United States District Court, D. Delaware
B. Blumenfeld, Derek J. Fahnestock, MORRIS, NICHOLS, ARSHT
& TUNNELL LLP, Wilmington, Delaware; Errol B. Taylor,
Fredrick M. Zullow, Anna Brook, Jordan P. Markham, Kyanna
Lewis, Nathaniel T. Browand, Venus Allahyarzadeh, MILBANK,
TWEED, HADLEY & MCCLOY LLP, New York, New York Counsel
C. Phillips, Jr., David A. Bilson, PHILLIPS, GOLDMAN,
MCLAUGHLIN, & HALL, P.A., Wilmington, Delaware; George C.
Lombardi, Michael K. Nutter, Ivan M. Poullaos, John R.
McNair, WINSTON & STRAWN LLP, Chicago, Illinois; Nimalka
R. Wickramasekera, WINSTON & STRAWN LLP, Los Angeles,
California Counsel for Defendants
F. CONNOLLY UNITED STATES DISTRICT JUDGE.
Orexo AB and Orexo US, Inc. (collectively, "Orexo")
filed this Hatch-Waxman patent suit against Defendants
Actavis Elizabeth LLC, Actavis Pharma, Inc., Teva
Pharmaceuticals USA, Inc., and Teva Pharmaceutical
Industries, Ltd. (collectively, "Actavis"). Orexo
alleged in its complaint that Actavis's generic versions
of the anti-opioid-addiction drugs Suboxone® and
Subutex® directly and indirectly infringed claim 2 of
U.S. Patent No. 8, 454, 996 (the "#996 patent").
D.I. 1. The Court held a five-day trial, after which the jury
found that Actavis did not induce or contribute to
infringement. D.I. 274. Consistent with the jury's
verdict, this Court entered judgment for Actavis. D.I. 279.
has moved pursuant to Federal Rule of Civil Procedure 59(a)
for a new trial "on the issues of infringement,
willfulness, and damages." D.I. 283. Orexo argues a new
trial is warranted because (1)1 erroneously precluded it from
presenting at trial the fact that Judge Sue L. Robinson had
ruled in a previous patent case (the "Zubsolv®
case") that the #996 patent was not invalid and was
infringed by a generic version of another
anti-opioid-addiction drug, Zubsolv®, D.I. 284 at
3-10; and (2) I erroneously "excluded the
introduction of Orexo's patents and published patent
applications (other than the [#]996 patent),"
id. at 10, and "other publications,"
id. at 14.
Zubsolv®, Suboxone®, and Subutex®
undisputed that Zubsolv® is an embodiment of the #996
patent. It is also undisputed that Zubsolv®,
Suboxone®, and Subutex® are sublingual (i.e., applied
under the tongue) drugs used to treat opioid addiction, that
all three drugs have the same active ingredient
(buprenorphine), and that all three drugs have a material
that acts as a disintegrant.
parties also agree that Zubsolv® differs from
Suboxone® and Subutex® in certain respects. It is
undisputed, for example, that Zubsolv® contains
croscarmellose sodium but Suboxone® and Subutex® do
not; and that Suboxone® and Subutex® contain
crospovidone, but Zubsolv® does not.
similarly undisputed that Zubsolv® has a different amount
of buprenorphine and a different particle size distribution
than do Suboxone® and Subutex®. Actavis attempted at
trial to prove Suboxone® and Subutex®'s non-
infringement of the #996 patent in part by adducing testimony
about these differences. Orexo objected to that testimony. In
the words of Orexo's counsel:
This testimony is irrelevant and it's misleading.
Comparisons between the commercial embodiment and the accused
product is generally disfavored and it's not the
appropriate analysis to do patent infringement[I]t has to be
the accused product and a claim. ... [T]o be comparing the
particle size of Zubsolv with the... accused product is going
to lead the jury to think that is a relevant comparison and
For infringement, it's not [relevant]. And it also goes
to the other issue that [Actavis's counsel] has been
arguing. There's a difference in the amount of active
ingredient in the [accused] product... [and in] Zubsolv....
Tr. at 488:21-491:22. I sustained Orexo's objection.
See Tr. at 494:5-22.
Actavis's Motion in Limine Regarding The Zubsolv®
days before the pretrial conference, the parties filed a 1,
173-page proposed pretrial order (PTO). D.I. 254; D.I. 255;
D.I. 256. Each side represented in the PTO that both the
validity and infringement of the #996 patent would be
litigated at trial. And each side included in the PTO three
motions in limine.
first in limine motion bears on Orexo's pending motion
for a new trial. Actavis sought in its in limine motion to
preclude Orexo "from presenting [at trial] evidence or
argument concerning the parties' prior litigation over
the [#]996 patent and Judge Robinson's order [in the
Zubsolv® case] holding the patent valid and
infringed." D.I. 256, Ex. 16, Defendant's Motion
In Limine No. 1, at 1. Actavis argued that the
Zubsolv® case was irrelevant to both invalidity and
infringement. And it emphasized in its motion that any
"reference [to] the Zubsolv® litigation would be
highly confusing to the jury, which will be charged with
determining whether the products at issue in this
case infringe, and extremely and unfairly prejudicial to
Actavis." Id. (emphasis in the original).
Actavis also noted in its motion two undisputed facts: (1)
Actavis knew about the #996 patent by 2013-three years before
Judge Robinson's 2016 ruling in the Zubsolv® case,
see Id. at 2-3; and (2) Actavis launched its generic
Suboxone® and Subutex® in 2013 and 2015,
respectively-again, before Judge Robinson issued her ruling
in the Zubsolv® case, see Id. at 2.
response to Actavis's motion, Orexo argued that
"[t]he Zubsolv decision, finding the [#]996 patent valid
and infringed is highly relevant in this case (same
defendant, same patent, similar buprenorphine product, and
same issues)" and that "[t]he decision is probative
of willful infringement and intent, and should not be
excluded." D.I. 256, Ex. 16, Orexo's Response to
Defendant's Motion In Limine No. 1, at 1. Orexo
contended that Actavis's Zubsolv® was "based on
their generic Suboxone" and that Actavis "knew that
their generic Zubsolv had a material [i.e., croscarmellose
sodium] that was a disintegrant and bioadhesive, and that
their generic Suboxone and Subutex products had a material
[i.e., crospovidone] identified in the [#]996 patent as a
disintegrate and bioadhesive." Id. Thus, Orexo
argued, "[t]he jury should consider whether [Actavis]
should have recognized the risk of infringing a patent that
survived a validity and infringement challenge by the same
defendant[ ] based on a similar product (based on the accused
reviewed carefully the parties' briefing on Actavis's
motion in limine, and mindful of the five other in limine
motions, eight Daubert motions, jury instructions,
and other issues that needed to be addressed before trial, I
stated at the pretrial conference that "I'm not
going to hear argument on [the motion]" and proceeded to
announce my decision. Tr. of Mar. 11, 2019 Hr'g at 74:4.
I then explained:
I've made the determination under [Federal] Rule [of
Evidence] 403 that I think the admission of evidence related
to [the] Zubsolv litigation would confuse the jury. I think
it would unfairly prejudice the defendants. It was a bench
trial and not a jury trial. There were different theories of
invalidity. There was an appeal, there were litigation
decisions made during the course of that [case] for strategic
reasons that may be irrelevant. It involved a different
So there was prior art not presented in that case that
apparently will be in this case,  and I think that therefore
the degree of unfair prejudice is so significant that it
would substantially outweigh the probative value that the
[Zubsolv® case] evidence would have, especially since, as
I understand it, there's no debate even that the patent
was known to the defendants prior to the Zubsolv
litigation....[S]o I am going to grant the motion.
Id. at 74:6-25 (emphasis added).
counsel immediately asked if he might "be heard on the
issue of mostly clarification." Id. at 75:2-3.
He then proceeded to argue the merits of the motion,
essentially repeating the argument Orexo had put forward in
its papers- namely that Judge Robinson's rulings in the
Zubsolv® case were probative of willfulness and intent.
See Id. at 75:6-76:6. The following exchange then
THE COURT: I don't deny there's probative value that
the Zubsolv litigation has with respect to that question.
I've got to conduct a balancing under Rule 403, and I
think the probability is significant that references to the
Zubsolv litigation will confuse the jury, will unfairly
prejudice the defendants], will mislead the jury, and I think
that that danger of unfair prejudice substantially outweighs
the probative value it would have towards willfulness....
[OREXO'S COUNSEL]: Your Honor, does that ruling apply for
example, if defendants themselves put that case and things
that happened in that case in issue?
THE COURT: Well, if they put the litigation in issue, that
would open the door. I can't imagine [they would]. Now,
if you mean by that can they bring in evidence that was
adduced in th[e] [Zubsolv®] litigation here, I mean, I
would have to see, but my ruling doesn't prevent you from
bringing in evidence from th[at] litigation. It's just
[that] we're not going to refer to Judge Robinson's
rulings, and I mean, that's what I understood [the motion
in limine covered].
then proceeded to argue again the merits of the motion,
see Id. at 77:19-83:14, after which I stated:
Look, I will say it again. I'm not saying that the
Zubsolv litigation result is not probative of willfulness,
knowledge, intent. I'm just doing a [Rule] 403
balanc[ing]. I've got to do it. I've got to weigh
probative [value] versus potential unfair prejudice, and I
don't think it's a close call. I think that the
prejudicial value, the unfair prejudicial value, the
potential for misleading the jury, confusing the jury and
unfairly prejudicing the defendant substantially outweighs
the probative value. That's my discretionary call and
that's where we are.
Id. at 83:15-24. When I finished explaining my
ruling, counsel stated:
Thank you, Your Honor. And I appreciate your statement that,
you know, should it come up at trial where I believe that
defendants opened the door on this issue ... you will hear
[from] me again.
Monday morning that trial began, I learned that the parties
had filed over the weekend a stipulation that removed the
issue of the #996 patent's invalidity from the case.
See Tr. at 3:8-5:6. In light of the stipulation, I
asked the parties if I should reduce the amount of time I had
originally set aside for the trial. See Id. at
5:3-13. Orexo's counsel responded: "[W]e believe
that our affirmative case [i.e., for infringement] will be
essentially the same even though validity is out of the
case." Id. at 5:19-21. Counsel did not argue or
suggest in any way that Actavis's decision not to pursue
an invalidity defense warranted reconsideration of my
decision to preclude Orexo from presenting argument or
evidence about the Zubsolv® case.
end of the first day of trial, the following exchanged
[OREXO'S COUNSEL]: I was reminded there's one other
issue, and this is following up on Your Honor's order . .
. precluding us . . . [from] referring to the . . .
THE COURT: Yes.
[OREXO'S COUNSEL]: Even today there have been issues that
in our view have touched on that litigation and things that
we might have wanted to respond to by referring to the
litigation. For example, things that allude to why we
didn't sue other generic companies or the timing of this
THE COURT: Well, wait. I don't think in fairness, Mr.
Taylor [Orexo's counsel], I don't recall any
testimony about the timing of this lawsuit....
[OREXO'S COUNSEL]: I don't want to argue that. But I
was just going to mention, Your Honor, that we'd like
leave to submit to Your Honor an offer of proof on evidence
that we ...