Daewoong Pharmaceutical said Tuesday that a U.S. appeals court has granted the company's interim injunction application for suspending the execution of an administrative order to ban the import of Nabota, its botulinum toxin (BTX) product, in the U.S.
The company submitted the application last Friday.
The decision comes after the order to ban imports and sales of Nabota took effect on Monday, as the U.S. President reviewed and approved the ITC's final decision. The ITC had determined that Daewoong violated Article 337 of the U.S. Customs Act and banned the import and sale of Nabota for 21 months in December last year.
The U.S. Court of Appeals for the Federal Circuit granted an emergency motion to interim stay order until the court judges the company's appeal to nullify the U.S. International Trade Commission (ITC) order.
As a result of the appeals court decision, Evolus can sell Nabota through deposit payments. Evolus will have to pay bonds at $441 per vial of 100 Nabota units, and Daewoong will not be responsible for making any of the bond payments.
"We welcome the court's prompt decision to allow Evolus to continue its business during the appeal period," a Daewoong spokesperson told Korea Biomedical Review. "The company plans to correct the ITC's wrong ruling during the appeal process."
The official added that Medytox is making false claims by distorting the ITC's ruling and that the company plans to prove that the ITC's decision was misjudgment through its appeal this week.
"The company will prove the false claims and evidence made by Medytox during the ITC litigation during the U.S. and local trials," she said. "The company also plans to sue Medytox for making such false claims separately.”
In response, Medytox said that even if Daewoong Pharmaceuticals appeals to the U.S. court, it is unlikely that the company's guilty charges made through extensive evidence will change.
"The U.S. president accepting the ITC's final judgment has revealed the truth that Daewoong stole Medytox strain and manufacturing technology," a Medytox official said. "Daewoong bears not only legal but moral responsibility for making false claims to customers and regulators for a long time."
The official reiterated Medytox’s intention to pursue legal actions in Korea.
"As we have submitted ITC's evidence that helped convict Daewoong to local courts, we expect that the speed of domestic civil litigations and prosecution investigations will accelerate," he said.