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Amgen Inc. v. Sandoz Inc.

Fed Cir Cautions Against Over-Application of Doctrine of Equivalents

Amgen Inc. v. Sandoz Inc., __ F.3d __, 2019 WL 2017501 (Fed. Cir. May 8, 2019) (LOURIE, O’Malley, Reyna) (N.D. Cal.: Seeborg) (3 of 5 stars)

Fed Cir affirms summary judgment of noninfringement as to one claim at issue in BPCIA case, and endorses district court’s claim construction as to another claim. Amgen’s patents relate to its biologic products filgrastim (Neupogen) and pegfilgrastim (Neulasta), indicated for treating neutropenia. The sole claim addressed in the judgment relates to a method for protein purification. The district court did not err in determining that two steps in the claim (“washing the separation matrix” and “eluting the protein from the separation matrix”) require distinct solutions, utilized at different times. Per Mformation, 764 F.3d 1392 (Fed. Cir. 2014), the claim language logically requires performance of the steps in sequence, and not at the same time. The specification also consistently described the two steps as separate ones, performed using separate solutions. Because there was no dispute that Sandoz’s process for protein purification uses only one step, and no separate washing or eluting steps, summary judgment of no literal infringement was appropriate. The district court also did not err in rejecting Amgen’s equivalence argument, as it would have undermined the claim’s recitation of separate “washing” and “eluting” steps (and a separate “refolding” step). The opinion characterizes the doctrine of equivalence as applying “only in exceptional cases,” and emphasizes that it “cannot be used to effectively read out a claim limitation.” Op. at 11 (latter quoting Duncan Parking, 914 F.3d 1347 (Fed. Cir. 2019)).

The district court also did not abuse its discretion in denying Amgen a continuance on the entry of judgment based on indications that Sandoz was planning to modify its purification processes, but had not submitted an amended aBLA giving the details of the modification. The law did not require such a continuance, and the opinion notes a concession by Amgen that the modified process probably would not infringe the claim either. The opinion also notes that Amgen is not without a remedy for future infringement, as the doctrines of res judicata and collateral estoppel permit a new infringement action based on changed facts.

The district court also correctly construed “disease treating-effective amount” in a separate claim of a separate patent not part of the judgment but addressed in the district court’s claim construction order. The opinion rejects Amgen’s contention that the term covered only the amount, and did not require actual application for treatment of a disease (i.e., so long as the amount was correct, the claim would cover applications aimed not at treatment but at “stem cell mobilization”). The opinion reasons that disease treatment is properly part of the claim, based on both the claim and written description. “Had Amgen simply wanted to claim a method of mobilizing stem cells, in any context, it could have done so.” Op. at 15.

KEYWORDS: BIOLOGICS; SUMMARY JUDGMENT (YES); INFRINGEMENT (NO); CLAIM CONSTRUCTION; DOCTRINE OF EQUIVALENTS