By John Presper

On January 26, 2022, the ITC issued a Notice of Investigation in Certain Adalimumab, Processes for Manufacturing or Relating to Same, and Products Containing Same(Inv. No. 337-TA-1296).

By way of background, this investigation is based on a December 17, 2021 complaint filed by AbbVie Inc. of Chicago, Illinois; AbbVie Biotechnology Ltd. of Bermuda; and AbbVie Operations Singapore Pte. Ltd. of Singapore. (collectively, “AbbVie”) alleging violations of section 337 by Respondents AlvoTech hf. of Iceland; Alvotech Germany GmbH of Germany; Alvotech Swiss AG of Switzerland; Alvotech USA Inc. of Arlington, Virginia; Ivers-Lee AG of Switzerland; Teva Pharmaceuticals Industries, Ltd. of Israel; and Teva Pharmaceuticals USA Inv. of North Wales, Pennsylvania (collectively, “Respondents”) in the unlawful importation/sale of certain 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.

According to the complaint, the accused products are human monoclonal antibodies that are biosimilars to AbbVie’s adalimumab (HUMIRA®) used to treat rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn’s disease, ulcerative colitis, hidradenitis suppurativa, uveitis, and juvenile idiopathic arthritis.  AbbVie alleges that Respondents have hired away its employees and used trade secrets known by those employees to work on their rival AVT02 product.

AbbVie is requesting that the Commission issue limited exclusion orders and permanent cease-and-desist orders directed to Respondents.  According to the Notice of Investigation, the Office of Unfair Import Investigations will participate as a party in the investigation.  Lastly, Acting Chief ALJ Clark S. Cheney issued a notice indicating that ALJ Monica Bhattacharyya will preside in the investigation.