[Federal Register Volume 61, Number 118 (Tuesday, June 18, 1996)]
[Notices]
[Pages 30915-30916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15364]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: This is 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 embodies in 
U.S. Patent No. 5,385,936 and U.S. Patent Applicant No. 08/379,872 to 
Cary Medical Corporation of Great Falls, Virginia. U.S. Patent No. 
5,385,936 is directed toward a method of treating cancers using 
Gossypol Acetic Acid (GAA). U.S. Patent Application No. 08/379,872 is 
directed toward the use of Gossypol for the treatment of cancer. 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.
    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 a copy of the issued patent, patent 
application, inquiries, comments, and other materials relating to the 
contemplated license 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; Fax: (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 the 
NIH

[[Page 30916]]

Office of Technology Transfer on or before August 19, 1996 will be 
considered. Comments and objections will not be made available for 
public inspection and, to the extent permitted by law, will not be 
subject to disclosure under the Freedom of Information Act, 5 U.S.C. 
552.

    Dated: June 6, 1996.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 96-15364 Filed 6-17-96; 8:45 am]
BILLING CODE 4140-01-M