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ARTICLE · 02 JANUARY 2024

EYLEA® (Aflibercept) And Soliris® (Eculizumab) IPR Updates

Venable LLP
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On December 8, 2023, the PTAB instituted three of Samsung Bioepis's pending IPRs against Alexion's Soliris® (eculizumab), IPR2023-00933, IPR2023-00998, and IPR2023-00999.

United StatesIntellectual Property
Robert S. Schwartz, Ph.D.
Robert S. Schwartz, Ph.D.

Soliris® (eculizumab)

On December 8, 2023, the PTAB instituted three of Samsung Bioepis's pending IPRs against Alexion's Soliris® (eculizumab), IPR2023-00933, IPR2023-00998, and IPR2023-00999. The challenged patents include composition of matter, formulation, and method of treatment claims. Samsung Bioepis filed two additional IPRs in June, IPR2023-01069 and IPR2023-01070, that are awaiting institution decisions. While Samsung Bioepis has not yet announced an aBLA filing for a Soliris® biosimilar in the U.S., its biosimilar candidate Epysqli" (eculizumab) was approved in the E.U. in May 2023.

Soliris® patents previously faced IPR challenges by Amgen in 2019 that resulted in settlements. To date there have not been any public announcements of aBLA filings for Soliris® biosimilars, nor have there been any BPCIA litigations related to a Soliris®biosimilar.

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