CAFC affirms Apotex biosimilars do not infringe Amgen patent

The U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a district court ruling that two biosimilars from Apotex Inc. (Toronto, Ontario) do not infringe a patent held by Amgen Inc. (NASDAQ:AMGN). Amgen sought a ruling that Apotex's biosimilar versions of neutropenia drugs Neulasta pegfilgrastim and Neupogen filgrastim infringed Amgen's U.S. Patent No. 8,952,138, which covers a process of protein refolding.

CAFC agreed with the U.S. District Court for the Southern District of Florida ruling that Amgen failed to prove that Apotex's refolding process infringes the '138 patent (see BioCentury, Sept. 12, 2016). ...