An Old Method Using an Old Product From a New Source Is Not New

BIOGEN MA INC. v. EMD SERONO, INC.

Before Newman, Linn, and Hughes.  Appeal from the District Court of the District of New Jersey.

Summary: A known method of administering a known product made by a new process is not novel.

Biogen sued Serono and other parties for contributory infringement of Biogen’s patent directed toward a method of treatment for viral conditions by administration of a pharmaceutically effective amount of recombinant interferon-β produced by a non-human host.  Serono argued that the patent’s claims were anticipated by prior art teaching the administration of native interferon-β harvested from human cells to treat viral conditions.  The jury agreed with Serono, holding that all claims were invalid as anticipated.

Biogen moved for judgment as a matter of law, arguing that the claims were not anticipated.  The district court granted Biogen’s motion of no anticipation, reasoning that no reasonable jury could find anticipation because the prior art entailed administration of native interferon-β, which was undisputedly not recombinantly produced.  The district court declined to apply a product-by-process analysis to the method claim with a product-by-process limitation nested therein, concluding that no precedent required such an analysis.  In the alternative, the district court held that even by employing a product-by-process analysis, the structural differences between recombinant and native interferon-β precluded a finding of anticipation.

On appeal, the Federal Circuit held that there was sufficient evidence to support the jury’s finding and that it was improper for the district court to reject the product-by-process analysis in evaluating novelty in favor of relying on structural differences between recombinant and native interferon-β.  The Federal Circuit reasoned that there was no logical reason to reject the novelty analysis of a product-by-process limitation based on its inclusion within a method of treatment.  Moreover, the Federal Circuit previously applied the product-by-process analysis to a nested limitation in Purdue Pharma L.P. v. Epic Pharma, LLC, 811 F.3d 1345 (Fed. Cir. 2016).  Accordingly, the Federal Circuit explained that the source limitation of producing recombinant interferon-β by a non-human host cannot confer novelty unless the product itself is novel.  The Federal Circuit further explained that here, just as in Amgen Inc. v. Hoffman-La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009), the recitation of a recombinant origin of a recited composition is not enough to avoid anticipation in view of the prior art non-recombinant product—native interferon-β.  The Federal Circuit provided that the rule from Amgen was a necessary outgrowth of the principle that an old product made by a new process is not novel and that logic compels extending that rule such that an old method of administering an old product made by a new process is not novel.  Lastly, the Federal Circuit explained that the structural differences between recombinant and native interferon-β were not distinguishing because such differences were absent from the claim limitations.  Accordingly, the Federal Circuit reversed the district court’s grant of judgment as a matter of law of no anticipation and remanded with instructions to reinstate the jury verdict of anticipation.

Editor: Paul Stewart