[Federal Register Volume 61, Number 217 (Thursday, November 7, 1996)]
[Notices]
[Page 57694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28633]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Prospective Grant of Exclusive License: Therapeutic Uses of 
Microtubule Stabilizing Agents Including Taxol (Paclitaxel) for 
Fibroproliferative Vascular Diseases Including Atherosclerosis and 
Restenosis and Excluding Cancer

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

ACTION: Notice.

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SUMMARY: This is notice in accordance with 15 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 
a worldwide, limited field of use, exclusive license to practice the 
inventions embodied in the patents and patent applications referred to 
below to Angiotech Pharmaceuticals Inc. of Vancouver, British Columbia, 
Canada. The patent rights in these inventions have been assigned to the 
government of the United States of America. The patents and patent 
applications to be licensed are: ``Methods of Treating Atherosclerosis 
or Restenosis Using Microtubule Stabilizing Agent,'' U.S. Patent 
Application Serial No. 08/099,067 filed July 29, 1993; and all 
continuation applications, divisional applications, continuation-in-
part applications, and foreign counterpart applications related to U.S. 
Patent Application Serial No. 08/099,067.
    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 ninety 
(90) days with 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.

SUPPLEMENTARY INFORMATION: Atherosclerosis is the cause of the vast 
majority of cases of chronic peripheral arterial occlusive disease. The 
arteries most frequently involved, in order of occurrence, include 
femoropopliteal-tibial, aortioiliac, carotid and vertebral, splanchnic 
and renal, and brachycephalic. Fibromuscular dysplasia, inflammatory 
arteridities, and congenital arterial malformations are much rarer 
causes of arterial insufficiency. The process of repair after 
angioplasty continues over several months, involving re-
endothelialization, proliferation of vascular smooth muscle cells, and 
remodelling of the extracellular matrix proteins. Restenosis, the 
natural regrowth of muscle cells, has been noted as the single greatest 
complication (30-50%) of interventional intravascular procedures which 
number approximately 500,000 procedure annually, and at $10,000 per 
procedure is costing the health care system approximately $5 billion 
annually. While both interventional and invasive treatments continue to 
improve, restenosis causes a first-time failure rate of up to 50% or 
more. Reduction in the restenosis rate for cardiovascular disease 
procedures is cited as the most critical factor in future improvements. 
If the rate could be reduced to 25%, it would represent a savings to 
the health care system of around $1 billion annually.
    Preventing or reducing fibroproliferative vascular disease in a 
patient may be achieved by treating the patient with a pharmaceutical 
preparation comprising a therapeutically effective amount of a 
microtubule stabilizing chemotherapeutic agent such as taxol 
(placlitaxel). In particular, treatment with a low dose of a 
microtubule stabilizing agent such as taxol or a water-soluble taxol 
derivative may present or reduce atherosclerosis or restenosis after 
arterial injury. The low dose used prevents artery blockage while 
minimizing any negative side effects associated with the drug. Unlike 
classical anti-microtubule agents like colchicine and the vinca 
alkaloids which induce depolymerization of microtubules, taxol induces 
tubulin polymerization and forms extremely stable and nonfunctional 
microtubules.

ADDRESS: Requests for a copy of these patent applications, inquiries, 
comments, and other materials relating to the contemplated license 
should be directed to: J. Peter Kim, Technology Licensing Specialist, 
Office of Technology Transfer, National Institutes of Health, 6011 
Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; 
Telephone: (301) 496-7056, ext. 264; Facsimile: (301) 402-0220. A 
signed Confidential Disclosure Agreement will be required to receive a 
copy of any pending patent application. Applications for a license 
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 5, 1997 will be considered. Comments and objections submitted 
in response 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: October 29, 1996.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 96-28633 Filed 11-6-96; 8:45 am]
BILLING CODE 4140-01-M