Boryung lost the first court battle to block a price cut for its hypertension drug "Kanarb (ingredient name: fimasartan)."
On the 12th, the Seoul Administrative Court ruled against the plaintiff in the first trial of a lawsuit Boryung filed against the Ministry of Health and Welfare seeking to overturn the "decision to lower the reimbursement ceiling price." The court found the Kanarb price cut justified.
With this ruling, the existing price, which had been maintained under a stay of execution, is now more likely to enter a renewed reduction process. Kanarb is a key product that accounts for about 15% of Boryung's total sales. By the court's decision, the company's sales structure is expected to be affected significantly.
The issue was the scope of the patent. Kanarb's compound patent expired in 2023. However, Boryung has argued that the indication patent for "reducing proteinuria" in patients with type 2 diabetic chronic kidney disease accompanied by hypertension remains valid until 2036, and that it is unfair to cut the price on the same basis as follow-on drugs.
The court, however, determined that the ministry's price cut decision conforms to current price-setting rules.
Ahead of the launch of generics, the ministry had announced it would cut Kanarb 30 mg from 439 won to 307 won, 60 mg from 642 won to 450 won, and 120 mg from 758 won to 531 won.
Boryung is expected to appeal immediately. The industry sees a strong likelihood that Boryung will seek another stay alongside the second trial and pursue a strategy to defend the price until a final ruling.
A Boryung official said, "There is no change in our position that follow-on drugs cannot fully replace Kanarb," and added, "We will closely review the ruling and respond proactively to protect the rights of the new drug."
Kanarb is a domestically developed new drug approved in 2010. The "Kanarb family," which expanded from a monotherapy to combination therapies, recorded cumulative sales in the mid-160 billion won range last year. If the price cut materializes, observers say an annual sales decline in the hundreds of billions of won will be inevitable.