[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
