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MINOXIDIL IMPORT CASE: INITIAL DETERMINATION TO BE REVIEWED

Executive Summary

MINOXIDIL IMPORT CASE: INITIAL DETERMINATION TO BE REVIEWED by the International Trade Commission (ITC). In an April 13 Federal Register notice, ITC said that after reviewing the record of the investigation of imported minoxidil powder, salts, and compositions, the agency has decided to review portions of the administrative law judge's February 16 initial finding of a violation of section 337 of the Tariff Act of 1930. Specifically, the commission will review: "Whether sufficient evidence exists in the record to show that the FDA will approve . . . the Upjohn Company's new drug application for its topical minoxidil [Rogaine] compositions which are the subject of this investigation, and when." Upjohn submitted its minoxidil NDA for treatment of male pattern baldness in December 1985. Upjohn had initiated the ITC action with an April 7, 1987 complaint. The Upjohn petition requested an investigation into unfair acts resulting from importation of minoxidil products, an exclusion order forbidding the entry of such products except for lawful noninfringing uses, and a permanent cease and desist order prohibiting 10 foreign and 10 domestic respondents from selling or transfering their minoxidil products for use in the U.S. in topical compositions ("The Pink Sheet" April 13, 1987, T&G-6). The commission also will review "whether it is possible, as a matter of law, in this case, to find that allegedly infringing imports have a tendency to substantially injure a domestic industry which is not authorized to make sales." Another issue to be considered is "whether sufficient evidence, particularly of a quantitative nature, exists in the record to show a tendency to substantially injure, and where in the record such evidence can be found." The Commission stated that if it finds that a violation has occurred it may "issue an order which could result in the exclusion of the subject articles from entry into the U.S. and/or cease and desist orders which could result in one or more respondents being required to cease and desist from engaging in unfair acts in the importation and sale of such articles." All 20 companies named as respondents in the original Upjohn petition have either defaulted, entered into settlements promising not to infringe Upjohn's composition patents, or have been dropped as respondents. On Dec. 28, ITC agreed to Upjohn's request that the commission drop the firm S.S.T. from investigation because of a lack of evidence that the company was infringing. The Mexican company Hair-Gro was also taken out of the complaint ("The Pink Sheet" Jan. 18, T&G-7). After the administrative law judge issued the initial determination, the commission's investigative attorney filed a petition for review of the determination. Upjohn submitted a response to the attorney's petition during the second week of March.

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