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: finleys@od.nih.gov. A 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.