[Federal Register Volume 62, Number 154 (Monday, August 11, 1997)]
[Notices]
[Pages 43002-43003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21094]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Diagnostic Methods 
Derived From the Human Metastasis Suppressor Gene KAI1

AGENCY: National Institutes of Health, Public Health Service, 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 
world-wide license to practice the inventions embodied in U.S. Patent 
Applications SN 08/430,225 and corresponding foreign patent 
applications entitled, ``Diagnostic Methods and Gene Therapy Using 
Reagents Derived From the Human Metastasis Suppressor Gene KAI1'' to 
Centocor, Inc. of Malvern, PA. The patent rights in these inventions 
have been assigned to the United States of

[[Page 43003]]

America and Johns Hopkins University. The prospective exclusive license 
field of use may be limited to: The use of KAI1 monoclonal antibodies 
in the diagnostic/prognostic fields of use for prostate cancer.

DATES: Only written comments and/or applications for a license which 
are received by NIH on or before October 10, 1997.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
comments and other materials relating to the contemplated licenses 
should be directed to: Joseph K. Hemby, Jr., J.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. 265; Facsimile: (301) 402-0220. A 
signed Confidentiality Agreement will be required to receive copies of 
the patent applications.

SUPPLEMENTARY INFORMATION: 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 license would not be consistent with the 
requirements of 35 U.S.C. 209 and 37 CFR 404.7.
    The invention relates to the KAI1 gene which has been shown to 
suppress metastasis of prostate cancer and is down regulated in human 
malignant prostate cancers. The invention further provides methods of 
detection of alterations in the wild-type KAI1 gene sequence, KAI1 
mRNA, and KAI1 protein useful in determining the presence of malignant 
cancer in a subject or genetic predisposition to malignancy in a 
subject. Other uses of the KAI1 gene include the possible treatment of 
patients who are diagnosed with early stage prostate cancer.
    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 licenses. 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: July 18, 1997.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 97-21094 Filed 8-8-97; 8:45 am]
BILLING CODE 4140-01-M