The parties in Amgen v. Apotex have completed briefing in Amgen’s appeal to the Federal Circuit from the district court’s judgment of noninfringment. As we have previously reported, in September 2016 the District Court for the Southern District of Florida ruled that Apotex’s proposed filgrastim and pegfilgrastim products will not infringe the asserted claims of Amgen’s ’138 patent (U.S. Patent. No. 8,952,138). The ’138 patent is directed to methods of refolding proteins that were expressed in non-mammalian expression systems. Amgen filed its opening brief on December 5, 2016, Apotex responded on January 17, 2017, and Amgen filed a reply on January 31, 2017.
On appeal, Amgen argued that the district court made five distinct errors:
Apotex disputed each of these arguments. Now that the briefing is complete, we expect the Federal Circuit to announce the schedule for oral arguments within the next few weeks.
Stay tuned to Big Molecule Watch for further developments.