On April 28, 2021, Chief ALJ Charles E. Bullock issued the public version of Order No. 10 (dated April 16, 2021) granting-in-part Complainant EMD Serono, Inc.'s ("EMD Serono") motion for summary determination of violation by the defaulting respondents in Certain In Vitro Fertilization Products, Components Thereof, and Products Containing the Same (Inv. No. 337-TA-1196).

By way of background, this investigation is based on a March 11, 2020 complaint filed by EMD Serono alleging violations of section 337 by way of unlawful importation and/or sale of certain in vitro fertilization products, components thereof, and products containing the same that infringe U.S. Trademark Registration Nos. 4,689,651; 1,772,761; 3,777,170; 3,389,332; 3,816,320; 1,972,079; 3,604,207; and 3,185,427 (collectively, "the Asserted Trademarks"). The Commission instituted the investigation on April 10, 2020, naming three respondents: FastIVF, Hermes Eczanesi, and General Plastik Drug Stores. On September 1, 2020 respondents FastIVF and Hermes Eczanesi (collectively, "the Defaulting Respondents") were found to be in default, and on October 13, 2020, ALJ Bullock issued an Initial Determination granting EMD Serono's motion to terminate the investigation as to General Plastik Drug Stores based on withdrawal of the complaint.

According to the Order, EMD Serono moved for a summary determination of violation by the Defaulting Respondents and requested entry of a general exclusion order ("GEO"). Specifically, EMD Serono requested summary determination that the Defaulting Respondents infringe the Asserted Trademarks, that both the technical and economic prongs of the domestic industry requirement have been satisfied, and that the Defaulting Respondents have engaged in unfair competition with respect to false representation of source, false advertising, and injury to domestic industry.

ALJ Bullock found that EMD Serono had shown by reliable, probative, and substantial evidence that a domestic industry exists and a violation of section 337 has occurred with respect to U.S. Trademark Registration Nos. 1,772,761; 3,777,170; 3,389,332; 3,816,320; 1,972,079; 3,604,207; and 3,185,427. The ALJ also found that the Defaulting Respondents engaged in false representation of source in violation of Section 337(a)(1)(A). However, ALJ Bullock found no violation of section 337 with respect to U.S. Trademark No. 4,689,651, holding that EMD Serono had provided no evidence that any of the imported products include the name "Gonal-f RFF RediJect." The ALJ further found no violation regarding EMD Serono's claims of false advertising and injury to domestic industry, noting that EMD Serono had failed to establish that FastIVF engaged in false advertising or that EMD Serono had suffered injury to its domestic industry. Accordingly, ALJ Bullock granted-in-part EMD Serono's motion for summary determination of violation.

With respect to remedy, the ALJ recommended that the Commission issue a GEO prohibiting the entry of all in vitro fertilization drugs, components thereof, and products the same labeled, in whole or in part, Gonal-f, Ovidrel, or Ovitrelle that infringe U.S. Trademark Registration Nos. 1,772,761; 3,777,170; 3,389,332; 3,816,320; 1,972,079; 3,604,207; and 3,185,427. Specifically, ALJ Bullock found that a GEO is necessary to prevent circumvention of a limited exclusion order directed to the Defaulting Respondents and that a widespread pattern of violation exists. Further, the ALJ recommended that the Commission impose a 100 percent bond during the Presidential review period.

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