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Injunctions Biosimilars

A&O Shearman

[Webinar] Exclusively Life Sciences Series - CREATES Act: What we've learned so far and recommendations for the industry -...

A&O Shearman on

In late 2019, Congress enacted the “CREATES Act”, which established a private right of action in which generic or biosimilar manufacturers may sue an innovator for an injunction and monetary award for not selling samples of...more

Patterson Belknap Webb & Tyler LLP

Supreme Court Decides Amgen v. Sandoz: Patent Dance Cannot Be Enforced by Federal Injunction, Notice of Commercial Marketing Can...

On June 12, 2017, the Supreme Court decided Amgen v. Sandoz, the landmark case about the meaning of the Biologics Price Competition and Innovation Act (BPCIA). First, the Supreme Court held that no federal injunction is...more

Patterson Belknap Webb & Tyler LLP

Apotex Prevails in Neulasta Biosimilar Litigation, Files for Cert on 180-Day Issue

Among the first generation of biosimilar litigation under the Biologics Price Competition and Innovation Act (BPCIA) is a dispute between Amgen and Apotex over Apotex’s proposed biosimilar versions of Amgen’s Neupogen...more

McDonnell Boehnen Hulbert & Berghoff LLP

Sandoz' NEUPOGEN® Biosimilar Now on the Market

Sandoz is having a good year. The company succeeded in having their NEUPOGEN® (filgrastrim) biosimilar product, Zarxio™, approved by the FDA in March, a mere ten months after filing its biosimilar application last July. The...more

Patterson Belknap Webb & Tyler LLP

Amgen Panel Denies Emergency Motion for Injunction Pending En Banc Consideration

Recently, the Federal Circuit panel that decided Amgen v. Sandoz (summary; opinion) denied Amgen’s emergency motion for an injunction pending consideration of its petition for en banc review. The panel (Judges Lourie, Newman,...more

Polsinelli

First Biosimilar Drug Now Available; Ongoing Legal Dispute Remains

Polsinelli on

The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxio™ (filgrastim-sndz) earlier today, after the Federal Circuit denied Amgen Inc.'s attempt to stall the launch. The launch...more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Circuit Lifts Injunction Against Sandoz

Sandoz successfully (at least for now) has overcome conventional wisdom, the plain language of the Biologics Price Competition and Innovation Act (BPCIA) (or, at least those provisions regarding patent litigation) and Amgen...more

Patterson Belknap Webb & Tyler LLP

Federal Circuit Oral Arguments in Amgen v. Sandoz

On June 3, the parties in Amgen v. Sandoz presented oral arguments to the Federal Circuit as part of their dispute over the Biologics Price Competition and Innovation Act (BPCIA). The appeal is focused on two questions:...more

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