Overview
On January 15, 2020, Hospira, Inc. filed a petition for rehearing en banc of the Federal Circuit’s December 16, 2019 panel decision in Amgen, Inc. v. Hospira, Inc., Nos. 2019-1067, 2019-1102 (Fed.Cir. 2019) in which Hospira lost on the issue of whether its EPO biosimilar manufacturing activities are entitled to Safe Harbor protections. The petition requested review on the question of “[w]hether 35 U.S.C. § 271(e)(1) provides a safe harbor against infringement of patents claiming a method of manufacture, when the product manufactured is used to generate information for submission to the Food and Drug Administration (‘FDA’) in order to seek approval of a biosimilar drug.” Petition, page 1. Hospira also alleges that the panel decision is contrary to the Safe Harbor precedent of the US Supreme Court and the Federal Circuit, as well as erring in its claim construction by improperly “reading out a claim limitation” relating to the meaning of “mixture…of isoforms.” The Federal Circuit has yet to decide on the petition.
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