01-28706. Government-Owned Inventions; Availability for Licensing: Method of Treating HIV With 2′, 3′-Dideoxyinosine (ddI; didanosine)

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

The inventions listed below are owned by agencies of the U.S. Government and are available for nonexclusive licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for non-exclusive licensing.

(1) U.S. Patent No. 4,861,759, issued August 29, 1989, entitled “Antiviral Compositions and Methods” (PHS Reference No. E-081-87/1)

(2) U.S. Patent No. 5,254,539, issued October 19, 1993, entitled “Antiviral Compositions and Methods” (PHS Reference No. E-081-87/4)

(3) U.S. Patent No. 5,616,566, issued April 01, 1997, entitled “Method of Inhibiting HIV Replication with 2′, 3′-Dideoxyadenosine” (PHS Reference No. E-081-87/6)

(4) U.S. Patent Application No. 08/246,916, filed May 20, 1994, entitled “Antiviral Compositions and Methods” (PHS Reference No. E-081-87/7)

(5) U.S. Patent No. 5,026,687, issued June 25, 1991, entitled “Treatment of Human Retroviral Infections with 2′, 3′-Dideoxyinosine” (PHS Reference No. E-051-90/0)

(6) U.S. Patent No. 5,376,642, issued December 27, 1994, entitled “Treatment of Human Retroviral Infections with 2′, 3′-Dideoxyinosine” (PHS Reference No. E-051-90/2)

ADDRESSES:

Licensing information may be obtained by contacting Sally Hu, Ph.D., M.B.A., at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; Telephone: [phone] ext. 265; Fax: [phone]; E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Human Immunodeficiency Virus (HIV) and other retroviruses need three viral enzymes for replication: reverse transcriptase (RT), protease and integrase. The current focus for treatment of acquired immune deficiency syndrome (AIDS) is the development of antiviral drugs that target the infection and replication of HIV. The patents and patent applications describe group novel compounds discovered by Dr. Hiroaki Mitsuya, Dr. Robert Yarchoan and Dr. Samuel Broder at the National Cancer Institute. It has been shown that the drugs 2′, 3′-dideoxyinosine (ddI), 2′, 3′-dideoxyadenosine (ddA), and 2′, 3′-dideoxyguanosine (ddG), and their triphosphate derivatives are useful for treatment of retroviral infections, particularly HIV-infection and AIDS. ddI, ddA, and ddG are metabolized in vivo to active triphosphate derivatives that inhibit HIV and retroviral reverse transcriptase, an enzyme required for retroviral replication. Liposomal encapsulated dideoxynucleosides, salts and esters are also claimed since triphosphates ordinarily do not penetrate cell membranes and the triphosphate derivatives of this invention are delivered by liposomes, small particles that serve as intracellular transport systems. ddI (didanosine) is licensed for human use in the U.S. and around the world as a treatment for HIV infections.

Dated: November 6, 2001.

Jack Spiegel,

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