March 17, 2011
News Release 11-027
Inv. No. 337-TA-766
Contact: Peg O'Laughlin, 202-205-1819

The U.S. International Trade Commission (USITC) has voted to institute an investigation of certain gemcitabine and products containing same. The products at issue in this investigation are drugs approved for the treatment of various types of cancer.

The investigation is based on a complaint filed by Eli Lilly and Company of Indianapolis, IN, January 20, 2011. Letters supplementing the complaint were filed on February 9, February 16, and March 9, 2011. The complaint alleges violations of section 337 of the Tariff Act of 1930 in the importation into the United States and sale of certain gemcitabine and products containing same that infringe a patent asserted by Eli Lilly. The complainant requests that the USITC issue an exclusion order and a cease and desist order.

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

Jiangsu Hansoh Pharmaceutical Co., Ltd., of China;
Intas Pharmaceuticals Ltd. of India;
ChemWerth, Inc., of Woodbridge, CT; and
Hospira, Inc., of Lake Forest, IL.

By instituting this investigation (337-TA-766), the USITC has not yet made any decision on the merits of the case. The USITC's Chief Administrative Law Judge will assign the case to one of the USITC's six administrative law judges (ALJ), who will schedule and hold an evidentiary hearing. The ALJ 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 USITC will make a final determination in the investigation at the earliest practicable time. Within 45 days after institution of the investigation, the USITC will set a target date for completing the investigation. USITC 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.