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Preemption Commercial Marketing

Goodwin

Amgen v. Sandoz: Sandoz Requests Remand to District Court

Goodwin on

As we have previously reported, on June 12, 2017, the Supreme Court issued a unanimous opinion in Amgen v. Sandoz holding that notice of commercial marketing may be given prior to FDA approval. The Court also held that no...more

Foley & Lardner LLP

Does Amgen Have Viable State Law Claims Against Sandoz Arising From The Zarxio Biosimilar Patent Dispute?

Foley & Lardner LLP on

In Sandoz Inc. v. Amgen Inc. (which you can read more about here), the Supreme Court held that 42 USC § 262(l)(9)(C) sets forth the exclusive federal remedy for failing to provide a copy of the biosimilar application to the...more

Mintz - Health Care Viewpoints

SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs

On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral...more

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

The Patent Dance Is Optional

In Sandoz Inc. v. Amgen Inc., the Supreme Court brought greater certainty to two key issues relating to the “patent dance” under the Biologics Price Competition and Innovation Act (BPCIA). First, the Court held that where a...more

Foley & Lardner LLP

How Will The Supreme Court Choreograph The Biosimilar Patent Dance?

Foley & Lardner LLP on

On April 26, 2017, the Supreme Court heard oral arguments in Amgen v. Sandoz, where the parties have asked the Court to interpret two of the biosimilar patent dance provisions of the Biologics Price Competition and Innovation...more

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

One More Hurdle Cleared – Amgen’s Preliminary Injunction Motion for Filgrastim is Denied

On March 19, 2015, Judge Seeborg of the United States District Court for the Northern District of California denied Amgen Inc.’s motion for a preliminary injunction in the Amgen v. Sandoz case, thereby removing one more...more

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