Korean Pharma wins first-instance ruling in patent challenge over Sirturo

Intellectual Property Trial and Appeal Board upholds non-infringement claims by BC World and Yungjin

Generic drugmakers have secured a first-instance victory in a patent dispute surrounding Sirturo (bedaquiline), a treatment for tuberculosis.

According to industry sources on the 19th, the Intellectual Property Trial and Appeal Board (IPTAB) ruled in favor of BC World Pharmaceutical and Yungjin Pharm in a passive scope confirmation (non-infringement) trial concerning the composition patent for Sirturo Tab (Patent No. 10-1514700), filed against Janssen. The two companies had submitted the petition in September.

With the favorable ruling in the avoidance trial, analysts say BCWorld and Yungjin have moved one step closer to early market entry for generic versions of Sirturo.

Three Sirturo Tab patents are listed in the Ministry of Food and Drug Safety's patent directory. The substance patent expired this June. Excluding this, a use patent expiring in December 2026 and a composition patent expiring in December 2027 remain.

BC World and Yungjin’s strategy is to avoid the composition patent expiring in 2027 and strategically launch generics early, promptly upon the expiration of the use patent next year.

Sirturo is Janssen’s tuberculosis treatment that was approved in 2014. It features a novel mechanism of action that inhibits the energy metabolism of Mycobacterium tuberculosis and is used in the treatment of multidrug-resistant tuberculosis (MDR-TB). The World Health Organization (WHO) recommends Sirturo as one of the standard treatments for MDR-TB.

According to the MFDS, Sirturo recorded import sales of USD 4.1 million (approximately KRW 5.7 billion) in 2023. Although the overall market size is relatively small, the drug has become a key target for generic manufacturers due to the lack of suitable alternatives in MDR-TB treatment. Furthermore, given that tuberculosis treatment regimens last nearly a year, the launch of a generic version is expected to enable stable revenue generation.