US appeals court says Medytox arguments unrelated to ITC ruling

Medytox's legal arguments came under pressure from the bench during a hearing at the US Court of Appeals for the Federal Circuit (CAFC) in its appeal of a botulinum toxin trade secret case against Hugel. The court's skepticism signals a setback for Medytox's efforts to overturn a US International Trade Commission (ITC) decision that rejected claims a competitor stole its technology.

According to Law360 on Nov. 10, a CAFC judge said at the Nov. 9 hearing that Medytox's arguments had "nothing to do with the ITC's ruling." The panel reportedly expressed bewilderment at Medytox's position that the ITC wrongly dismissed claims that a competitor stole its wrinkle-reduction technology.

The case began in March 2022 when Medytox filed a complaint with the ITC against Hugel and its partner Croma-Pharma, alleging misappropriation of botulinum toxin strains and manufacturing processes. The aim was to block imports and sales of Hugel's products in the United States, the world's largest toxin market. However, the ITC concluded in its final determination in October 2024 that Hugel did not violate Section 337 of the Tariff Act.

Medytox appealed the ITC's final determination to the CAFC in December 2024. Hugel, meanwhile, has moved aggressively into the US market after the ITC ruling removed business uncertainty. Hugel's botulinum toxin product Letybo received US Food and Drug Administration (FDA) approval in February 2024 and has been commercialized through its local distribution partner, Beneb.

Hugel aims to capture a 10% share of the US market within three years of entry and generate annual revenue of 300 billion won (about $221 million). At the JPMorgan Healthcare Conference in San Francisco in January 2026, Hugel CFO Eva Hwang said, "The ITC's clear final determination is a decisive victory for Hugel," adding, "The other party has appealed, but it is against the ITC, not Hugel, and it contains no new evidence."

Medytox previously secured royalties and equity through a settlement with Daewoong Pharmaceutical's US partner, Aeon Biopharma. The dispute with Hugel now awaits the CAFC's final decision, and the outcome of the appeal is expected to test Medytox's strategy for protecting its toxin intellectual property in the United States.

(Dollar figures are approximate, converted automatically at 1,000 won = $0.735, the rate on Nov. 10, 2026.)

※ This article is an AI translation of the Korean original published by Korea Credit News; it was checked by automated quality guards and published by the English edition desk.