Pharmbio Korea Secures Early Victory in Orafang Tablet Patent Defence

Pharmbio Korea has gained an early advantage in the ongoing patent battle over its blockbuster drug, Orafang Tablet. According to industry sources, the Patent Tribunal recently dismissed two patent scope confirmation trials filed by Samchundang Pharm against Pharmbio Korea.

Samchundang Pharm initiated its patent offensive in 2022, aiming to release a generic version of Pharmbio Korea's colonoscopy preparation drug, Orafang Tablet. Initially, only one formulation patent, expiring in 2038, was registered with the Ministry of Food and Drug Safety (MFDS). However, Samchundang Pharm discovered another unregistered patent expiring in 2037 and filed for a trial.

During the trials, Samchundang Pharm employed a two-track strategy, filing both passive rights confirmation trials and invalidation trials for the two patents, resulting in a total of four simultaneous trials. Despite these efforts, in February this year, approximately 15 months after the first trials were filed in November 2022, the Patent Tribunal ruled in favor of Pharmbio Korea in the two invalidation trials.

With the recent dismissal of the passive rights confirmation trials, Pharmbio Korea appears to have secured a strategic victory. However, Samchundang Pharm appealed the invalidation trials in April, and it is expected that the passive rights confirmation trials will also proceed to a second round.

Orafang Tablet, launched by Pharmbio Korea in 2019 as the world's first tablet-form colonoscopy preparation, has gained significant attention. Traditional colonoscopy preparations required patients to drink up to four liters of water, leading to complaints and rescheduled procedures due to inadequate preparation. Orafang Tablet, developed to meet market needs, has seen its annual sales surpass $7.2 million, quickly becoming a blockbuster.

To further expand its market presence, Pharmbio Korea signed a co-promotion agreement with Dongkook Pharm in June last year and is exploring export opportunities to tap into the global market.

Samchundang Pharm remains the sole generic drug company actively pursuing a patent trial. If successful, it could secure exclusive sales rights, driving its aggressive patent strategy.