[Federal Register Volume 69, Number 64 (Friday, April 2, 2004)]
[Notices]
[Page 17421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7504]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Use of Inhibitors of 3-
Hydroxy-3-Methylglutaryl Coenzyme A Reductase as a Modality in Cancer 
Therapy

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 part 404.7(a)(1)(i), that the National Institutes of Health, 
Department of Health and Human Services, is contemplating the grant of 
an exclusive patent license to practice the inventions embodied in U.S. 
Patent 6,040,334 issued March 21, 2000, entitled ``Use of Inhibitors of 
3-Hydroxy-3-Methylglutaryl Coenzyme A Reductase as a Modality in Cancer 
Therapy'' (DHHS Reference No. E-146-1992/0), and all related foreign 
patents/patent applications, to Bionaut Pharmaceuticals, Inc., which is 
located in Cambridge, MA. The patent rights in these inventions have 
been assigned to the United States of America.
    The prospective exclusive license territory will be worldwide and 
the field of use may be limited to human pharmaceutical use of 
inhibitors of 3-Hydroxy-3-Methylglutaryl Coenzyme A Reductase as anti-
cancer agents.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before June 
1, 2004, will be considered.

ADDRESSES: Requests for copies of the patent, inquiries, comments and 
other materials relating to the contemplated exclusive license should 
be directed to: George G. Pipia, PhD, Technology Licensing Specialist, 
Office of Technology Transfer, National Institutes of Health, 6011 
Executive Boulevard, Suite 325, Rockville, MD 20852-3804; telephone: 
(301) 435-5560; facsimile: (301) 402-0220; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: The invention provides a method for treating 
mammalian adenocarcinomas and sarcomas comprising administration of an 
effective amount of an inhibitor of HMG Co-A or homologues of the 
inhibitor. Adenocarcinoma is known to afflict the prostate, stomach, 
lung, breast, and colon, as well as other sites. An example of a 
sarcoma within the meaning of the present invention is Ewing's sarcoma, 
which is a medullary bone tumor typically attacking the long bones.
    Examples of compounds useful in the present invention are 
lovastatin and simvastatin as well as their homologues. Also included 
are compounds classified as HMG Co-A inhibitors, as well as their 
homologues or analogues. Generally, these HMG Co-A inhibitors are known 
to lower serum cholesterol in humans. However, the present invention is 
not so limited. That is, an inhibitor of HMG Co-A or one of its 
homologues may work in the method of the present invention without 
necessarily lowering serum cholesterol. The invention focuses not on 
the compound's ability to lower cholesterol, but rather on the 
compound's ability to treat selected cancers, such as adenocarcinomas 
of the prostate, stomach, lung, breast, and colon and certain sarcomas 
such as Ewing's sarcoma. Typically, the oral route is preferred.
    Also provided by the invention is a method of reducing prostate 
specific antigen (PSA) levels in a patient having prostatic 
adenocarcinoma comprising administration of an effective amount of a 
compound which is an inhibitor of HMG Co-A or a homologue of such 
inhibitor. The invention also includes a method of reducing PSA in 
conjunction with another treatment modality.
    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 part 
404.7. The prospective exclusive license may be granted unless within 
sixty (60) days from the date of this published notice, the NIH 
receives written evidence and argument that establish that the grant of 
the license would not be consistent with the requirements of 35 U.S.C. 
209 and 37 CFR part 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: March 24, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-7504 Filed 4-1-04; 8:45 am]
BILLING CODE 4140-01-P