Product-by-Process Within a Method Claim

by Dennis Crouch

Biogen MA, Inc. v. EMD Serono, Inc. & Pfizer Inc. (Fed. Cir. 2020) [BiogenSerono]

After a five-week-trial, the jury returned a verdict that Biogen’s asserted claims were anticipated by two prior art references. In the lawsuit, Biogen had asserted infringement of its US7588755 against Serono and Pfizer based upon their sale of Rebif (IFN-β used for MS treatment).

In a post-judgment order, the District Court rejected this portion of the jury verdict–holding that no reasonable jury could have found anticipation. In addition to JMOL, the district court also conditionally granted a new trial on anticipation under R.59.  The jury had sided with Biogen on other grounds of infringement/validity and so it looked like a win for the patentee. Because the original jury had found the patent invalid, it did not award any damages.  Thus, the district court entered a “partial judgment” and scheduled a new trial on damages.

Appeal before a Damages Trial: 28 U.S.C. § 1292(c)(2), provides appellate jurisdiction once a patent case is “final except for an accounting.”  In Robert Bosch, LLC v. Pylon Mfg. Corp., 719 F.3d 1305 (Fed. Cir. 2013)(en banc) the court determined that “accounting” as used in that provision included a jury trial on damages.  Thus, appeal was appropriate at this point.

Product-by-Process Within a Method: On appeal, the Federal Circuit agreed with the jury that prior administration of native IFN-β anticipates the claims here.  The district took issue with the conclusion since the claims expressly require treatment using “recombinant” inf-β produced in a “non-human host” and that had been “transformed by a recombinant DNA molecule.”

Although the claim is a method claim, it requires use of a particular product (IFN-β) produced by a particular process (recombinant transformation in a non-human host). Of note, the claim does not appear to require the manufacturing step, only that administration of a product created in that manner.  On appeal, the Federal Circuit determined that this setup is appropriate for the product-by-process rule: an old product is not patentable even if it is made by a new process. See Gen. Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364 (1938).

In applying the product-by-process rule to a method claim, the court reasoned as follows:

If the novelty of the recombinant IFN-β composition requires comparing its structure to the structure of native IFN-β, as Amgen requires, 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.

There is no logical reason why the nesting of a productby-process limitation within a method of  treatment claim should change how novelty of that limitation is evaluated. Indeed, we have previously applied product-by-process analysis to a nested limitation. . . . 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.

Slip Op. (Citing Purdue Pharma L.P. v. Epic Pharma, LLC, 811 F.3d 1345 (Fed. Cir. 2016)).

Biogen also argued that the prior art was inadequate because there was no proof that it was had the same structure.  Although the native molecule had the same polypeptide sequence, there was no evidence that it had folded in the same manner — and thus did not necessarily meet the “therapeutically effective amount” limitation.  On appeal, the court noted that the prior art was the same polypeptide sequence as required by the claim and had also shown therapeutic activity — the claim did not require that it be the identical therapeutic activity or identical folding pattern as the patentee’s product.

After reviewing these issues, the appellate panel found the jury had a reasonable basis for its invalidity decision.

= = =

The new trial issue is a bit trickier.  The rule states that the court my grant a new trial “for any reason for which a new trial has heretofore been granted.” R. 59.  Here, the new trial was apparently justified on “the same legal errors” as the JMOL determination. “None of the additional considerations noted by the district court in support of its conditional grant of a new trial are independently sufficient to support its decision.”  Thus, the new trial is also reversed.

On remand, the defendant wins and the patent claims are invalid.

7 thoughts on “Product-by-Process Within a Method Claim

  1. 3

    Here’s the shorthand way one law firm entitled a casenote on this decision:
    “Known Method of Administering a Known Treatment Made by a New Process is Not Novel”

  2. 2

    What seems to have torpedoed the patent was the claim term “polypeptide”, which the specification gratuitously defined as a linear sequence of amino acids. The jury was charged with that narrow definition, which of course encompasses the natural peptide sequence.

    Biogen’s method of making it can’t render the known sequence patentable; and any glycosylation and/or folding differences – even if experimentally proven – do not limit the scope of the claims. Compare to Amgen Inc. v. Hoffman-La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009), where the opposite was true.

  3. 1

    Quiry the form of the printed jury question 12 quoted above? Was the jury really being offered the opportunity to find the same patent claims proven invalid as to two parties and not proven invalid as to a third party by checking both boxes?

    1. 1.1

      No, They were instructed to select either “Yes” or “No” — not both. Biogen is the patentee.

      1. 1.1.1

        Jury questions need to be idiot-proof and proper use of “or” here should have been obvious.

        1. 1.1.1.1

          The parentheticals seem designed to add clarity by telling the jury who they’re favoring if they check the box. Q12 is fairly straightforward, but it’s easy to imagine confusion where, e.g., a question uses a double or triple-negative phrasing to state a legal standard properly.

          For this question, I would guess that jurors who’ve sat through a five-week trial will readily grasp that “(Serono & Pfizer)” refers to the defendant and “(Biogen)” refers to the plaintiff. Commenters breezing through a blog post and looking at the screenshot in isolation might find the form a bit more confusing.

          1. 1.1.1.1.1

            Also, the verdict form (from PACER) at the beginning includes the instruction:

            “To assist you, each question identifies which answer supports Biogen and which supports Serono and/or Pfizer.”

            They needed the “and/or” in the instruction because some of the indirect infringement jury questions were directed to Serono only, and others to Pfizer only.

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