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USITC Institutes Section 337 Investigation of Certain Gabapentin Immunoassay Kits and Test Strips, Components Thereof, and Methods Therefor

January 19, 2021
News Release 21-006
Inv. No. 337-TA-1239
Contact: Peg O'Laughlin, 202-205-1819
USITC Institutes Section 337 Investigation of Certain Gabapentin Immunoassay Kits and Test Strips, Components Thereof, and Methods Therefor

The U.S. International Trade Commission (USITC) has voted to institute an investigation of certain gabapentin immunoassay kits and test strips, components thereof, and methods therefor.  The products at issue in the investigation are described in the Commission’s notice of investigation.

The investigation is based on a complaint filed by ARK Diagnostics, Inc., of Fremont, CA, on December 2, 2020.  A supplement to the complaint was filed on December 2, 2020 and an amended complaint was filed on December 23, 2020.  The complaint, as amended, alleges violations of section 337 of the Tariff Act of 1930 in the importation into the United States and sale of certain gabapentin immunoassay kits and test strips, components thereof, and methods therefor that infringe patents asserted by the complainant.  The complainant requests that the USITC issue a limited exclusion order and cease and desist orders. 

The USITC has identified the following as respondents in this investigation:

Hangzhou AllTest Biotech Co., Ltd. of Hangzhou, China;
Shanghai Chemtron Biotech Co., Ltd. of Shanghai, China;
Chemtron Biotech Co., Ltd. of San Diego, CA;
Zhejiang Orient Gene Biotech Co., Ltd. of Zhejiang, China;
Healgen Scientific, LLC of Houston, TX;
Kappa City Biotech, SAS of Montlucon, France;
12PanelMedical, Inc. of Sarasota, FL;
Acro Biotech, Inc. of Rancho Cucamonga, CA;
AlcoPro, Inc. of Knoxville, TN;
American Screening, LLC of Shreveport, LA;
Confirm Biosciences, Inc. of San Diego, CA;
Mercedes Medical, LLC of Lakewood Ranch, FL;
TransMed Co., LLC of Alpharetta, GA; and
Transmetron, Inc. of Salt Lake City, UT.

By instituting this investigation (337-TA-1239), the USITC has not yet made any decision on the merits of the case.  The USITC’s Chief Administrative Law Judge will assign the case to one of the USITC’s administrative law judges (ALJ), who will schedule and hold an evidentiary hearing.  The ALJ will make an initial determination as to whether there is a violation of section 337; that initial determination is subject to review by the Commission.

The USITC will make a final determination in the investigation at the earliest practicable time.  Within 45 days after institution of the investigation, the USITC will set a target date for completing the investigation.  USITC remedial orders in section 337 cases are effective when issued and become final 60 days after issuance unless disapproved for policy reasons by the U.S. Trade Representative within that 60-day period.

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