[Federal Register Volume 62, Number 82 (Tuesday, April 29, 1997)]
[Notices]
[Page 23257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-11009]



[[Page 23257]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Treatment of Cancer Using 
Human Chorionic Gonadotropin (hCG)

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 (NIH), 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 Application Serial Number 08/286,299, and entitled; 
``Treatment of Cancer Using Human Chorionic Gonadotropin (hCG)'', and 
corresponding U.S. and foreign patent applications to Serono 
Laboratories, Inc., of Norwell, Massachusetts. 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. 
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 field of use for this prospective exclusive license may 
be limited to ``Treatment of Cancer''.

SUPPLEMENTARY INFORMATION: Clinical observations of the regression of 
Kaposi's sarcoma (KS) in women during pregnancy and its return after 
birth has suggested the existence of a naturally-occurring KS 
therapeutic. Research performed at the National Cancer Institute 
suggested the cause of this phenomena was hCG. hCG is a hormone which 
is naturally produced by the placenta during pregnancy. In the male, 
hCG stimulates the development of accessory organs. hCG is composed of 
an alpha chain that is identical in structure to several other hormones 
and a unique beta chain. The beta chain of hCG was found to induce 
apoptosis, or programmed cell death in primary cultures of KS cells. 
Studies performed in KS tumors in nude mice confirmed the anti-KS 
effect of hCG.
    The above captioned patent application describes the use of various 
hormones in the treatment of cancer. In particular, the use of hCG or 
the  subunit thereof and luteinizing hormone or the  
subunit thereof in the treatment of cancer, including breast, prostate, 
ovary and stomach carcinomas and, in particular, KS are described. KS 
is the most common neoplasm in HIV-infected patients and hCG has been 
used to treat KS patients (Gill, et al., ``The Effects of Preparations 
of Human Chorionic Gonadotropin on AIDS-related Kaposi's Sarcoma'', New 
Eng. J. Med. 1996 Oct. 24:335(17):1261-69.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
comments and other materials relating to the contemplated licenses 
should be directed to: Raphe Kantor, 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. 247; Facsimile: 301/402-0220. A 
signed Confidentiality Agreement will be required to receive copies of 
the patent applications. 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. Only written comments and/or 
applications for a license which are received by NIH on or before June 
30, 1997 will be considered. 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: April 16, 1997.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 97-11009 Filed 4-28-97; 8:45 am]
BILLING CODE 4140-01-M