[Federal Register Volume 71, Number 94 (Tuesday, May 16, 2006)]
[Notices]
[Pages 28367-28368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7435]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: The Development of C-6 
and C-8 Modified cAMP-Derivatives for the Treatment of Cancer

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

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 (HHS), is contemplating the 
grant of an exclusive patent license to practice the inventions 
embodied in U.S. Patent Application No. 07/198,489 filed May 23, 1988, 
entitled ``Use of 8-Cl-cAMP as Anticancer Drug'' [HHS Reference No. E-
132-1988/0-US-01], PCT Application filed May 19, 1989 [HHS Reference 
No. E-132-1988/0-PCT-02], U.S. Patent Application No. 07/896,452 filed 
June 4, 1992, entitled ``Use of 8-Cl-cAMP as Anticancer Drug'' [HHS 
Reference No. E-132-1988/0-US-04], U.S. Patent 5,792,752 filed October 
27, 1994 and issued August 11, 1998, entitled ``Use of 8-Cl-cAMP as 
Anticancer Drug'' [HHS Reference No. E-132-1988/0-US-05], U.S. Patent 
5,902,794 filed September 22, 1997 and issued May 11, 1999, entitled 
``Use of 8-Cl-cAMP as Anticancer Drug'' [HHS Reference No. E-132-1988/
0-US-06] and Canadian Patent Application No. 133572 filed May 19, 1989, 
entitled ``Use of 8-Cl-cAMP as Anticancer Drug'' [HHS Reference No. E-
132-1988/0-CA-03], to Kuhnil Pharm. Co. Ltd., which has offices in 
Seoul, Republic of Korea. The patent rights in these inventions have 
been assigned and/or exclusively licensed to the Government of the 
United States of America.
    The prospective exclusive license territory may be worldwide, and 
the field of use may be limited to the treatment of cancer with 8-Cl-
cAMP.
    This notice replaces the Prospective Grant notice published in the 
Federal Register on Tuesday, May 9, 2006 (71 FR 26979).

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before July 
17, 2006 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: David A. Lambertson, PhD., Technology 
Licensing Specialist, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
MD 20852-3804; Telephone: (301) 435-4632; Facsimile: (301) 402-0220; E-
mail: [email protected].

SUPPLEMENTARY INFORMATION: Cyclic AMP (cAMP) is a natural biological 
product with a number of regulatory functions at physiological levels. 
At higher than physiological concentrations, cAMP has the ability to 
inhibit the aberrant growth of malignant cells. Because cAMP is a 
natural product involved in normal biological function, this inhibition 
occurs without causing significant toxicity. However, this is not a 
feasible method for treating cancer in vivo because of potential 
interference with the physiological role of cAMP.
    C-6 and C-8 modified cAMP derivatives also inhibit the growth of 
malignant cells. One such derivative, 8-Cl-cAMP, has effectively 
decreased tumor growth in vitro and in vivo. Specifically, 8-Cl-cAMP 
showed the ability to decrease tumor growth in leukemia mouse models 
and xenografts of human tumors. Because of the low toxicity associated 
with 8-Cl-cAMP, this compound has promise as an anti-cancer agent, 
particularly with regard to hematological malignancies.
    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

[[Page 28368]]

within sixty (60) days from the date of this published notice, the 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.
    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 exclusive license. 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: May 10, 2006.
David R. Sadowski,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer, National Institutes of Health.
[FR Doc. E6-7435 Filed 5-15-06; 8:45 am]
BILLING CODE 4140-01-P