Court Rules "Cancellation of Invossa Product Approval is Legal"…Kolon Life Science Loses First Trial

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[Asia Economy Reporter Minji Lee] Kolon Life Science lost the first trial in an administrative lawsuit it filed in opposition to the authorities' decision to revoke the approval of the osteoarthritis gene therapy Invossa KJ (hereafter Invossa).

The Seoul Administrative Court Administrative Division 12 (Presiding Judge Hong Soon-wook) ruled on the 19th that Kolon Life Science lost the lawsuit filed against the Minister of Food and Drug Safety, demanding the cancellation of the decision to revoke the manufacturing and sales approval.

On this day, the court pointed out, "The plaintiff knew data that could raise doubts about the identity of Invossa's second component, which should have been cartilage-derived cells, at the time of applying for product approval," and "On the other hand, the defendant was unaware of such information, so the information about Invossa was only with the plaintiff."

Furthermore, the court noted, "The plaintiff did not honestly and openly inform the defendant of some matters and did not sufficiently share the materials necessary for the product approval review with the defendant under its independent judgment, thereby losing the opportunity to correct errors regarding the identity and safety of Invossa's second component." Although it is unclear whether Kolon Life Science intentionally concealed the fact that Invossa's components were incorrect, the court's judgment is clear that the company did not provide unfavorable information to the MFDS during the approval process.

The court also stated regarding Invossa's safety, "It is insufficient to recognize Invossa as a drug lacking safety to the extent that it poses a risk to public health," but judged, "It is difficult to reject the defendant's claim that clinical trials and product approval reviews for Invossa were not conducted sufficiently to verify safety and efficacy."

Additionally, the court explained, "Since pharmaceuticals directly affect human life and health, if it is revealed that the main component significantly differs from what was stated in the product approval application, the approval decision should be considered seriously flawed," and "Since Invossa's second component was confirmed to be kidney-derived cells, not cartilage-derived cells subject to product approval, the defendant can revoke the approval ex officio."

Regarding this, Kolon Life Science's legal representative said about the ruling, "Since it is the result of a thorough review by the court over a long period, we respect the court's judgment, but as there was a not guilty verdict in the criminal case, we will carefully and legally review the reasons for the ruling."

Previously, the Seoul Central District Court Criminal Division 25-3 (Presiding Judges Kwon Seong-su, Kim Sun-hee, and Im Jeong-yeop) acquitted two executives of Kolon Life Science who were indicted on charges including submitting false documents (obstruction of official duties by deception) during the process of obtaining MFDS approval for Invossa.

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