Botox 5-Year War Ends... Each Side Claims "We Won" (Comprehensive)

Medytox Gains Victory in US ITC Final Ruling
Daewoong Pharmaceutical's Import Ban Reduced from 10 Years to 21 Months

[Image source=Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] The U.S. International Trade Commission (ITC) ruled in favor of Medytox in the final decision regarding the five-year-long dispute over botulinum strains between Medytox and Daewoong Pharmaceutical. However, by significantly reducing the import ban period on Daewoong Pharmaceutical's botulinum toxin product 'Nabota' from 10 years to 21 months, both parties are considered to have gained both face and practical benefits.

On the 16th (local time), the ITC ordered a 21-month import ban within the U.S., stating that Daewoong Pharmaceutical's botulinum toxin formulation 'Nabota' (U.S. product name Jeuveau) violated Section 337 of the Tariff Act. Following the ITC's final ruling, the U.S. President must exercise approval or veto power within 60 days.

ITC: "Botulinum Strain Is Not a Trade Secret"

The core of this final ruling is the ITC's judgment that the botulinum strain is not a trade secret. While the ITC's preliminary ruling had found that Daewoong Pharmaceutical had misappropriated Medytox's strain and manufacturing technology, the final decision concluded that only the manufacturing technology was involved.

Daewoong Pharmaceutical evaluated this as a "de facto victory," whereas Medytox stated, "Although it was not recognized as a trade secret, it has been confirmed that Daewoong Pharmaceutical's claim of discovering the strain is false." Jeon Seung-ho, CEO of Daewoong Pharmaceutical, said in a phone interview with Asia Economy, "The core of the dispute between the two companies is the strain, and I am very satisfied that it was recognized that the strain is not a trade secret," adding, "It is effectively Daewoong Pharmaceutical's victory."

On the other hand, Medytox viewed that it was proven that Daewoong Pharmaceutical misappropriated Medytox's strain and manufacturing process to develop Nabota. Medytox said, "The ITC judged that the strain does not fall under regulatory conditions and thus did not recognize it as a trade secret, but it has been confirmed that Daewoong Pharmaceutical's claim of discovering the botulinum strain in soil from Yongin is a clear falsehood."

Until the day of this final ruling, it was impossible to predict which company would win. The ITC ruled in favor of Medytox in the preliminary ruling in July this year but accepted Daewoong Pharmaceutical's request for reconsideration in September. The final ruling was postponed twice from the 6th to the 19th of last month and then to the 16th of this month, leading some to speculate that, like the trade secret infringement lawsuit between LG Energy Solution and SK Innovation over electric vehicle batteries, it might be postponed three times.

[Image source=Yonhap News]

Medytox Rebounds, Daewoong Defends U.S. Market

Medytox has gained an opportunity for resurgence with this victory. Although the Ministry of Food and Drug Safety canceled the product approval for Medytox's botulinum toxin product 'Medytoxine,' placing it in a precarious position in the domestic market, the ITC's final ruling in its favor provides momentum to continue expanding into overseas markets such as China.

Daewoong Pharmaceutical also retains the possibility of re-entering the U.S. market with Nabota, which was the first Korean product to receive approval from the U.S. Food and Drug Administration (FDA). When Nabota was launched in the U.S. market in 2018, it ranked third in market share. Daewoong Pharmaceutical plans to immediately file for a provisional injunction to suspend the execution of the 21-month import ban on Nabota, aiming for second place in market share. CEO Jeon said, "Through the presidential veto or appeals to the U.S. Federal Circuit Court of Appeals, the issue regarding the misappropriation of manufacturing technology can be resolved within six months at most," adding, "Even if appeals are not accepted, the 21-month import ban period will not significantly hinder our U.S. business."

This content was produced with the assistance of AI translation services.