By John Presper

On April 6, 2022, the ITC issued a notice of its final determination to issue a limited exclusion order (“LEO”) and cease-and-desist order (“CDO”) in Certain In Vitro Fertilization Products, Components Thereof, and Products Containing the Same (Inv. No. 337-TA-1196).

By way of background, this investigation was based on a March 11, 2020 complaint filed by Merck KGaA affiliate EMD Serono, Inc. of Rockland, Massachusetts (“EMD”) alleging violations of section 337 by Respondents FastIVF of Scottsdale, Arizona (“FastIVF”), Hermes Eczanesi of Turkey, and General Plastik Drug Stores of Turkey in the unlawful importation/sale of certain “gray market” 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.  The products at issue were unauthorized versions of EMD’s fertility drugs, including Gonal-f, Ovidrel, and Ovitrelle.  FastIVF and Hermes Eczanesi were found in default, the investigation was terminated as to General Plastik Drug Stores based on withdrawal of the complaint.  EMD requested in its complaint that the Commission issued a general exclusion order (“GEO”), and on April 16, 2021, then-Chief ALJ Charles E. Bullock agreed with EMD in an initial determination (“ID”) and found that a GEO would be an appropriate remedy because the unauthorized fertility drugs were sold through “semi-anonymous internet pharmacies” that could easily circumvent an LEO.  See our May 5, 2021 post for more details regarding the ID.  On October 6, 2021, the Commission vacated the SD in part with respect to the finding that the economic prong of the domestic industry requirement had been satisfied, and remanded the investigation.  See our November 5, 2021 post for more details regarding the Commission’s opinion vacating the ID.

On remand, EMD withdrew its request for a GEO and instead sought an LEO against the defaulting respondents and a CDO against FastIVF.  The Chief ALJ issued a remand final initial determination (“FID”) in December 2021 finding a violation of section 337 and recommended an LEO against the defaulting respondents and a CDO against FastIVF.  The Commission subsequently affirmed the FID and requested briefing on remedy, public interest, and bonding.  Having examined the record of this investigation, including EMD’s and the Commission Investigative Staff’s submissions on remedy, public interest, and bonding, the Commission determined that the appropriate remedy is an LEO directed to the defaulting respondents, and a CDO directed to FastIVF.  The Commission also set the bond amount at 100%.

We will post the public version of the Commission’s opinion when it becomes available.