A local court has decided to temporarily suspend the legal effect of an administrative order to revoke the clinical trials of Invossa until the end of August. The period to “suspend the order’s effect,” initially set to end on July 29, will be extended for about a month.
“The ruling is not something that can be decided easily as the claims from both parties are equally strained,” the Seoul Administrative Court said, during the litigation hearing on Friday. “We also have to consider the right of patients participating in clinical trials, which may be affected by the ruling.” The decision on whether to suspend the trial will be held after three to four weeks, the court added.
Until the court makes a ruling, the effect of the order to cancel the clinical trials of Invossa will be temporarily suspended. The Ministry of Food and Drug Safety initially revoked the clinical trial approval for Invossa on July 3.
However, the court had suspended the order’s effects until July 29, after Kolon Life Science filed a suit with the court against the Ministry of Food and Drug Safety to invalidate its administrative order. The court will review the additional data submitted by the two sides and make a ruling regarding the request for the suspension of execution about a month later.
The revocation of Invossa’s sales approval has also been postponed once again since the hearing on Tuesday.
After four hours of heated debate between the two sides, the court said, “We will decide around Aug. 13, after receiving additional data from both sides.” It then decided to postpone the period to suspend the order’s effects until the decision date.
The court also decided to suspend the nullification of Invossa’s sales license temporarily until Aug. 14.
Industry watchers said the extension of temporary suspension reflects the court’s agony over the final decision, as the opinion from Kolon Life Science and the Ministry of Food and Drug Safety are opposed sharply against each other.
Such a fierce debate was witnessed during the litigation inquiry on Tuesday and Friday, as both sides strongly refuted each other’s claims.
Meanwhile, the Daejeon District Court was supposed to make a ruling on the order to recall and destroy Invossa injections as early as on Friday.