Patent War Begins for K-CAB... HK Innoen Wins Round 1

HK Innoen announced on the 31st that it won the passive scope confirmation trial regarding the compound (substance) patent of K-CAB, a new drug developed for gastroesophageal reflux disease. However, since this trial is of a first-instance nature, related litigation must continue until the final trial, but this victory increases the likelihood that HK Innoen will secure exclusive rights until 2031.

HK Inno.N's gastroesophageal reflux disease treatment 'K-CAB'
[Photo by HK Inno.N]

K-CAB is a potassium-competitive acid blocker (P-CAB) class treatment for gastroesophageal reflux disease, approved in July 2018 as Korea's 30th domestic new drug. It has advantages such as faster onset of efficacy compared to existing proton pump inhibitor (PPI) class drugs and the ability to be taken regardless of meals, leading to prescription sales exceeding 150 billion KRW last year and becoming a leading product in the market.

The related patents of K-CAB are broadly divided into a substance patent expiring in 2031 and a crystalline form patent expiring in 2036. Among these, the substance patent's expiration was extended from December 2026 to August 2031 in recognition of the time required for pharmaceutical research and development (R&D).

Generic drug developers argued that this patent extension only applies to two indications of gastroesophageal reflux disease, erosive and non-erosive types, which were approved before the patent extension among the five domestic indications of K-CAB. They adopted an 'indication splitting' strategy targeting subsequent indications such as ▲gastric ulcer ▲Helicobacter pylori eradication combination therapy ▲maintenance therapy after erosive gastroesophageal reflux disease treatment. Through this, they initiated litigation for generic launch in 2026, but this first-instance loss has reduced such possibilities.

However, regarding the crystalline form patent, HK Innoen lost in the first instance. The company has filed an appeal related to this.

An HK Innoen official stated, “Had we lost this trial, the extended patent rights of the new drug would have been excessively narrowed, leading substance patent holders to abandon subsequent research, which would have been a negative outcome,” adding, “This case is significant as it fully recognizes the value of domestic new drugs and simultaneously suggests the direction the Korean pharmaceutical industry should take.”

This content was produced with the assistance of AI translation services.