Executives at Kolon Life Science who were put on trial on charges of falsifying ingredients for the osteoarthritis treatment "Invossa-K Inj. (Invossa)" and submitting false documents to authorities have been acquitted, and the verdict is final.
The Supreme Court's Second Division (Presiding Justice Eom Sang-pil) on the 25th upheld the lower court's acquittal in the appeals trial of a person surnamed Cho, a senior manager at Kolon Life Science, and a person surnamed Kim, who had been indicted on charges including fraud under the Act on the Aggravated Punishment of Specific Economic Crimes.
However, for the charge that Cho provided money and valuables to an official at the Ministery of Food and Drug Safety along with a request for favors during the Invossa development process (bribery), a fine of 10 million won was imposed.
Cho was the clinical development team leader at Kolon Life Science, and Kim was the head of the biopharmaceutical research institute. To obtain Ministery of Food and Drug Safety approval, they were each brought to trial in Dec. 2019 and Feb. 2020 on charges of submitting false data about Invossa's ingredients.
Invossa is a gene therapy for osteoarthritis composed of Solution 1 containing human chondrocytes and Solution 2 containing transduced cells introduced with the chondrocyte growth factor (TGF-β1). As a gene therapy, it received Ministery of Food and Drug Safety approval in Korea for the first time in 2017.
Later, the transduced cells in Solution 2 were found to be kidney cells capable of causing tumors, not the chondrocytes stated in the data submitted at the time of approval. For this reason, the approval was revoked in 2019.
In the first trial, the court acquitted the Kolon Life Science executives. The first-instance court acknowledged that the materials contained information inconsistent with the facts but said, "It is questionable whether the Ministery of Food and Drug Safety's verification was insufficient during the Invossa product approval process." It followed Supreme Court precedent that if an administrative agency lightly believes false materials and grants approval, obstruction of performance of official duties by fraudulent means by the applicant cannot be recognized. The appellate court also found not guilty on the charge of submitting false documents.
In the first trial, Cho was fined 5 million won for the charge of providing money and valuables to a Ministery of Food and Drug Safety official along with a request for favors during the Invossa development process. In the second trial, the court additionally found that Cho provided entertainment to a Ministery of Food and Drug Safety official and obtained internal documents, and imposed a fine of 10 million won.
Prosecutors appealed the ruling, but the Supreme Court dismissed the appeal, finding no misinterpretation of the law in the lower court's judgment.
Lee Woong-yeol, honorary chairman of Kolon, who was brought to trial over the Invossa case, was also acquitted in the appellate court in Feb. this year. Prosecutors later withdrew their appeal, making the acquittal final.