Janssen Wants Drug Ingredient Classification Cases Assigned to Choe-Groves, Stayed

Three Court of International Trade cases filed by Janssen Ortho should be assigned to Judge Jennifer Choe-Groves and stayed, Janssen argued in an Oct. 27 brief at CIT now that the U.S. Court of Appeals for the Federal Circuit has issued its opinion in the appeal. In April, the Federal Circuit upheld Choe-Groves' decision that the active pharmaceutical ingredient imported by Janssen in one of its HIV medications was eligible for duty-free treatment (see 2104260034). The API was darunavir ethanolate (Janseen Ortho LLC v. United States, CIT #13-00052, #14-00094, #14-00198).

The three cases should be assigned to Choe-Groves since she presided over the original CIT case, the brief said. Also, the cases should be stayed so that the Justice Department and Janssen have time to resolve the refund issues associated with the actions, the brief said. "Finally, the Subject Actions should also be stayed because the refund calculations are complex and will require adequate time to resolve," it said. "Drawback claims were filed for many of the entries in dispute in the Litigated Case and the Subject Actions, and accelerated payment of estimated drawback for certain entries has already been issued, thereby complicating the calculation of the refunds owed. Calculating interest owed on the refunded duties likewise is a complex undertaking. The Court should therefore stay the Subject Actions so that the parties have sufficient time to complete these accounting tasks consistently and fully across all actions."