[Federal Register Volume 59, Number 69 (Monday, April 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8608]
[[Page Unknown]]
[Federal Register: April 11, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Prospective Grant of Exclusive License: Use of Monoclonal
Antibodies Having Binding Specificity to Tag-72 and Human Carcinomas
for Targeting Tumor Necrosis Factor and Phospholipase A2 Activating
Protein as Cancer Therapeutics
AGENCY: National Institutes of Health, Public Health Service, DHHS.
ACTION: Notice.
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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, is contemplating the grant of
a limited field of use exclusive license in the United States to
practice the invention embodied in U.S. Patent Application Number 07/
073,685 entitled ``Second Generation Monoclonal Antibodies Having
Binding Specificity to Tag-72 and Human Carcinomas and Methods for
Employing the Same'' to Enzon, Inc., having a place of business in
Piscataway, NJ. The patent rights in this invention has 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.
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 would be limited to using the monoclonal
antibodies of the subject invention with Tumor Necrosis Factor (TNF)
and/or Phospholipase A2 Activating Protein (PLAP) as immunoconjugates
for cancer therapy.
The subject invention relates to monoclonal anti-tumor antibodies,
including CC49, which recognizes the tumor associated glycoprotein,
TAG-72. The CC49 antibody may be used to develop potential therapeutics
for cancers expressing the TAG-72 antigen. The TAG-72 antigen is
expressed on at least 75% of colorectal cancers; 85% of ovarian,
endometrial, gastric, and pancreatic cancers; 60% of prostate cancers;
and approximately 50% of breast and lung cancers.
Of particular importance is the fact that B72.3, the first
generation monoclonal antibody specific for TAG-72, was the first and
continues to be the only monoclonal antibody to be approved by the Food
and Drug Administration (FDA) for in-vivo use. The CC49 monoclonal
antibody of the subject invention is the second generation monoclonal
antibody specific for the TAG-72 glycoprotein and in pre-clinical
studies has shown superior results over the first generation FDA
approved B72.3.
Requests for a copy of the patent application, inquiries, comments
and other materials relating to the contemplated license should be
directed to: Mr. Daniel R. Passeri, Office of Technology Transfer,
National Institutes of Health, Box OTT, Bethesda, MD 20892. Telephone:
(301) 496-7735; Facsimile: (301) 402-0220. A signed Confidentiality
Agreement will be required to receive copies of the patent application.
Properly filed competing applications for a license filed in response
to this notice will be treated as objections to the contemplated
license. Only written comments and/or application for a license which
are received by the NIH Office of Technology Transfer within sixty (60)
days of this notice will be considered.
Dated: April 1, 1994.
Donald P. Christoferson,
Acting Director, Office of Technology Transfer.
[FR Doc. 94-8608 Filed 4-8-94; 8:45 am]
BILLING CODE 4140-01-M
