Supreme Court Rules K-CAB Compound Patent Valid Through 2031
Generic manufacturers lose final appeal as Korea’s top court upholds extended patent scope for K-CAB.
A long-running patent dispute over the gastroesophageal reflux disease (GERD) treatment K-CAB has concluded decisively in favor of the original patent holder, ending industry hopes for an early generic launch. With the Supreme Court’s latest ruling, the compound patent’s August 25, 2031 expiry is now effectively final.
According to the Pharmaceutical Patent Research Association’s Daily Alert, the Supreme Court’s Special Division 3 on November 20 dismissed the cancellation suits filed by Samchundang Pharmaceutical, SK Chemicals, Samil Pharmaceutical, Hanwha Pharma, and Korea Pharma against RaQualia Pharma Inc., the holder of the K-CAB compound patent. The Court issued a “dismissal without deliberation,” affirming the lower court decision without additional hearings.
This outcome aligns with earlier rulings by both the Intellectual Property Trial and Appeal Board (IPTAB) and the Patent Court, which rejected the generics’ key defense of “indication splitting.” Industry observers note that once both tribunals sided with the patent holder, the chances of a Supreme Court reversal were minimal.
At the center of the dispute was the scope of the extended compound patent. The generics argued that because the extension was granted for reasons unrelated to clinical use, protection should apply only to K-CAB’s original GERD indication, not to later-added indications such as gastric ulcers. HK inno.N, the marketing authorization holder, countered that the patent should be defined by K-CAB’s enteric-coated acid-suppression mechanism, which underlies all approved indications. All three adjudicating bodies agreed with HK inno.N’s position.
With the compound patent now firmly upheld, generic manufacturers may only seek earlier entry through K-CAB’s separate formulation patent, which expires in 2036. While some companies have found pathways to launch roughly five years ahead of that date, none have succeeded in bypassing the 2031 barrier. Given the precedent set by this Supreme Court decision, most generics without exclusivity rights are now expected to wait until at least May 2032.
K-CAB recorded approximately $122 million in sales last year.