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Biogen MA v. EMD Serono

Claimed Treatment Applying Known Compound, Made by New Process, Lacks Novelty

Biogen MA, Inc. v. EMD Serono, Inc., __ F.3d __, 2020 WL 5755468 (Fed. Cir. Sept. 28, 2020) (Newman, LINN, Hughes) (D.N.J.: Cecchi) (3 of 5 stars)

Fed Cir reverses JMOL and reinstates jury verdict of anticipation. Biogen’s patent relates to its recombinant interferon-β (“IFN-β”) product, Rebif, used in the treatment of multiple sclerosis. The district court erred by not analyzing whether the prior art “native” IFN-β was or was not identical to the claimed recombinant IFN-β. “The district court’s refusal to consider the identity of recombinant and native IFN-β runs afoul of the longstanding rule that ‘an old product is not patentable even if it is made by a new process.’” Op. at 11 (quoting Amgen, 580 F.3d 1340 (Fed. Cir. 2009)). That Biogen’s claim was styled as a method of treatment claim with an embedded product-by-process limitation did not make Amgen inapplicable. The opinion reasons that excusing method of treatment claims from Amgen “could have the absurd result that a recombinant composition could be non-novel, the method of administration could be non-novel, but the method of administration of the composition defined by the process of its manufacture would be novel as a matter of law.” Id. at 14.

The district court’s holding that even were Amgen applicable, the record lacked substantial evidence of identity between the prior art native IFN-β and the claimed recombinant IFN-β, was also incorrect. The opinion describes how the record could support a determination of identity even though the three-dimensional structure of the prior art protein was unknown. It notes that there was no dispute that the prior art and claimed proteins had identical amino acid residue sequences, and that Biogen’s patent defined “polypeptide” in terms of linear, not three-dimensional, structure. That the claim also required antiviral activity, and that only “folded three-dimensional” proteins can have such activity, did not require otherwise. The opinion also notes that Biogen never sought a jury instruction requiring comparison of three-dimensional structures.

KEYWORDS: PRODUCT BY PROCESS; ANTICIPATION (YES); METHOD OF TREATMENT; LIFE SCIENCES