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Pfizer Inc. v. Mylan Laboratories

November 17, 2006


The opinion of the court was delivered by: Terrence F. McVerry United States District Court Judge


Presently before the Court are two Motions to Preclude Expert Testimony. Plaintiff and Counterclaim-Defendant Pfizer Inc. ("Pfizer") filed a MOTION IN LIMINE TO PRECLUDE THE TRIAL TESTIMONY OF KEVIN BURGESS Ph.D. Defendants and Counterclaim-Plaintiffs Mylan Laboratories, Inc. and Mylan Pharmaceuticals, Inc. (collectively referred to as "Mylan") filed a MOTION IN LIMINE TO STRIKE DR. ANDERSON'S EXPERT REPORT AND PRELUDE HIS TESTIMONY REGARDING UNRELIABLE METHODOLOGY. The issues have been fully briefed and replied and the matter is ripe for disposition.

After a careful consideration of the motions, the Court finds that there is no basis to exclude any of the proposed testimony being challenged. Therefore, these Motions will be denied for the following reasons.


The facts of the case have been amply set forth in the previous opinions rendered by the Court in this case.*fn1 Therefore, the Court will merely provide an abridged summary of facts for the purpose of this Opinion.

This is a patent infringement action brought by Pfizer, whose two patents cover an amlodipine besylate product sold under the trade name, Norvasc(r): United States Patent No. 4,572,909 ("the '909 patent") and United States Patent No. 4,879,303 ("the '303 patent").*fn2 On May 22, 2002, Mylan filed an Abbreviated New Drug Application ("ANDA") in which it sought approval to sell generic amlodipine besylate. By letter dated July 23, 2002, Mylan certified pursuant to 21 C.F.R. 314.94(a)(12)(i)(A)(4) that it was seeking approval to market its generic copy of Norvasc(r) prior to the expiration of the '909 and '303 patents. The application stated that to the best of Mylan's knowledge neither the '909 nor the '303 patents would be infringed by the manufacture, use or sale of the proposed generic amlodipine besylate.

On September 20, 2002, Pfizer sued Mylan for infringement of both patents pursuant to 35 U.S.C. § 271(e)(2)(A).

On October 4, 2005, Mylan announced that it had received final approval from the FDA of its ANDA application. To date, however, Mylan has not begun to market the generic Mylan Amlodipine Tablets described in ANDA No. 76-418.

The '909 patent expired on July 31, 2006; the '303 patent will expire in March 2007. A non-jury trial is scheduled to commence in this matter on November 28, 2006.


Rule 702 of the Federal Rules of Evidence governs the testimony of expert witnesses and provides that such testimony is permitted if it will "assist the trier of fact to understand the evidence or to determine a fact in issue." Fed. R. Evid. 702. Rule 702 embodies three distinct substantive restrictions on the admission of expert testimony: qualifications, reliability, and fit. Oddi v. Ford Motor Co., 234 F.3d 136, 145 (3d Cir. 2000); Elcock v. Kmart Corp., 233 F.3d 734, 741 (3d Cir. 2000); In re Paoli Railroad Yard PCB Litig., 35 F.3d 717, 742 (3d Cir. 1994). The requirements of Rule 702 "mandate[s] a policy of liberal admissibility." Paoli, 35 F.3d at 741. In other words, the role of a district court is to only exclude expert testimony that clearly does not meet the requirements of Rule 702.

Pursuant to Rule 702, the Court must first determine whether the witness is qualified by virtue of "specialized knowledge" regarding the area of the proposed testimony. "The basis of this specialized knowledge 'can be practical experience as well as academic training and credentials'." Waldorf v. Shuta, 142 F.3d 601, 625 (3d Cir. 1998). The United States Court of Appeals for the Third Circuit has interpreted the specialized knowledge requirement liberally. Id. It would be an abuse of the trial court's discretion to exclude testimony "simply because the trial court does not deem the proposed expert to be the best qualified or because the proposed expert does not have the specialization that the court considers most appropriate." In re: Unisys Savings Plan Litigation, 173 F.3d 145, 170 (3d Cir.), cert. denied, Meinhardt v. Unisys Corp., 528 U.S. 950 (1999). However, "at a minimum, a proffered expert witness . . . must possess skill or knowledge greater than the average layman . . . ." Waldorf, 142 F.3d at 625 (quoting Aloe Coal Co. v. Clark Equip. Co., 816 F.2d 110, 114 (3d Cir.), cert. denied, 484 U.S. 853 (1987). This does not mean that an expert must rely solely on his own work, but he can rely on another's information or work, if it is of the type normally relied upon by an expert in the course of his work. United States v. Arias, 678 F.2d 1202, 1206 (4th Cir.1982), cert. denied, 495 U.S. 910 (1982); Polymer Dynamics, Inc. v. Bayer Corp., 2005 WL 1041197, at *2 (E.D. Pa. May. 4, 2005).

With regard to the second two factors, reliability and fit, the United States Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), held that the district court is to act as a "gatekeeper" to evaluate whether an expert's testimony "rests on a reliable foundation and is relevant to the task at hand." Daubert, 509 U.S. at 597. In assessing the "reliability" of the testimony, the factors to consider are: (1) whether a method consists of a testable hypothesis; (2) whether the method has been subjected to peer review; (3) the known or potential rate of error; (4) the existence and maintenance of standards controlling the technique's operation; (5) whether the method is generally accepted; (6) the relationship of the technique to methods which have been established to be reliable; (7) the qualifications of the expert witness testifying based on the methodology; and (8) the non-judicial uses to which the method has been put. Oddi, 234 F.3d at 741 (citing Paoli, 35 F.3d at 742 n. 8). "The test of admissibility is not whether a particular scientific opinion has the best foundation or whether it is demonstrably correct. Rather, the test is whether 'the particular opinion is based on valid reasoning and reliable methodology'." Oddi, 234 F.3d at 145-46 (quoting Kannankeril v. Terminix Int'l Inc., 128 F.3d 802, 806 (3d Cir. 1997)). In addition, even if the expert's methodology is found to be sufficient, to be admissible the testimony must also be found to assist the trier of fact. Paoli, 35 F.3d at 743. However, the district court should only determine if the expert testimony is sufficient to satisfy ...

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