Fresh From the Bench: Latest Federal Circuit Court Cases
CASE OF THE WEEK
GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., Appeal No. 2018-1976, -2023 (Fed. Cir. Oct. 2, 2020)
Our Case of the Week focuses on the question of induced infringement, and particularly induced infringement in the context of prescription pharmaceuticals. The district court concluded that product labeling in and of itself was insufficient to satisfy the causation requirement for inducement, at least where there were other likely reasons why consumers would have used the product besides the product labeling. Ultimately, a panel of the Federal Circuit, in an opinion by Judge Newman, concluded that product labeling and promotional materials are enough to support a jury finding of induced infringement to use a product in an infringing way, even if the market may be aware of infringing uses from other sources.
Biogen MA Inc. v. EMD Serono, Inc., Appeal No. 2019-1133 (Fed. Cir. Sept. 28, 2020)
In this appeal, the Court reversed a district court grant of judgement as a matter of law (“JMOL”) of no anticipation in favor of Biogen after a jury verdict finding the patent at issue was anticipated. The patent at issue was “directed to a method of treating a viral condition, a viral disease, cancers or tumors, by administration of a pharmaceutically effective amount of recombinant polypeptide.” “Serono argue[d] that the district court erred by holding that the lack of a recombinantly produced polypeptide in the prior art references compelled a finding of no anticipation.” The Court agreed, finding that “[t]he 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.’” Instead of comparing the source of the IFN-β, the proper analysis requires the comparison of the “claimed recombinant polypeptide and the prior art native polypeptide.” Thus, “the district court erred in concluding that the mere absence of recombinantly produced polypeptide in the prior art was sufficient to grant JMOL of no anticipation.
The Court also addressed the district court’s alternative theory of no anticipation that “no reasonable jury could have found anticipation because the jury lacked sufficient evidence of identity between the claimed recombinant ‘polypeptide’ and the native IFN-β.” The district court reasoned that the “native polypeptide anticipates the ‘recombinant polypeptide’ only if their respective folded three-dimensional proteins share identical structure and function.” Since the prior art did not disclose the folded three-dimensional structure in the claims at issue, the district court found that the prior art did not anticipate the claims. But, the Court again rejected the district court’s reasoning. The Court found that the district court’s reading of the specification was flawed because it required the prior art references to contain structures “not specifically recited in the claims rather than the claimed and lexicographically defined ‘polypeptide.’” So the district court improperly distinguished between structural forms of the polypeptide rather than focusing on the “‘product’ in the claimed method[, which] is the ‘polypeptide.’” Accordingly, the Court reversed and remanded the matter to the district court with instructions to reinstate the jury verdict of anticipation.