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Vectura Limited v. Glaxosmithkline LLC

United States District Court, D. Delaware

March 26, 2019


          Kelly E. Farnan and Christine D. Haynes, RICHARDS, LAYTON, & FINGER, P.A., Wilmington, DE; Dominick A. Conde, Christopher P. Borello, Brendan M. O'Malley, and Damien N. Dombrowski, VENABLE LLP, New York, NY, attorneys for Plaintiff.

          Jack B. Blumenfeld and Jeremy A. Tigan, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE; Martin J. Black, Kevin M. Flannery, Robert Ashbrook, and Sharon K. Gagliardi, DECHERT LLP, Philadelphia, PA; Blake B. Green, DECHERT LLP, Austin, TX, attorneys for Defendants.



         Currently pending before the Court is Plaintiffs motion to exclude the testimony of William 0. Kerr, Ph.D. (D.I. 129). The parties have fully briefed the issues. (D.I. 129, 139, 160). At oral argument on the parties' summary judgment motions, I requested further briefing. (Hr'g Trans, at 95:20-25). The supplemental briefing was completed on March 25, 2019. (D.I. 256, 258, 265, 266). After full consideration of the parties' briefing, Plaintiffs motion is GRANTED-IN-PART and DENIED-IN-PART.

         I. BACKGROUND

         Plaintiff Vectura Limited sued Defendants GlaxoSmithKline LLC and Glaxo Group Limited on July 27, 2016 alleging infringement of U.S. Patent Nos. 8, 303, 991 ("the '991 patent") and 8, 435, 567 ("the '567 patent"). (D.I. 1). Plaintiff has narrowed its infringement allegations to claim 3 of the '991 patent and claim 3 of the '567 patent ("the Asserted Claims"). The patents-in-suit "relate to pharmaceutical compositions for inhalation and methods of making them." (D.I. 82 at 1). The asserted claims are dependent claims that only cover compositions where the additive is magnesium stearate. (D.I. 195 at 9).

         Before this litigation, the parties had entered a license agreement on August 5, 2010 ("the 2010 Agreement"). (D.I. 256 at 6; D.I. 258 at 5). The 2010 Agreement included a covenant not to sue for certain of Plaintiffs patents and patent applications ("the Non-Assert Patents"), including the patents-in-suit. (D.I. 256 at 7; D.I. 258 at 5). The 2010 Agreement provided Defendants "with an option to license Non-Assert Patents by identifying or 'nominating' them on or before July 31, 2016." (D.I. 256 at 7; D.I. 258 at 5). On July 26, 2016, Defendants formally notified Plaintiff under the 2010 Agreement that they declined to exercise the option and thereby terminated both the covenant not to sue and the option to license. (D.I. 256 at 7; D.I. 258 at 6-7).


         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 or 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 ...

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