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Judge Dismisses Amgen’s BPCIA Declaratory Judgment Action Against Sandoz

Judge Chesler of the U.S. District Court for the District of New Jersey has dismissed one of Amgen’s pending lawsuits against Sandoz under the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act (“BPCIA”).  Amgen and Sandoz are involved in a web of biosimilar litigation regarding Sandoz’s proposed biosimilar versions of Amgen’s related drugs Neupogen (filgrastim) and Neulasta (pegfilgrastim).  In March of this year, Amgen filed a lawsuit seeking a declaratory judgment that Sandoz violated the BPCIA by attempting  to cut short the BPCIA’s patent dance as part of its efforts to market its Neulasta biosimilar.  Shortly thereafter, however, Sandoz re-initiated the patent dance, and the parties successfully completed the rounds of disclosures and negotiations set forth in the BPCIA, leading to separate patent litigation.  Sandoz then moved to dismiss Amgen’s declaratory judgment action, arguing that it was moot.

In his July 22, 2016 opinion, Judge Chesler granted Sandoz’s motion to dismiss, holding that because Sandoz had ended up following the BPCIA’s patent dance, Amgen’s complaint did not present a justiciable case or controversy.  Any declaratory relief the court might grant, he held, “would not impact Sandoz’s behavior in the dispute currently before this Court,” because Sandoz had already completed the steps of the BPCIA that Amgen alleged it had failed to follow.  Thus, there was “no concrete dispute left for the Court to decide as to the information exchange steps of the BPCIA.”  Indeed, Judge Chesler felt that an order compelling Sandoz to follow the patent dance “would be completely pointless now, because Sandoz has already complied, on Amgen’s preferred timeline.”

Though Amgen’s BPCIA suit in New Jersey has now been dismissed, Amgen is still seeking to prevent sales of Sandoz’s biosimilar of Neulasta.  As noted, Amgen filed a patent infringement complaint in the Northern District of California in May, alleging infringement of two of its patents and acknowledging that Sandoz followed the BPCIA’s patent dance.

Categories: BPCIA
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