On March 30, 2022, Medytox Inc. of the Republic of Korea ("Medytox") filed a complaint requesting that the ITC commence an investigation pursuant to section 337.
The complaint alleges that Hugel, Inc. of the Republic of Korea, Hugel America, Inc. of Irvine, California, and Croma Pharma GmbH of Austria (collectively, "Respondents") unlawfully import into the U.S., sell for importation, and/or sell within the U.S. after importation certain botulinum neurotoxin ("BTX") drug products manufactured using a proprietary strain of Clostridium botulinum (C. botulinum) bacteria and related trade secrets owned by and stolen from Medytox. The accused BTX drug products are marketed and sold under the trade names Botulax® and Letybo®.
The complaint states that Medytox previously filed complaints in the ITC, California, Indiana, and Korea concerning its proprietary strain of C. botulinum and related trade secrets against Daewoong Pharmaceuticals Co., its U.S. marketing partners, and a former employee.
Medytox alleges that a domestic industry exists under 19 C.F.R. §§ 210.12(a)(6)-(8) for Jeuveau®, MT10109L, ABP-450, and other BTX products (including Allergan's Botox® products, Merz's Xeomin® product, Ipsen's Dysport® product, Supernus' Myobloc® product, and Revance's Daxi product), and that the total value of the BTX market in the U.S. is approximately $3.5 billion.
With respect to potential remedy, Medytox requests that the Commission issue a permanent limited exclusion order and permanent cease-and-desist order directed to each proposed Respondent.
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