As we previously reported, Amgen filed an appeal brief challenging the district court’s resolution of its discovery dispute with Hospira and addressing the issue of whether the Federal Circuit had jurisdiction to hear the appeal.
On October 25, 2016, Hospira filed a responsive appeal brief asserting that (1) the Court does not have jurisdiction over this appeal, and (2) if the Court does exercise jurisdiction, then the Court should affirm the district court’s discovery ruling. Hospira asserted that Amgen’s allegations that Hospira’s aBLA did not disclose the exact composition of four raw materials that Hospira purchased from third parties were incorrect. Hospira argued that it had fully described its manufacturing process and that the facts and information Amgen sought about the raw materials were “not unique to Hospira’s product, were not developed by Hospira, and are irrelevant to the patents [at issue].”
We will continue to report on updates to this and other BPCIA litigations at the Big Molecule Watch.