Medytox appeals ITC ruling in favor of Hugel over BTX dispute

Medytox has appealed the U.S. International Trade Commission’s (ITC) ruling in favor of Hugel in their botulinum toxin (BTX)-related lawsuit, as confirmed on Tuesday.

On the same day, Hugel announced, “Medytox filed an appeal against the ITC with the U.S. Court of Appeals for the Federal Circuit (CAFC) in December last year. We will participate in the appeal process as an interested party.”

Medytox has appealed the U.S. ITC's ruling in favor of Hugel in their botulinum toxin dispute. (Credit: Getty Images)

In 2022, Medytox filed a complaint with the ITC, accusing Hugel, its U.S. subsidiary Hugel America, and its distribution partner Chroma Pharma of stealing its strain and manufacturing process to produce BTX for export to the U.S.

BTX, a protein derived from the botulinum bacterium, is used in medical treatments to paralyze muscles and reduce wrinkles.

However, in June and October of last year, the ITC issued preliminary and final rulings, respectively, rejecting Medytox's claims of strain theft and concluding that Hugel did not violate Section 337 of the Tariff Act or any laws.

Industry observers suggest that the CAFC is unlikely to overturn the ITC’s ruling, given the commission's clear decision that Hugel was not guilty of BTX misappropriation or related manufacturing violations. Some also speculate that the appellate court’s decision and responses from both companies could reignite the dispute.

However, Medytox has remained reserved about its post-appeal strategy.

A company official confirmed, “It is correct that we filed the appeal. We will diligently proceed with the upcoming procedures,” but declined to comment further.