News & Analysis as of

Motion to Dismiss Sandoz v Amgen

Goodwin

Litigation Update: Amgen and Sandoz Stipulate to Dismiss ‘784 Patent

Goodwin on

The parties in Amgen v. Sandoz (N.D. Cal.) (filgrastim, pegfilgrastim) have submitted a joint stipulation to dismiss, without prejudice, Amgen’s U.S. Patent No. 5,824,784 patent from the litigation. The ‘784 patent is...more

Patterson Belknap Webb & Tyler LLP

Amgen’s Federal Circuit Appeal to Address Important BPCIA Disclosure Issue

The Federal Circuit has now issued two decisions interpreting the Biologics Price Competition and Innovation Act of 2009 (BPCIA). In Amgen v. Sandoz, the first decision to interpret the BPCIA, the majority held that...more

Patterson Belknap Webb & Tyler LLP

Judge Dismisses Amgen’s BPCIA Declaratory Judgment Action Against Sandoz

Judge Chesler of the U.S. District Court for the District of New Jersey has dismissed one of Amgen’s pending lawsuits against Sandoz under the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act...more

McDermott Will & Emery

ANDA Update - Volume 2, Number 2

McDermott Will & Emery on

180-Day Notice Period for Biosimilar Approval Is Always Mandatory and Enforceable by Injunction - Amgen Inc., v. Apotex Inc., (Fed. Cir. July 5, 2016) - A year after analyzing the patent dance and notice...more

Fish & Richardson

Fall-Out from the Federal Circuit’s Decision in Amgen v. Apotex

Fish & Richardson on

The repercussions of Amgen v. Apotex, No. 2016-1308 (Fed. Cir. July 5, 2016) (“Apotex”), continue as BPCIA litigants submit letters to their respective judges addressing the Federal Circuit’s latest ruling on the Act’s notice...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

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

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