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Amarin Pharma, Inc. v. West-Ward Pharmaceuticals International Ltd.

United States District Court, D. Nevada

January 2, 2020

AMARIN PHARMA, INC., et al., Plaintiffs,



         I. SUMMARY

         This is a consolidated patent infringement case brought under the Hatch-Waxman Act where Plaintiffs Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Limited seek to prevent Defendants West-Ward Pharmaceuticals International Limited (“West-Ward”), Hikma Pharmaceuticals USA Inc. (“Hikma”), and Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd. (collectively, “DRL”) from launching generic competitor drugs to Plaintiffs' drug Vascepa. Before the Court are the parties' consolidated motions in limine (ECF Nos. 291, 292), [1] and two motions to seal corresponding to responses to those motions (ECF Nos. 297, 300). As further explained below, the Court will grant in part, and deny in part, Defendants' motions in limine, mostly deny Plaintiffs' motions in limine, grant Defendants' motion to seal (ECF No. 297), and deny Plaintiffs' motion to seal (ECF No. 300)-but will also give Defendants an opportunity to show cause why the Court should not unseal the exhibits attached to Plaintiff's response (ECF No. 299).


         The Court incorporates the background facts set forth in the Court's order on the parties' motions for summary judgment. (ECF No. 278 at 1-4.)


         A motion in limine is a procedural mechanism to limit testimony or evidence in a particular area in advance of trial. See United States v. Heller, 551 F.3d 1108, 1111-12 (9th Cir. 2009). It is a preliminary motion whose outcome lies entirely within the discretion of the Court. See Luce v. United States, 469 U.S. 38, 41-42 (1984). To exclude evidence on a motion in limine, “the evidence must be inadmissible on all potential grounds.” See, e.g., Ind. Ins. Co. v. Gen. Elec. Co., 326 F.Supp.2d 844, 846 (N.D. Ohio 2004). “Unless evidence meets this high standard, evidentiary rulings should be deferred until trial so that questions of foundation, relevancy and potential prejudice may be resolved in proper context.” Hawthorne Partners v. AT & T Tech., Inc., 831 F.Supp. 1398, 1400 (N.D. Ill. 1993). This is because although rulings on motions in limine may save “time, cost, effort and preparation, a court is almost always better situated during the actual trial to assess the value and utility of evidence.” Wilkins v. Kmart Corp., 487 F.Supp.2d 1216, 1218 (D. Kan. 2007).

         In limine rulings are provisional. Such “rulings are not binding on the trial judge . . . [who] may always change h[er] mind during the course of a trial.” Ohler v. United States, 529 U.S. 753, 758 n.3 (2000). “Denial of a motion in limine does not necessarily mean that all evidence contemplated by the motion will be admitted at trial.” Ind. Ins. Co., 326 F.Supp.2d at 846. “Denial merely means that without the context of trial, the court is unable to determine whether the evidence in question should be excluded.” Id.

         Evidence is relevant if “it has any tendency to make a fact more or less probable than it would be without the evidence” and “the fact is of consequence in determining the action.” Fed.R.Evid. 401. Only relevant evidence is admissible. See Fed. R. Evid. 402. Relevant evidence may still be inadmissible “if its probative value is substantially outweighed by a danger of . . . unfair prejudice, confusing the issues, misleading the jury, undue delay, wasting time, or needlessly presenting cumulative evidence.” Fed.R.Evid. 403. “Unfairly prejudicial” evidence is that which has “an undue tendency to suggest decision on an improper basis, commonly, though not necessarily, an emotional one.” United States v. Gonzalez-Flores, 418 F.3d 1093, 1098 (9th Cir. 2005) (quoting Old Chief v. United States, 519 U.S. 172, 180 (1997)).


         Defendants filed two motions in limine. (ECF No. 291.) The Court addresses each, in turn, below.

         A. Rat and Mice Studies

         Defendants first move in limine to preclude Plaintiffs from relying on the preclinical carcinogenicity rat and mice studies included in the product labelling to support Plaintiffs' induced infringement theory because Plaintiffs did not preserve this argument in its contentions, or alternatively because Plaintiffs' experts did not rely on these animal studies to support their infringement opinions. (ECF No. 291 at 2, 2-5.) Plaintiffs counter that they were never required to disclose the precise evidence they intended to rely on to support their infringement theory, but were merely required to disclose the theory itself. (ECF No. 299 at 2-9.) Plaintiffs further argue they have always been consistent in asserting their theory that the labeling read in its entirety induces infringement, so they have not waived reliance on the rat and mice studies. (Id.)

         The Court mostly agrees with Plaintiffs, but also agrees with Defendants that Plaintiffs' experts will not be allowed to express opinions at trial that were not included in their expert reports. The Court will therefore grant in part, and deny in part, the motion. Plaintiffs' experts are prohibited from testifying about the rat and mice studies at trial to the extent they did not rely on those studies in their expert reports. See Fed. R. Civ. P. 26(a)(2)(B)(i) (providing that opening expert reports are normally expected to include a complete statement of all opinions the witness will express at trial and their bases); seealso Aidini v. Costco Wholesale Corp., ...

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