[Federal Register Volume 67, Number 14 (Tuesday, January 22, 2002)]
[Notices]
[Page 2897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-1437]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Specific Killing of HIV 
Infected Lymphocytes by a Recombinant Immunotoxin Directed Against the 
HIV-1 GP 120 Envelope Glycoprotein

AGENCY: National Institutes of Health, Public Health Service, and DHHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This 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, Department of 
Health and Human Services, is contemplating the grant of an exclusive 
patent license to practice the inventions embodied in U.S. Patent 
Application, 60/088,860 (refiled): ``Specific Killing of HIV Infected 
Lymphocytes by a Recombinant Immunotoxin Directed Against the HIV-1 GP 
120 Envelope Glycoprotein'' (DHHS Ref. E-201-98/0); PCT Patent 
Application, PCT/US99/12909 (refiled): ``Specific Killing of HIV 
Infected Lymphocytes by a Recombinant Immunotoxin Directed Against the 
HIV-1 GP 120 Envelope Glycoprotein'' (DHHS Ref. E-201-98/1); Related 
Foreign Filed National Stage Applications claiming priority to 60/
088,860, (pending) in Europe, Canada, Japan, Australia and the National 
Stage United States Application [S/N 09/673,707 (DHHS Ref. E-201-98/
2)]: ``Specific Killing of HIV Infected Lymphocytes by a Recombinant 
Immunotoxin Directed Against the HIV-1 GP 120 Envelope Glycoprotein;'' 
US Patent 4,892,827, S/N 06/911,227: ``Recombinant Pseudomonas 
Exotoxin: Construction of an Active Immunotoxin with Low Side 
Effects,''--excluding any foreign equivalents corresponding to 
4,892,827 (DHHS Ref. E-385-86/0); US Patent 5,747,654, S/N 08/077,252: 
``Recombinant Disulfide-Stabilized Polypeptide Fragments Having Binding 
Specificity.'' PHS is an owner of corresponding foreign rights in 
national phase prosecution in Canada, Australia, Japan, and the 
European Patent Office. (DHHS Ref. E-163-93/0); US Patent 6,147,203, S/
N 09/002,753: ``Recombinant Disulfide-Stabilized Polypeptide Fragments 
Having Binding Specificity,'' (DHHS Ref. E-163-93/4); US Patent 
6,051,435, S/N 07/865,722: ``Recombinant Antibody-Toxin Fusion 
Protein,'' (DHHS Ref. E-135-89/1) US Patent 5,863,745, S/N 08/461,825: 
``Recombinant Antibody-Toxin Fusion Protein,'' (DHHS Ref. E-135-89/2); 
and US Patent 5,696,237, S/N 08/463,163: ``Recombinant Antibody-Toxin 
Fusion Protein,'' (DHHS Ref. E-135-89/3) to IVAX Corporation which is 
located in Miami, Florida. The patent rights in these inventions have 
been assigned to the United States of America.
    The prospective exclusive license territory will be worldwide and 
the field of use may be limited to human therapeutics for the treatment 
of HIV-associated diseases using 3B3(scFv)-PE38 or 3B3(dsFv)-PE38 
immunotoxin constructs.

DATES: Only written comments and/or license applications which are 
received by the National Institutes of Health on or before March 25, 
2002 will be considered.

ADDRESSES: Requests for copies of the patent, inquiries, comments and 
other materials relating to the contemplated exclusive license should 
be directed to: Richard U. Rodriguez, M.B.A., Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, MD. 20852-3804; 
Telephone: (301) 496-7056, x287; Facsimile: (301) 402-0220; and E-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: The primary technology is directed to an 
immunotoxin that specifically binds to and kills cells expressing an 
HIV gp-120 coat protein. The immunotoxin comprises an anti-gp-120 
antibody directed to the conserved CD4 binding site of gp 120 attached 
to a cytotoxin (e.g., a Pseudomonas exotoxin). In one preferred 
embodiment, the immunotoxin is a recombinantly expressed fusion protein 
comprising a disulfide linked Fv region attached to a modified 
Pseudomonas exotoxin [i.e., 3B3 (Fv)-PE38]. The technology is also 
directed to: a pharmaceutical composition; a composition of the 
immunotoxin; methods for killing HIV infected cells; and to a kit for 
killing cells that display a gp-120 protein.
    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 sixty 
(60) days from the date of this published notice, the NIH receives 
written evidence and argument that establish that the grant of the 
license would not be consistent with the requirements of 35 U.S.C. 209 
and 37 CFR 404.7.
    Applications for a license in the field of use filed in response to 
this notice will be treated as objections to the grant of the 
contemplated exclusive license. Comments and objections submitted 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: January 14, 2002.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 02-1437 Filed 1-18-02; 8:45 am]
BILLING CODE 4140-01-P