Prospective Grant of Exclusive License: Insulin Producing Cells Differentiated from Non-Insulin Producing Cells by GLP-1 and Exendin-4 and Use Thereof

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 an exclusive license worldwide to practice the invention embodied in: PCT Patent Application Serial Number PCT/US99/180899 (PHS Ref. E-151-97/1) entitled “Insulin Producing Cells Differentiated from Non-Insulin Producing Cells by GLP-1 and Exendin-4 and Use Thereof” filed on August 18, 1999, claiming priority of August 10, 1998, to Amylin Pharmaceuticals, Inc., having a place of business in San Diego, CA. The patent rights in this invention have been assigned to the United States America.

DATES:

Only written comments and/or application for a license which are received by the NIH Office of Technology Transfer on or before December 18, 2000 will be considered.

ADDRESSES:

Requests for a copy of the patent applications, inquiries, comments and other materials relating to the contemplated license should be directed to: John Rambosek, Ph.D., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Email: jr312d@nih.gov; Telephone: (301) 496-7056, ext. 270; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION:

The patent application relates to a population of insulin producing cells differentiated from non-insulin producing cells by contacting the non-insulin producing cells with Glucagon-like peptide-1 (GLP-1), Exendin-4, or related peptides. The application also relates to the methods for obtaining the insulin producing cells and therapeutic uses in the treatment of diabetes mellitus.

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 limited to the field of use for development of products and methods for treatment of diabetes. The field for use would include development, use, manufacture, distribution, import, export, marketing and sale of the licensed invention, throughout the world. The prospective exclusive license may be granted unless, within 60 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.

Properly filed competing applications for a license filed in response to this notice will be treated as objections to 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.