02-9093. Prospective Grant of Exclusive License: Glycoprotein Hormone Superagonists

AGENCY:

National Institutes of Health, Public Health Service, HHS.

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. 09/185,408 filed May 6, 1996, and U.S. Patent Application Serial No. 10/057,113 filed January 24, 2002, entitled “Glycoprotein Hormone Superagonists,” to Trophogen, having a place of business in the state of Maryland. The field of use may be limited to the treatment of human infertility, Graves Disease, thyroid cancer, and contraceptives. The United States of America is the assignee of the patent rights in this invention. This announcement replaces three previous notices to grant an exclusive license to this technology: July 19, 1999 (64 FR 38685), February 7, 2000 (65 FR 5878-5879), and May 15, 2001 (66 FR 26871).

DATES:

Only written comments and/or application for a license, which are received by the NIH Office of Technology Transfer on or before June 14, 2002, 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, Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3821; Telephone: [phone], ext. 285; Facsimile: [phone]; E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

This invention relates generally to modified glycoprotein hormones and specifically to modifications to a human glycoprotein, which create superagonist activity. Glycoprotein hormones comprise a family of hormones, which are structurally related heterodimers consisting of a species common α sub-unit and a distinct β sub-unit that confers the biological activity for each hormone. However, this invention is not limited to specific hormones, specific subjects such as humans as well as non-humans mammals, specific amino acids, specific clinical conditions, specific analogs, or specific methods.

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: April 3, 2002.

Jack Spiegel,

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