04-20093. Prospective Grant of Exclusive License: Antitumor Macrocyclic Lactones, Compositions and Methods of Use

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 part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in International Patent Application PCT/US98/15011, all related foreign and domestic patents and patent applications, entitled “Antitumor Macrocyclic Lactones, Compositions and Methods of Use” (DHHS Ref. No. E-244-1997/0), and in International Patent Application PCT/US00/05582, all related foreign and domestic patents and patent applications, entitled “Vacuolar-Type (H⁺)-ATPase Inhibiting Compounds, Compositions, And Use Thereof ” (DHHS Ref. No. E-244-1997/3), to Reata Discovery, Inc., located in Dallas, TX. The patent rights in these inventions have been assigned to the United States of America.

The prospective exclusive license territory will be worldwide and the field of use may be limited to human therapeutics for the treatment of cancer.

DATES:

Only written comments and/or license applications which are received by the National Institutes of Health on or before November 2, 2004 will be considered.

ADDRESSES:

Requests for copies of the patent, inquiries, comments and other materials relating to the contemplated exclusive license should be directed to: George G. Pipia, PhD, Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone]; Facsimile: [phone]; and e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The present inventions include macrocyclic lactones, and specifically salicylihalamides and related compounds, which are among the classes of compounds identified from biological sources. The NIH licensee for this technology might have some obligations to the source-country of the biological material. The present inventions further provide a method of preventing or treating cancer, which comprises administration to a patient an effective anticancer amount of at least one compound of the present invention. Furthermore, these compounds act as vacuolar-type (H⁺)-ATP-ase inhibitors and can possibly be useful for the treatment of osteoporosis, development of drug resistance in tumor cells, Alzheimer's disease, glaucoma, abnormal urinary acidification and treatment or prevention of viral infections (e.g., baculoviruses and retroviruses).

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 part 404.7. The prospective exclusive license may be granted unless within sixty (60) days from the date of this published notice, the NIH receives written evidence and argument that establish that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.7.

Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted 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: August 25, 2004.

Steven M. Ferguson,

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