IP Law Daily JMOL of no anticipation rejected in multiple sclerosis treatment
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Monday, September 28, 2020

JMOL of no anticipation rejected in multiple sclerosis treatment

By Linda Panszczyk, JD

A reasonable jury could've found the patent claims anticipated on the record presented.

Because a reasonable jury could find the claims of Biogen MA’s U.S. Patent Number 7,588,755 (the "’755 patent") for a method of treating a viral condition anticipated on the record presented in this case, the Federal Circuit has reversed a district court’s judgment as a matter of law (JMOL) of no anticipation and its conditional grant of new trial on that ground and remanded the case with instructions to reinstate the jury verdict of anticipation. Biogen MA sued EMD Serono, Inc. and Pfizer, Inc. (together, Serano) alleging contributory and induced infringement of the’755 patent by the sale and marketing in the U.S. of Rebif, a recombinant interferon-β (“IFN-β”) product used for the treatment of multiple sclerosis. The jury had found that the ’755 patent claims were anticipated by two references teaching the use of native IFN-β to treat viral diseases and that the asserted claims were not invalid for lack of enablement or written description, or for obviousness, and the district court had granted JMOL of no anticipation in favor of Biogen and conditionally granted a new trial on anticipation (Biogen MA v. EMD Serono, Inc., September 28, 2020, Linn, R.).

Background. 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 IFN-β. The human immune system naturally produces IFN-β in small amounts, and it is undisputed that IFN-β harvested from human cells (“native IFN-β”) was used in the prior art to treat viral conditions. The jury held, among other things, that all claims in the ’755 patent were invalid as anticipated by native IFN-β; not invalid for obviousness, lack of enablement or lack of written description; and that Serono was liable for contributory infringement but not induced infringement.

The district court granted Biogen’s motion of no anticipation as a matter of law, holding that no reasonable jury could find anticipation under Serono’s reading of the claims. First, applying a structural reading of the recombinant limitations, the district court held that Serono had not identified any prior art that disclosed treatment with a therapeutically effective amount of a composition comprising a recombinant’ interferon-β polypeptide produced in a non-human host that had been transformed by a recombinant DNA molecule. The district court reasoned that, because treatment in the prior art entailed administration of native IFN-β, which was undisputedly not recombinantly produced, no reasonable jury could find anticipation.

The district court declined to apply a product-by-process analysis to a product-by-process limitation contained within a method of treatment claim, concluding that no precedent required such an analysis and that the policy informing product-by-process claims—to enable an inventor to claim an otherwise difficult-to-define product—was inapplicable to the instant method of treatment claims. In the alternative, the district court held that no reasonable jury could have found anticipation even applying a product-by-process analysis. The district court held that the jury lacked substantial evidence that the native IFN-β protein was structurally or functionally identical to the claimed three-dimensional recombinant IFN-β protein. Thus, the district court granted JMOL of no anticipation and conditionally granted Biogen’s motion for a new trial on anticipation. Serano appealed.

Anticipation of claim. In evaluating the evidentiary record presented to the jury on the question of anticipation, 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 analysis, required identity of three-dimensional structures not specifically recited in the claims rather than the claimed and lexicographically defined polypeptide. According to the Federal Circuit, both determinations led to an erroneous conclusion on anticipation.

The district court, focusing on the process of making recombinant IFN-β, concluded that it need not analyze whether native IFN-β and recombinantly produced IFN-β were identical because neither prior art reference taught a method of treatment using recombinant IFN-β. Also, the district court reasoned that no binding precedent required it to apply a product-by-process analysis to a limitation contained in a method of treatment claim, and held that the rationale underlying the use of product-by-process claims—to allow claiming of an otherwise difficult-to-define invention, did not apply to the claims in this instance because the product itself was sufficiently described. The district court thus concluded there could be no anticipation, regardless of whether Serono had shown the identity of native IFN-β and recombinant INF-β.

On the merits, Serono asserted that a source limitation alone cannot confer novelty unless the product itself is novel, arguing that the district court erred by holding that the lack of a recombinantly produced IFN-β product in the prior art compelled a finding of no anticipation. Biogen argued that the source of the IFN-β matters is an independent limitation. The court agreed with Serono.

The district court’s refusal to consider the identity of recombinant and native IFN-β ran afoul of the longstanding rule that an old product is not patentable even if it is made by a new process, according to the Federal Circuit.

The nature of the origin or source of the composition recited in the claims at issue in this case was, in all relevant respects, identical to that considered in Amgen Inc. v. Hoffman-La Roche Ltd. The key question for anticipation in this case, as in Amgen, was thus whether the recombinant product is identical to the prior art product—not whether the prior art product was made recombinantly.

Biogen argued that Amgen is limited to composition claims and is not applicable to the method of treatment claims at issue here. Biogen’s only basis for novelty of the method of treatment claims at issue in this instance is the novelty of the recombinant IFN-β composition that is administered. That composition is claimed in terms of the process by which it is manufactured. If the novelty of the recombinant IFN-β composition requires comparing its structure to the structure of native IFN-β, as Amgen requires, the Federal Circuit opined that it would defy all reason to excuse that analysis for a method of administration claim using that composition. 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, the court indicated. There was 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, said the appellate court. 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.

Product by process analysis. The appellate court was also unpersuaded by the district court’s and Biogen’s reasoning that a product-by-process-type analysis was inappropriate in this case because the composition was otherwise capable of definition other than by the process. Logic compelled extending that rule to the present case, according to the appellate court, which added that an old method of administration of an old product made by a new process is not novel and cannot be patented.

Where, as here, the novelty of the method of administration rested wholly on the novelty of the composition administered, which in turn rested on the novelty of the source limitation, the Amgen analysis will necessarily result in the same conclusion on anticipation for both forms of claims, according to the court.

Finally, the district court erred in considering the advantages of the recombinant process—the new capability of manufacturing enough IFN-β through recombinant technology—as a reason not to apply a 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. This did not fail to give force and effect to the heart of the claimed invention, but rather, it protects the public from attempts to excise old products from the public domain.

Because a proper anticipation analysis of the claims in the ’755 patent turned not on the source of the claimed polypeptide but on a comparison of the claimed recombinant polypeptide and the prior art native polypeptide, the district court erred in concluding that the mere absence of recombinantly produced IFN-β in the prior art was sufficient to grant JMOL of no anticipation, the Federal Circuit indicated.

The district court also held that even applying a product-by-process type analysis, 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. In particular, the district court concluded that just because recombinant and native IFN-β share the same linear amino acid sequence was not enough for purposes of anticipation. The district court took the position that native polypeptide anticipates the recombinant polypeptide only if their respective folded three-dimensional proteins share identical structure and function. The district court reasoned that without a disclosure in the prior art of such three-dimensional protein, a showing of the native polypeptide alone would not necessarily produce antiviral activity when administered in a therapeutically effective amount, as recited in the claims. This was error, the appellate court said.

Biogen argued that the district court was correct in requiring identity not just of the polypeptide, but also of the folded proteins, because the claims require the administration of a therapeutically effective amount of a composition and that the DNA sequences in the claims must code for a polypeptide displaying antiviral activity. Biogen asserted that only three-dimensional proteins can be therapeutically effective and have antiviral activity, and therefore that the product to be analyzed for novelty was the folded three-dimensional protein, not just the amino acid sequence. However, the appellate court rejected this argument.

Biogen’s argument failed to give effect to Biogen’s explicit definition of polypeptide in the specification and did not attempt to square its theory with the definition in the specification. Further, Biogen drew the wrong conclusion from the claimed antiviral activity limitation. The claims, in calling for antiviral activity, do not recite any specific folded three-dimensional structure that gives rise to that activity. Finally, and importantly, the court stressed, Biogen did not ask for a jury instruction on anticipation that required comparing the three-dimensional protein structures of prior art IFN-β and the claimed recombinant IFN-β. Neither Biogen nor the district court could reframe the anticipation inquiry on JMOL to focus on the unclaimed three-dimensional protein structure, where the jury was instructed, without objection, to decide anticipation based on the linear amino acid sequence. The jury was correctly instructed that, to be entitled to a patent, the invention must be new. It was undisputed that the prior art here taught the administration of native IFN-β that has a linear amino acid sequence identical to the linear amino acid sequence of the recited recombinant IFN-β and that showed antiviral activity. The jury thus had sufficient evidence to find that native IFN-β polypeptide is identical to recombinant IFN-β polypeptide, was administered in therapeutically effective amounts, and showed antiviral activity in the prior art. The district court thus erred in granting JMOL of no anticipation.

This case is No. 19-1133.

Attorneys: Nicholas P. Groombridge (Paul, Weiss, Rifkind, Wharton & Garrison LLP) for Biogen MA Inc. Mark Andrew Perry (Gibson, Dunn & Crutcher LLP) for EMD Serono, Inc. and Pfizer Inc.

Companies: Biogen MA Inc.; EMD Serono, Inc.; Pfizer Inc.

MainStory: TopStory Patent GCNNews FedCirNews

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