Known Method of Administering a Known Treatment Made by a New Process is Not NovelSeptember 30, 2020

On September 28, 2020, in Biogen Ma Inc. v. EMD Serono, Inc, the US Court of Appeals for the Federal Circuit (“Federal Circuit”) reversed a district court’s grant of judgment as a matter of law of no anticipation, reinstating a jury verdict.

The claims at issue in Biogen’s patent cover the multiple sclerosis treatment Avonex and are directed toward a method of treating a viral condition comprising the step of administering to a patient an effective amount of a composition comprising a recombinant IFN-β polypeptide produced in a non-human host that had been transformed by a recombinant DNA molecule. This type of a claim is a “method of treatment” claim with a “product-by-process” limitation contained within. The human immune system naturally produces IFN-β and it is not disputed that IFN-β from human cells was used to treat viral conditions in the prior art.

After a trial, a jury held all claims in Biogen’s patent anticipated by native IFN-β. Responding to a petition for judgment as a matter of law (“JMOL”), the district court granted Biogen’s motion of no anticipation as a matter of law. The district court held that no reasonable jury could find anticipation because Serono had not identified any prior art that disclosed a treatment with a therapeutically effective amount of a composition comprising a recombinant IFN-β polypeptide produced in a non-human host that had been transformed by a recombinant DNA molecule. Instead, the district court reasoned, the prior art taught administration of native IFN-Β which is not recombinantly produced.

The district court did not apply a product-by-process analysis to the product-by-process limitation, concluding that no precedent required such analysis. Moreover, the district court stated that the policy informing product-by-process claims ­­‑ enabling an inventor to claim an otherwise difficult-to-define product – was inapplicable to the method of treatment claims at issue. Alternatively, the district court held that no reasonable jury could have found anticipation even applying a product-by-process analysis because the claims require administration of a “therapeutically effective amount” of a recombinant polypeptide with “antiviral activity.” These limitations result in a product necessarily folded into its appropriate three-dimensional structure. Therefore, the district court reasoned, there is no evidence that the native IFN-β protein is structurally or functionally identical to the claimed three-dimensional recombinant IFN-β.

The Federal Circuit found the district court’s ruling on anticipation erroneous because the district court did not apply a product-by-process analysis to the claimed limitations, and because the district court considered the required identity of three-dimensional structures not specifically recited in the claims.

The Federal Circuit stated that the district court’s ruling is contrary to the rule that “an old product is not patentable even if it is made by a new process.” The recombinant origin of the recited composition does not confer novelty on that composition if the product is identical to the prior art non-recombinant product. The requirements that the claimed polypeptide is “recombinant” and “produced by a non-human host transformed by a recombinant DNA molecule” describe the process by which the product is formed, and are not considered structural limitations. The key question for anticipation is whether the recombinant product is identical to the prior art product, not whether the prior art product was made recombinantly, and that the nesting of a product-by-process limitation within a method of treatment claim should not change how novelty of that limitation is evaluated.

The district court also held that even applying a product-by-process type analyses, there is no anticipation because there is insufficient evidence of identity between the claimed recombinant polypeptide and the native IFN-β. The district court concluded that just because recombinant and native IFN-β share the same linear amino acid sequence is not enough for anticipation, and that the native IFN-β only anticipates the recombinant IFN-β if their respective folded three-dimensional proteins share the identical structure and function. The district court held that the prior art lacked a disclosure of such three-dimensional protein and therefore would not necessarily produce antiviral activity when administered. The Federal Circuit disagreed because the claims do not recite any specific folded three-dimensional structure and the jury had sufficient evidence to find that native IFN-β is identical to recombinant IFN-β.

Julie L. Spieker is an Intellectual Property Attorney in the MVS  Biotechnology & Chemical Practice Group as well as the Mechanical  and Electrical Practice Group. To learn more, visit our MVS website , or contact Julie directly via email .