HK inno.N defends patent for new GERD drug K-CAB < Pharma < Article

HK inno.N said Friday that it has won the defensive confirmation trial for the scope of a right for its patent (Patent No. 1088247) on a compound (substance) for the K-CAB Tablet treating gastroesophageal reflux disease (GERD).

As a result, HK inno.N is likely to secure market exclusivity for K-CAB until 2031, the company added.

The K-CAB family of products (Courtesy of HK inno.N)

K-CAB is a P-CAB-based GERD treatment approved in July 2018 as the 30th new drug in Korea. It has become a leading product in the market, with prescription sales of over 150 billion won ($108 million) last year alone. This is due to its faster onset of action than existing PPIs and the fact that it can be taken regardless of meals.

K-CAB has a compound (substance) patent that expires in 2031 and a crystal patent that expires in 2036. The substance patent was extended from December  6, 2026, to August 25, 2031, in recognition of the time spent on drug research and development.

Generic makers have sought passive scope determination judgments against the original product, K-CAB, to launch products in 2026. They are using the so-called “indication splitting” strategy, which excludes the first licensed indication of K-CAB and only launches products in subsequent licensed indications. The generic manufacturers have challenged the patent, arguing that the extended life of the K-CAB patent does not extend to subsequent licensed indications.

“Since its launch, K-CAB has steadily expanded its indications and developed various formulations to become a true P-CAB-based GERD drug. If we had lost this case, it would have resulted in the negative consequence of material patent holders abandoning further research by excessively reducing the extended patent rights of new drugs,” a company official said.

The official added that the Intellectual Property Trial and Appeal Board’s decision is significant in that it upholds its existing position on the scope of the effectiveness of extended patent rights, fully recognizes the value of homegrown new drugs, and provides a direction for the Korean pharmaceutical industry.

“We look forward to positive outcomes in other ongoing appeals,” the official said.

HK inno.N is also appealing another patent, a determinate patent, against the generic companies. The determinate patent runs until March 12, 2036.

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