Samsung BioEpis has succeeded in nullifying the patent for cancer treatment Herceptin (Ingredient: trastuzumab) in Korea.
|Samsung Bioepis's cancer treatment Samfenet|
According to industry sources, the Intellectual Property Trial and Appeal Board (KIPO) ruled in favor of Samsung BioEpis’ claims for patent invalidation and passive rights filed against the patent for Herceptin’s main composition, on Thursday.
The patent is the last remaining patent in Korea registered for Herceptin as existing patents have expired or have been invalidated by Celltrion.
The Ministry of Drug and Food Safety approved the domestic sales of Samfenet on Nov. 8, 2017, and Daewoong Pharmaceutical launched it in March 2018.
Herceptin is one of the most purchased biomedicine with an estimated 7.8 trillion won ($6.9 billion) in sales. It has applications for early and metastatic breast cancer and metastatic gastric cancer.
With the nullification, the company’s Herceptin biosimilar Samfenet will be able to enter the domestic market without the burden of patent infringement.
Despite its launch last year, sales for the drug have been sluggish. According to IQVIA, the market research firm, the total sales of Samfenet only reached 5.5 million won in the local market last year.
Daewoong Pharmaceutical could not be reached for immediate comment regarding whether the patent nullification will have an impact on the sales of Samfenet.
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