Updates on Sandoz’s Pegfilgrastim Biosimilar / Amgen v. Sandoz

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  • Today, Sandoz announced that its biosimilar of Neulasta®  (pegfilgrastim) has been accepted by the European Medicines Agency (EMA) for regulatory review.  According to the press release, the data package submitted as part of the Marketing Authorization Application “strongly demonstrates that the biosimilar pegfilgrastim matches the reference medicine in terms of safety, efficacy and quality.”
  • On October 25, in the ongoing Amgen v. Sandoz litigation (which is related to both Sandoz’s filgrastim biosimilar, Zarxio, and its pegfilgrastim biosimilar, which is pending FDA approval), Sandoz filed two motions for summary judgment:
    • a motion for summary judgment of non-infringement of the ‘878 patent, in which Sandoz argues that Amgen cannot show that Sandoz’s manufacturing process performs the “sequence of at least three separate, sequential steps in order” as required by the ‘878 patent claims; and
    • a motion for summary judgment regarding damages, which argues that (1) Amgen’s subsidiary Amgen Manufacturing Limited lacks standing to sue for infringement, (2) Amgen is not permitted to seek lost profit damages, (3) even if Amgen were permitted to claim lost profit damages, such damages are not available because Amgen has not carried its burden to show there are no non-infringing alternatives to the ‘878 patent, and (4) the date for the hypothetical negotiation over reasonable royalty damages should be set at January 27, 2015, the date of the first act of infringement raised by Amgen’s complaint.
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