Yesterday, Amgen filed suit in an action for patent infringement arising under the Biologics Price Competition and Innovation Act of 2009 (“the BPCIA”), following Sandoz’s submission of an abbreviated Biologics License Application through subsection (k) pathway to license a pegfilgrastim product. The patents at issue, U.S. Patent Nos. 8,940,878 and 5,824,784, claim a method of purifying proteins to manufacture a biological product, and the use and manufacture of a biological product, respectively.
Stay tuned to the Big Molecule Watch for further developments.