Neulasta Biosimilar: Smooth Patent Dance, Stumble On Launch Notification

Amgen patent infringement suit follows information exchange with Apotex; Federal Circuit’s ruling on commercial notification to be tested.

Amgen Inc.’s Neulasta (pegfilgrastim) patent infringement suit against Apotex Inc. shows how litigation plays out when both parties exchange patent information as specified in the biosimilars statute. But the process has derailed over the timing of market notification.

The complaint may be the first case in which both parties followed the patent information exchange steps laid out in...