On Monday, the Federal Circuit issued its opinion in Biogen MA Inc. v. EMD Serono, Inc., a case we have been tracking because it attracted an amicus brief. In the opinion, a panel of the court composed of Judges Newman, Linn, and Hughes unanimously reversed the district court’s grant of judgment as a matter of law and remanded with instructions to reinstate the jury verdict finding that the patent-in-suit was invalid as anticipated. Here is a summary of the opinion.

As explained in our argument preview, Serono appealed the district court’s judgment, which rejected challenges to the validity of the patent claims. On the issue of anticipation, Serono argued that there is “[s]ubstantial evidence . . . that recombinant IFN-β polypeptides are identical to their native counterparts” and that “making an old product in a new way confers novelty only when it results in something new.” Serono argued that, because the method claimed by the ’755 patent did not result in making a new product, the ’755 patent was anticipated and thus invalid. Serono received support in the form of an amicus brief making additional arguments concerning anticipation.

Judge Linn wrote the opinion for the panel, which, as mentioned, reversed the district court’s grant of JMOL and remanded with instructions to reinstate the jury verdict that the ’755 patent was invalid on anticipation grounds. Because the court overturned the JMOL on the anticipation grounds, it declined to discuss the other grounds on appeal. 

Judge Linn summarized the relevant facts as follows:

The ’755 patent is 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”). The human immune system naturally produces IFN-β in small amounts . . . . For purposes of this opinion, we refer to “recombinant IFN-β” as shorthand for the recombinant protein that meets these claim limitations. . . . In its charge on anticipation, the district court told the jury that “[t]he term ‘polypeptide’ means ‘a linear array of amino acids connected one to the other by peptide bonds between the α-amino and carboxy groups of adjacent amino acids.’” . . . The jury held, inter alia, that all claims in the ’755 patent were invalid as anticipated by native IFN-β. . . . As relevant here, the district court granted Biogen’s motion of no anticipation as a matter of law. . . . In a comprehensive opinion, the district court held that no reasonable jury could find anticipation under Serono’s reading of the claims.

In evaluating the record, the Federal Circuit determined that the district court “(1) declined to apply a product-by-process analysis to the claimed recombinant IFN-β source limitation; and (2) in its alternative ground analysis, required identity of three-dimensional structures not specifically recited in the claims.”

First, the court found the district court failed to apply the appropriate product-by-process analysis.

The district court determined that “it need not analyze whether native IFN-β and recombinantly produced IFN-β were identical” because nothing in the prior art disclosed recombinantly produced IFN-β. Serano, on the other hand, argued that the native IFN-β and recombinantly-produced IFN-β were identical, and that a source limitation cannot confer novelty unless the product itself is novel. The court agreed with Serono.

The court maintained that the district court’s refusal to consider whether the products were identical “runs afoul of the longstanding rule that ‘an old product is not patentable even if it is made by a new process.’ Amgen, 580 F.3d at 1366.”

Biogen argued that the court’s precedent was limited to composition claims and not applicable to the method of treatment claims at issue in this case. The court, however, declined to limit its product-by-process analysis to composition claims. The court explained this would create “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.”

Next, the court addressed the district court’s alternative grounds that the jury lacked sufficient evidence of identity between the claimed recombinant IFN-β and the native IFN-β.

The district court held that the native IFN-β could anticipate the recombinant IFN-β “only if their respective folded three-dimensional proteins share identical structure and function,” but that no such three-dimensional protein was disclosed in the prior art. The Federal Circuit noted, however, that Biogen explicitly defined “polypeptide” in its claims as a “linear array of amino acids . . . .” Furthermore, the Federal Circuit highlighted, the district court charged the jury with the same language, adding that the jury “must accept [the court’s] definition of these words in the claims as correct.”

Biogen asserted that the three-dimensional structure is inherent in the claim because only three-dimensional proteins can be therapeutically effective and have antiviral activity, which the claim requires. The Federal Circuit, however, held that Biogen’s argument fails because its claims explicitly defined “polypeptide” in terms of its linear sequence. Furthermore, Biogen’s claim, explained the court, never recited a specific three-dimensional structure. Finally, the court noted that Biogen did not object to the jury charge or request an instruction related to the three-dimensional structure. Thus, the Federal Circuit concluded that the jury was permitted to determine the identity of the claimed recombinant IFN-β and the native IFN-β based on their linear array of amino acids.

Because the Federal Circuit found that a reasonable jury could find that the claims of the ’755 patent were anticipated, the Federal Circuit reversed the district court’s grant of JMOL and remanded the case with instructions for the district court to reinstate the jury’s verdict of invalidity due to anticipation. Aa mentioned, based on this holding, the Federal Circuit declined to address the several other issues raised on appeal.