Amgen Inc. v. Hospira, Inc.

Under 262(l)(2)(A) of the Biologics Price Competition and Innovation Act of 2009 ("BPCIA''), a biosimilar applicant is required to provide the sponsor of the previously approved biologic with "information that describes the process or processes used to manufacture the biological product that is the subject of [the biosimilar] application.'' In this case, the sponsor (Amgen) alleges that the biosimilar applicant (Hospira) had failed to satisfy this obligation by refusing to "fully disclose the specific composition of the cell-culture medium used in the manufacture'' of Hospira's biosimilar product. Amgen sought discovery on the composition of Hospira's cell-culture medium. Hospira refused Amgen's discovery requests, and the district court denied Amgen's motion to compel. On appeal, the Federal Circuit held that it lacks jurisdiction over the appeal under the collateral order doctrine, rejecting Amgen's argument that the lack of immediate appeal over the particular discovery order in this case will render it "effectively unreviewable.'' The appellate court also denied Amgen's petition for a writ of mandamus, in part because the nature of the cell-culture medium used by Hospira is irrelevant to the question of infringement of the patents that have been asserted by Amgen, which "relate to the biological product and methods of producing the biological product, rather than the specific cell-culture medium used during its manufacturing process.''