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PTAB to Review Alexion’s Soliris Patents as Amgen Cries Foul

September 9, 2019

The Patent Trial and Appeal Board (PTAB) launched an inter partes review (IPR) of patents covering Alexion Pharmaceuticals’ immunosuppressive drug Soliris (eculizumab), following a petition by Amgen.

Amgen, which is itching to get its Soliris biosimilar on U.S. shelves, is challenging three patents that would prolong market exclusivity for the drug until 2027 should the PTAB rule in Alexion’s favor.

Amgen claimed in its petition that drugmakers were aware of eculizumab, the drug’s active ingredient, before the agency approved Soliris in March 2007, and that the ingredient had even been the subject of 17 clinical trials.

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