The Federal Circuit, in Amgen Inc. v. Sandoz Inc., Nos. 2018-1551, 2018-1552 (May 8, 2019), upheld a lower court’s claim construction and noninfringement finding in actions brought under the Biologics Price Competition and Innovation Act. The claim construction issue involved a claim that recited separate steps of “refolding,” “washing,” and “eluting” solutions. Amgen, slip op., at 11. The Federal Circuit held that the “claim language logically requires that the process steps . . . be performed in sequence” and that “washing and eluting are consistently described in the specification as separate steps performed by different solutions.” Id. at 9. The Federal Circuit then upheld the district court’s findings of no literal infringement or infringement under the doctrine of equivalents since Sandoz’s one-step, one-solution process could not literally infringe the multi-step claim, nor could such a one-step, one-solution process “overrid[e] the natural language” of the claim. Id. at 11. The Federal Circuit explained that “[t]he 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.’” Id. The Federal Circuit concluded that “Sandoz does not infringe . . . under the doctrine of equivalents because its one-step, one-solution purification process works in a substantially different way from the claimed three-step, three-solution process.” Id.
Slip opinion available at http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/18-1551.Opinion.5-8-2019.pdf.