CAFC won't reconsider patent dance case
The U.S. Court of Appeals for the Federal Circuit denied requests from Amgen Inc. (NASDAQ:AMGN) and the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) for a panel of judges to reconsider a ruling interpreting provisions of the Biologics Price Competition and Innovation Act (BPCIA). The CAFC did not provide an explanation for its decision to deny the en banc hearing.
A July decision by three CAFC judges in the case left both companies dissatisfied. The court ruled against Amgen by determining that the "patent dance" provisions in the BPCIA are optional. Those provisions outline steps for biosimilars manufacturers to disclose manufacturing processes and other information to the manufacturers of reference biologics as part of a procedure for settling patent claims. Amgen had requested that the court bar the launch of Zarxio filgrastim-sndz from Sandoz, a biosimilar version of Amgen's Neupogen filgrastim, because Sandoz did not comply with those provisions (see BioCentury Extra, Aug. 25). ...