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USITC Institutes Section 337 Investigation of Certain Adalimumab, Processes for Manufacturing or Relating to Same, and Products Containing Same

January 26, 2022
News Release 22-015
Inv. No. 337-TA-1296
Contact: Jennifer Andberg, 202-205-1819
USITC Institutes Section 337 Investigation of Certain Adalimumab, Processes for Manufacturing or Relating to Same, and Products Containing Same

The U.S. International Trade Commission (USITC) has voted to institute an investigation of certain adalimumab, processes for manufacturing or relating to same, and products containing same.  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 AbbVie Inc. of Chicago, IL, AbbVie Biotechnology Ltd of Hamilton, Bermuda, and AbbVie Operations Singapore Pte. Ltd. of Singapore, on December 17, 2021.  A supplement to the complaint was filed on January 4, 2022.  The complaint, as supplemented, alleges violations of section 337 of the Tariff Act of 1930 in the importation into the United States or sale of adalimumab, processes for manufacturing or relating to same, and products containing same by reason of the misappropriation of trade secrets and tortious interference with contractual relations, the threat or effect of which is to destroy or substantially injure an industry in the United States.  The complainants request that the USITC issue a limited exclusion order and cease and desist orders.  

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

Alvotech hf., of Reykjavik, Iceland; 
Alvotech Germany GmbH, of Julich, Nordrhein-Westfalen, Germany; 
Alvotech Swiss AG, of Zurich, Switzerland; 
Alvotech USA Inc., of Arlington, VA; 
Ivers-Lee AG, of Bern, Switzerland; 
Teva Pharmaceutical Industries Ltd., of Petach Tikva, Israel; and
Teva Pharmaceuticals USA Inc., of North Wales, PA.

By instituting this investigation (337-TA-1296), 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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