Celltrion Wins Appeal in Taiwan Patent Case for 'Truxima'

Celltrion's 'Truxima', a biosimilar of 'Rituxan' (generic name Rituximab)

[Asia Economy Reporter Lee Chun-hee] Celltrion announced on the 20th that it won the patent invalidation appeal lawsuit against Roche (Genentech) in Taiwan. This patent is related to one of the indications for rheumatoid arthritis (RA) of Rituxan (European product name Mabthera, generic name Rituximab), the original drug of the biosimilar 'Truxima'. It is a Taiwanese patent that Celltrion had already invalidated domestically in 2017.

With this victory, Celltrion will expand the sales approval of Truxima to the full label indications approved for the original drug. Additionally, as in Korea, the patent linkage system has been introduced in Taiwan, and with the successful patent challenge, Celltrion will receive exclusive rights for the RA indication for one year from the start of sales. Celltrion explained that through this, it "expects to gain market superiority compared to other biosimilar competitors."

In April 2020, Celltrion filed a patent invalidation lawsuit at the Taiwan Intellectual Property Court (hereinafter the Patent Court) against the RA indication patent of Rituxan and won the ruling in October last year. Roche appealed the first-instance ruling, but the appeal court also ruled the patent invalid, consistent with the first instance.

Truxima is a biosimilar of Rituxan used to treat RA, blood cancers, and non-Hodgkin lymphoma. After receiving sales approval from the Korean Ministry of Food and Drug Safety in 2016, it was approved by the European Medicines Agency (EMA) in 2017 and the U.S. Food and Drug Administration (FDA) in 2018, supplying major global markets. In Taiwan, sales have been conducted since February 2020 with a skinny label (excluding indications still under patent protection) excluding the RA indication.

A Celltrion official stated, “With this victory, it is now possible to sell Truxima with the full label including the RA indication in Taiwan, in addition to the previously secured indications, so we expect to expand market share. We will continue to do our best as we have so far to provide Taiwanese patients with high-quality biosimilars at reasonable prices.”