Samsung Biologics Faced with Patent Lawsuit from Regeneron in US

Samsung Biologics has been embroiled in another patent infringement lawsuit. On Jan. 16, US pharmaceutical company Regeneron filed a patent infringement and prevention claim against Samsung Biologics and its subsidiary Samsung Bioepis in Seoul Central District Court in Korea.

Regeneron claims that a copycat drug being developed by Samsung Bioepis infringes on some patents on its eye disease treatment (Eylea), which it registered with the Korean Intellectual Property Office.

Eylea is the world’s No. 1 eye disease drug. According to Regeneron, sales of Eylea hit US$7.7 billion (10.2641 trillion won) in 2022, accounting for more than half of the total eye drug market during that period.

However, Eylea’s patent expires in June of this year in the United States and May 2024 in Europe. This means that copycat drugs can enter the market after this period. This is why drug companies which developed original drugs sometimes file patent infringement lawsuits to extend patent protection. This possibly explains why Regeneron filed the lawsuit, analysts say.

Apart from the lawsuit, Regeneron has been engaged in a patent dispute with Samsung Bioepis at Korea’s Intellectual Property Trial and Appeal Board since October 2022.

The patent on Lucentis co-developed by Roche’s subsidiary Genentech and Novartis expired in 2021. Lucentis sales were estimated to be US$3.5 billion in 2021, but only US$416 million in the first quarter of this year.

Samsung Bioepis, which prepared a Lucentis biosimilar, is selling a biosimilar drug in Korea, the United States, Europe, and Canada, along with U.S. firm Biogen and Korea’s Samil Pharmaceutical at a price 40 percent lower than the original.

The global market for macular degeneration drugs is expected to reach 16 trillion won (US$12 billion) this year and 24 trillion won (US$18 billion) by 2028, according to market research firm Pharma Intelligence Center.