The U.S. International Trade Commission (USITC) has voted to institute an investigation of certain pre-filled syringes for intravitreal injection and components thereof. The products at issue in the investigation are described in the Commission’s notice of investigation.
The investigation is based on a complaint filed by Novartis Pharma AG of Basel, Switzerland, and Novartis Pharmaceuticals Corporation and Novartis Technology LLC, both of East Hanover, NJ, on June 19, 2020. The complaint alleges violations of section 337 of the Tariff Act of 1930 in the importation into the United States and sale of certain pre-filled syringes for intravitreal injection and components thereof that infringe a patent asserted by the complainants. The complainants request that the USITC issue a limited exclusion order and cease and a desist order.
The USITC has identified Regeneron Pharmaceuticals, Inc., as the respondent in this investigation.
By instituting this investigation (337-TA-1207), 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.