Biogen MA Inc. v. EMD Serano, Inc., No. 19-1133 (Fed. Cir. Sept. 28, 2020)

In reversing a district court's judgment as a matter of law (JMOL) of no anticipation, the Federal Circuit clarified that a method-of-treatment claim reciting a product-by-process limitation can be anticipated by prior art disclosing the same product produced by a different process.

At the district court, the jury found anticipation of claims reciting a method of treatment with a pharmaceutically effective amount of a recombinant polypeptide.  In particular, the evidence showed that an identical amino acid sequence for the polypeptide was disclosed in the prior art, albeit in its native form, rather than in recombinant form.  Following the jury verdict, the district court granted JMOL of no anticipation, holding that no reasonable jury could find anticipation because the prior art did not disclose the recombinant form of the polypeptide.  In reaching this conclusion, the district court declined to apply a product-by-process analysis to a product-by-process limitation recited by the claims.  The district court alternatively opined that even under a product-by-process analysis, the recombinant form of the polypeptide required a three-dimensional structure, and there was insufficient evidence that the prior art disclosed such a structure.

The Federal Circuit reversed the district court's JMOL of no anticipation and remanded with instructions to reinstate the jury's finding of anticipation.  The Federal Circuit explained that under its precedent, an old product is not patentable even if it is made by a new process, and further clarified that this principle applies to method-of-treatment claims that include product-by-process limitations.  The Federal Circuit explained that the claims' requirement that the polypeptide is “recombinant” merely described the process by which the product is formed, and does not add structural limitations.  Under the proper legal framework, the Federal Circuit held that a reasonable jury could find the claims anticipated.

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Originally Published by Winston & Strawn, January 2021

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