[Federal Register Volume 65, Number 174 (Thursday, September 7, 2000)]
[Notices]
[Pages 54292-54293]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22885]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Drug and Method for the 
Therapeutic Treatment of Human Brain Tumors

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

ACTION: Notice.

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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 
world-wide license to U.S. Patents and Patent Applications USPA SN: 60/
185,039, entitled: ``Anti-EGFRvIII with Improved Cytotoxicity and 
Yield, Immunotoxins Based

[[Page 54293]]

Thereon and Methods of Use Thereof''; USP SN: 4,892,827, entitled, 
``Recombinant Pseudomonas Exotoxin: Construction of an Active 
Immunotoxin with Low Side Effects''--excluding any foreign equivalents 
corresponding to 4,892,827 (= USSN 06/911,227 ); USP SN: 5,747,654, 
entitled, ``Recombinant Disulfide-Stabilized Polypeptide Fragments 
Having Binding Specificity''; USPA SN: 09/002,753, entitled: 
``Recombinant Disulfide-Stabilized Polypeptide Fragments Having Binding 
Specificity''; USP SN: 6,051,435, entitled: ``Recombinant Antibody-
Toxin Fusion Protein''; USPN 5,863,745, entitled: Recombinant Antibody-
Toxin Fusion Protein; USPN 5,696,237, entitled: ``Recombinant Antibody-
Toxin Fusion Protein'' and corresponding foreign patent applications to 
IVAX Corporation having an address in Miami, Florida. The United States 
of America is an assignee of the patent rights in these inventions and 
the contemplated exclusive license may be limited to the use of TGF-
Alpha-PE38 and MR-1-1(dsFv)-PE38KDEL [= Anti-EGFRvIII (dsFv)-PE38KDEL] 
based immunotoxins as an In vitro diagnostic and therapeutic modality 
for the treatment of human brain tumors.

DATES: Only written comments and/or applications for a license which 
are received by NIH on or before November 6, 2000 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
comments and other materials relating to this contemplated exclusive 
licenses should be directed to: J. R. Dixon, Ph.D., Technology 
Licensing Specialist, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804. Telephone: (301) 496-7735 ext. 206; Facsimile: 
(301) 402-0220, E-Mail: [email protected]. A signed Confidentiality 
Agreement will be required to receive copies of any patent 
applications.

SUPPLEMENTARY INFORMATION: The technology is directed to the use of 
TGF-Alpha-PE38 and MR-1-1(dsFv)-PE38KDEL [= Anti-EGFRvIII(dsFv)-
PE38KDEL] based immunotoxins as an in vitro diagnostic and therapeutic 
modality for the treatment of human brain tumors.
    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, NIH receives written evidence and argument that 
establishes that the grant of the exclusive license would not be 
consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.
    Applications for a license [i.e., completed ``Application for 
License to Public Health Service Inventions''] in the field of use of 
TGF-Alpha-PE38 and MR-1-1(dsFv)-PE38KDEL [= Anti-EGFRvIII(dsFv)-
PE38KDEL] based immunotoxins as an in vitro diagnostic and therapeutic 
modality for the treatment of human brain tumors filed in response to 
this notice will be treated as objections to the grant of the 
contemplated exclusive license. Comments and objections will not be 
made available for public inspection and, to the extent permitted by 
law, will not be subject to disclosure under the Freedom of Information 
Act, 5 U.S.C. 552.

    Dated: August 30, 2000.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 00-22885 Filed 9-6-00; 8:45 am]
BILLING CODE 4140-01-P