01-1465. Prospective Grant of Exclusive License: Method for Preparing 17α-Acetoxy-11β-(4-,N-Dimethylaminophyl)-19-Norpregna-4, 9-Diene-3,20-Dione, Intermediates Useful in the Method, and Methods for the Preparation of Such Intermediates

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: U.S. Patent Application Serial No. 08/413,755, filed March 30, 1995, issuing as U.S. Patent 5,929,262 entitled, “Method for Preparing 17α-Acetoxy-11β-(4-N,N-Dimethylaminophyl)-19-Norpregna-4, 9-Diene-3,20-Dione, Intermediates Useful in the Method, and Methods for the Preparation of such Intermediates” to HRA Pharma, a corporation of France, having a place of business in Paris, France. The patent rights in this invention have been assigned to the United States of America, as represented by the Department of Health and Human Services.

DATES:

Only written comments and/or application for a license which are received by the NIH Office of Technology Transfer on or before April 18, 2001 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: Dennis H. Penn, Pharm.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone], ext. 211; Facsimile: [phone].

SUPPLEMENTARY INFORMATION:

In an effort to develop an efficacious treatment for human reproductive disorders this invention describes methods for the synthesis of 17α-Acetoxy-11β-(4-N,N-Dimethylaminophyl)-19-Norpregna-4,9-Diene-3,20-Dione Intermediates Useful in the Method, and Methods for the Preparation of such Intermediates This compound may have utility in treating human reproductive disorders and hormone sensitive tumors.

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 90 days from the date of this published Notice, NIH received 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.

The field of use may be limited to the use of the invention for the synthesis 17α-Acetoxy-11β-(4-N,N-Dimethylaminophyl)-19-Norpregna-4, 9-Diene-3,20-Dione and intermediates useful in the method of synthesis and preparation of such intermediates.

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.

Dated: January 8, 2001.

Jack Spiegel,

Director, Division of Technology Development and Transfer, Office of Technology Transfer.