International Trade Commission launches investigation into Alvotech’s adalimumab biosimilar – International Law


United States: International Trade Commission launches investigation into Alvotech’s adalimumab biosimilar

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As noted in our December 21, 2021 article, plaintiffs AbbVie Inc., AbbVie Biotechnology Ltd. and AbbVie Operations Singapore Pte. ltd. filed a complaint with the International Trade Commission against defendants Alvotech hf., Alvotech Germany GmbH, Alvotech Swiss AG, Alvotech USA Inc., Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals USA Inc. and Ivers-Lee AG alleging competition unfair under Section 337 of the Tariff Act of 1930 (19 USC § 1337). The complaint alleges misappropriation of trade secrets and tortious interference with contractual relationships. AbbVie has requested an exclusion order prohibiting the importation into the United States of Alvotech’s pre-commercial adalimumab biosimilar named AVT02 (marketed in Europe under the product names Libmyris and Hukyndra).

On January 31, the Commission’s Notice of Initiation was published in the Federal Register indicating the initiation of the investigation. The investigation bears investigation number 337-TA-1296 and was assigned to Administrative Judge Bhattacharyya, who was appointed to the bench in September last year. The parties were ordered to propose, among other things, a target date for the completion of the investigation and a timetable for discovery by February 25.

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