Novartis AG et al v. Actavis Inc. et al

Filing 284

MEMORANDUM ORDER re (209 in 1:14-cv-01487-LPS) MOTION for Summary Judgment is DENIED as moot; (216 in 1:14-cv-01487-LPS) MOTION to Preclude is DENIED as moot; (208 in 1:14-cv-01487-LPS) MOTION to Preclude is DENIED; Rulings on the various m otions in limine as set forth in the PTO; the Court allocates a maximum of eleven (11) hours per side (see trial schedule). Signed by Judge Leonard P. Stark on 4/17/17. Associated Cases: 1:14-cv-01487-LPS, 1:15-cv-00150-LPS, 1:15-cv-00151-LPS, 1:15-cv-00975-LPS (ntl)

i:N THE UNITED STATES DiSTRlCT COURT
FOR THE DISTRlCT OF DELAWARE
NOVARTIS AG, NOVARTIS
PHARMACEUTICALS CORPORATION;
MITSUBISHI TANABE PHARMA
CORPORATION, and MITSUI SUGAR CO.,
LTD.,
Plaintiffs,

C.A. No. 14-1487-LPS

v.
ACTAVIS ELIZABETH LLC;
Defendant.
NOVARTIS AG, NOVARTIS
PHARMACEUTICALS CORPORATION,.
MITSUBISHI TANABE PHARMA
CORPORATION, arid MITSUI SUGAR CO.;
LTD.,
Piaintiffs,

v.
EZRA VENTURES, LLC,
Defendant.

C.A. No. 15-150-LPS

..

NOVARTIS AG, NOVARTIS
PHARMACEUTICALS CORPORATION,
MITSUBISHI TANABE PHARMA
CORPORATION, and MITSUI SUGAR CO.,
LTD.,

C.A. No. 15-151-LPS

Plaintiffs,

v.
HBC PHARM CO., LTD., HBC PHARM
GROUP, and HBC PHARM USA INC.,
Defendants.
NOVARTIS AG, NOVARTIS
PHARMACEUTICALS CORPORATION,
MITSUBISHI TANABE PHARMA
CORPORATION~ and MITSUI SUGAR CO.~
LTD.,
Plaintiffs,

C.A. No. 15-975-LPS

v.
APOTEX INC. and APOTEX CORP.,
Defendants.

MEMORANDUM ORDER
At Wilmington this 17th day of April, 2017, having reviewed the parties' proposed
pretrial order (C.A. No. 14-1487 1 D.L 275), including briefing on various motions in limirie; and
the parties; Daubert motions and motioh for summary judgment (D.I. 208; 209),
_IT IS HEREBY OIIDEilEn that:

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Al1 references to the docket index ("D.L") are to C.A. No. 14-1487, unless otherwise

noted.
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1.

The 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 Chander Raman.
B.
C.
2.

Plaintiffs' motion for summary judgment (D.I. 209).
Defendants' motion to preclude testimony of patent law expert (D.L 216).

In Daubert v. Merrell DowPhannaceuticals; 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 ah 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 fot
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).
3.

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. Karnak
is a biostatistician who is regularly consulted by members of research teains evaluating drugtreatment efficacy. (See D.I. 228 Ex. 1 at~~ 1-6; Ex. 2) Dr. Komak has relevant technical

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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. Komak does not meet either parties' proposed definition of a person of ordinary
skill in the art does not mean that he lacks relevant expertise. Rather, Dr. Kornak's knowledge,
skill, experience, training, and education are iikely to assist the trier of fact.
4.

Plaintiffs' inotion to exclude the testimony of Drs; Anthony DeFtanco and Steven

Tanis (D.I. 208) is DENIED. Plaintiffs do not 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 aiid methods to the facts of this case.
Plaintiffs contend, instead, that the opinions expressed by these witnesses are based on erroneous
instruction ori applicable law, inaking them unreliable. Specifically, Plaintiffs assert that these
opinioris apply an incorrect commercial-use standard for enablement and fail to analyze each
asserted claim separately. i3ut 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.1. 241 Ex. 2
at ifif 97-102; Ex. 4 at ifif 51-57) Further, the expert reports· show that Drs. Defranco and Tanis
did sufficiently consider each asserted claim separately. (See D.I. 241 Ex. 2 at if~ 81-91; 268-71;
Ex. 4 at if~ 64, 67-84, 236-51) Nor is the Court persuaded that Dr. Tanis' written-description
opinion is unreliable or insufficient. Additionally, all of Plaintiffs' concerns may be adequately
addressed at trial through cross-examination.
5.

Plaintiffs' motion in limine No. 1, to preciude Defendants froin introducing

argument and evidence regarding the breadth of unasserted claims, is DENIED without prejudice
to renew in post-trial briefing. Defendants contend that discussion ofunasserted claims is
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required, because each of the asserted claims is a dependent claim th~t necessarily depends from ·
unasserted, independent claims. The Court agrees. Further, the.Cqurt 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 Pls. 3) Invalidity is evaluated on a claim-by-claim
basis, see Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1379 (Fed. Cir. 2009);
Capon v. Eshhar, 418 F.3d 1349, 1360 (Fed. Cir. 2005), and this unconte~ted statement oflaw
may have implications for what legal arguments will ultimately be persuasive. Still; it will be
most helpful to the Court for Plaintiffs to address in their post-trial brie~ng any concerns that
Defendants ate 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 admitted.
6.

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 inelevant, and the Court is not persuaded that the evidence is unfairly
prejudicial or will confuse the issues. 2·
7.

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,

oti

this defense and, therefore, cannot meet its burden to

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Given Defendants' withdrawal of the obviousness defense (see D.L 281), this motion is
moot with respect to Dr. Coleman's testirnony.

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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 il.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
Cat Pls. 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 oh double patenting. (PTO
Ex. 13 Cat Defs. 1)
8.

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 oh 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." EEC,
618 F.3d at 267.
9.

The parties' disputes regarding the Court's standing decision, the order of
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presentation at trial, and identifying which witnesses will be called to testify at trial (PTO at 9-16,
33-34) will be discussed at the pretrial conference tomorrow.
10.

Plaintiffs' proposal regarding witness sequestration (PTO at 13) is ADOPTED.

11.

Defendants' proposal regarding impeachment with prior inconsistent testimony

(PTO at 20-21) is ADOPTED.
12.

Defendants' request that the Court strike portions of Plaintiffs' Statement of

Uncontested Facts and Statement of Law (D.I. 276; see also PTO at 34-36) is DENIED. The
Court is not persuaded that Plaintiffs' revisions introduced any new ot surprising legal or factual
disputes into this case. Nor does the Comi view Plaintiffs' conduct, in the totality of
circumstances, to be unfairly prejudicial to Defendants; who may (if they wish) supplement their
statement of facts prior to trial, 3 will have a full and fair opportunity to present ·evidence at trial,
and will be pennitted to submit proposed findings of fact as well as legal argument in post-trial
briefs.
13.

Given the remaining issues to be tried, the Court allocates to each side a

maximum of eleven (11) hours for its trial presentation. This amount of time will be sufficient
for both sides to make fair and reasonable presentations of all the evidence ahd argument the
Court will need in order to resolve the disputed issues, particularly given the extensive post-trial
briefing which the parties have proposed (PTO at 32) and which the Court will allow.
14.

The Court will hold trial, subject to the parties' time allocation noted above, at

some or all of the following times:
a.

Tuesday, April 25: 1 :00 p.m. - 6:00 p.m.

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Defendants shall propose a deadline fot doing so, should they wish.
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b.

Wednesday, April 26: 10:00 a.m. - 6:00 p.m.

c.

Thursday, April 27: 8:30 a.m. - 6:00 p.m.

d.

Friday, April 28: 8:30 a.m. - 1:00 p.m.

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HONORABLE LEONARD P. STARK
UNITED STATES DISTRICT JUDGE

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