A jury verdict that Hospira Inc.'s pre-approval manufacture of several batches of its biosimilar to Amgen Inc.'s Epogen (epoetin alfa) infringed one of Amgen's manufacturing process patents could lead to a new fight over how much biosimilar production is permitted for an FDA submission.
In its Sept. 22 verdict, a jury of the US District Court for the District of Delaware concluded that Hospira (now a subsidiary of Pfizer Inc.) infringed Amgen patent No. 5,856,298 and that 14 of 21 batches of its biosimilar were not protected by the safe harbor defense
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