The Winner of the 'Toxin War' is Hugel... US ITC Rules "No Intellectual Property Infringement"

Medytox Claims "Hugel Stole Strains"
3-Year Legal Battle Following ITC Complaint
Final Ruling Favors Hugel

Hugel won the second round of the 'Botulinum Toxin War' filed by Medytox. Following the first round dispute against Daewoong Pharmaceutical, which Medytox had previously won, Medytox also filed a dispute against Hugel but was defeated this time.

According to Hugel on the 11th, the U.S. International Trade Commission (ITC) issued a final ruling on the 10th (local time) stating that there was no violation by Hugel in the case where Medytox sued Hugel, its partner Austrian company Chromapharma, and their joint venture Hugel America, alleging that Hugel had stolen its trade secrets related to the toxin products produced by Hugel.

Earlier in June, the ITC had also decided in a preliminary ruling that it "does not support Medytox's claim of 'strain theft'" and confirmed that "there was no violation of Section 337 of the Tariff Act in importing certain botulinum toxin products or their manufacturing or related processes into the United States." This decision reaffirmed that earlier ruling. Section 337 of the U.S. Tariff Act restricts unfair imports of goods that infringe on intellectual property rights such as patents, trademarks, and copyrights. The preliminary ruling is made by a single administrative law judge, and the final ruling is issued by a full commission of six members, where the ITC also ruled in favor of Hugel.

Thus, the patent dispute between the two companies, which has continued for over three years since 2022, ended with Hugel's victory. Medytox had previously won the lawsuit against Daewoong Pharmaceutical, with both the U.S. ITC and domestic courts recognizing Daewoong Pharmaceutical's strain theft.

Hugel's botulinum toxin 'Letibo'
Photo by Hugel

Hugel established Hugel America in 2018 together with Chromapharma and has been attempting to enter the U.S. market, including applying for FDA approval of the toxin product Botulex (export name Retivo) in October 2022. Botulex successfully received FDA approval in March after three attempts. In relation to this, Medytox filed a complaint with the ITC in May 2022, claiming that Hugel's toxin was made by stealing its toxin strain and that Hugel was attempting to export it to the U.S.

At that time, Medytox claimed that Hugel not only stole the toxin strain but also misappropriated related trade secrets such as manufacturing processes. However, during the subsequent litigation, Medytox requested the ITC to exclude strain-related issues from the investigation and even removed manufacturing process issues from the complaint, leading industry analysts to conclude that Hugel gained the upper hand. This was because the two most critical issues were consecutively excluded, and the trial proceeded only on relatively minor trade secrets such as personnel outflow.

Currently, Hugel's botulinum toxin Retivo received FDA approval in February and shipped its first export volume in July. Although direct sales through Hugel America were anticipated, Hugel chose to collaborate with the local aesthetic company Benev. This decision is interpreted as being largely influenced by the ability to immediately launch and expand sales in the U.S. market.

A Hugel representative stated, "The ITC's final ruling has revealed that Medytox's claim of strain theft against Hugel has no basis, resolving uncertainties about Hugel's U.S. business. Hugel will continue to make company-wide efforts to strengthen corporate trust and shareholder value and plans to sustain growth in global markets including the U.S."

Medytox expressed deep regret over the ITC's decision and stated that it will take all necessary measures to protect its intellectual property rights. A Medytox official said, "We believe the full commission's decision is very wrong. We will review countermeasures and take all necessary actions to reveal the truth to the end."