United States District Court, D. Delaware
NOVARTIS AG, NOVARTIS PHARMACEUTICALS CORPORATION, MITSUBISHI TANABE PHARMA CORPORATION, and MITSUI SUGAR CO., LTD., Plaintiffs,
ACTAVIS ELIZABETH LLC, Defendant. NOVARTIS AG, NOVARTIS PHARMACEUTICALS CORPORATION, MITSUBISHI TANABE PHARMA CORPORATION, and MITSUI SUGAR CO., LTD., Plaintiffs,
EZRA VENTURES, LLC, Defendant. NOVARTIS AG, NOVARTIS PHARMACEUTICALS CORPORATION, MITSUBISHI TANABE PHARMA CORPORATION, and MITSUI SUGAR CO, LTD, Plaintiffs,
HEC PHARM CO., LTD, HEC PHARM GROUP, and HEC PHARM USA INC, Defendants. NOVARTIS AG, NOVARTIS PHARMACEUTICALS CORPORATION, MITSUBISHI TANABE PHARMA CORPORATION, and MITSUI SUGAR CO, LTD, Plaintiffs,
APOTEX INC. and APOTEX CORP, Defendants.
HONORABLE LEONARD P. STARK UNITED STATES DISTRICT JUDGE.
Wilmington this 17th day of April, 2017, having reviewed the
parties' proposed pretrial order (C.A. No.
14-1487 D.L 275), including briefing on various
motions in limine, and the parties'
Daubert motions and motion for summary judgment
(D.I. 208, 209), IT IS HEREBY ORDERED that:
following motions are DENIED as moot in light of their
withdrawal (see D.I. 281, 282):
A. Plaintiffs' motion to preclude Defendants'
experts' testimony at trial (D.I. 208) with respect to
witnesses Drs: Robert S. Coleman and Chartder Raman.
B. Plaintiffs' motion for summary judgment (D.I. 209).
C. Defendants' motion to preclude testimony of patent law
expert (D.L 216).
Daubert v. Merrell Dow Pharmaceuticals, Inc., 509
U.S. 579, 597 (1993), the Supreme Court explained that
Federal Rule of Evidence 702 creates "a gatekeeping role
for the [trial] judge" in order to "ensur[e] that
an expert's testimony both rests on a reliable foundation
and is relevant to the task at hand." Rule 702(a)
requires that expert .testimony "help the trier of fact
to understand the evidence or to determine a fact in
issue." Expert testimony is admissible only if "the
testimony is based on sufficient facts or data, "
"the testimony is the product of reliable principles and
methods, " and "the expert has reliably applied the
principles and methods to the facts of the case."
Fed.R.Evid. 702(b)-(d). There are three distinct requirements
for proper expert testimony: (1) the expert must be
qualified; (2) the opinion must be reliable; and (3) the
expert's opinion must relate to the facts. See Elcock
v. Kmart Corp., 233 F.3d 734, 741 (3d Cir. 2000).
Plaintiffs' motion to exclude testimony of Dr. John
Kornak (D.I. 208) is DENIED. Plaintiffs contend that Dr.
Kornak is not a person of skill in the art and, therefore, is
not qualified to offer an opinion about, the experimental
examples of the '229 patent. Dr. Kornak is a
biostatistician who is regularly consulted by members of
research teams evaluating drug-treatment efficacy.
(See D.L 228 Ex. 1 at ¶¶ 1-6; Ex. 2) Dr.
Kornak has relevant technical expertise and is qualified to
offer opinions about the statistical significance of the
experiments reported in the patent. See SEB S.A. v.
Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed.
Cir. 2010). That Dr. Kornak does not meet either parties'
proposed definition of a person of ordinary skill in the art
does riot mean that he lacks relevant expertise. Rather, Dr.
Kornak's knowledge, skill, experience, training, and
education are likely to assist the trier of fact.
Plaintiffs' motion to exclude the testimony of Drs;
Anthony DeFfanco and Steven Tanis (D.I. 208) is DENIED.
Plaintiffs do riot question these experts' qualifications
or contend that their opinions are based on insufficient
facts or data, unreliable scientific principles or methods,
or unreliable application of scientific principles arid
methods to the facts of this case. Plaintiffs contend,
instead, that the opinions expressed by these witnesses are
based on erroneous instruction on applicable law, making them
unreliable. Specifically, Plaintiffs assert that these
opinions apply an incorrect commercial-use standard for
enablement and fail to analyze each asserted claim
separately. But Plaintiffs do not take issue with the
recitations of law included in the expert reports, which do
not purport to apply a commercial-use standard. (See
D.L 241 Ex. 2 at ¶¶ 97-102; Ex. 4 at ¶¶
51-57) Further, the expert reports show that Drs. DeFranco
and Tanis did sufficiently consider each asserted claim
separately. (See D.L 241 Ex. 2 at ¶¶
81-91, 268-71; Ex. 4 at ¶¶ 64, 67-84, 236-51) Nor
is the Court persuaded that Dr. Tanis'
written-descfiption opinion is unreliable or insufficient.
Additionally, all of Plaintiffs' concerns may be
adequately addressed at trial through cross-examination.
Plaintiffs' motion in limine No. 1, to preclude
Defendants frorii introducing argument and evidence regarding
the breadth of unasserted claims, is DENIED without prejudice
to renew in post-trial briefing. Defendants contend that
discussion of unasserted claims is required, because each of
the asserted claims is a dependent claim that necessarily
depends from unasserted, independent claims. The Court
agrees. Further, the Court disagrees with Plaintiffs that
Defendants' evidence and arguments "are calculated
to confuse the issues, waste time, and cause unfair
prejudice." (PTO Ex/13 A at Pis. 3) Invalidity is
evaluated on a claim-by-claim basis, see
MartekBiosciences Corp. v. Nutrihova, Inc., 579 F.3d
1363, 1379 (Fed, Cir. 2009); Capon v. Eshhar, 418
F.3d 1349, 1360 (Fed. Cir. 2005), and this uncontested
statement of law may have implications for what legal
arguments will ultimately be persuasive. Stilly it will be
most helpful to the Court for Plaintiffs to address in their
post-trial briefing any concerns that Defendants are making
improper arguments about the breadth of the unasserted
claims, rather than ask the Court - before or during trial -
to make a broad finding as to what arguments Defendants may
properly make based on certain evidence that will be
Plaintiffs' motion in limine No. 2, to preclude
Defendants from using the inventors' journey to discovery
to support invalidity defenses, is DENIED. Evidence on the
quantity of experimentation by the inventors may be relevant
to the enablement inquiry. See Enzo Biochem, Inc. v.
Calgene, Inc., 188 F.3d 1362, 1372-73 (Fed. Cir. 1999).
Therefore, the disputed evidence is not irrelevant, and the
Court is not persuaded that the evidence is unfairly
prejudicial or will confuse the issues.
Plaintiffs' motion in limine No. 3, to preclude
Defendant Ezra from offering at trial its double-patenting
defense, is DENIED. Plaintiffs contend that Ezra has
submitted no evidence, including no expert testimony, on this
defense and, therefore, cannot meet its burden to show
invalidity due to double patenting by clear and convincing
evidence. A motion in limine is a vehicle to exclude
inadmissible or prejudicial evidence before it is offered at
trial. See Luce v. United States, 469 U.S. 38, 40
ii.2 (1984). But Plaintiffs do not identify any specific
evidence they seek to exclude here. Moreover* the Court
disagrees with Plaintiffs' suggestion that "the
Court has already rejected" the entirety of
Defendants' double patenting defense(s). (PTO Ex. 13 C at
Pis. 1) While Defendants confront a heavy burden, the Court
cannot reject at this point their contention that sufficient
facts are and will be in evidence - even in the absence of
expert testimony - to persuade the Court to invalidate
asserted claims based on double patenting. (PTO Ex.
Defendants' motion in limine, to strike entries
1, 3, 4, 5, 8 and 9 of the deposition errata of Peter Waibel,
is DENIED. Defendants contend that Mr. Waibel's errata
materially changed his answers to several questions. To the
extent that Mr. Waibel's testimony remains relevant
despite the Court's ruling oil standing (see
D.I. 230), it is within the discretion of the Court to allow
substantive changes to deposition testimony. See EBC,
Inc. v. Clark Bldg. Sys., Inc., 618 F.3d 253, 268 (3d
Cir. 2010). Any prejudice to Defendants stemming from Mr.
Waibel's changed testimony has already been addressed by
Mr. Waibel's second deposition, in which Defendants had
the opportunity to question him about his changes
(see D.I. 275 Ex. 14 at 17-19, 23), and may further
be alleviated by cross-examining him at trial. Moreover, Mr.
Waibel's "earlier testimony is not expunged from the
record, thus subjecting [him] to cross-examination and
impeachment at trial with respect to the contradictory
testimony." EBC, 618F.3dat267.
parties' disputes regarding the Court's standing
decision, the order of presentation at trial, and identifying
which witnesses will be called to testify at trial (PTO at