Celltrion said on Tuesday that it won a patent invalidation lawsuit against Roche (Genentech) in Taiwan for the Rheumatoid Arthritis (RA) indication of Truxima, a biosimilar of the original drug Rituxan (ingredient name: rituximab).

Celltrion had previously invalidated the related patent in Korea in 2017.

With the winning of the lawsuit, Celltrion will expand the sales license of Truxima to the full label approved for original drugs and also be given exclusive rights to RA certificates for one year from the start of the sale due to the licensing patent linkage system in Taiwan, Celltrion said.

Accordingly, Celltrion hopes to have a market advantage of Truxima over other biosimilar competitors.

Celltrion filed a lawsuit with the Taiwan Intellectual Property Court in April 2020 to invalidate the patent of Rituxan's RA indication, and won the first trial ruling in October 2021. An appeal was then filed by Roche, a patentee, against the first trial's ruling, and again, the court ruled that the patent was invalid.

Celltrion’s Rituxan biosimilar is used to treat RA, blood cancer, and non-Hodgkin lymphoma, and has been supplied to major global markets with sales permission from the Ministry of Food and Drug Safety in February 2017 and the FDA in November 2018.

However, sales in Taiwan have been conducted for all indications excluding RA since February 2020, also referred to as “skinny labelling”.

"With this victory, we are eager to expand our market share for our Rituxan biosimilar as we can now sell the full indication including RA in Taiwan," said a Celltrion official. "We will strive to ensure that patients in Taiwan are provided with reasonably priced, high-quality biopharmaceuticals."