ITC INSTITUTES SECTION 337 INVESTIGATION
ON CERTAIN INSULIN DELIVERY DEVICES,
INCLUDING CARTRIDGES HAVING ADAPTOR TOPS, AND COMPONENTS THEREOF
The U.S. International Trade Commission (ITC or Commission) has voted to institute an investigation of certain insulin delivery devices, including cartridges having adaptor tops, and components thereof. The products at issue in this investigation are insulin delivery systems comprised of a durable pen-shaped device and disposable insulin-filled cartridges with adaptors that enable use with the other components.
The investigation is based on a complaint filed by Novo Nordisk A/S of Denmark; Novo Nordisk Inc. of Princeton, NJ; and Novo Nordisk Pharmaceuticals Industries, Inc., of Clayton, NC, on May 8, 2006. Supplemental letters were filed on May 11 and May 23, 2006. The complaint, as supplemented, 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 insulin delivery devices, including cartridges having adaptor tops, and components thereof that infringe a patent owned by Novo Nordisk of Denmark. The complainants request that the ITC issue a permanent limited exclusion order and a permanent cease and desist order.
The ITC has identified the following as respondents in this investigation:
By instituting this investigation (337-TA-572), the ITC has not yet made any decision on the merits of the case. The case will be referred to the Honorable Sidney Harris, an ITC administrative law judge, who will schedule and hold an evidentiary hearing. Judge Harris 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.