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Discovery BPCIA

Goodwin

Scheduling Order Entered in Amgen v. Adello Filgrastim Biosimilar Litigation

Goodwin on

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

McDermott Will & Emery

No Right to Discovery of Unidentified Patents During BPCIA Litigation

McDermott Will & Emery on

Addressing for the first time the issue of whether a sponsor has the right to obtain discovery related to infringement of non-asserted patents in a biosimilar litigation, the US Court of Appeals for the Federal Circuit...more

BakerHostetler

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

BakerHostetler on

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

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

Goodwin on

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Section 337’s Potential for Defending Biologics Market Share Against Biosimilars

Enforcement of biologic patents at the United States International Trade Commission under Section 337 provides certainty and tactical advantages to patent holders that are unavailable in district court under the BPCIA. For...more

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