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.