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Samsung Seeks To Scrub US Soliris Patents With A Pair Of USPTO Challenges

Small Pool Of Eculizumab Biosimilar Developers Includes Settler Amgen

 
• By Dean Rudge

Samsung Bioepis has taken to five its number of IPR challenges to Alexion’s US Soliris intellectual property portfolio, filing two simultaneously.

Macro photo of tooth wheel mechanism with PATENTS concept letters
• Source: Shutterstock

With designs on securing US Food and Drug Administration approval for its proposed SB12 biosimilar Soliris (eculizumab) candidate, Samsung Bioepis has filed a pair of petitions with the US Patent and Trademark Office requesting an inter partes review of two US patents shielding Alexion’s rare blood disease monoclonal antibody.

According to Samsung Bioepis, the two US patents, 10,590,189 and 10,703,809, both covering a method of treating paroxysmal nocturnal hemoglobinuria using the heavy and light chains of eculizumab, “never should have issued,” because “years before” a March 2007 priority date, “eculizumab was known as an anti-C5 antibody that was

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