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Preemption FDA Approval Unfair Competition

McDermott Will & Schulte

No Supremacy Clause Preemption Where State Statute Doesn’t Conflict With Federal

The US Court of Appeals for the Fifth Circuit explained that ordinarily, when state law contradicts with federal law, the state law may be preempted by the federal law under the US Constitution’s Supremacy Clause. However,...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

Supreme Court Decision Largely Favors Biosimilar Applicants

Foley & Lardner LLP on

The U.S. Supreme Court rendered its first interpretations of the biosimilar patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA), ruling largely in favor of Sandoz on both issues...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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