2024years1month3day, Alex Pharma (Alexion Pharmaceuticals, Inc. ) And Alexei Pharma International Operations Limited (Alexion Pharma International Operations Ltd. ) In U. S. District Court for the District of Delaware vs. SamsungBioepisLimited company (Samsung Bioepis Co. Ltd. ) Filed a lawsuit, Basis of charge "Biologics Price Competition and Innovation Act (BPCIA) " Regulation of, Submitted by SamsungSB12The biologics licensing application violates it6The right to a patent. aboveSB12It's Shuleri (SOLIRIS) , Ecuzumab (eculizumab) , Of biosimilar drugs. Judging by the content of the indictment, Ekuzumab is a humanized antibody, It can bind to complement proteinsC5To block patients with paroxysmal sleep hemoglobinuria (PNH) The impact of the patient's complement pathway. This is the first case involving a biosimilar of eccucumabBPCIAlawsuit.

Yali brother said, Samsung in2023years7month7To the U. S. Food and Drug Administration (FDA) submittedSB12Biologics license application, And on the same day according "United States Code (U. S. C. ) " 42Ed262 (l) (8) (A) The provisions of the commercial marketing notice provided.

Alex brother claimed, three-starSB12Biosimilar products will infringe on the No9732149Us Patent No (The patent relates to ecucumab as the active compound in sularil) , The first9718880Us Patent No (The patent relates to compounds containing eccucumab) And #9725504No, The first10590189No, The first10703809Sign and number9447176Us Patent No (The patent relates to a method of treating patients with ecumizumab) . Alex Brothers hopes that the verdict will show that Samsung has infringed or will infringe the above patents, It also asked the court for a preliminary injunction and a permanent injunction to prevent Samsung from selling its biosimilar products on the market.

In response, Samsung to one5The validity of the patent was questioned (Viz9732149No, The first9718880No, The first9725504No, The first10703809Sign and number10590189Patent No) . It is reported, Patent Trial and Appeal Board (PTAB) It appears to have agreed to all five requests in the recent past. (Be compiled fromwww. mondaq. com)

TRANSLATORS: Liu Peng　proofread: Wu Xian



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