ITC agrees to review its decision in Botox dispute

Daewoong Pharmaceutical's Nabota. [DAEWOONG PHARMACEUTICAL]

The Botox war between Medytox and Daewoong Pharmaceutical has taken an unexpected turn as the U.S. International Trade Commission (ITC) decided to partially review its initial determination in favor of Medytox.

In its initial determination in July, the ITC concluded that Nabota — Daewoong’s botulinum toxin product currently sold in the U.S. market as Jeuveau — was made with bacteria and intellectual property stolen from Medytox. If that same conclusion is retained in the final determination in November, Daewoong’s Nabota would be banned from the country for 10 years.

Following the decision, Daewoong filed a complaint asking for a review of the initial determination, claiming the conclusion was flawed and relied on the opinion of Medytox experts. The request was accepted by the ITC.

According to its statement, the ITC will once again examine the existence of trade secret, misappropriation and subject matter jurisdiction on whether the U.S. government body is eligible to rule in a dispute between non-U.S. companies.

The complaint that provoked the U.S. ITC procedure in the first place was filed by Medytox and its U.S. partner Allergan in January 2019.

Daewoong has claimed Allergan is not the direct owner of the trade secret in question and therefore the U.S. ITC does not have jurisdiction in the matter.

For the review, the Commission also requested both parties answer how the Medytox strain is different from other Hall A-hyper strains which were first discovered the 1920s. Hall A-hyper strains are one of the manufacturing secrets Medytox claims has been stole by Daewoong.

Daewoong welcomed the decision, calling the review an “all-over re-examination.”

“The ITC practically accepted all of our objections,” it said in a Tuesday statement. “Not only did it decide to review juridical issues, but made an exceptional decision to re-examine the core facts on theft of strains and production methods.”

Medytox, on the other hand, brushed off such claims, emphasizing that the review was “partial” and a “conventional” part of ITC disputes.

“Partial reviews of the initial determination are a conventional procedure that commonly occurs in ITC suits. It rarely overturns results in the final determination,” the company said in a statement. “The initial determination was based on scientific facts and evidence. We are confident the final determination will ultimately accept the initial ruling.”

The final ruling of the Medytox versus Daewoong Pharmaceutical case is slated for Nov. 6.

BY SONG KYOUNG-SON [song.kyoungson@joongang.co.kr]