United States District Court, D. Delaware
MEMORANDUM AND ORDER
F. Bataillon Senior United States District Judge
matter is before the court on the parties' motions in
limine (D.I. 383, D.I. 384, D.I. 385, D.I. 386, D.I. 387,
D.I. 388, D.I. 392, D.I. 393, D.I. 394, D.I. 395, D.I. 396,
and D.I. 397).
the motion in limine is an important tool available to the
trial judge to ensure the expeditious and evenhanded
management of the trial proceedings, performing a gatekeeping
function and sharpening the focus for later trial
proceedings, some evidentiary submissions cannot be evaluated
accurately or sufficiently by the trial judge in such a
procedural environment. Jonasson v. Lutheran Child and
Family Servs., 115 F.3d 436, 440 (7th Cir. 1997). A
motion in limine is appropriate for “evidentiary
submissions that clearly ought not be presented to the jury
because they clearly would be inadmissible for any
purpose.” Id. In other instances, it is
necessary to defer ruling until during trial, when the trial
judge can better estimate the impact of the evidence on the
jury. Id. The Eighth Circuit has noted that
“[e]videntiary rulings made by a trial court during
motions in limine are preliminary and may change depending on
what actually happens at trial.” Walzer v. St.
Joseph State Hosp., 231 F.3d 1108, 1113 (8th Cir. 2000).
Evidentiary rulings, especially ones that encompass broad
classes of evidence, should generally be deferred until trial
to allow for the resolution of questions of foundation,
relevancy, and potential prejudice in proper context. See
Leonard v. Stemtech Health Scis., Inc., 981
F.Supp.2d 273, 276 (D. Del. 2013).
extent that a party challenges the probative value of the
evidence, an attack upon the probative sufficiency of
evidence relates not to admissibility but to the weight of
the evidence and is a matter for the trier of fact to
resolve. United States v. Beasley, 102 F.3d 1440,
1451 (8th Cir. 1996).
court is unable to evaluate the relevance of much of the
challenged evidence in the context of a pretrial motion. The
parties' concerns may warrant a cautionary or limiting
instruction, but the court cannot determine the scope of such
an instruction at this time. The court will admit the
challenged evidence only on a showing that it is relevant to
the remaining issues in the case, and only to the extent that
the relevance of the evidence outweighs its potential to
cause prejudice or confusion under Fed.R.Evid. 403.
those principles in mind, the court finds as follows.
Minerva's Motion in Limine No. 1: to Exclude Improper
Willfulness Evidence (D.I. 383)
moves to exclude the following improper evidence relating to
Hologic's claim of willful infringement: (1) FDA
equivalence documents and testimony; (2) unfounded
third-party statements; and (3) any reference to lack of
opinion of counsel.
argues Hologic should be precluded from using any documents
or testimony relating to any communications between the FDA
and Minerva comparing Minerva's Endometrial Ablation
System (“EAS”) to Hologic's NovaSure in order
to get FDA approval. In particular, it seeks exclusion of
PTX-0041 (D.I. 293-2, Ex. 65), an email between the FDA and
Minerva in July of 2010 wherein Minerva's employee
stated: “The Minerva device is almost dead identical to
NovaSure except using plasma energy (RF).” It argues
the statement was made in the context of getting FDA approval
for a clinical study and had nothing to do with the
manufacturing or design of Minerva's infringing product.
It contends the probative value of the evidence outweighs the
potential for prejudice.
court cannot determine the admissibility of any ostensible
evidence on “FDA equivalence” in a pretrial
motion. To the extent it relates to infringement or
invalidity issues it has been rendered moot. It may be
relevant to willfulness, depending on the circumstances.
Minerva's motion seems to go to the weight rather than
the admissibility of the evidence.
next contends Hologic should be precluded from using any
third-party statements where no live witness or deposition
testimony can provide proper foundation. Particularly, it
challenges the admissibility of PTX-0058 (D.I. 293-4 at Ex.
83), a third party (Dr. Ted L. Anderson) email communication
dated January 27, 2011 to Minerva's employee (Michael
Regan). Dr. Anderson was never deposed and is not on the
witness list and the recipient of the email stated at his
deposition that he did not recognize it. Minerva contends
Hologic has no way of laying a proper foundation to introduce
court finds a blanket prohibition is not warranted. The court
is unable to rule on the admissibility of the challenged
evidence in a pretrial motion. The proponent of the evidence
will have to establish foundation and overcome any hearsay
objections. Evidence will be admitted only on a proper
showing of foundation and only if the probative value of the
evidence outweighs its potential for prejudice or confusion.
also seeks preclusion of “any reference to lack of
opinion of counsel” under 35 U.S.C. § 298. That
The failure of an infringer to obtain the advice of counsel
with respect to any allegedly infringed patent, or the
failure of the infringer to present such advice to the court
or jury, may not be used to prove that the accused infringer
willfully infringed the patent or that the infringer intended
to induce infringement of the patent.
35 U.S.C. § 298. The protection granted by 35 U.S.C.
§ 298 dissolves in the event defendants “open the
door” by attempting to refute a claim of willful
infringement by implying that they relied on the advice of
the court is unable to evaluate the issue in this context.
The issue depends on the evidence at trial. Minerva produced
an opinion of counsel and has its opinion counsel, Mr. Burt
Magen, on its witness list. Accordingly, the court finds
Minerva's motion should be ...