The U.S. International Trade Commission (USITC) has voted to institute an investigation of certain strontium-rubidium radioisotope infusion systems and components thereof including generators. The products at issue in the investigation are systems used to generate and infuse radiopharmaceuticals, such as rubidium-82, for intravenous administration in applications such as diagnostic medical imaging.
The investigation is based on a complaint filed by Bracco Diagnostics Inc. of Monroe Township, NJ, on March 27, 2018. The complaint alleges violations of section 337 of the Tariff Act of 1930 in the importation into the United States and sale of certain strontium-rubidium radioisotope infusion systems and components thereof including generators that infringe patents asserted by the complainant. The complainant requests that the USITC issue a limited exclusion order and cease and desist orders.
The USITC has identified the following as respondents in this investigation:
Jubilant DraxImage Inc. of Kirkland, Quebec, Canada;
Jubilant Pharma Limited of Singapore; and
Jubilant Life Sciences of Noida, Uttar Pradesh, India.
By instituting this investigation (337-TA-1110), 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 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.