Amgen created and commercialized two related biologic products, filgrastim (marketed as Neupogen®) and pegfilgrastim (marketed as Neulasta®), indicated for treating neutropenia, which is a deficiency of white blood cells. Neupogen® also mobilizes stem cells from the bone marrow into the bloodstream for collection for stem cell transplantation.
Sandoz submitted abbreviated Biologics License Applications to market biosimilar products of filgrastim and pegfilgrastim. Amgen filed a declaratory judgment action alleging that the biosimilars would infringe its patent, which related to a method of manufacturing the products.
When construing the method steps, the district court construed the claim to mean that the steps must be performed as separate steps requiring separate solutions, and must be performed in the order recited. Amgen stipulated to non-infringement because Sandoz’s process only involves a one-step, one-solution process. Summary judgment was granted, and Amgen appealed.
Was the claim correctly constructed? (continue reading)
Summary by: Jason French
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