ITC Preliminary Ruling Review... Daewoong "Confident of Final Victory" vs Medi "Routine Procedure" (Comprehensive)

Summary Excerpt of ITC Posting on Partial Reconsideration of Daewoong Pharmaceutical's Objection

[Asia Economy Reporter Cho Hyun-ui] Regarding the dispute over the botulinum toxin strain between Medytox and Daewoong Pharmaceutical, the U.S. International Trade Commission (ITC) decided on the 21st (local time) to partially accept Daewoong Pharmaceutical's objections. Following the ITC's preliminary ruling in favor of Medytox, the partial reconsideration of Daewoong Pharmaceutical's objections has drawn attention to how it might affect the final decision scheduled for November.

According to industry sources on the 22nd, the ITC decided to accept and review the objections raised by Daewoong Pharmaceutical concerning the preliminary ruling issued in July for both companies.

Earlier, in July, the ITC preliminarily ruled that "Daewoong Pharmaceutical misappropriated Medytox's botulinum strain and manufacturing process trade secrets" and issued a 10-year import ban order on Daewoong Pharmaceutical's botulinum toxin product 'Nabota' (U.S. name: Jeuveau).

In response, Daewoong Pharmaceutical submitted a petition to contest the preliminary ruling on the 19th of the same month. The petition raised issues not only about the misappropriation of the botulinum strain and manufacturing process but also questioned whether the matter falls under the ITC's jurisdiction and whether the U.S. domestic industry requirements were met.

The two companies have shown contrasting reactions to the ITC's decision to review the preliminary ruling. Daewoong Pharmaceutical expects to overturn the preliminary ruling and win in the final decision through this review, while Medytox emphasized that this is just a routine procedure.

Jeon Seung-ho, CEO of Daewoong Pharmaceutical, said in a phone interview with Asia Economy on the same day, "Most of the objections raised, including plaintiff standing, jurisdiction, and the establishment of trade secrets, which are fundamental to the lawsuit, have been accepted. This is the best-case scenario among the expected outcomes. It couldn't be better."

He added, "This decision means we have returned to the 'original review' stage. We expect it to have a positive impact on the final decision," and asserted, "We will do our best based on this outcome in the final decision."

On the other hand, Medytox stated, "The review of the preliminary ruling is a routine and general procedure that occurs during the ITC litigation process." According to Medytox, the ITC committee, composed of five commissioners, conducts a review if even one member decides to accept an objection.

A Medytox official said, "It is rare for the preliminary ruling to change through partial review," and added, "Since the ITC administrative law judge made the correct ruling based on scientific evidence and proof, we are confident that the ITC committee will ultimately adopt the preliminary ruling result as is."

The ITC's final decision will be made on November 6. The actual confirmation will be after the U.S. president's approval on January 6 of next year. The ITC will review Daewoong Pharmaceutical's objections and examine the legal regulatory measures of the preliminary ruling. They will also assess whether the 10-year import ban on Nabota imposed by the administrative law judge is an appropriate level of regulation.