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DOXORUBICIN IMPORTED BY CETUS AND BRISTOL-MYERS DOES NOT INFRINGE

Executive Summary

DOXORUBICIN IMPORTED BY CETUS AND BRISTOL-MYERS DOES NOT INFRINGE Erbamont's process patent for the anticancer agent, International Trade Commission Administrative Law Judge Sidney Harris ruled May 22. Erbamont's process patent, Harris concluded, is "anticipated by prior art"; "would have been obvious at the time it was invented to one of ordinary skill in the art"; is "unenforceable by reason of inequitable conduct before the U.S. Patent and Trademark Office"; and, even if valid and enforceable, is not infringed by the doxorubicin products imported and sold in the U.S. by Cetus-Ben Venue and Bristol-Myers Squibb. The decision is subject to review by the commission. Erbamont, which markets its doxorubicin product Adriamycin in the U.S. through subsidiary Adria, filed the ITC infringement suit in May 1989 shortly after Cetus-Ben Venue and Bristol-Myers obtained ANDA approvals for the drug. Both companies have had generic doxorubicin products on the market now for about a year. In the ITC suit, Erbamont alleged that doxorubicin imported by Cetus-Ben Venue from Societa Italiana Corticosteroidi (SICOR), of Milan, Italy, and by Bristol-Myers Squibb from Meiji Seika Kaisha, of Tokyo, Japan, was made by a process that infringed Erbamont's process patent on the compound. The process patent expires in April 1991. The companies are also fighting out the marketing status of doxorubicin in two federal court cases: a patent case initiated by Erbamont and a suit brought by Cetus. The Cetus suit charges Erbamont, its parent, Montedison, and their affiliate, Farmitalia, with unfair competition and violation of U.S. antitrust laws. Bristol filed a request for a declaratory judgment against Erbamont's patent in Delaware federal court in March 1989. Erbamont filed a counterclaim in mid-April 1989 ("The Pink Sheet" April 17, 1989, T&G-16). Commenting on the Administrative Law Judge's ruling, Erabmont said it is "confident that the commission will support our belief that our patent is valid and enforceable and that our competitors' actions infringe our patent." Erbamont "intends to continue its fight to protect its patents from unauthorized use by others." The firm also noted that it has filed an application "for approval of a new dosage form of Adriamycin incorporating some additional patented technology." Cetus estimates that U.S. sales of doxorubicin are over $160 mil.
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