HK inno.N announced on May 31st that the Patent Tribunal ruled in favor of the company in a passive confirmation of scope trial, filed by a South Korean pharmaceutical company to avoid the compound (substance) patent (Patent No. 1088247) of the gastroesophageal reflux disease treatment, K-Cab Tablet.

The company stated that the ruling increases the likelihood of HK inno.N maintaining exclusive rights to the K-Cab market until 2031. K-Cab is a P-CAB class gastroesophageal reflux disease treatment, approved in July 2018 as South Korea's 30th new drug. It quickly gained prominence in the market with its rapid efficacy and the convenience of being taken regardless of meals, recording over $109.5 million in prescriptions last year alone.

K-Cab holds two major patents: the compound (substance) patent expiring in 2031 and the crystalline form patent expiring in 2036. The duration of the substance patent was extended from December 6, 2026, to August 25, 2031, in recognition of the time required for drug research and development.

Generic drug manufacturers have been filing passive confirmation of scope trials against the original product K-Cab in an attempt to release their products in 2026 using a strategy known as 'indication splitting.' This strategy involves launching products based only on subsequent approved indications, excluding the initially approved indication of K-Cab. According to HK inno.N, these generic manufacturers argue that the extended duration of K-Cab's substance patent does not apply to the subsequent approved indications, thereby challenging the validity of K-Cab's patent.

An HK inno.N representative stated, "Since its launch, K-Cab has consistently expanded its indications and developed various formulations to establish itself as a true P-CAB class new drug for gastroesophageal reflux disease. If we had lost this trial, it would have excessively narrowed the scope of the extended patent rights, leading to negative outcomes where patent holders might abandon further research. The Patent Tribunal's decision upheld the existing stance on the scope of extended patent rights, fully recognizing the value of new drugs and indicating the future direction for South Korea's pharmaceutical industry. We expect positive outcomes in other ongoing trials as well."

Meanwhile, HK inno.N has appealed against generic manufacturers concerning another patent, the crystalline form patent, which is valid until March 12, 2036.