Amgen and Roche target Samsung’s Bioepis in patent suit

Amgen and  Roche have filed a joint patent infringement claim against Samsung’s biopharmaceutical company  Bioepis.

The  complaint, which was filed yesterday, April 30 at the US District Court for the District of New Jersey concerns the drug Enbrel (etanercept) which is used to treat chronic diseases.

The patents in dispute are US numbers 8,063,182 and 8,163,522, which are owned by Roche and licensed exclusively to Amgen. Three of Amgen’s patents (US numbers 7,915,225; 8,119,605; and 8,722,631) are also in dispute.

According to the complaint, Amgen owns all of the rights to sell Enbrel in the US.

Both Amgen and Roche said Bioepis had infringed the patents in dispute and wrongly sought authorisation to manufacture and sell a biosimilar version of Enbrel, called Eticovo.

The complaint comes within days of Bioepis’s Eticovo being approved by the US Food and Drug Administration for sale in the US market.

“Bioepis infringed the patents-in-suit by seeking FDA approval before the expiration of the Amgen and Roche patents,” the complaint said.

The complaint alleged that “given the size of the market, it is reasonable to infer” that while developing a biosimilar, Bioepis would have determined “whether and what patents protected the innovative drug Bioepis sought to target”.

Additionally, the complaint said Bioepis’s biosimilar has the “identical primary amino acid sequence as Enbrel”.

Amgen and Roche said Bioepis was “wilfully blind” to the existence of the patents in dispute during the development and approval process of its biosimilar product, adding that “Bioepis is piggybacking on the fruits” of Amgen and Roche’s efforts.

The complaint comes within days of Samsung’s Eticovo being approved by the FDA for sale in the US market.

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