Court Rules "Unjust to Reclaim Inbosa Research Support Funds"… Kolon Life Science Wins Case

[Image source=Yonhap News]

[Asia Economy Reporter Lee Jung-yoon] Kolon Life Science won a lawsuit against the government seeking to cancel the disposition to recover research and development funds for the gene therapy for osteoarthritis, 'Invossa-K', whose approval was revoked.

The Seoul Administrative Court Administrative Division 3 (Presiding Judge Yoo Hwan-woo) ruled on the 23rd in favor of the plaintiff in the lawsuit filed by Kolon Life Science against the Ministry of Science and ICT and the Ministry of Health and Welfare, requesting the cancellation of the disposition to recover research funds.

Invossa is an injectable gene therapy for osteoarthritis that was selected for the government's Global Advanced Biopharmaceutical Technology Development Project in October 2015 and received a total of 8.2 billion KRW in support funds over three years. However, when the Ministry of Food and Drug Safety revoked Invossa's product approval in May 2019 due to a change in the main ingredient, the Ministry of Health and Welfare and others imposed a disposition to recover research funds and restrict participation in research and development projects on Kolon Life Science. Kolon Life Science filed an administrative lawsuit in objection to the disposition.

Previously, Kolon Life Science also filed an administrative lawsuit against the Ministry of Food and Drug Safety seeking cancellation of the product approval revocation disposition, but lost in the first trial.

Invossa is an injectable gene therapy for osteoarthritis composed of two components: the first component containing human chondrocytes and the second component containing transformed cells introduced with the chondrocyte growth factor (TGF-β1). It was the first gene therapy approved by the Ministry of Food and Drug Safety in Korea in 2017, but the product approval was revoked after it was revealed that the transformed cells in the second component were not the chondrocytes described in the submitted data at the time of approval, but kidney cells that could potentially cause tumors.

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