A court has upheld the government’s decision to revoke a license it had given to Kolon Life Science to sell its gene therapy drug, Invossa. 

The Seoul Administrative Court on Friday ruled against the local pharmaceutical company in a suit filed against the minister of food and drug safety at the time over her decision to cancel an earlier approval for manufacturing and selling the drug. 

The gene therapy drug for osteoarthritis had obtained regulatory approval in 2017. But the Food and Drug Safety Ministry revoked it in 2019 after learning that a key ingredient of the drug was derived from a kidney cell rather than cartilage, as stated in documentation submitted for approval.

Earlier in the day, the Seoul Central District Court acquitted two Kolon Life Science executives of allegations that they had tampered with the key ingredient. The court acknowledged the submission of partially false documentation by the pharmaceutical firm but still held the ministry more responsible, saying it remains doubtful whether it had conducted a thorough review. 

In its own case, the Seoul Administrative Court said it is difficult to conclude that the company intentionally omitted what could work against them in regulatory approval. Nonetheless, the court said that false statement is a crucial defect that merits approval revocation given the pharmaceutical products’ direct impact on the lives and health of the public.