On January 19, 2021, the ITC issued a Notice of Investigation in Certain Gabapentin Immunoassay Kits and Test Strips, Components Thereof, and Methods Therefor (Inv. No. 337-TA-1239).

By way of background, this investigation is based on a December 2, 2020 complaint filed by ARK Diagnostics, Inc. of Fremont, California (“ARK”) alleging a violation of Section 337 by fourteen respondents in the unlawful importation and sale in the U.S. of certain gabapentin immunoassay kits and test strips, and components of such kits and test strips, that infringe ARK’s U.S. Patent No. 8,828,665 or that are made, produced, or processed in a manner that infringes ARK’s U.S. Patent No. 10,203,345. According to the complaint, the asserted patents generally relate to isolated antibodies that can be used to test for the presence of gabapentin in samples such as blood or urine samples. ARK is requesting that the Commission issue a permanent limited exclusion order and a permanent cease and desist order directed at respondents. According to the Notice of Investigation, the Office of Unfair Import Investigations will not participate as a party in the investigation. Lastly, Chief ALJ Charles E. Bullock issued a notice indicating that he will preside in the investigation.