[Federal Register Volume 61, Number 248 (Tuesday, December 24, 1996)]
[Notices]
[Pages 67842-67843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32581]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Prospective Grant of Exclusive License: Gossypol Acetica Acid for
the Treatment of Cancer
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 and Human
Services, is contemplating the grant of an exclusive world-wide license
to practice the inventions embodied in U.S. Patent No. 5,385,936 and
U.S. Patent Application No. 08/379,872 to IVAX Corporation of Miami,
Florida. U.S. Patent No. 5,385,936 is directed towards a method of
treating cancers using Gossypol Acetic Acid (GAA). U.S. Patent
Application No. 08/379,872 is directed towards the use of Gossypol for
the treatment of cancer. The patent rights in
[[Page 67843]]
these inventions have been assigned to the United States of America.
This notice revises a previous notice of a prospective grant of
exclusive license to Cary Medical Corporation of Great Falls, Virginia
for the same technology. See Federal Register, Vol. 61, No. 118, p.
30915-16 (June 18, 1996).
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.
Gossypol is a biphenolic compound derived from crude cottonseed oil
that has been widely used in China as a male contraceptive. Clinical
Trials have demonstrated GAA's efficacy against gliomas and adrenal
cancer. Clinical trials are planned or underway for the use of GAA in
breast and prostate cancer. GAA exhibits low toxicity relative to other
chemotherapeutic agents and does not appear to cause myelosuppression,
significant hair loss, cardiac failure or neurotoxicity. The milder
side effects of the use of GAA include mild fatigue, muscle tremor, dry
mouth, dry skin and occasional nausea. Patients treated with GAA,
therefore, may be able to continue normal activities.
ADDRESSES: Requests for copies of the issued patent, patent
application, inquiries, comments and other materials relating to the
contemplated licenses should be directed to: Allan Kiang, 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. 270; Facsimile:
(301) 402-0220. A signed Confidentiality Agreement will be required to
receive copies of the patent application. 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 license. Only written
comments and/or applications for a license which are received by NIH on
or before February 24, 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: December 12, 1996.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 96-32581 Filed 12-23-96; 8:45 am]
BILLING CODE 4140-01-M
