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Executive Summary

MERCK's INDOMETHACIN UNFAIR COMPETITION COMPLAINT NOT VIABLE, Mylan maintained in an Aug. 30 motion to dismiss an Internatl. Trade Commission (ITC) investigation requested by Indocin-mfr. Merck. Mylan contended in its motion that "Merck has no 'patent rights' to enforce and has no viable claim for any 'unfair competition'" and that Merck "never had such a claim." Mylan argues that Merck acquired assignment of only one of five patents for manufacturing processes invented by a Japanese firm, Sumitomo Chemical Co. Because the five processes are closely related, the U.S. Patent Office in 1971 had required Sumitomo to sign a "terminal disclaimer," which provides that the patent for any of the five processes "shall expire immediately if it ceases to be commonly owned with the patents" for the other four processes. Consequently, Mylan said, because the process patent assigned to Merck is not owned by the same entity (Sumitomo) that owns the other four patents, it has expired as of Dec. 27, 1983, the date of assignment. Merck, ITC's Unfair Import Investigations Div; and the other domestic and foreign drug firms named by Merck as respondents in the case are scheduled to file responses to Mylan's motion by Sept. 7. An ITC administrative law judge is expected to rule on the motion shortly thereafter. "Merck has no assignment and no ownership of any of the" other four Sumitomo process patents for indomethacin, Mylan argued. "Consequently and unquestionably, as of Dec. 27, 1983 the requirement in the terminal disclaimer that the patents remain 'commonly owned' has been violated. Since that date there has been no common ownership" of the five patents. Therefore, the generic firm said: "Inescapably by virtue of the unequivocal language and covenant of Sumitomo's own terminal disclaimer, the . . . patent here in suit immediately expired when Merck took its assignment and transfer of title of that patent."

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