As we previously reported, Amgen filed a complaint against Adello Biologics and Amneal alleging infringement of several patents, including certain claims of U.S. Patent No. 8,952,138, directed to a protein refolding process. In their answer, Adello sought a declaratory judgment that certain claims of the ’138 patent were not infringed or invalid. The validity of the ’138 patent was simultaneously challenged by Apotex in IPR2016-01542 in which the Patent Trial and Appeal Board found all claims except claim 18 unpatentable on obviousness grounds. On May 20, 2019, the PTAB reversed its prior decision and sua sponte found claim 18 of the ’138 patent obvious over the prior art. In light of this decision, Amgen, Amneal, and Kashiv Biosciences (replacing Adello) jointly stipulated to dismiss claims of infringement, non-infringement, and invalidity directed to the ’138 patent.
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