News & Analysis as of

Preemption Amgen v Sandoz

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen Inc. v. Sandoz Inc. (Fed. Cir. 2017) -- One Last Dance . . .

Last June, in Sandoz Inc. v. Amgen Inc., the Supreme Court handed down its interpretation of the Biologics Price Competition and Innovation Act ("BPCIA") for the approval of biosimilar drugs. As we reported at the time, the...more

Goodwin

Analysis of Amgen v. Sandoz Federal Circuit Opinion

Goodwin on

The Federal Circuit Court of Appeals issued its long-awaited decision in the remand of Amgen v. Sandoz from the U.S. Supreme Court. In that decision, the Federal Circuit held that Amgen’s state law claims, based on the...more

Goodwin

U.S. Argues Amgen’s State Law Claim Preempted by BPCIA, Supporting Sandoz

Goodwin on

Yesterday, in the remanded appeal in Amgen v. Sandoz, the United States submitted an amicus brief to the Federal Circuit that generally supports Sandoz’s position that Amgen’s state-law claim for an injunction under...more

Goodwin

Amgen v. Sandoz: Federal Circuit Vacates Opinion and Mandate, Reinstates Appeal, Orders Further Briefing on Remanded Issues

Goodwin on

As we previously reported, following the Supreme Court’s decision in Sandoz v. Amgen, Sandoz requested a remand to the District Court to answer the two questions that the Supreme Court had remanded to the Federal Circuit,...more

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

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

Mintz

Amgen v. Sandoz: The Supreme Court’s First Tussle with the BPCIA

Mintz on

On April 26, 2017, the U.S. Supreme Court heard oral argument in the much-anticipated Amgen v. Sandoz case, representing the first time the Court has had to grapple with the Biologics Price Competition and Innovation Act...more

Epstein Becker & Green

Benefits Litigation Update – Spring 2017

Epstein Becker & Green on

Welcome to the Spring edition of Benefits Litigation Update, brought to you by The ERISA Industry Committee (ERIC) and the law firm Epstein Becker & Green. As a new Congress, and a new executive branch, work on major...more

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