Judge Sleet Denies Motion for Judgment on the Pleadings and Motion for Sanctions

January 30, 2018

Publication| Intellectual Property

In Amgen Inc. v. Alkem Laboratories Ltd., C.A. No. 17-CV-815-GMS (D. Del. Dec. 19, 2017), Judge Sleet denied a motion for judgment on the pleadings and a motion for sanctions filed by two defendants in this consolidated Hatch-Waxman Act litigation. According to the Court, the movants alleged that their proposed ANDA product, lacking excipients required by the asserted patent, could infringe only under the doctrine of equivalents, but that prosecution history estoppel barred such an infringement theory. Judge Sleet stated that conducting the requisite analysis (whether there was a narrowing amendment made substantially for reasons related to patentability) would require the resolution of disputed issues of fact that could not be accomplished on a 12(c) motion, and that there was insufficient information in the briefing regarding any alleged equivalents to allow the Court to determine the scope of any surrender. Pointing out that this case was in its early stages (and finding it not appropriate to convert the motion to summary judgment), Judge Sleet denied the motion. The Court further found that the motion for sanctions was based on the same issue addressed in the motion for judgment on the pleadings and thus denied the motion as premature.

Key Point: Although the movants, in seeking to end the case on a motion for judgment on the pleadings, relied on Judge Sleet’s decision in In re Bendamustine, No. 13-2046-GMS (D. Del. Apr. 29, 2015), granting a Rule 12(c) motion in a Hatch-Waxman litigation, Judge Sleet emphasized that the facts at issue in that decision were not in dispute.

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