Prospective Grant of Exclusive License: The Development of Thalidomide Analogs for the Treatment of Cancer

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 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 US Patent Application 60/792,098 entitled “Tetrahalogenated Compounds Useful as Inhibitors” [HHS Ref. E-080-2006/0-US-01], PCT Application PCT/US2007/008849 entitled “Tetrahalogenated Compounds Useful as Inhibitors” [HHS Ref. E-080-2006/0-PCT-02], Australian Patent Application 2007238785 entitled “A New Series Of Thalidomide Analogs That Have Potent Anti-angiogenic Properties” [HHS Ref. E-080-2006/0-AU-03], Canadian Patent Application 2,648,216 entitled “A New Series Of Thalidomide Analogs That Have Potent Anti-angiogenic Properties” [HHS Ref. E-080-2006/0-CA-04], European Patent Application 07755201.6 entitled “A New Series Of Thalidomide Analogs That Have Potent Anti-angiogenic Properties” [HHS Ref. E-080-2006/0-EP-05], US Patent Application 12/287,597 entitled “A New Series Of Thalidomide Analogs That Have Potent Anti-angiogenic Properties” [HHS Ref. E-080-2006/0-US-06], and all continuing patents, patent applications, and foreign counterparts thereto, to CuriRx, Inc., which has offices in Andover, Massachusetts. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America.

The prospective exclusive license territory may be worldwide, and the field of use may be limited to:

The use of Gu998 (Compound 19e), Gu973 (Compound 19f), Gu1029 (Compound 20d) or Gu992 (Compound 20g) as cancer therapeutics.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before July 20, 2009 will be considered.

ADDRESSES:

Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: David A. Lambertson, Ph.D., Senior Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-4632; Facsimile: (301) 402-0220; e-mail: lambertsond@od.nih.gov.

SUPPLEMENTARY INFORMATION:

The invention concerns the use of tetrahalogenated thalidomide derivatives for the treatment of cancer. Thalidomide has been shown to be a potent inhibitor of angiogenesis (the formation of new blood vessels). The popular belief is that angiogenesis enhances tumor formation by providing tumors with increased nutrients, allowing their sustained growth. However, thalidomide is a natural teratogen that can cause severe birth defects, and has a propensity towards causing neotropenia and deep venous thrombosis in recipients of the drug. This led researchers to seek out safer derivatives of thalidomide that retain an anti-cancer activity. The tetrahalogenated derivatives disclosed by this technology may represent both a safer alternative to thalidomide and potentially a more successful alternative to the angiogenesis inhibitors currently being clinically tested.

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 sixty (60) days from the date of this published notice, the 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.

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.