Federal Circuit Decides in Favor of Novartis in Biosimilars Patent Dispute with Amgen

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The US Court of Appeals for the Federal Circuit has decided in favor of Novartis’ Sandoz in rendering the opinion that Amgen cannot use state laws to prohibit or delay the marketing of biosimilars.

In a Dec. 14, 2017 decision, the United States Court of Appeals for the Federal Circuit found in favor of Sandoz, the generic drug arm of Novartis, in an ongoing biosimilars patent dispute between the pharma major and Amgen. The court decided that Sandoz cannot be compelled by any state to give a 180-day exclusivity notice to Amgen when it plans to launch a biosimilar version of Neupogen (filigrastim), Amgen’s innovator biologic drug for treating neutropenia (low white blood cell count).

The court stated in its decision that state laws do not preempt federal law, “…we affirm the dismissal of Amgen’s unfair competition and conversion claims. Amgen’s state law claims are preempted on both field and conflict grounds.”

The decision has implications on the timing of when a biosimilar can be marketed, with the suggestion that a biosimilar can potentially be marketed sooner. This decision comes after a landmark ruling by the US Supreme Court in June 2017 in favor of biosimilar developers and their interpretation of the 180-day exclusivity period under the Biologics Price Competition and Innovation Act of 2009 (BPCIA).


Source: US Court of Appeals for the Federal Circuit