Lee & Ko wins all 10 cases for domestic blockbuster drug Dukarb®

Lee&Ko successfully defeated the generics’ challenge against Boryong’s patent covering Dukarb®, which is a domestic blockbuster drug, before the IPTAB and subsequently the IP High Court. On November 30, 2023, the IP High Court ruled in favor of the patentee in all 10 cases, including both scope confirmation actions and invalidation actions, filed by dozens of generic companies, including Arlico pharmaceuticals, against the Dukarb® combination product patent. 

Dukarb tablet, as a combination of Kanarb® (fimasartan) with amlodipine, is a blockbuster drug that has shown excellent antihypertensive effects and generated sales of KRW 40 billion in 2022. In 2021, more than 45 domestic generic companies filed scope confirmation actions and invalidation actions to assert non-infringement and invalidity of the Dukarb® patent, but the patentee prevailed in all cases. The generic companies subsequently filed 10 appeal cases to the IP High Court, but the IP High Court upheld the decisions of the IPTAB on November 30, 2023.

The generic companies alleged invalidity of the patent at issue on various grounds such as novelty, inventiveness, lack of the description requirement, and incomplete invention, while simultaneously claiming non-infringement on the grounds of compound differentiation and salt change. Therefore, it was essential for the patentee to present a consistent and strategic response to the various claims made by different generic companies. Despite unfavorable case precedents on combination drug patents, Lee & Ko successfully argued for inventiveness of the patent at issue by focusing on the synergistic effects of the combination product. Likewise, in the negative scope confirmation action cases, Lee & Ko presented persuasive claim construction and equivalent infringement based not only on the claim language but also on the specification and the common technical knowledge of the pharmaceutical industry. Ultimately, Lee & Ko prevailed in all 10 cases, again demonstrating the team’s expertise in healthcare and IP.