The U.S. International Trade Commission (ITC) has voted to institute an investigation of certain products and pharmaceutical compositions containing recombinant human erythropoietin. The products at issue in this investigation are pharmaceutical compositions that are used to treat patients with anemia.

The investigation is based on a complaint filed by Amgen Inc. of Thousand Oaks, CA, on April 11, 2006. An amended complaint was filed on April 27, 2006. The complaint, as amended, alleges violations of section 337 of the Tariff Act of 1930 in the importation into the United States of certain products and pharmaceutical compositions containing recombinant human erythropoietin that infringe patents owned by Amgen. The complainant requests that the ITC issue permanent exclusion orders and permanent cease and desist orders.

The ITC has identified the following as respondents in this investigation:

Roche Holding Ltd. of Basel, Switzerland;
F. Hoffmann-La Roche, Ltd., of Basel, Switzerland;
Roche Diagonistics GmbH, of Mannheim, Germany; and
Hoffmann La Roche, Inc., of Nutley, NJ.

By instituting this investigation (337-TA-568), the ITC has not yet made any decision on the merits of the case. The case will be referred to the Honorable Paul J. Luckern, an ITC administrative law judge, who will schedule and hold an evidentiary hearing. Judge Luckern 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.