Biogen MA Inc. v. EMD Serono, Inc. — Federal Circuit Holds Source Limitations Cannot Confer Novelty on Recombinant Proteins
The Federal Circuit reversed a judgment for Biogen and reinstated a jury verdict of invalidity, holding that a recombinant polypeptide cannot be distinguished from its native counterpart for novelty purposes when the molecules are structurally identical — a product-by-process analysis applies even w