Court: "Recovery of Inbosa Research Funds Unfair, Research Conducted Diligently"

[Asia Economy Reporter Bae Kyunghwan] The court ruled that the development project of the osteoarthritis treatment 'Invossa,' whose approval by the Ministry of Food and Drug Safety was canceled, cannot be considered a failed research.

According to the legal community on the 28th, the Seoul Administrative Court Administrative Division 3 (Chief Judge Yoo Hwanwoo) ruled on the 23rd to cancel the government's decision to reclaim research funds from Kolon Life Science, stating that "Kolon Life Science and others diligently carried out the research project."

Invossa, Korea's first gene therapy, received approval from the Ministry of Food and Drug Safety in 2017, but it was revealed that it contained components that could cause tumors, contrary to the data submitted at the time of approval, leading to the cancellation of the approval the year before last. Subsequently, Kolon Life Science filed a lawsuit challenging the government's restriction on participation in national research and development projects and the reclamation of research funds amounting to approximately 8.2 billion KRW after the Ministry of Food and Drug Safety revoked Invossa's product approval.

However, the court evaluated that Kolon Life Science successfully achieved three out of four detailed tasks of the project and also made sincere efforts regarding the controversial task of "Production of Invossa clinical samples and approval application" due to the change in components.

Meanwhile, the U.S. FDA lifted the clinical trial suspension order for Invossa in April last year, allowing clinical trials to resume. It is known that Kolon Life Science plans to resume patient administration for Invossa's Phase 3 clinical trials in the U.S. starting from the fourth quarter of this year.