HK inno.N Scores Another Win in K-CAB Material Patent Battle

HK inno.N has secured another decisive victory in the material patent dispute over its gastroesophageal reflux disease (GERD) therapy K-CAB (tegoprazan), with patent holder RaQualia Pharma Inc. prevailing in consecutive cases.

According to the Pharmaceutical Patent Research Association’s Daily Alert, the Patent Court’s Second Division on August 13 ruled in favor of RaQualia in a scope confirmation trial filed by Samchundang Pharmaceutical and 21 other companies. This follows a similar ruling by a different Patent Court panel in February.

K-CAB is protected by a material patent valid until August 25, 2031, and a crystalline form patent valid until 2036. The material patent’s original expiry date of December 6, 2026, was extended by five years to account for R&D and regulatory review periods.

Generic drugmakers sought to launch their versions immediately after the 2026 date, arguing the patent extension should apply only to K-CAB’s initial erosive and non-erosive GERD indications, not to subsequent approvals. They filed scope confirmation trials on three later-approved indications.

However, both the Intellectual Property Trial and Appeal Board and the Patent Court rejected these arguments, most recently in May. The latest decision further solidifies the likelihood that K-CAB’s material patent will remain in force until 2031.

Launched in July 2018, K-CAB is a potassium-competitive acid blocker (P-CAB) for GERD. Since its 2019 market debut, the drug has expanded its indications and formulations, generating approximately $145 million in outpatient prescription sales last year and retaining its position as Korea’s top-selling peptic ulcer treatment.