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Executive Summary

BRISTOL's CEFADROXIL MONOHYDRATE PATENT IS POTENTIALLY SUSTAINABLE, the Washington, D.C. federal appeals court decided Dec. 8 in a ruling clearing the way for Bristol-Myers Squibb to obtain an interim order from the International Trade Commission against importation of generic cefadroxil monohydrate. An initial determination from ITC Administrative Law Judge Janet Saxon in response to the appellate decision is expected in mid-December. The full commission has until March 15, 1990 to decide whether it concurs with the appeals court and will bar the antibiotic's import. The three-judge appellate panel's ruling unanimously reversed a June 13 interim determination by ITC administrative judge Saxon. The first decision denied a Bristol request for temporary relief to bar the cefadroxil importation. Saxon based her interim determination on a holding that it was likely that Bristol's patent would be held invalid. The appeals panel concluded the opposite: "We review this ruling in light of our holding that the validity of the . . . patent is likely to be sustained." On that basis, the appeals panel said: "We conclude that the commission exceeded its discretionary authority, committed an error of law, and seriously misjudged the evidence." If the full ITC does concur with the appeals court, as is likely, Biocraft and Purepac would lose access to their foreign sources of cefadroxil monohydrate. Biocraft and the Kalipharma subsidiary began selling imported cefadroxil in mid-March after receiving favorable first-round rulings in two patent lawsuits filed by Bristol ("The Pink Sheet" March 13, p. 15). Bristol is arguing before the ITC that its patent 4,504,657 (the '657 or Bouzard patent, issued March 12, 1985) for cefadroxil monohydrate (Mead Johnson's Duricef) is being infringed by Biocraft and Purepac. The two generic firms are claiming that Bristol's patent was anticipated by two earlier patents. If found to be valid in a full trial, Bristol's process patent would be in force until 2002. Bristol took its patent case to ITC in March after losing in the preliminary rounds of the court cases. Biocraft said Dec. 12 that it remains "hopeful" of prevailing and indicated that it will appeal a decision against the company. Zenith Labs is the third generic firm to have received an ANDA approval for cefadroxil monohydrate; however, the company decided not to market the product after Bristol threatened to sue. The ITC case deals purely with injunctive relief for the importation of the antibiotic; however, if Bristol is successful in defending its patent in the federal court and in subsequent appeals, the company could seek damages from Biocraft and Purepac.

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