Argument Preview

Next week is argument week at the Federal Circuit, and four cases slated to be argued attracted amicus briefs. A patent case, Biogen MA v. EMD Serono, Inc., drew interest from Bayer Healthcare Pharmaceuticals on the issue of invalidity of a patent “for the use of recombinant IFN-β ‘polypeptides’ to treat various diseases.” Here is our argument preview.

EMD Serono, Inc. and Pfizer Inc. filed the appeal. In their joint opening brief, they present three questions for the Federal Circuit to resolve:

  1. “Whether the asserted claims are invalid because:”
    • (A) “They were anticipated by the prior art;” or
    • (2) “They are not enabled and lack sufficient written description.”
  2. “Whether the asserted claims are not infringed because:”
    • (A) “The steps of the method, properly construed, were not practiced in this country during the patent term;” or
    • (B) “Serono lacked the scienter required for indirect infringement.”
  3. “Whether the asserted claims are ineligible for patenting.”

On the first issue, the appellants first contend that the patent in suit, which relates to the administration of IFN-β-related polypeptides, lacks novelty. They argue that there is “[s]ubstantial evidence . . . that recombinant IFN-β polypeptides are identical to their native counterparts.” Appellants contend, moreover, that a wealth of authority indicates that “making an old product in a new way confers novelty only when it results in something new.” Further, they argue the proper analysis is “not whether native and recombinant polypeptides ‘share the same linear amino acid sequence,’” but instead “whether the ‘three dimensional structure’ of the two proteins is the same.”

With respect to the enablement and written description requirements, they argue that “[t]he district court erred in instructing the jury that the genus of non-human hosts need not be enabled or described.”

On the second issue, non-infringement, the appellants argue that two key process steps (“produced by” and “transformed by”) were “not performed in the United States during the patent’s term.” They argue “[s]ubstantial evidence established that Serono held” a “reasonable belief that the use of Rebif does not directly infringe” and therefore Serono was not liable for induced infringement. Further, they argue against the district court’s ruling that, “as a matter of law, ‘a good-faith belief in non-infringement’ is ‘inapplicable to contributory infringement.’”

On the third issue, ineligibility, appellants contend that “[t]he patent claims are directed to [a] natural phenomenon” and that “the district court’s ruling that method of treatment claims are categorically eligible is legally erroneous.” 

In its response brief, the appellee, Biogen MA Inc., argues that the patent in suit, which claims “methods of treatment using recombinant interferon-beta made in a non-human host cell,” was not anticipated because the prior art discloses only treatments with “native, human interferon-beta harvested from human cells.”

With respect to the written description and enablement requirements, Biogen contends that the “district court . . . correctly instructed the jury that it is the methods of treatment—not the polypeptides themselves or the host cells themselves—that must be described and enabled.”

With respect to direct infringement, Biogen argues that “the [patent in suit] has only one method ‘step’: ‘administering a recombinant interferon-beta polypeptide.’” Biogen contends that the appellants’ “two additional steps” are “source limitations—requirements that the product come from a
specific place or be made in a specific way,” as opposed to steps of the claimed method.

Regarding inducement, Biogen points out that, at trial, only Serono “argued that it lacked the intent to induce infringement because it believed in good faith in its three-step claim construction, under which there would be no direct infringement,” but “no evidence supported a defense based on that purported belief.” Biogen also maintains that Pfizer waived its good faith defense by not raising it below. Regarding contributory infringement, Biogen maintains that “a good-faith but incorrect belief in a non-infringing claim construction” is not defense to contributory infringement.

Finally, Biogen contends that the patent in suit is not directed to ineligible subject matter because it claims “the administration of a man-made substance to a patient to treat disease.”

In their reply brief, EMD Serono, Inc. and Pfizer Inc. argue that “[o]ver the course of a five-week trial, Serono and Pfizer proved that Biogen invented nothing.” They maintain they “meticulously established, with clear and convincing documentary and testimonial evidence, that the treatment of viruses with IFN-β was known in the prior art, that others invented biologically active recombinant IFN-β proteins, and that recombinant and native IFN-β polypeptides are identical.” They argue “[a] properly instructed jury made the factual finding that the claimed use of recombinant IFN-β polypeptides to treat viruses was anticipated” and “[t]he district court erred as a matter of law in substituting its own evaluation of the evidence for the jury’s on this quintessentially factual issue.”

As mentioned, Bayer Healthcare Pharmaceuticals filed an amicus brief in support of the appellants. Notably, it was a party to the case in the district court, but the district court severed the claims against Bayer from those against Serono and Pfizer. In its brief, Bayer argues that Dr. Walter Fiers, the named inventor on the relevant patent, was not the first to “find a way to use genetic-engineering technology to produce IFN-β.” Bayer argues that the patent in suit “is clearly invalid,” providing “additional perspective that Appellants do not cover.”

Bayer attempts to adds to the appellants’ argument by explaining (1) “why the law requires that a new process of making a product must impart both structural and functional differences from prior-art products to impart novelty,” and (2) “that the district court erred as a matter of law by relying on the asserted efficiency advantages of Dr. Fiers’s process as a functional difference in the resulting product of that process.” Additionally, Bayer argues that “the astonishing overbreadth of the genus of muteins of claim 1 of the Fiers Patent . . . dooms it to fail the written description requirement of 35 U.S.C. § 112.”

We will keep track of this case and report on developments.