GlaxoSmithKline LLC et al v. Teva Pharmaceuticals USA Inc.
MEMORANDUM ORDER re decisions on various motions in limine and other pretrial issues. Signed by Judge Leonard P. Stark on 5/25/17. (ntl)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
GLAXOSMITHKLINE LLC and SMITHKLINE
. BEECHAM (CORK) LIMITED
C.A. No. 14-878-LPS-CJB
TEVA PHARMACEUTICALS USA, INC.
At Wilmington this 25th day of May, 2017, having reviewed the proposed pretrial order
submitted by GlaxoSmithKline LLC, SmithKline Beecham (Cork) Limited ("GSK" or
"Plaintiffs") and Teva Pharmaceuticals USA, Inc. (':'Teva" or "Defendant") (D.I. 356, 360)
("PTO"), including briefing on various motions in limine ("MIL"),
IT IS HEREBY. ORDERED that:
GSK's MIL #1, to preclude Teva from arguing that physicians do not read generic
drug labels, is DENIED. The evidence GSK seeks to exclude is relevant to the intent element of
GSK' s induced infringement claim and to damages. Unlike in a Hatch-Waxman case, this case
involves an already-marketed product; evidence as to how many, if any, physicians and patients
read the label on Teva's product (and Teva's understanding of how often its label is read) is
probative evidence ofTeva's intent and of the amount of damages Teva may owe GSK. The ,
jury, properly instructed, is not so likely to be misled or confused as to render the Rule 403
balance one in which this relevant evidence should pe excluded. Nor is the risk of unfair
prejudice nor waste of time so great as to cause the concerns of Rule 403 to substantially
outweigh the probative weight of Teva's evidence.
GSK's MIL #2, to preclude Teva from referencing foreign patent proceedings, is
GRANTED. Neither side shall inform the jury of the existence or outcome of any foreign patent
proceedings. Such evidence is not relevant to any of the issues in the case and, even if it were, its
probative value would be substantially outweighed by the risk of confusion of the jury and unfair
·prejudice to GSK. However, evidence that is otherwise relevant and admissible or otherwise
permitted by the Rules. of Evidence - such as portions of the prosecution history developed
before the U.S.P.TD., or prior inconsistent testimony~ is not excluded by this Order solely
because such evidence may also have been part of a foreign patent proceeding.
GSK's MIL #3, to preclude Teva from referencing its patents related to
manufacturing carvedilol, is DENIED .. This evidence is relevant at least to damages. The parties
should include in their proposed final jury instructions an instruction that ensures the jury will
not mistakenly conclude that Teva.cannot infringe GSK's asserted patent solely because Teva has
its own patents. GSK's concern that a properly-instructed jury will somehow reach a conclusion
contrary to the law is unpersuasive. The probative value ofTeva's evidence substantially
outweighs the risks identified by GSK.
The partie_s should be prepared to address Teva's MIL #1, to preclude GSK from
offering any testimony from their patent law expert (Nicholas Godici), at the pretrial conference
Teva's MIL #2, to exclude testimony from GSK's medical expert (Peter
McCullough) regarding Tev.a's intent and state of mind, is DENIED. Just as evidence as to
whether and how often physicians read Teva's labels (and what Teva knows about how often this
happens) is probative of Teva's intent (see supra at if 1), so, too, is the expert opinion of Dr.
McCullough, as to how Teva's actions (including marketing materials) are understood by
physicians. The Court agrees with GSK that "[ e]xpert testimony is appropriate to demonstrate
how a person of skill in the art would understand Teva' s actions and communications because
those actions and communications include technical information that goes beyond the jury's
knowledge." (D.I. 360-2 Ex. 11 ·at GSK Ans. at 2) The Rule 403 balance does not provide a
meritorious basis to exclude the challenged testimony.
Teva's MIL #3, to exclude expert testimony regarding Teva's generic product's
AB-rating and Teva's "inaction" (i..e., not telling physicians, pharmacists, and others that Teva's
generic product was not FDA approved to reduce the risk of mortality caused by heart failure,
during a particular period), is DENIED. This evidence is relevant to GSK's induced
infringement claim; the risks of unfair prejudice, confusion of the jury, or any of the other
concerns of Rule 403 do not substantially outweigh the probative value of this evidence. GSK
does not rely solely on the AB-rating to support its inducement claim for the "skinny label"
period, but rather the rating "in combination with other facts, such as [Teva] juxtaposing its ABrating next to COREG® in informational material without mentioning that its carvedilol was not
approved for heart failure." (D.I. 360-2 Ex. 11 at GSK Br. at 3) Teva should propose jury
instructions that preclude the possibility GSK will "attempt to confuse the jury into drawing a
legally impermissible inference." (D.I. 360-2 Ex. 11 at Teva Rep. Br. at 1)
Having identified certain disputes in the PTO, IT-IS FURTHER ORDERED
With respect to identifying and advising the Court of objections related to
deposition testimony, the Court adopts GSK's proposal (PTO at 12-13) pr~vided that the
deadli:o.es are modified so that the Court receives a submission with respect to any unresolved
objections no later than 7 :00 p.m. two (2) nights before the testimony will be offered (e.g., by
7:00 p.m. Monday for testimony to be offered on Wednesday). ·
The Court adopts GSK's proposal (PTO at 16) with respect to use of
documents not specifically identified or offered for admission.
The Court adopts Teva's proposal (PTO at 18) to require the parties to
exchange in advance demonstratives to be used in opening statements and closing arguments.
The Courtroom Deputy will keep a running total of trial time used by
counsel. If any party uses all of its allotted trial time, the Court will terminate that party's trial
presentation. (See PTO at 20)
The parties shall be prepared to discuss any remaining disputes in the PTO, as well as any
pending motions, at tomorrow's pretrial conference.
HONORABLE LEONARD P. STARK
UNITED STATES DISTRICT JUDGE
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