The Seoul Administrative Court has set a date for the verdict in the lawsuit between the Ministry of Food and Drug Safety (MFDS) and PharmaResearchBio regarding the latter's claims to cancel the MFDS' order to recall, destroy, and halt its botulinum toxin (BTX) product.

The court will make the ruling on Nov. 23, industry sources said.

PharmaResearchBio faced a major setback in December 2021 when MFDS revoked the license for Rentox, its BTX, over indirect export allegations.

Domestically sold biopharmaceuticals are required to obtain separate national lot release approvals, which are aimed at ensuring product integrity and screening for foreign substances.

However, PharmaResearchBio pursued "indirect exports"by distributing its BTX products to local distributors without obtaining the required lot release approval.

Consequently, the MFDS revoked Rentox's product license across all units and issued an order for the company to recall and dispose of all products on the market. This action prompted PharmaResearchBio to file an administrative lawsuit, contending that indirect exports should not be considered domestic sales.

As the company won a stay of execution, it managed to maintain its product license until the first ruling was made, and the forthcoming judgment in November will determine whether the company will be able to maintain its product license or not.

Industry watchers predict a high likelihood of PharmaResearchBio winning the lawsuit. Their optimism stems from a similar case where another company, Medytox, successfully contested a ruling in their favor this past July.

In that prior case, the Daejeon District Court ruled in favor of Medytox, acknowledging the sales to export businesses intended for exports as a legitimate export process.

Following the judgment favoring Medytox, companies such as Hugel, PharmaResearchBio, Jetema, BMI Korea Aesthetics, BNC Korea, and Huons BioPharma, all entangled in similar legal battles, hold hopes of attaining similarly favorable verdicts.

However, the journey might be challenging for PharmaResearchBio even if the company wins its initial ruling.

Drawing parallels with the Medytox case, it's expected that their lawsuit may also become a protracted legal battle as Medytox's victory was not easily accepted, as the MFDS appealed against the ruling.

Therefore, even in the event of PharmaResearchBio's victory, an appeal could elevate the case to a higher court, possibly extending it to the Supreme Court.

Meanwhile, there's sharp criticism directed at the MFDS for appealing the ruling decision against Medytox, within the industry.

"The MFDS should be focused on regulations and approvals related to safety and efficacy," an industry official told Korea Biomedical Review, asking to remain anonymous due to the issue's sensitivity. "Their excessive interference in commercial regulations is raising eyebrows."

The official emphasized that since the rationale employed by the MFDS, which deemed indirect exports without national approvals as domestic sales and a breach of the Pharmaceutical Affairs Law, was invalidated in the Medytox verdict, many hold optimistic views regarding PharmaResearchBio's chances.