The U.S. International Trade Commission (ITC) has voted to institute an investigation of certain alendronate salts and products containing same. The products at issue in this investigation are alendronate salts in powder or tablet form which are used to treat osteoporosis and Paget’s disease conditions.

The investigation is based on a complaint filed by Merck & Co., Inc., of Whitehouse Station, NJ, on August 22, 2006. The complaint alleges violations of section 337 of the Tariff Act of 1930 in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain alendronate salts and products containing same that infringe a patent owned by Merck. The complainant requests that the ITC issue a permanent exclusion order and a permanent cease and desist order.

The ITC has identified CIPLA, Ltd., of Mumbai, India, as the respondent in this investigation.

By instituting this investigation (337-TA-584), the ITC has not yet made any decision on the merits of the case. The case will be referred to the Honorable Charles E. Bullock, an ITC administrative law judge, who will schedule and hold an evidentiary hearing. Judge Bullock will make an initial determination as to whether there is a violation of section 337; that initial determination is subject to review by the Commission.

The ITC will make a final determination in the investigation at the earliest practicable time. Within 45 days after institution of the investigation, the ITC will set a target date for completing the investigation. ITC remedial orders in section 337 cases are effective when issued and become final 60 days after issuance unless disapproved for policy reasons by the U.S. Trade Representative within that 60-day period.