Federal Circuit Upholds Ruling in Favor of Sandoz in Filgrastim/Pegfilgrastim Biosimilar Appeal

This past May, in the Amgen v. Sandoz BPCIA litigation concerning Sandoz’s ZARXIO (filgrastim-sndz) biosimilar and proposed pegfilgrastim biosimilar, a Federal Circuit panel affirmed the district court’s judgment of non-infringement in favor of Sandoz. The panel found that Amgen could not prevail on its infringement claims under the doctrine of equivalents, and noted in its reasoning 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’” (citation omitted). In June, as we previously reported, Amgen filed a petition for rehearing en banc, arguing that the panel’s reasoning that the doctrine of equivalents applies only in “exceptional cases” runs contrary to Supreme Court precedent.

Today, the Federal Circuit denied Amgen’s petition for rehearing en banc. Instead, the panel deleted the phrase “applies only in exceptional cases and” from its May opinion, thus preserving Sandoz’s prior appellate victory.