Federal Circuit Reinstates Jury Verdict Finding Claims of Biogen’s MS Drug Were Anticipated

“The nesting of the product-by-process limitation within a method of treatment claim does not change the proper construction of the product-by-process limitation itself.” – Judge Linn

On Monday, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in Biogen MA, Inc. v. EMD Serono, Inc., reversing the U.S. District Court for the District of New Jersey’s judgment as a matter of law (JMOL) for Biogen. The New Jersey court had found no anticipation of Biogen’s patent claims, overturning a jury’s finding that the claims were anticipated by the prior art. The Federal Circuit’s decision, which turned on the issue of applying a product-by-process novelty analysis to certain nested claim limitations, said that a reasonable jury could find the claims anticipated and remanded with instructions to reinstate the jury verdict.

District of New Jersey Grants JMOL Overturning Jury Verdict on Anticipation

Biogen first filed suit against EMD Serono and other defendants in the case over infringement claims stemming from the defendant’s marketing of Rebif, a treatment for multiple sclerosis which uses a cytokine, a substance typically excreted by immune system cells, known as recombinant interferon-? (INF-?). Biogen asserted claims of U.S. Patent No. 7588755, DNA Sequences, Recombinant DNA Molecules and Processes for Producing Human Fibroblast Interferon-Like Polypeptides. The claims of the ‘755 patent cover a method for administering a pharmaceutically effective amount of a recombinant polypeptide related to INF-? to treat viral diseases or tumors.

After a five-week trial, the jury found that the asserted claims were anticipated by a pair of prior art references teaching the use of INF-? native within the human body to treat viral diseases like hepatitis. However, Biogen filed a motion for JMOL of no anticipation, which was granted by the district court. Ruling that no reasonable jury could find anticipation, the court noted that the prior art on treating viral diseases with INF-? only involved the use of native INF-?, which is undisputedly not recombinant INF-? and thus the recombinant form couldn’t be anticipated. In applying a structural reading of the ‘755 patent’s claimed recombinant limitations, the lower court also declined to apply a product-by-process analysis to a product-by-process limitation contained within the asserted ‘755 patent claims, stating that no precedent existed to require such an analysis.

The use of product-by-process claims, from a policy standpoint, enables inventors to claim inventive products that are otherwise difficult to define. The district court found this policy reasoning was inapplicable to method of treatment claims, leading the court to determine that the product-by-process analysis was inappropriate. Claim 1 of the ‘755 patent claims a method for immunomodulation or treating viral conditions or cancers, but nested within that claim was a further limitation claiming that the method comprised “a recombinant polypeptide produced by a non-human host transformed by a recombinant DNA molecule.” According to the Federal Circuit, the district court’s failure to apply the product-by-process analysis to the claimed recombinant INF-? source limitation led the court to an erroneous conclusion on anticipation.

‘No Logical Reason’ to Change Novelty Analysis on Product-by-Process Limitations

“There is no logical reason why the nesting of a product-by-process limitation within a method of treatment claim should change how novelty of that limitation is evaluated,” wrote Senior Circuit Judge Richard Linn in the panel’s opinion. “The nesting of the product-by-process limitation within a method of treatment claim does not change the proper construction of the product-by-process limitation itself.” Judge Linn proceeded to note that the Federal Circuit has previously applied that very type of analysis in Purdue Pharma v. Epic Pharma (2016). In Purdue Pharma, the Federal Circuit found it appropriate to focus on the identity of the product of the claimed processes instead of the limitation created by the product’s source.

The key question on anticipation in this case, according to the Federal Circuit, is the same one which the court previously answered in Amgen v. F. Hoffman-La Roche (2009), a case which the New Jersey district court cited in its JMOL ruling without distinguishing from the present case. In Amgen, the Federal Circuit analyzed whether patent claims covering the recombinant formation of a protein known as erythropoietin (EPO) were anticipated by prior art that taught the purification of EPO produced from human urine. The claimed EPO composition in Amgen couldn’t avoid being anticipated simply because the urinary EPO in the prior art was not recombinantly formed, so the key question was whether the production of EPO by recombinant technology resulted in a new product distinguishable from the prior art.

“As in Amgen, the recombinant origin of the recited composition cannot alone confer novelty on that composition if the product itself is identical to the prior art non-recombinant product,” Judge Linn wrote. Claim 1 of the ‘755 patent claims a polypeptide that is “recombinant” and “produced by a non-human host transformed by a recombinant DNA molecule,” but these requirements are not additional structural limitations, the Federal Circuit found. Thus, the key question, as in Amgen, is whether the recombinant INF-? is identical to the native INF-? in the prior art without regard to how either form of INF-? was created.

On appeal, Biogen had argued that Amgen’s holding was inapplicable to the ‘755 patent’s method of treatment claim, citing In re Thorpe (1985) for the premise that product-by-process analyses are limited to “otherwise patentable product[s]” and noting the general distinction drawn by patent law between the scope of composition claims and method of treatment claims. However, the Federal Circuit found that Biogen’s only basis for novelty was the recombinant INF-? composition which is claimed in terms of how it is made. If novelty required comparing the structures of recombinant and native INF-?, “it would defy all reason to excuse that analysis for a method of administration claim using that composition,” Judge Linn wrote:

Such a rule could have the absurd result that a recombinant composition could be non-novel, the method of administration could be non-novel, but the method of administration of the composition defined by the process of its manufacture would be novel as a matter of law.

An Old Product Made by a New Process is Not Novel

The Federal Circuit was also unswayed by arguments from Biogen and the district court that, because the composition could be defined apart from the process of making it, the product-by-process analysis of the nested limitation was inappropriate. However, in Amgen, the claimed EPO product was also well-defined, and the rule from that case is based on the legal principle that an old product made by a new process is not novel and cannot be patentable. The district court also erred in considering the advantages of the recombinant process for forming INF-? in deciding to not apply the product-by-process analysis. “That consideration may well be relevant in considering the novelty of the recombinant process, but, a new process, regardless of its novelty, does not make an old product created by that process novel,” Judge Linn wrote.

In its JMOL ruling, the district court found that, even if a product-by-process analysis were applied, no reasonable jury could have found that the native INF-? anticipated if it shared an identical three-dimensional structure with the recombinant INF-?. Simply sharing the same linear sequence of amino acids was not enough for anticipation in the lower court and the prior art contained no disclosure of native INF-?’s three-dimensional structure. However, the Federal Circuit found that the ‘755 patent’s definition of polypeptide in the specification refers to a “linear array of amino acids” without regard to a three-dimensional folded protein structure.

Biogen argued on appeal that requiring identity of the folded protein structure was appropriate because only three-dimensional proteins can be “therapeutically effective” and have “antiviral activity” as required by the patent claim. In dismissing this argument, the Federal Circuit noted that Biogen’s theory didn’t square with the polypeptide definition given by its patent, and that the claim’s references to antiviral activity do not include any recitation of a specific folded three-dimensional structure. “While it is indisputable that an amino acid sequence alone cannot give rise to antiviral activity, it is also indisputable that every linear sequence of proteins will fold into some three-dimensional configuration,” Judge Linn wrote. Biogen also failed to request a jury instruction on anticipation requiring a comparison of three-dimensional structures between the claimed and prior art, so it was improper to reframe the anticipation inquiry on JMOL when the jury was asked to decide anticipation based on the linear amino acid sequence.

Reversing the New Jersey district court’s JMOL ruling and the conditional grant of a new trial, the Federal Circuit remanded the case, instructing the lower court to reinstate the jury verdict on anticipation. The Court did not address any other issues raised on appeal.


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