BIOGEN MA INC. v. EMD SERONO, INC., Appeal No. 2019-1133 (Fed. Cir. September 28, 2020).  Before Newman, Linn and Hughes.  Appealed from D.N.J. (Judge Cecchi).  (Anticipation)


Plaintiff owns a patent directed to a method of treating a viral condition, a viral disease, cancers or tumors, by administration of a pharmaceutically effective amount of a recombinant polypeptide related to human interferon-β (“IFN-β”).  Defendant sold and marketed Rebif, a recombinant interferon-β product used for the treatment of Multiple Sclerosis, and Plaintiff sued Defendant for infringement (alleging contributory and induced infringement).

After a five-week trial, a jury found that the asserted claims were anticipated by two references teaching the use of native IFN-β to treat viral diseases—i.e., the human immune system naturally produces IFN-β (which, given the definition of “polypeptide” in the patent, meets the claim limitations) in small amounts, and it was undisputed that IFN-β harvested from human cells (“native IFN-β”) was used in the prior art to treat viral conditions.

On cross-motions, the district court granted judgment as a matter of law (JMOL) of no anticipation in favor of Plaintiff and conditionally granted a new trial on anticipation.  The district court concluded that just because recombinant and native IFN-β share the same linear amino acid sequence is not enough for purposes of anticipation in this case because the claims expressly required administration of a “therapeutically effective amount” of a recombinant polypeptide that “displays antiviral activity” and thus the product resulting from the claimed recombinant process is further defined by the folded three-dimensional structure of the protein.  Defendant appealed.


Did the district court err in granting JMOL of no anticipation? (continue reading)

Summary byBenji Prebyl

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