03-31325. Prospective Grant of Exclusive License: “Methods of Making, Using and Pharmaceutical Formulations Comprising 7α, 11β-dimethyl-17β-hydroxyestra-4,14-dien-3-one and 17 Esters Thereof and 17 Esters of 7α-methyl-17β-hydroxylestra-4,14-dien-3-...

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: USSN 60/193,530 and USSN 60/194,440, converted into combined PCT Application, PCT/US01/10293, and national stage filed in the U.S., Canada, Australia, Europe and Japan. A PCT-CIP was also filed and given a PCT Application Number of PCT/US02/09886, followed by national stage filings in the U.S., Canada, Australia, Europe, and Japan. The potential licensee is Torotech, LLC, having a place of business in the State of Maryland. The field of use may be limited to the therapeutic treatment of hypogonadism and human reproduction therapy. The United States of America is the assignee of the patent rights in this invention. This announcement is the first notice to grant an exclusive license to this technology.

DATES:

Only written comments and/or application for a license which are received by the NIH Office of Technology Transfer on or before February 17, 2004 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: Marlene Shinn-Astor, Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone]; Facsimile: [phone]; e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

This technology relates to compounds that possess potent androgenic activity. These compounds offer a potential therapeutic benefit in the treatment of hypogonadism, regardless of cause, as an adjuvant in hormone replacement therapy for both men and women and for androgen stimulation of anabolism in a broad spectrum of disease entities involving debilitation.

These compounds are far more active and retain their potency after oral administration more than that achieved with the current oral androgen standard, methyltestosterone. An additional expected benefit is that liver toxicity, if any, should be minimal because 7α, 11β-dimethyl-17β-hydroxy-4-estren-3-one bucyclate is not alkylated at the C17 position.

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 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.

Dated: December 12, 2003.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.