Blog Big Molecule Watch June 22, 2021

Amgen v. Hospira Pegfilgrastim Case Stayed Pending Potential Summary Judgment Practice

On June 16, 2021, the District Court for the District of Delaware issued a claim construction order construing a key term in the ongoing patent dispute between Amgen and Hospira over Hospira’s proposed biosimilar of Amgen’s Neulasta® (pegfilgrastim).  In the Order, the Court construed the term “between about 0.1 M and about 1.0”  to have “its plain and ordinary meaning (that is, ‘between approximately 0.1 M and approximately 1.0 M’) and is not a functional limitation.”

After issuing the claim construction order, the Court also issued a second order that stayed the case “until a determination is made about whether the Court should entertain summary judgment practice on the issue of noninfringement.”  The Court further ordered that the parties shall jointly submit a status update by July 12, 2021.

The Parties previously indicated in a joint letter that the claim term “between about 0.1 M and about 1.0” is “central to the parties’ disputes” and potentially dispositive of the issue of infringement.

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