Argument Recap

Our final argument recap this month comes in Biogen MA Inc. v. EMD Serono, Inc. As we noted in our argument preview, in this case the court confronts invalidity and infringement arguments related to IFN-β-related polypeptides, which can be used to treat multiple sclerosis. Last Friday, the parties (Plaintiff-Appellee Biogen MA, Inc. and Defendants-Appellants EMD Serono, Inc. and Pfizer Inc.) presented their arguments to a panel of the court that included Judges Newman, Linn, and Hughes.

Arguing on behalf of Defendants-Appellants EMD Serono, Inc. and Pfizer Inc., Mark A. Perry began with the issue of invalidity. He noted that “the jury made the factual finding that the asserted claims are anticipated by prior art uses of native interferon beta,” and argued that “that finding is supported by substantial evidence.” Perry then quoted testimony that “the Beta interferon made recombinantly is the same interferon polypeptide as native human interferon.”

The judges sought clarification on the issue at hand and asked whether the inquiry was the identical nature of the amino acid sequence or carbohydrates attached to the polypeptides. Perry responded that the question of whether the carbohydrates attached to the polypeptides were identical was never posed to the jury, but argued it was actually answered after the verdict by the district court, despite the jury never addressing it. Perry went on to explain why the appellee’s classification of the issue, centered upon the carbohydrates attached to the polypeptides, is, in his view, fundamentally flawed. Perry argued that Biogen waived the carbohydrate argument by not requesting a jury instruction on the issue. He pointed out, moreover, that Biogen’s expert testified that the only difference between the recombinant IFN-β polypeptides and the native counterparts are the carbohydrate structure, about which the jury was never instructed.

The judges brought up the claim language “therapeutic effectiveness,” which by definition might require a three dimensional structure. Perry contended, however, that the claims refer only to a polypeptide, and argued that that is the reason the jury was never instructed on a three dimensional structure. Moreover, he maintained that the evidence is clear concerning the three dimensional structure and shows that the three dimensional structures of both the native and recombinant IFN-β are identical.

Judge Newman then asked Perry to address the district court’s finding that what is claimed is the use of a synthetic product as opposed to a natural product. Perry explained that not even Biogen is attempting to suggest that the patent-in-suit claims a new use of the synthetic product. Turning to  another issue, Judge Hughes asked how the jury could have found anticipation but not obviousness, considering it appears there is a well-known method of using the natural form and the recombinant versions were also in the prior art but not “put together.” Perry conceded that it was his burden to prove that the two molecules were the same, but he argued that he met that burden by proving the claims of the polypeptide and the naturally-occurring polypeptides are the same.

Turning to the issue of infringement, the judges questioned the jury instruction on contributory infringement, which did not allow the jury to consider as a defense the appellants’ reasonable belief of non-infringement. Perry referred to the Supreme Court’s Commil decision, which indicated that a reasonable belief of non-infringement (as opposed to invalidity) is a defense to both contributory and inducement to infringement. Therefore, Perry argued, the appellants should have at least had the chance to present their theory of non-infringement to the jury.

Arguing on behalf of Plaintiff-Appellee Biogen MA, Inc., Nicholas Groombridge also began with the issue of invalidity. He claimed that there is no evidence that the native and recombinant IFN-β are the same. On the contrary, Groombridge argued that all of the evidence points to the conclusion that the molecules are not the same. Groombridge conceded that while the linear amino acid chains are the same, the sugar (or carbohydrates) hanging off the amino acid chains are different. Responding to a question by Judge Newman, Groombridge argued that “the differences reside within the sugars or carbohydrates.” He continued by explaining that “that is the difference and it is what makes the recombinant product novel: It did not exist in nature and therefore it can be patented . . . and the use of it is not anticipated by the use of native beta interferon.”

Moving forward, Judge Hughes posed a hypothetical: “If [Biogen] could have proved that the recombinant and native interferon are exactly the same, would the fact that there is no prior art on the recombinant [interferon] matter?” Groombridge claimed that it would, because the relevant claim is a method claim and not a product claim. More specifically, Groombridge argued the inquiry with respect to method claims is whether the steps have been disclosed in the prior art. Pressing further, Judge Hughes asked if the claim is limited to the polypeptide, and the native interferon is equally effective as the recombinant interferon, then why isn’t it the same? Groombridge argued that the source limitation is the difference. That limitation, he explained, requires that the creation of the recombinant interferon must be done by someone, but not by the same person that administers the recombinant interferon.

Next, Groombridge addressed the issue of whether the sugar molecules, which hang from the amino acid chain, are claimed or not. He contended that, because the source limitation (recombinant production) necessarily leads to a difference at the molecular level of the carbohydrates, those differences are a part of the claim.

With respect to infringement, Groombridge suggested that the issue before the court, which he claimed has not been resolved by the Federal Circuit or the Supreme Court, is the difference between the scienter requirements of contributory infringement and inducement. Groombridge argued that the origin of contributory infringement, as a type of indirect infringement separate from inducement, leads to the conclusion that the intent to infringe can be presumed in some circumstances. But, he claimed, if the court adopts his counterpart’s view of inducement and contributory infringement, then the two standards become the same. Ultimately, Groombridge argued that contributory infringement requires less scienter. He, however, argued that the Federal Circuit has never explained what that lower standard is.

In response, Judge Newman asked Groombridge to explain why the “rule of non-infringing use” is not the difference between the two scienter requirements. Groombridge argued that the only reason for contributory infringement is to capture infringers who are injecting, into the stream of commerce, products that have only an infringing use. Judge Linn asked whether, if the appellants reasonably believed that their selling of IFN-β did not infringe the patent-in-suit, then why that is not relevant to contributory infringement. Groombridge argued that for inducement the appellants’ reasonable belief of non-infringement would be relevant, but for contributory infringement it is not.

In rebuttal, Perry attacked the issue of the jury instruction not addressing the presence of sugar groups, which, he said, the appellees’ validity argument relies upon on appeal. Perry supported this argument by discussing the invention story of the patent-in-suit, explaining that the inventor’s “experiment set out to prove that he could force an E.coli cell (a bacterium) to produce this polypeptide with no glycosylation and still have a three dimensional structure and biological activity.” Perry contended that this fact destroys the appellee’s argument that glycosylation is the source of novelty for the patent-in-suit because the inventor’s experiment expressly set out to not produce glycosylation. Further, Perry argued that the appellee’s argument causes § 112 issues to arise, because the patent-in-suit never speaks to glycosylation in a way that would teach anything to a person having ordinary skill in the art.       

We will monitor the case and report on its outcome.