Kolon Life Science filed a lawsuit against the Korean Ministry of Food and Drug Safety (MFDS), claiming that the revocation of the license for its osteoarthritis gene therapy Invossa-K Inj. was invalid but lost the appeal.
On Feb. 7, the Seoul High Court ruled in favor of the plaintiff in the appeal of a lawsuit filed by Kolon Life Science against the head of the KFDA to cancel the revocation of the manufacturing and sales item license like the first trial.
In the process of obtaining permission to sell Invossa in Korea from the Korean Ministry of Food and Drug Safety in July 2017, Kolon Life Science said that the product is a gene therapy used to treat osteoarthritis and that its main substance is allogenic chondrocytes.
However, it was later found that the main substance was fetal kidney-derived cells, which can cause tumors, so the distribution and sales of Invossa was suspended in March 2019. The KFDA determined that Kolon Life Science had submitted false data after checking the main substance and related data and running its own tests.
In May of the same year, the KFDA revoked the product license for Invossa. However, Kolon Life Science filed a lawsuit at the Seoul Administrative Court.
The first court ruled in favor of the KFDA, stating that there was no violation in the revocation, as the main substance of Invossa was found to be different. As a result, the effect of the KFDA’s ruling, including the revocation of the Invossa product license, was upheld.
“Now that it was confirmed that the main substance of Invossa, which is directly administered to the human body, is fetal kidney-derived cells rather than allogeneic cartilage-derived cells, the KFDA can ex officio revoke the product license,” the court ruled.
The court also ruled that Kolon Life Sciences lost an opportunity to identify the identity of Invossa by failing to notify the KFDA and that the KFDA’s ex officio revocation of the product license was not illegal. The court rejected Kolon Life Science’s claims of procedural violations and an abuse of discretion.
Meanwhile, Kolon Life Science executives who were accused of manipulating substances for approval for Invossa were acquitted on appeal in October 2023 and are awaiting the Supreme Court’s verdict.