wide license to practice the invention embodied in U.S. Patent Application Serial Nos. 08/119,677 (filed 09/10/93), 08/487,826 (filed 06/07/95), and 08/568,459 (filed 12/07/95), entitled "Binding Domains from Plasmodium Vivax and Plasmodium Falciparum Erythrocyte Binding Proteins," and related foreign patent applications, to EntreMed, Inc. of Rockville, MD. The patent rights in these inventions have been assigned to the United States of America.
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. It is anticipated that this license may be limited to vaccine for Malaria.
This 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.
SUPPLEMENTARY INFORMATION: The patent applications identify functional domains of Plasmodium proteins which can be used for the prevention or treatment of malaria. The parasite invades erythrocytes by attaching to surface receptors. The erythrocyte binding domains of the sialic acid binding protein (SABP) of P. falciparum and the Duffy antigen binding protein (DABP) can be used in vaccines to induce immune responses which block erythrocyte binding and invasion by P. falciparum and P. vivax merozoites. USSN 08/487,826 further includes genes and nucleotide sequences and predicted polypeptide sequences of the P. falciparum DBL (Duffy-binding like) gene family which codes for antigenically variant binding domains.
ADDRESS: Requests for a copy of the patent applications, inquiries, comments and other materials relating to the contemplated license should be directed to: Gloria H. Richmond, Patent Advisor, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: 301/496-7057; Facsimile: 301/402-0220; E-mail: Gloria Richmond@NIH.GOV. A signed Confidential Disclosure Agreement will be required to receive a copy of the patent applications.
Applications for a non-exclusive or exclusive license filed in response to this notice will be treated as objections to the grant of the contemplated license. Only written comments and/or applications for a license which are received by NIH on or before [insert date 60 days after date of publication in the FEDERAL REGISTER] will be considered.
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.