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Court: Apotex biosimilars don't infringe Amgen patent

September 8, 2016 7:00 AM UTC

A federal judge ruled 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.

In his opinion, the judge said Amgen "has not met its burden" to prove that Apotex's refolding process infringes the '138 patent. Amgen declined to comment on whether it would appeal. The case was heard in the U.S. District Court for the Southern District of Florida. ...