Briefing Complete in Appeal in Amgen v. Apotex

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:

• The district court’s construction of claim terms related to the concentration of buffers used in the claimed method erroneously imposed an upper limit on the concentration of a certain component.

• The district court erroneously held that the buffer that Apotex used was not equivalent to the claimed buffer.
• The district court erroneously gave insufficient weight to certain statements from Apotex regarding the concentration of protein in solution during Apotex’s refolding process.
• The district court erroneously allowed Apotex to introduce new arguments concerning its refolding process at trial, which gave Amgen insufficient opportunity to respond to the alleged new arguments.
• The district court should have applied the Federal Circuit’s holding in the 2013 decision in Sunovion Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. In Sunovion, the Federal Circuit held that in Hatch-Waxman litigation regarding conventional small-molecule drugs, if the product specifications in a defendant’s ANDA permits a product or process that is within the scope of an asserted claim, then the defendant infringes that claim.  Amgen argued that the district court should have applied this principle to Apotex’s aBLA in the BPCIA litigation.

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.