New development: On March 31, 2019, ALJ Cameron Elliot joined the Commission bench, thus completing the ITC's roster of six Administrative Law Judges.

  • Federal Circuit affirms commission decision not to institute synthetically produced predominantly EPA Omega-3 products, Inv. No. 337-TA-3247: On May 1, 2019, a Federal Circuit panel (Chief Judge Sharon Prost and Circuit Judges Evan J. Wallach and Todd M. Hughes) affirmed the Commission's decision not to institute an investigation into the importation of certain synthetically produced Omega-3 products. Complainant Amarin alleged such products were falsely labeled as "dietary supplements," and were actually "new drugs" as defined in the Food, Drug, and Cosmetic Act (FDCA) that were not approved for sale or use in the US. Amarin contended this violated both Section 43(a) of the Lanham Act (15 U.S.C. §1125(a)) and the FDCA (21 U.S.C. §321 et seq.).

    The court held that "claims based on such allegations are precluded by the FDCA, at least where the FDA has not yet provided guidance as to whether violations of the FDCA have occurred," because the FDCA "provides the United States with 'nearly exclusive enforcement authority.'" The court also found that "the FDA has not provided guidance as to whether the products at issue ... should be considered 'new drugs' that require approval."
  • Commission stays remedial order pending appeal to Federal Circuit of PTAB decision in Magnetic Tape Cartridges, Inv. No. 337-TA-1058: On August 17, 2018, ALJ Clark S. Cheney issued an ID finding that respondent Fujifilm infringes two of complainant Sony's patents covering magnetic tape used for computer system storage and data archiving. On that same date, the ALJ also issued an RD that an exclusion order not be enforced with regard to one patent claim pending an appeal to the Federal Circuit of a PTAB decision holding the claim invalid. On March 29, 2019, the Commission affirmed the ALJ's recommendation to stay the remedial order pending the Federal Circuit review of the PTAB decision.

    This was the first time that a Commission decision to issue an exclusion order was stayed pending the result of a PTAB proceeding, although the Commission noted in its opinion that the remedial order is still in effect with respect to other asserted patent claims.

    In a later investigation, Memory Modules, Inv. No. 337-TA-1089, Chief ALJ Charles E. Bullock more broadly interpreted the Commission's willingness to stay a remedial order pending Federal Circuit review of a PTAB decision. In that investigation, Judge Bullock issued an order denying a motion to stay pending a PTAB proceeding because of the late stage of the ITC investigation and early stage of the PTAB proceeding. However, Judge Bullock addressed the lack of undue prejudice in the proceeding, stating that the Commission has "signaled a willingness to suspend the enforcement of remedial orders" if the asserted claims are cancelled in a PTAB proceeding pending final resolution by the Federal Circuit.

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