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MARION MERRELL DOW CLAIMS CARDIZEM PROCESS PATENT INFRINGEMENT BY COPLEY, MYLAN

Executive Summary

MARION MERRELL DOW CLAIMS CARDIZEM PROCESS PATENT INFRINGEMENT BY COPLEY, MYLAN and two European bulk suppliers of diltiazem in suits filed Nov. 24 by MMD and its Cardizem licensor and supplier, the Japanese firm Tanabe Seiyaku. The complaint alleges that generic diltiazem marketer Copley Pharmaceutical and its bulk supplier, the Finnish firm Orion/Fermion, are knowingly infringing a process claimed in U.S. patent 4,438,035 which protects Tanabe's processes for manufacturing diltiazem until March 20, 2001. The same charges are made against Mylan Labs and its supplier, the Italian firm Profarmaco Nobel srl, in a separate complaint. The suits claim that the "defendants' infringement of the '035 patent is willful, wanton and deliberate" and request "a permanent injunction restraining the defendants from further infringement" of '035 as well as unspecified monetary damages. Additional marketers and suppliers may be named in later actions, MMD said. MMD's immediate-release diltiazem exclusivity expired Nov. 5. Mylan, Copley and Lederle have approved ANDAs for generic versions of the calcium channel blocker; Copley is also supplying the product to Geneva, Aligen, Major, Martec and Schein. Rugby Labs has been marketing an authorized generic version of diltiazem produced by MMD subsidiary Blue Ridge Labs since October. Lederle, which does not use Fermion or Profarmaco, was not named in the suit. Mylan responded to the suit with a statement that it previously had offered to provide to the plaintiffs "scientific and manufacturing data which Mylan firmly believes would have demonstrated non- infringement of the Tanabe patent." Mylan added: "Despite repeated efforts, Mylan received no answers or requests for this information." The generics firm said it "believes it has fulfilled its statutory obligations with regard to the act in question" and will "vigorously defend itself" in the suit. Copley said that its supplier, Fermion, has assured it that the bulk diltiazem does not infringe Tanabe's patent. The Nov. 24 complaint against Copley follows by just one week the resolution to a previous suit filed by MMD claiming trade dress infringement for Cardizem. That suit, filed in Philadelphia federal court, claimed that Copley's generic version infringed the color and shape for Cardizem tablets. A countersuit filed by Copley maintained that MMD had no protectable trade dress rights for Cardizem tablets and that Copley had not infringed any protectable rights. The two firms agreed "to settle both suits without further litigation" and Copley agreed to change the colors of its tablets before Dec. 1, MMD said. The latest round of litigation is part of MMD's attempt to protect a potentially $1 bil. product line. For the first nine months of 1992, the Cardizem line generated $746 mil. in sales, with 30% of sales from the once-a-day formulation Cardizem CD ("The Pink Sheet" Oct. 26, p. 10). CD is approved for both angina and hypertension. MMD also markets a twice-daily formulation, Cardizem SR, for hypertension. The latest suits were filed in Boston federal court. Marion Merrell Dow is being represented in the case by trial counsel Leslie Misrock of the New York office of Pennie & Edmonds. Alexander Pratt of the Boston office of Peabody & Arnold is also involved in the case for MMD.
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