US ITC: "Hugel Did Not Infringe Medytox's Toxin Intellectual Property Rights"

Medytoks filed a complaint with the U.S. International Trade Commission (ITC) alleging that Hugel had stolen its trade secrets related to botulinum toxin products, but the ITC has ruled that "there was no violation of Hugel's intellectual property rights."

Hugel's botulinum toxin 'Botulax' (export name Letibo) [Photo by Hugel]

On the 10th (local time), the ITC stated, "In the final preliminary determination on this matter, it was confirmed that there was no violation of Section 337 of the Tariff Act regarding the importation into the United States of certain botulinum toxin products and related manufacturing processes." 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.

With this, the patent dispute between the two companies, which has lasted for over three years since 2022, has tilted in favor of Hugel. However, this decision is a preliminary ruling, and a final judgment is expected to be issued again in October.

Hugel established Hugel America in 2018 and continued its attempts to enter the U.S. market, including applying for FDA approval of its botulinum toxin product Botulex (export name Retivox) in October 2022. Botulex successfully received FDA approval last March after three attempts. However, Medytoks filed a complaint with the ITC, claiming that Hugel's botulinum toxin was made by stealing Medytoks' Hyper Hall A strain and that Hugel was attempting to export it to the U.S.

At the time of the complaint, Medytoks alleged that Hugel not only stole the botulinum toxin strain but also misappropriated related trade secrets. However, during the litigation process, Medytoks requested to exclude investigations related to trade secret theft, leading to speculation that Medytoks might have put itself at a disadvantage. Additionally, recent decisions by Bain Capital, Hugel's former largest shareholder, to exercise large-scale convertible bond (CB) conversion rights have been analyzed as a sign that Hugel is gaining the upper hand in the ruling. It is also believed that the stock price is expected to rise after this preliminary ruling due to the high likelihood of victory.