Overview

PATENT CASE OF THE WEEK

Amgen Inc. v. Sandoz Inc., Appeal No. 2018-1551 (Fed. Cir. May 8, 2019)

In an appeal from a district court’s summary judgment of non-infringement, the Federal Circuit affirmed claim construction and non-infringement opinions in a case brought under the Biologics Price Competition and Innovation Act.

The claims recite a sequence of steps for purifying a protein. At issue was whether the steps must be performed in the sequence recited in the claims. Three of the claims recited:

(e) directly applying the refold solution to a separation matrix under conditions suitable for the protein to associate with the matrix;

(f) washing the separation matrix; and

(g) eluting the protein from the separation matrix, wherein the separation matrix is a non-affinity resin selected from the group consisting of ion exchange, mixed mode, and a hydrophobic interaction resin.

The district court, as a matter of claim construction, held that these three steps required:

(e) applying the refold solution to a separation matrix … ,

(f) applying a solution to remove … unwanted components of the refold solution … while preserving [protein] binding … ; and

(g) applying a solution that reverses the binding of the purified protein … .

In other words, steps (f) and (g) required adding additional solutions. The court clarified that these had to be separate steps and that the “eluting” step must occur after the “washing” step. At issue for purposes of claim construction was whether the steps had to be performed sequentially. Sandoz’s process requires only one solution and take place in only one step.

The Federal Circuit affirmed the district court’s claim construction, holding that “the claim language logically requires that the process steps, lettered (a) through (g), be performed in sequence,” citing a prior line of cases concerning when and whether claim steps in a method must be performed sequentially. The Court also affirmed the district court’s construction that certain steps require applying solutions. Because Sandoz uses only a single step and one solution, there was no literal infringement.

Amgen therefore asserted infringement under the doctrine of equivalents. The district court held that using one step and one solution is not equivalent to patent claims that require three steps and three solutions. The Federal Circuit affirmed, holding that a one-step, one-solution process does not function in the same way as the claimed process. The Court continued: “The doctrine of equivalents applies only in exceptional cases and is not ‘simply the second prong of every infringement charge, regularly available to extend protection beyond the scope of the claims.” (Citing London v. Carson Pirie Scott & Co., 946 F.2d 1534, 1538 (Fed. Cir. 1991).)

The Court therefore affirmed the district court’s grant of summary judgment of non-infringement under the doctrine of equivalents.

The opinion can be found here.

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