[Federal Register Volume 61, Number 248 (Tuesday, December 24, 1996)]
[Pages 67842-67843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32581]



Prospective Grant of Exclusive License: Gossypol Acetica Acid for 
the Treatment of Cancer

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 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]