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.