United States District Court, D. Delaware
SANOFI-AVENTIS U.S. LLC, SANOFI-AVENTIS DEUTSCHLAND GMBH, and SANOFI WINTHROP INDUSTRIE, Plaintiffs,
MERCK SHARP & DOHME CORP., Defendant.
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.
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.
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
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
Dr. McLean's Testimony
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.
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
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; ...