Amidst various court battles surrounding the osteoarthritis gene therapy drug’Invossa Kayju’ (hereinafter referred to as Invossa), interest is focused on the background as the two courts ruled contradicting each other on the same day. Following the criminal trial and administrative litigation, attention is also drawn to the results of civil litigation that will proceed in the future.
On the 19th, the first trial court raised the hand of the Ministry of Food and Drug Safety at a courtroom held by the Ministry of Food and Drug Safety and Kolon Life Sciences over the cancellation of the product license.
Part 12 of the Seoul Administrative Court (Deputy Judge Hong Soon-wook) said in the judgment of the first trial of a lawsuit for canceling the disposition of manufacturing and selling item permission filed against the Ministry of Food and Drug Safety by Kolon Life Science. There is no illegality,” and he ruled, “We will dismiss the claim of the plaintiff (Kolon Life Science).” The court ruled that the cost of the lawsuit was also borne by the plaintiff, Kolon Life Sciences.
Invossa, a treatment for osteoarthritis developed by Kolon Life Sciences, was approved by the Ministry of Food and Drug Safety as the first gene treatment in Korea in 2017. Invossa consists of one solution containing human chondrocytes and two solutions containing transformed cells into which chondrocyte growth factor (TGF-β1) was introduced.
However, in 2019, it was discovered that two of the transformed cells were not cartilage-derived cells, but kidney-derived cells that could induce tumors, which caused a safety controversy, and the Ministry of Food and Drug Safety canceled the product license from Invossa in the same year. did. In response to this, Kolon Life Sciences filed an administrative lawsuit against the Ministry of Food and Drug Safety, asking for the cancellation of the product permission cancellation.
On that day, the first trial court said, “The evidence submitted by the defendant alone is insufficient to admit that Invossa is a drug that lacks safety.” It was revealed that “the drug has a direct effect on human life or health, so other facts were recorded in the product license. If you lose, you should see that there is a serious flaw.”
In addition, the judge said, “Invossa is a therapeutic agent made with cutting-edge science and technology,” and “Scientific researchers should only select favorable results and not exclude adverse results when conflicting experimental results come out. In this situation, the plaintiff was aware of enough data to question the safety, but it seems that the defendant did not know when the information was controlled.”
The court judged that Kolon Life Sciences had missed the opportunity to correct Invossa’s identity because it did not submit some safety data.
On the other hand, in the criminal trial held on the same morning, the court more strongly pointed out the responsibility of the Ministry of Food and Drug Safety.
The Seoul Central District Court ruled innocent against charges such as interfering with the execution of hierarchical public affairs, the aggravated punishment law for certain economic crimes, violations of the Subsidy Act, etc. by Mr. Jo Mo and Mr. Kim, director of Cororon Life Science.
The Tribunal of the First Trial stated that Kolon Life Sciences contained inconsistent information in the data, but it was suspected that the verification by the Ministry of Food and Drug Safety was insufficient during the product approval review process.
The controversy over Invossa seems to continue in the future, as the two rulings made on the same day cited conflicting responsibilities. In addition, Kolon Life Science is facing a lawsuit for damages filed by 900 patients who received Invossa.
Attorney Eom Tae-seop, an attorney at Law Firm Okims, who served as legal representative for the lawsuit, said, “In both the morning and afternoon administrative litigations, Kolon Life Sciences consistently admits that it has submitted false documents to the Ministry of Food and Drug Safety. As a result, the court saw that it was not enough to apply charges of obstructing the execution of public affairs to individual executives.”
Attorney Eom said, “As Kolon’s hierarchical behavior is recognized, it is a meaningful decision ahead of a civil lawsuit,” he said. “We will faithfully deal with civil lawsuits.”
Kolon Life Sciences did not disclose a separate position regarding the two rulings that came out on the day.
“The results from the morning and the results from the afternoon are different,” said Jaewoo Park of Hwawoo, a law firm in charge of the legal representative of Kolon Life Sciences. After reviewing the two judgments closely, I will express my opinion if necessary.”