Sandoz files response to Amgen’s petition for rehearing en banc

On July 29, Sandoz filed a response to Amgen’s petition for rehearing en banc of the Federal Circuit’s decision affirming summary judgment of non-infringement of Amgen’s U.S. Patent No. 8,940,878 (“the ‘878 patent”). The ‘878 patent concerns a protein purification method that is allegedly used in the manufacture of Amgen’s NEUPOGEN (filgrastim) and NEULASTA (pegfilgrastim) reference products.  Amgen asserted that the Sandoz process for manufacturing its ZARXIO (filgrastim) and LA-EP2006 (pegfilgrastim) biosimilar candidates infringed the ‘878 patent. The Federal Circuit previously affirmed the district court’s ruling that “Sandoz’s one-step, one-solution purification process works in a substantially different way from the claimed three-step, three-solution process,” also noting that “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.’” As we recently reported, in the petition for rehearing, Amgen challenges the panel’s reasoning that the doctrine of equivalents applies only in “exceptional cases,” and asserted that the court’s reasoning runs contrary to U.S. Supreme Court precedent.

Sandoz argues, in its response, that Amgen’s rehearing petition is based on a false premise because the panel did not in fact apply an “exceptional case” standard for the doctrine of equivalents. Sandoz contends that “the court correctly rejected Amgen’s equivalents argument applying well-settled law” to the facts of this case. Sandoz further asserts that the rest of Amgen’s petition reargues the facts, “which cannot justify en banc relitigation” and therefore, that “rehearing should be denied or, in the alternative, denied with an amendment to the Court’s opinion to strike the words ‘applies only in exceptional cases and’, with the Court’s opinion and judgment otherwise remaining the same.”

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