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Discovery Amgen

Goodwin

District Court Postpones Trial in Amgen v. Hospira Filgrastim Biosimilar Litigation

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As we previously reported, Amgen sued Pfizer and its affiliate Hospira in July 2018 based on Hospira’s submission of an aBLA for a biosimilar of NEULASTA (filgrastim). That same month, Pfizer obtained FDA-approval and, in...more

Goodwin

Scheduling Order Entered in Amgen v. Adello Filgrastim Biosimilar Litigation

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Today, the district court entered a scheduling order in the Amgen v. Adello BPCIA litigation concerning Adello’s aBLA for a biosimilar of Neupogen® (filgrastim). The scheduling order is generally consistent with the joint...more

Goodwin

Amgen v. Coherus: Coherus Files Reply in Support of Motion to Stay

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As we have previously reported, on July 25th, Coherus filed a motion to stay discovery pending the result of its motion to dismiss in its litigation against Amgen regarding pegfilgrastim, and Amgen filed an opposition on...more

BakerHostetler

Federal Circuit Suggests Solution to Patent Owner’s Dilemma When Applicant for Biosimilar Product Refuses Discovery

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In Amgen, Inc. v. Hospira, Inc., Appeal No. 2016-2179 (Fed. Cir. Aug. 10, 2017), the Federal Circuit suggested what an owner of a reference product suing an applicant for a biosimilar under the Biologics Price Competition and...more

Goodwin

Federal Circuit dismisses Amgen’s appeal and mandamus petition

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Today, the Federal Circuit dismissed Amgen’s appeal from and mandamus petition regarding the U.S. District Court for the Delaware’s order denying Amgen’s motion to compel discovery for lack of jurisdiction under the...more

Goodwin

Update: Coherus’ Motion to Stay Discovery in Amgen v. Coherus

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Earlier this week Coherus filed a motion to stay the BPICA litigation brought by Amgen in the District of Delaware, arguing that in light of the FDA’s complete response letter delaying the launch of Coherus’ pegfilgrastim...more

Goodwin

Hospira Files Responsive Appeal Brief in Amgen v. Hospira Litigation

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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...more

Goodwin

Amgen’s Appeal of District Court Discovery Rulings in Amgen v. Hospira

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As we covered in a previous post, the Court in Amgen v. Hospira ruled on some novel issues relating to litigation under the BPCIA during a hearing on discovery issues a few months ago. Background: To recap: this...more

Goodwin

Amgen v. Hospira: Amgen Appeals Discovery Ruling

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In the Amgen v. Hospira litigation, Amgen has filed a Notice of Appeal relating to Judge Andrew’s oral ruling denying Amgen’s request to compel Hospira to produce certain manufacturing information related to its Epogen®...more

Goodwin

Amgen v. Hospira: Court Considers Issues Regarding the Scope of Discovery and the RPS’s Ability to Assert Additional Patents in...

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In a recent hearing held in Amgen v. Hospira, the parties offered arguments on some novel issues relating to litigation under the BPCIA, particularly: - ..Whether a reference product sponsor (“RPS”) can compel a...more

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