Daewoong Pharmaceutical "Appeal Procedure Initiated"... Endless Botox War

Daewoong Pharmaceutical "Will Correct Misjudgment at US Court of Appeals"
Despite Expedited Review Request... Conflict Expected to Continue Throughout This Year

[Asia Economy Reporter Kim Ji-hee] The dispute between Daewoong Pharmaceutical and Medytox over the strain of botulinum toxin (Botox) continues this year. Daewoong Pharmaceutical, which received a 21-month import ban on its Botox product 'Nabota' from the U.S. International Trade Commission (ITC) last year, has filed an appeal. Industry insiders are increasingly concerned that the 'Botox war,' now in its sixth year, will only deepen the wounds for both companies.

Daewoong Pharmaceutical announced on the 19th that the appeal process regarding the ITC's final decision issued last December at the U.S. Federal Circuit Court of Appeals has begun. Daewoong Pharmaceutical stated, "The ITC's final decision misjudged legal issues such as jurisdiction and party standing, and made an erroneous inference based solely on the similarity of manufacturing processes," adding, "We believe the Federal Circuit Court of Appeals can correct this misjudgment."

In December last year, the ITC issued a 21-month import ban order on Nabota, a Botox formulation, citing a violation of Section 337 of the Tariff Act. In the final ruling, the initially recommended 10-year import ban period from the preliminary ruling in July last year was significantly shortened, and it was determined that the botulinum strain is not a trade secret. However, the misappropriation of manufacturing technology, another key issue alongside the strain, was acknowledged.

To minimize damage, Daewoong Pharmaceutical also requested an expedited review process. However, even if expedited review proceeds, the 'litigation mode' is expected to continue throughout this year. A Daewoong Pharmaceutical official said, "The expedited review can shorten the appeal period," but added, "Considering the hearing process and submission of materials, it is expected to take more than six months." On the 15th, Daewoong Pharmaceutical received a preliminary injunction from the appellate court to suspend enforcement and resumed sales, temporarily easing the urgent situation.

On the other hand, Medytox views the dispute in the U.S. as effectively concluded and is turning its attention to ongoing lawsuits in Korea. This is because the domestic lawsuits are expected to accelerate following the ITC's final ruling. A Medytox official explained, "In the appeal, the plaintiff is Daewoong Pharmaceutical and the defendant is the ITC, so Medytox will only be a general reference party," adding, "Since the evidence used by the ITC to determine misappropriation has also been submitted to the Korean courts, the previously sluggish domestic lawsuits are expected to gain momentum."

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