Biogen MA Inc. v. EMD Serono, Inc.

Summary

The Federal Circuit reversed the district court's grant of JMOL of no anticipation, holding that a prior art method using native interferon-β (IFN-β) could anticipate claims reciting recombinant IFN-β. Applying *Amgen Inc. v. Hoffman-La Roche Ltd.*, the court ruled that a recombinant source limitation is a product-by-process limitation that cannot confer novelty if the product itself is identical to the prior art product. The court further held that the claims defined "polypeptide" as a linear amino acid sequence, not a three-dimensional folded protein, so the identical linear sequence of native and recombinant IFN-β supported the jury's anticipation verdict, which was reinstated.

Holdings

1. The recombinant source limitation alone cannot confer novelty; the key question is whether the recombinant product is identical to the prior art product.
2. The claims define 'polypeptide' as a linear array of amino acids, and the district court's focus on unclaimed three-dimensional structure was error.

Questions Presented

1. Whether the district court erred in granting JMOL of no anticipation by refusing to apply a product-by-process analysis to the recombinant source limitation.
2. Whether the district court erred in requiring identity of three-dimensional protein structures for anticipation when the claims define 'polypeptide' as a linear array.

Disposition

reversed_and_remanded