Daewoong Pharmaceutical: "US ITC States Appeal Is Meaningless... Final Decision Nullification Imminent"

Exterior view of Daewoong Pharmaceutical headquarters in Gangnam-gu, Seoul (Photo by Daewoong Pharmaceutical)

[Asia Economy Reporter Lee Chun-hee] On the 17th (local time), Daewoong Pharmaceutical announced on the 18th that the U.S. International Trade Commission (ITC) stated that an appeal to the U.S. Court of Appeals for the Federal Circuit (CAFC) regarding the ITC's final decision, including the import ban order on its botulinum toxin "Jubo" (the U.S. export name of Nabota), is moot.

Daewoong Pharmaceutical interpreted this announcement as the ITC determining that further litigation is meaningless due to a tripartite agreement made in February with Evolus, Medytox, and Allergan. This follows the ITC's decision on the 3rd (local time) to approve Daewoong Pharmaceutical's request to withdraw the import ban order on Jubo and that if the appeal at the CAFC is dismissed, the existing final decision would be nullified from the outset.

Daewoong Pharmaceutical emphasized, "With the ITC officially announcing that the appeal is moot, the ITC's final decision is effectively likely to be invalidated," adding, "In this case, the parties involved in the lawsuit will no longer be able to use the decision's contents in other trials within the United States." Accordingly, it also evaluated that the two new lawsuits filed by Medytox in U.S. courts to prevent this have significantly diminished in significance.

Previously, on the 14th (local time), Medytox filed lawsuits against Daewoong Pharmaceutical and Ionbio in the U.S. Central District Court of California, and against Daewoong and Daewoong Pharmaceutical in the U.S. Eastern District Court of Virginia. Ionbio is the exclusive partner holding the rights to approve, import, and sell Jubo for therapeutic purposes in the U.S., Europe, and Canada.

Daewoong Pharmaceutical stated, "We fully support this ITC announcement," and added, "We expect the CAFC to respect the ITC's position and promptly issue a ruling that nullifies the existing final decision from the outset." Furthermore, it added, "Based on the truth revealed so far, Daewoong Pharmaceutical will win the ongoing domestic civil and criminal lawsuits."

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