HK inno.N, a leading corporation in the domestic gastrointestinal reflux disease treatment market, has gained an upper hand in the patent lawsuit filed by generic drug corporations. The court recognized the compound patent, allowing HK inno.N to maintain exclusive rights until 2031.
HK inno.N won the second round of the lawsuit concerning the compound patent for the potassium competitive acid secretion inhibitor (P-CAB) class new drug 'K Cap,' following its victory in the first round against HLB PHARMA and Light Pharmaceutical Tech.
'K Cap,' the 30th new drug in South Korea, received domestic approval in July 2018. After launching in 2019, it recorded nearly 200 billion won in external prescription results in the past year alone, maintaining its position as the top product in the domestic ulcer medication market through various disease treatment targets and formulation developments.
HK inno.N holds compound patents for 'K Cap' that last until 2031 and crystalline patents that last until 2036. The duration of the compound patent was extended from Dec. 6, 2026, to Aug. 25, 2031, recognizing the time spent on drug research and development and approval.
However, the lawsuit regarding the crystalline patent for 'K Cap,' which remains valid until March 12, 2036, is currently ongoing after HK inno.N lost the first round.
'K Cap' is approved for five indications, including erosive and non-erosive gastroesophageal reflux disease, as well as gastric ulcer, peptic ulcer, and chronic atrophic gastritis.
Previously, generic drug corporations filed for a passive right scope confirmation judgment on the compound patent, claiming that they intended to launch 'K Cap' generics immediately after the expiration in 2026, following 'K Cap's approval for gastric ulcer, peptic ulcer, and chronic atrophic gastritis.
This ruling concerns one of the indications for 'K Cap,' specifically 'Helicobacter pylori eradication therapy.' The Patent Court ruled that the extended patent rights are effective for acid-related diseases that can be treated through acid secretion inhibition, the same as the initially approved indication.
A representative from HK inno.N noted, 'This ruling will serve as an opportunity for domestic pharmaceutical and biopharmaceutical corporations to strengthen their commitment to new drug development' and added, 'Since ongoing lawsuits also deal with similar issues as this ruling, we expect positive results.'