Judge Robinson Rules on Motions in Limine

January 5, 2016

Publication| Intellectual Property

In Takeda Pharmaceuticals USA, Inc. v. Par Pharmaceutical Companies Inc., et al., C.A. Nos. 13-1524-SLR, 13-1279-SLR, 14-268-SLR (D. Del. Nov. 24, 2015), Judge Robinson granted two pretrial motions in limine brought by plaintiff to exclude testimony of defendants’ experts and denied a motion in limine to exclude one of plaintiff’s infringement theories.

Defendant Amneal Pharmaceuticals, LLC’s expert, regulatory attorney Dr. Jur Strobos, opined that Takeda Pharmaceuticals USA, Inc. (“Takeda”) improperly listed several patents in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) and also that, based on Takeda’s approved label, it did not have approval to promote co-administration of two drugs. With respect to the former opinion, Judge Robinson found that Dr. Strobos’ three conclusory paragraphs did not “offer any insight into the legal issue presented by defendants.” With respect to the latter opinion, the Court had “several concerns,” including that his report at one point cited the incorrect regulations and ultimately provided an opinion on an issue in the case despite giving no indication that he would be offering such an opinion. Judge Robinson indicated that Dr. Strobos’ expert report was a legal interpretation rather than a report on the customs of the FDA, and held that, even assuming the propriety of the Takeda label was relevant, the issue was a matter for the FDA to determine.

Judge Robinson also granted Takeda’s motion to exclude the proposed testimony of an expert whose opinion was based on proposed labeling that had not yet been approved by the FDA. Judge Robinson noted that should the proposed labeling be approved during the course of the litigation and should Takeda maintain its infringement contentions based on the new label, the Court would then address the matter.

Finally, Judge Robinson denied defendants’ motion to exclude a “new” infringement theory. Despite the defendants’ argument that the new infringement theory was raised for the first time at an expert deposition, Judge Robinson concluded that the issue was already properly raised in the opening reports, addressed in rebuttal reports, and expanded upon during the deposition.

Analysis: This ruling is consistent with the dim view Judge Robinson takes on expert testimony on issues of law or proceedings before administrative agencies.

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