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Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp.

United States District Court, D. Delaware

May 29, 2018

SANOFI-AVENTIS U.S. LLC, SANOFI-AVENTIS DEUTSCHLAND GMBH, and SANOFI WINTHROP INDUSTRIE, Plaintiffs,
v.
MERCK SHARP & DOHME CORP., Defendant.

          MEMORANDUM ORDER

         I. BACKGROUND

         Pending before the Court are Plaintiffs' Motion to Exclude the Testimony of Dr. John McLean (D.I. 252) and Plaintiffs' Motion to Exclude the Testimony of Dr. Rodolfo Pinal (D.I. 253). The issues have been fully briefed. (D.I. 252, 253, 266, 269, 274, 276). For the reasons stated herein, Plaintiffs' Motion to Exclude the Testimony of Dr. John McLean (D.I. 253) is DENIED without prejudice, and Plaintiffs' Motion to Exclude the Testimony of Dr. Rodolfo Pinal (D.I. 253) is DENIED without prejudice.

         II. LEGAL STANDARD

         Federal Rule of Evidence 702 sets out the requirements for expert witness testimony and states:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if: (a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case.

         Fed. R. Evid. 702. The Third Circuit has explained:

Rule 702 embodies a trilogy of restrictions on expert testimony: qualification, reliability and fit. Qualification refers to the requirement that the witness possess specialized expertise. We have interpreted this requirement liberally, holding that "a broad range of knowledge, skills, and training qualify an expert." Secondly, the testimony must be reliable; it "must be based on the 'methods and procedures of science' rather than on 'subjective belief or unsupported speculation'; the expert must have 'good grounds' for his o[r] her belief. In sum, Daubert holds that an inquiry into the reliability of scientific evidence under Rule 702 requires a determination as to its scientific validity." Finally, Rule 702 requires that the expert testimony must fit the issues in the case. In other words, the expert's testimony must be relevant for the purposes of the case and must assist the trier of fact. The Supreme Court explained in Daubert that "Rule 702's 'helpfulness' standard requires a valid scientific connection to the pertinent inquiry as a precondition to admissibility."
By means of a so-called "Daubert hearing, " the district court acts as a gatekeeper, preventing opinion testimony that does not meet the requirements of qualification, reliability and fit from reaching the jury. See Daubert ("Faced with a proffer of expert scientific testimony, then, the trial judge must determine at the outset, pursuant to Rule 104(a) [of the Federal Rules of Evidence] whether the expert is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue.").

Schneider ex rel. Estate of Schneider v. Fried, 320 F.3d 396, 404-05 (3d Cir. 2003) (footnote and internal citations omitted).[1]

         III. ANALYSIS

         A. Dr. McLean's Testimony

         Plaintiffs wish to exclude two aspects of Dr. McLean's testimony. The first is Dr. McLean's rebuttal infringement testimony that relies on a construction of polysorbate 20 that limits polysorbate 20 to a particular chemical entity. The second is Dr. McLean's reliance on the Escherichia coli Metabolome Database of small molecule metabolites found or produced by E. coli strain K-12, MG1655.

         The parties' dispute regarding Dr. McLean's polysorbate 20 testimony appears to turn on whether the Court's claim construction for "polysorbate 20" from the Eli Lilly litigation is limited to a specific chemical entity that has 20 ethylene oxide units. (D.I. 252, p. 8; D.I. 266, p. 1). I think this issue is best addressed after trial in view of whatever evidence the parties present at trial.

         The parties also disagree as to whether Dr. McLean's use of the Database will provide reliable testimony. Dr. McLean plans to rely on the Database to argue that the trace amounts of polysorbate 20 detected by Plaintiffs' expert in Merck's product could have been attributable to other materials used in the manufacture of Merck's product. (D.I. 252, p. 15; ...


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