On September 22, 2017, a Delaware federal jury found that Hospira infringed one of Amgen’s Epogen® (EPO) patents. Hospira maintained that its production of EPO was protected by the safe harbor of 35 U.S.C. § 271(e)(1) which allows for use of patented processes for the purpose of gaining FDA approval. Amgen argued that the EPO batches were produced to create a stockpile of commercial product. The jury found that Hospira’s EPO batches were not protected by the safe harbor and awarded Amgen $70 million in damages. A copy of the jury verdict can be found here and a copy of the judgment can be found here.
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