[Press Release] HK inno.N, announced on Thursday (6th of February) that the company won the second-instance trial following its win in the first-instance trial related to the compound (substance) patent for its new acid-related disease treatment ‘K-CAB Tablet (K-CAB).’ 

Following the favorable ruling by the Intellectual Property Trial and Appeal Board (IPTAB), Intellectual Property High Court also ruled in favor of HK inno.N, the originator company, which indicates that K-CAB is granted patent protection until 2031.

K-CAB, the 30th new drug of South Korea, is a P-CAB class new drug for GERD treatment, which obtained marketing authorization from the Ministry of Food and Drug Safety in July 2018. Following its first launch in South Korea in 2019, K-CAB has succeeded in obtaining approval for a range of indications and development of different dosage forms, recording a total outpatient prescription sales close to KRW 200 billion from the last year alone and holding its position in the market as the steady No. 1 leader in peptic ulcer medications.

HK inno.N holds two types of registered patents, listed in the Korean Pharmaceutical Patent Index, related to K-CAB. ‘substance patent’ whose term lasts until 2031 and a ‘crystalline form patent’ until 2036. In the case of the substance patent, the original patent term was until December 6, 2026, but the term of the patent was extended to August 25, 2031 in recognition of the time required for research and development of the drug and the process of approval.

Generic drug manufacturers requested a trial to confirm the scope of a patent for three indications of K-CAB approved at a later stage, excluding the initially approved indications (erosive and non-erosive GERD) of K-CAB, the original drug, in order to launch generic products from 2026, shortly after the expiration of the original patent term. These manufacturers have argued that the scope of the extended patent only applies to the initially approved indications of K-CAB and not to subsequently approved indications.

Kim & Chang represented HK inno.N on the patent trial case, and the substance patent litigation has been ongoing. Last year, IPTAB (first-instance trial) ruled in favor of HK inno.N, the originator company, and the company also received a favorable ruling by the Intellectual Property High Court (second-instance trial).

The ruling relates to Helicobacter pylori eradication therapy among the approved indications of K-CAB. The Intellectual Property High Court ruled that as in the case of the initially approved indications, this indication is also an acid-related disease that can be treated by inhibiting gastric acid secretion, and therefore, is covered by the scope of the extended patent.

In the same decision as the IPTAB review, the ruling confirmed that the term "use" in Article 95 of the Patent Act should not be construed as limited to the initially approved indications.

An HK inno. N's representative commented, "This ruling will provide an opportunity for pharmaceutical and biotechnology companies in South Korea to enhance their motivation and commitment to new drug development. HK inno.N will contribute to maximizing the value of new drugs in Korea through our continuous dedication to research" and further stated, "We expect that the other ongoing patent litigation will also have favorable results as it also covers the same or similar point of argument as this ruling.”

Meanwhile, the second-instance trial on the crystalline form patent of K-CAB, whose term expires on March 12, 2036, is currently ongoing following its defeat in the first-instance trial.