Nature Cell(007390) affiliate RNL Bio Research Institute won in the first trial of a lawsuit seeking to cancel the Ministery of Food and Drug Safety's rejection of marketing approval for the degenerative arthritis stem cell therapy "Jointstem."
The court found that the Ministery of Food and Drug Safety, without a legal basis, effectively applied "superiority" over existing treatments as an approval standard, and that the review process also lost fairness.
In response, the Ministery of Food and Drug Safety said it will "closely review the court's decision and the intent of its reasoning and decide on follow-up measures."
On the 9th, the 14th panel of the Seoul Administrative Court ruled in favor of the plaintiff in a suit filed by RNL Bio Research Institute (formerly ALB Life Science) to cancel the refusal of marketing authorization for drug manufacture and sale by the head of the Ministery of Food and Drug Safety. The lawsuit was filed over the marketing approval of the severe knee osteoarthritis treatment "Jointstem."
The Ministery of Food and Drug Safety rejected the application, saying Jointstem did not sufficiently demonstrate clinical significance, and the company filed suit seeking to overturn that decision.
According to the decision, the court first rejected the Ministery of Food and Drug Safety's claim that only newly submitted data in the resubmission process should be subject to review. The court determined that because "clinical significance" is an indeterminate concept, the entire body of data, including previously submitted materials, must be reviewed comprehensively.
The court also found that statistical significance was confirmed in the phase 3 clinical trial of Jointstem according to the pre-established evaluation plan, and that the Central Pharmaceutical Affairs Advisory Committee had no particular objections to this point.
In particular, the court determined there was no basis under the Pharmaceutical Affairs Act for the Ministery of Food and Drug Safety to deny approval on the grounds that the product was not superior to existing treatments. Under the Pharmaceutical Affairs Act, the requirements for marketing authorization are safety and efficacy, and there is no legal basis to demand superiority over existing treatments as a separate approval requirement.
The court reasoned that "restricting market entry of new drugs by requiring effects superior to existing treatments without a legal basis could infringe on corporations' freedom of business."
It also pointed out problems with the fairness of the review procedure. The court found issues with fairness, considering that, during the first review, an executive from a competing company took part as a review committee member, and that, in the second review, the Ministery of Food and Drug Safety proceeded on the premise of the prior review results.
Accordingly, the court canceled the Ministery of Food and Drug Safety's refusal of marketing approval and ordered the Ministery of Food and Drug Safety to bear the litigation costs.