[Federal Register Volume 65, Number 184 (Thursday, September 21, 2000)]
[Notices]
[Pages 57202-57203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24241]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive License: Treatment of Gaucher 
Disease

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

ACTION: Notice.

-----------------------------------------------------------------------

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 
a worldwide exclusive license to practice the inventions embodied in 
the patents and patent applications referred to below to BioPrime, Inc. 
of New York, New York. The patents and patent applications to be 
licensed are: U.S. Patent 5,705,153 issued January 6, 1998, 
``Glycolipid enzyme-polymer conjugates''; U.S. Patent 5,620,884 issued 
April 17, 1997, ``Glycolipid enzyme-polymer conjugates''; U.S. Patent 
5,879,680 issued March 9, 1999, ``Cloned DNA for Synthesizing Unique 
Glucocerebrosidase''; U.S. Patent 6,074,864 issued June 13, 2000, 
``Cloned DNA for Synthesizing Unique Glucocerebrosidase''; and U.S. 
Patent Application 09/173,207 filed October 15, 1998, ``DNA Sequencing 
Surrounding the Glucocerebrosidase Gene''. Related cases include all 
continuation applications, divisional applications, continuation-in-
part applications, and foreign counterpart applications related to the 
above.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
December 20, 2000 will be considered.

ADDRESSES: Requests for a copy of these patents or patent applications, 
inquiries, comments, and other materials relating to the contemplated 
license should be directed to: Stephen L. Finley, Ph.D., Technology 
Licensing Specialist, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852; Telephone: (301) 496-7056, ext. 215; Facsimile: (301) 
402-0220; E-mail: [email protected]. A

[[Page 57203]]

signed Confidential Disclosure Agreement will be required to receive a 
copy of any pending patent applications.

SUPPLEMENTARY INFORMATION: Gaucher Disease is a rare inborn error of 
metabolism which affects between 10,000 and 20,000 people worldwide, 
40% in the United States. Gaucher Disease is the most common lipid 
storage disease. The symptoms associated with Gaucher Disease result 
from the accumulation of a lipid called glucocerebroside. This lipid is 
a byproduct of the normal recycling of red blood cells. When the gene 
with the instructions for producing an enzyme to break down this 
byproduct is defective, the lipid accumulates. The lipid is found in 
many places in the body, but most commonly in the macrophages in the 
bone marrow. There it interferes with normal bone marrow functions, 
such as production of platelets (leading to bleeding and bruising) and 
red blood cells (leading to anemia) and potentially death. The presence 
of glucocerebroside seems to also trigger the loss of minerals in the 
bones, causing the bones to weaken, and can interfere with the bone's 
blood supply.
    The field of use is directed to the development of therapies for 
remedying enzyme deficiencies in the treatment of Gaucher Disease.
    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 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.
    Applications for a license filed in response to this notice will be 
treated as objections to the grant of the contemplated license. 
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: September 11, 2000.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 00-24241 Filed 9-20-00; 8:45 am]
BILLING CODE 4140-01-M