PTAB Institutes Fresenius’ IPR On Amgen Pegfilgrastim Patent

As previously reported, earlier this year Fresenius filed a petition for inter partes review of claims 9-10, 13-21 and 23-30 of Amgen’s pegfilgrastim patent – U.S. Patent No. 9,643,997 (“997 patent”). The challenged claims of the ’997 patent relate to methods for purifying proteins of interest expressed in a non-native limited solubility form.  Yesterday, the PTAB instituted an inter partes review of all ‘997 patent claims raised in the petition.

First, the Board denied Amgen’s argument that the Board should exercise its discretion to deny institution because “the same or substantially the same prior art or arguments previously were presented to the Office.” The Board found that Fresenius had presented prior-art references that were not considered during prosecution of the patent and that “the relative strength of the preliminary merits . . . combined with the broad scope of the claims at issue, signals a need for an effective and efficient inter partes review of the ’997 patent that outweighs the potential for abuse by instituting the instant Petition.” Moreover, the Board stated that “the potential for abuse by instituting an arguably follow-on Petition in this case has been ameliorated” by the termination of an earlier Kashiv IPR proceeding against the same patent following a settlement agreement.

On the merits of the Petition, the Board found that Fresenius had established a reasonable likelihood that they would prevail on all grounds presented, including anticipation and obviousness.