US ITC Smiles On HUGEL Over Botulinum Toxin Battle Against Medytox
US ITC Smiles On HUGEL Over Botulinum Toxin Battle Against Medytox
  • BK Min
  • 승인 2024.06.12 03:55
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USITC Backs Hugel in Botulinum Toxin Dispute Against Medytox

Hugel has emerged victorious in the botulinum toxin lawsuit against Medytox in the United States. 

On June 11 (local time), the United States International Trade Commission (ITC) concluded that Hugel's botulinum toxin product, 'Letybo' (known domestically as Botulax), did not violate customs laws.

The ITC's preliminary ruling in the Hugel-Medytox case is a significant development. It states, "We confirm that there is no violation of Section 337 of the Tariff Act of 1930 concerning the importation of certain botulinum toxin products and their manufacturing processes into the United States." 

This ruling paves the way for the final decision and has the potential to reshape the botulinum toxin market.

Section 337 of the Tariff Act involves investigations conducted by the USITC into unfair import practices, particularly those related to intellectual property rights such as patent and trademark infringements. Depending on the findings, the USITC can order Customs to halt the importation of the offending products into the US.

The dispute between Hugel and Medytox over Letybo began in March 2022. The final ruling is scheduled for October 10.

With the ITC's preliminary finding favoring Hugel, the company's prospects in the US botulinum toxin market are set to soar. The US FDA's approval of Letybo in March already positioned Hugel as the first domestic company to enter the US, Chinese, and European markets simultaneously. This victory could further bolster Hugel's market position and reshape the competitive landscape.

A Hugel representative stated, "The preliminary ruling revealed that Medytox's claims of Hugel's strain theft were baseless. We will actively present our case and do our utmost in the litigation leading to the final decision in October."

The ITC's preliminary ruling has left Medytox in a challenging position. A Medytox representative expressed disappointment, stating, "We are very disappointed with the ITC's preliminary ruling that Hugel found no unlawful conduct. We still believe Hugel's botulinum toxin products are illegal and cause significant harm not only to Medytox but also to the US market." 

They added, "The administrative judge's decision is merely an initial step in the decision-making process, which includes the full ITC committee, the US Court of Appeals, and the President. We intend to request a review by the full ITC committee and believe that a ban on the product will be issued after all evidence and arguments are examined. This ruling could potentially have a significant impact on Medytox's market standing and future operations.

Botulinum toxin products are popular for therapeutic uses, such as treating muscle spasm disorders caused by nerve dysfunction, and cosmetic purposes, like wrinkle removal. The global market for these products is rapidly growing and is projected to reach 15 trillion won by next year.

The summary of this article in Korean is as follows

▶美 ITC, 보툴리눔 톡신 균주 도용 소송 예비판결서 "휴젤 손↗" 

2024년 6월 12일, 미국 국제무역위원회(ITC)는 메디톡스와 휴젤 간의 보툴리눔 톡신 소송에서 휴젤의 손을 들어주는 예비 판결을 내렸다. 메디톡스는 2022년 3월, 휴젤이 자사의 보툴리눔 톡신 균주와 제조 공정의 영업비밀을 도용했다고 주장하며 ITC에 소송을 제기했다.

주요 쟁점은 균주 도용과 영업비밀 유출 여부였다. 메디톡스는 휴젤이 자사의 균주를 불법 복제했다고 주장했지만, 휴젤은 자체 균주를 개발했다고 반박했다. 2023년 9월, 메디톡스는 균주 절취 주장을 철회했으며, 2024년 이달 11일(현지시각) ITC는 휴젤이 메디톡스의 균주 또는 영업비밀을 도용하지 않았다고 예비 판결을 내렸다.

ITC 행정법원 판사는 "메디톡스의 주장에 근거가 없으며, 휴젤의 제품 및 제조 공정은 미국 관세법 337조를 위반하지 않는다"고 판단했다. 최종 판결은 아직 내려지지 않았지만, 예비 판결이 최종 판결에 반영될 가능성이 높다.

이번 예비 판결로 인해 메디톡스의 미국 시장 진출은 지연될 수 있으며, 메디톡스는 다른 해외 시장에 초점을 맞출 수 있다. 반면 휴젤은 미국 시장 진출 기회를 확대할 수 있고, 브랜드 가치가 상승할 것으로 기대된다.



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