Orexo AB et al v. Actavis Elizabeth LLC et al

Filing 300

MEMORANDUM OPINION Signed by Judge Colm F. Connolly on 12/11/2019. (nmf)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
OREXO AB and OREXO US, INC.,
Plaintiffs,
Civil Action No. 17-205-CFC

V.

ACTAVIS ELIZABETH LLC,
ACTAVIS PHARMA, INC., TEVA
PHARMACEUTICALS USA, INC.,
and TEVA PHARMACEUTICAL
INDUSTRIES, LTD.,
Defendants.

Jack 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, rvIILBANK, TWEED, HADLEY & MCCLOY LLP, New York,
New York
Counsel for Plaintiffs
John 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
MEMORANDUM OPINION
December 11, 2019
Wilmington, Delaware

Plaintiffs 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. 1 D.I. 274.
Consistent with the jury's verdict, this Court entered judgment for Actavis. D.I.
279.
Orexo 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) I 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

1

Although the parties argued in the Pretrial Order that direct infringement was
disputed, the joint verdict form they submitted did not ask the jury whether Orexo
had proven direct infringement of claim 2 of the #996 patent. D.I. 271.

infringed by a generic version of another anti-opioid-addiction drug, Zubsolv®,
D.I. 284 at 3-10;2 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.

I.

BACKGROUND
A. Zubsolv®, Suboxone®, and Subutex®

It is 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.
The 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.
It is 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-

2

Orexo AB v. Actavis Elizabeth LLC, 217 F. Supp. 3d 756 (D. Del. 2016), rev 'don
other grounds, 903 F.3d 1265 (Fed. Cir. 2018).
2

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 it's not.

****

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.
B. Actavis's Motion in Limine Regarding The Zubsolv® Case

Five 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.
Actavis's 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

3

and infringed." D.I. 256, Ex. 16, Defendant's Motion In Limine No. 1, at I.
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.
In its 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

4

[i.e., crospovidone] identified in the [#]996 patent as a disintegrant 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 product)." Id.
Having 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 drug.
So there was prior art not presented in that case that
apparently will be in this case,3 and I think that therefore
the degree of unfair prejudice is so significant that it would
3

Orexo had not argued that Actavis was collaterally estopped from presenting an
obviousness defense or from relying in this case on prior art that it had advanced as
part of its obviousness defense in the Zubsolv® case. Orexo AB v. Actavis
Elizabeth LLC, 371 F. Supp. 3d 175, 187 n.7 (D. Del. 2019).
5

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).
Orexo's counsel immediately asked ifhe 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 papersnamely 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
occurred:
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
defendant[s], 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
6

I mean, that's what I understood [the motion in limine
covered].
Id. at 76:7-77:16.

Counsel 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.
Id. at 84:18-21.

On the 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
7

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.
At the end of the first day of trial, the following exchanged occurred:
[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 . . .
[Zubsolv®] litigation.
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 lawsuit.
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 would have permitted on the issues in
this case.
THE COURT: Well, I think it's kind of late in the game
for that. We litigated that motion. But what I said to you
is if the door were opened, you would have the opportunity
[to argue that evidence of the Zubsolv decision was
admissible]. So if you thought the door were opened
today, then you should ask for a sidebar and say, ["]Judge,
8

I think the door was opened. This is what I want to do.["]
But if you are talking about making an offer of proof on a
motion I've already decided, I mean -[OREXO'S COUNSEL]:
the motion.

I'm not seeking to reconsider

THE COURT: Okay.
[OREXO'S COUNSEL]: I'm just saying so we can have
an evidentiary record on possibly down the road if there's
an appeal in this case.
THE COURT: But that's too late. You should have made
that [record] when I made the ruling. So if you want to
make an offer of proof -- for instance, if a witness in your
mind opened the door, then -[OREXO' S COUNSEL]: I'm not saying that. I said there
were some allusions to things that implicated that.
THE COURT: Right.
[OREXO'S COUNSEL]:
If I thought the door was
opened, why didn't I ask you to reconsider that issue, I
would certainly have come to you.
THE COURT: What's the point of the offer of proof?
[OREXO'S COUNSEL]: Well, the offer of proof, Your
Honor, is just, you know, we have a burden in this case on
intent, and, you know, I thought when I argued this motion
before, I tried to impress on you the relevancy of this
evidence to this issue.
THE COURT: Right.
[OREXO'S COUNSEL]: And I just am asking for leave
to file an offer of proof as to what the evidence would have
been.
9

THE COURT: And that's denied. We litigated that
motion. I spent a lot of time reading your [1,]750 pages of
a Pretrial Order, and I think based on my questions and
based on my comments to date, it should have been
apparent, and I hope it's apparent to the Federal Circuit, I
spent a lot of time reviewing the papers and thinking about
the issues. And you had your opportunity to litigate that
motion. I pressed you on the relevance of [the Zubsolv®
case] and why it should be admitted.
I made a ruling under the Federal Rules of
Evidence. I think I articulated the ruling particularly in my
analysis under [Rule] 403, the other applicable rules, and
I decided, I granted the motion.
So, no. You had your opportunity to litigate the
motion. You made your record. You were offered an
opportunity to litigate your record in the Pretrial Order. As
far as I'm concerned, the record stands. I guess you can
file a motion for reconsideration if you want.
Tr. at 273:18-276:13. 4
Orexo never filed a motion for reconsideration. It did, however, revisit the
issue of the Zubsolv® case during the presentation of its infringement case, at
which point I reiterated for the record that "there's lots of really good reasons not

4

Federal Rule of Evidence 103(b) provides that "[o]nce the court rules definitively
on the record-either before or at trial-a party need not renew an objection or
offer of proof to preserve a claim of error for appeal." Since Orexo had briefed
and argued at the pretrial conference the merits of Actavis' s motion in limine and I
had made a definitive ruling on that motion before trial, there was no reason to
make an additional offer of proof at trial. As the Third Circuit held in Walden v.
Georgi.a-Pacific Corp., 126 F.3d 506 (3d Cir. 1997), "[w]hen a definitive
evidentiary ruling is made pretrial, there is surely no point to taking the time at trial
to make an objection if the in limine ruling admitted certain evidence, or to make
an offer ofproof if the in limine ruling excluded it." Id. at 517 (emphasis added).
10

to permit the Zubsolv litigation to be mentioned in front of a jury," id. at 44 7: 1618, including the facts that "Zubsolv [was] a bench trial" and involved "a different
product," id. at 445:20-21. Accordingly, I reminded counsel that "we're not going
to open that can of worms." Id at 447:18-19.
At no point before or during trial did Orexo ever argue that I should
reconsider my decision to grant Actavis' s motion in limine in light of Actavis' s
decision to drop its invalidity defenses.
C. Evidentiary Rulings Regarding "Other" Patents and Publications

Orexo called as its first witness its CEO, Nikolaj Sorensen, "to testify about
our company, Orexo, about our technology, about Zubsolv, the treatment of opioid
dependence, [and] the damages that we have incurred by the infringement of
Actavis." Id. at 164:3-6. He described Orexo as a "small pharmaceutical
company" that "[t]or many years ... focus[ ed] on sub lingual medicines" and in
"recent years ... focus[ed] more and more on improving [the] treatment of opioid
dependence." Id. at 164:9-12. Soresen testified that Orexo's "core technology
basically is a sublingual medicine where you mix the carrier particle with an active
ingredient with a bioadhesive." Id. at 165:20-22. He explained that "[y]ou ...
place the sublingual medicine under the tongue where it will disintegrate. The
bioadhesive will stick to the mucosal membrane and improve the absorption of the
active ingredient." Id. at 165:23-166:1. Sorensen testified that Orexo had

11

"developed three products that incorporate the technology[:] Abstral, for treatment
of breakthrough cancer treatment[,] Edluar for treatment of insomnia, and most
lately Zubsolv for treatment of opioid dependence." Id. at 166:22-25.
During Sorensen's direct examination, Orexo offered to admit exhibit PTX250, which consisted of a copy of U.S. Patent No. 6,761,910 (the "#910 patent")
and the #910 patent application. Id. at 190:21-191 :6. Actavis objected to the
admission of PTX-250 as irrelevant, prejudicial, and confusing under Rule 403.
Id. at 191:7-9. The following exchange then occurred:
THE COURT: Why is it admissible?
[OREXO'S COUNSEL]: Your Honor, it is the patent that
is the parent application to the patent-in-suit. It is
absolutely relevant to the case because it's the publication
of Orexo' s core technology ....

****

It was filed in 1998 and published in 2010. Now, we just
had a discussion about Orexo's other patents, other
products, Abstral and [Elduar]. Those products and the
patents covering those products, most of them emanate
from this [#]910 patent. ... The [#]996 patent just happens
to be the patent that emanated from this core group of
patents that is specific to a buprenorphine[-]containing
product like Zubsolv.
THE COURT: So why is it relevant -- we don't have
validity anymore. . ..
[OREXO'S COUNSEL]: Well, if their intent was not in
the case, Your Honor, then it would not be relevant. But
when you hear counsel speak about how they developed

12

this independently without knowledge of Orexo' s
technology, because the patent issued in 2013 -THE COURT: Right.
[OREXO'S COUNSEL]: -- it becomes very relevant as to
these other disclosures of the technology that we know that
their scientists were aware of.
THE COURT: But the only thing relevant in my mind to
willfulness is whether they knowingly and intentionally
infringed the [#]996 patent and to prove that you've got to
establish that they knew or should have known of the
patent, and so anything prior to the patent seems to me to
be irrelevant.
[OREXO'S COUNSEL]: Yes, but that's not what the jury
is hearing, Your Honor. If that were the only evidence in
the case, then I would agree with you. We just heard a
long exposition about things that we heard before. I mean

THE COURT: It's relevant that they came up with these
ideas before the patent. That's relevant because that
negates evidence that they were willfully infringing it. But
that seems to me to be totally consistent.
[OREXO'S COUNSEL]: Right. But it's relevant if they

came up with those ideas without relying on or knowledge
of the Orexo disclosures.
THE COURT: Only if it is the [#]996 patent.
[OREXO'S COUNSEL]: Well, when you have the same
disclosure, when it's the same technical information that-

THE COURT: The claims of the patent. That's the big
thing. Both of you have said the metes and bounds of the
patents are defined by the claims, whether they willfully
13

infringed the claims of the [#]996 patent. I'm going to
deny it. I don't think it's relevant.

****

[OREXO'S COUNSEL]: There's another reason why
these are relevant, Your Honor. Now, you've heard
counsel talk that, say that, you know, crospovidone is a
disintegrant and not a bioadhesive. Right. And that they
would not, never have known that crospovidone served as
a bioadhesive.
These patent publications from Orexo and others,5
they disclosed that.
THE COURT: So if you have a witness on the stand from
Actavis and you want to cross-examine them when they
say I never thought that it was a bioadhesion, that seems
to me fair game to bring it up at that time.
[OREXO'S COUNSEL]: That doesn't get the -- that
document into evidence.
THE COURT: Well, it may not. It all depends. But it
seems to me this is only relevant in terms of the witness'
mens rea, whether they knew or didn't know, or should
have known. And so I guess, you know, if you could prove
that they read this particular patent and that undermines
their credibility or somebody from Actavis read the patent,
therefore they should have known that it wasn't a
disintegrant or at least it wasn't only a disintegrant, that
seems to me to be relevant, but not through this witness.

Id. at 191: 10-195:23.

5

Orexo never identified before or during trial these "other[]" publications. Orexo
first identified an "other publication" in the 14-page "Addendum of Evidence" it
filed with its brief submitted in support of its motion for a new trial. D.I. 284 ,r,r
10-14. And even at that point, Orexo identified only "examples" of"other
publications." Id. ,r 14.
14

On the third day of trial, Orexo again raised the issue of the admissibility of
the #910 patent and other, unidentified patents and "publications" that disclosed
Orexo's "core technology." See id. at 448:6-451:15. I reiterated my earlier ruling
that Orexo could introduce any such patent or publication into evidence to show
willfulness if it could establish that an Actavis witness was aware of the existence
of the patent or publication at the time of the alleged infringement. See id.

II.

LEGAL STANDARDS FOR MOTION FOR A NEW TRIAL
Federal Rule of Civil Procedure 59(a) permits a district court judge, "on

motion," to grant a new trial "for any reason for which a new trial has heretofore
been granted in an action at law in federal court." The decision to grant a new trial
is committed to the district court's discretion. Allied Chem. Corp. v. Daiflon, Inc.,
449 U.S. 33, 36 (1980); Ole.fins Trading, Inc. v. Han Yang Chem Corp., 9 F.3d
282,289 (3d Cir. 1993) (reviewing a district court's grant or denial of a motion for
a new trial under deferential "abuse of discretion" standard). 6 "And, when the
motion for a new trial is predicated on asserted errors in evidentiary rulings that
were themselves discretionary, the motion is subject to particularly 'broad
discretion."' St. Clair Intellectual Prop. Consultants, Inc. v. Toshiba Corp., 2015

WL 5826815, at *1 (D. Del. Oct. 2, 2015). Although the standard for granting a

6

Regional circuit law governs the standards for deciding a motion for a new trial
in a patent case. Leader Techs., Inc. v. Facebook, Inc., 678 F.3d 1300, 1305 (Fed.
Cir. 2012).
15

new trial is less demanding than the standard for ordering judgment as a matter of
law, the bar is high. A new trial is appropriate when "the verdict is contrary to the
great weight of the evidence" such that another trial is "necessary to prevent a
miscarriage of justice." Roebuckv. Drexel Univ., 852 F.2d 715, 736 (3d Cir.
1988).

III.

DISCUSSION
A.

Exclusion of Evidence of The Zubsolv® Case

Orexo argues that my ruling to exclude evidence of Judge Robinson's
decision in the Zubsolv® case "was in error for two independent reasons." D.I.
284 at 3. First, it argues that my ruling was "based largely on the dismissed
invalidity allegations" and therefore "was clearly erroneous." Id. at 7; see also id.
at 8 ("By basing its exclusion ruling on clearly erroneous facts (the dismissed
invalidity claims), the Court abused its discretion warranting a new trial.").
Second, it argues that my Rule 403 analysis "did not properly weigh the necessity
and highly probative nature of this evidence against any prejudice to [Actavis]."

Id. at3-4.
1. Whether My Pretrial Ruling Was Based Largely on The

Dismissed Invalidity Allegations
Orexo' s initial argument fails for two reasons. First, Orexo waived the
argument. Second, I did not "largely base" my pretrial ruling on the dismissed
invalidity allegations.
16

a. Orexo Has Waived The Issue
Although Orexo revisited my pretrial ruling on numerous occasions during
the trial, see, e.g., Tr. at 273:18-276:14; id. at 444:5--446:2; id. at 447:2-449:23;
id. at 525:4-526:23, it never argued or suggested that I should reconsider that
ruling because of Actavis's decision to forgo an invalidity defense. When I asked
the parties on the first morning of trial if the removal of invalidity issues from the
case affected the amount of time needed for the parties to make their presentations
to the jury, Orexo's counsel responded that Orexo's "affirmative [infringement]
case will be essentially the same even though validity is out of the case." Id. at
5:19-21. He did not say or suggest that the removal of invalidity issues affected in
any way the case Orexo wished to present at trial.
At the end of the first day, when Orexo' s counsel asked for the opportunity
to make a belated "offer of proof' with respect to my pretrial ruling, he did not
state or suggest that the proposed offer of proof had any connection to Actavis' s
decision not to pursue an invalidity defense. To the contrary, counsel seemed to
suggest that his request was prompted by issues Actavis had put in front of the jury
that day:
[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 ... [Zubsolv®]
litigation.
THE COURT: Yes.

17

[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 law suit.
THE COURT: Well, wait. I don't think in fairness, Mr.
Taylor, 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 would have permitted on the issues in
this case.

Id. at 273:18-274:10.
But most important, when I pressed counsel on why I should entertain "an
offer of proof on a motion I've already decided," id. at 274:17-18, counsel
responded: "I'm not seeking to reconsider the motion," id. at 274:19-20. And
although I ended the discussion with the comment "I guess you can file a motion
for reconsideration if you want," id. at 276:12-13, Orexo never asked me (by
motion or otherwise) to reconsider my pretrial ruling to exclude evidence of Judge
Robinson's decision in the Zubsolv® case.

"A Rule 59 motion may not be used as a vehicle to advance additional
arguments that a party could have made before judgment but neglected to do so."

Procter & Gamble Co. v. Paragon Trade Brands, Inc., 15 F. Supp. 2d 406,409 (D.

18

Del. 1998). As Judge Hardiman explained in United States v. Dupree, 617 F.3d
724, 728 (3d Cir. 2010):
Th[e] raise-or-waive rule is essential to the proper
functioning of our adversary system because even the
most learned judges are not clairvoyant. See United States
v. Nee, 261 F.3d 79, 86 (1st Cir. 2001). Thus, we do not
require district judges to anticipate and join arguments that
are never raised by the parties. See United States v.
Griffiths, 47 F.3d 74, 77 (2d Cir. 1995). Instead courts rely
on the litigants not only to cite relevant precedents, but
also to frame the issues for decision. See id. ("The
government was required to offer some argument or
development of its theory. It failed to do so, and has
therefore waived the issue.").
Moreover, "[a] fleeting reference or vague allusion to an
issue will not suffice to preserve it for appeal[.]" In re Ins.
Brokerage Antitrust Litig., 579 F.3d 241, 262 (3d Cir.
2009). Rather, a party "must unequivocally put its
position before the trial court at a point and in a manner
that permits the court to consider its merits." Shell
Petroleum, Inc. v. United States, 182 F.3d 212, 218 (3d
Cir. 1999).
The "cardinal principle that issues not squarely raised in the district court will not
be entertained on appeal," Nee, 261 F.3d at 86 (internal quotation marks and
citation omitted), applies with equal force to Rule 59 motions. "This raise-orwaive rule prevents sandbagging ... [and] precludes a party from making a tactical
decision to refrain from objecting, and subsequently, should the case turn sour,
assigning error (or, even worse, planting an error and nurturing the seed as
insurance against an infelicitous result)." Id. (internal quotation marks and citation

19

omitted); see also Puckett v. United States, 556 U.S. 129, 134 (2009) (noting that
"the contemporaneous-objection rule prevents a litigant from sandbagging the
court-remaining silent about his objection and belatedly raising the error only if
the case does not conclude in his favor" (internal quotation marks and citations
omitted)).
Orexo had ample opportunities to seek reconsideration of my pretrial ruling
and to argue that the removal of invalidity issues from the case necessitated a new
Rule 403 balancing analysis. But not once before or during trial did it make even a
"fleeting reference or vague allusion" that would have put before me the issue of
whether Actavis's withdrawal of its invalidity defenses warranted reconsideration
of my decision to grant Actavis' s motion in limine. On the contrary, Orexo' s
counsel expressly stated that he was "not seeking to reconsider [my ruling on
Actavis's] motion." Tr. at 273:19-20. Having failed to raise before or during trial
that the Rule 403 analysis I employed in granting Actavis' s motion in limine
needed to be redone in light of the removal of invalidity from the case, Orexo
cannot now raise that issue in a Rule 59 motion.

b. The Pretrial Ruling Was Based on The
Prejudicial Effect of the Zubsolv® Case on Both
Infringement and Invalidity Defenses
Orexo' s assertion that I "largely based" my pretrial ruling on the dismissed
invalidity allegations is incorrect. D.I. 284 at 4. The thrust of Actavis's motion in

20

limine was that Orexo should be precluded from "suggest[ing] to this jury that
because Actavis was found to infringe in [the Zubsolv®] suit, the same result
should follow here." D.I. 256, Ex. 16, Defendant's Motion In Limine No. 1, at 2.
Actavis argued that allowing Orexo to adduce evidence of the Zubsolv® case
would lead to a "trial-within-a-trial on issues having nothing to do with
infringement" in this case. Id. And, it is clear from my oral ruling, that I based my
decision to grant Actavis's motion on the substantial risk of jury confusion and
unfair prejudice Actavis would suffer with respect to both its invalidity and its noninfringement defenses:
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 drug.
Tr. at 74:6-21 (emphasis added); see also id. at 447:6-19 (Court reiterating that
"there's lots of really good reasons not to permit the Zubsolv litigation to be
mentioned in front of a jury," including the fact that it involved "a different
product." (emphasis added)).
The drugs at issue in the Zubsolv® case and this case have no bearing on the
validity of the #996 patent. The only reason I mentioned that the Zubsolv® case

21

involved a different drug was to make the point that evidence of Judge Robinson's
decision in the Zubsolv® case would lead to jury confusion and unfair prejudice to
Actavis on infringement issues. I sought to avoid a trial-within-a-trial about the
similarities and differences between Zubsolv® and the accused products; and I
deemed it unfair to allow Orexo to attempt to prove that Suboxone® and Subutex®
infringed the #996 patent by adducing evidence about their similarities with
Zubsolv® and then linking that evidence to Judge Robinson's decision that
Zubsolv® infringed the same patent. See Johnson & Johnston Assocs. Inc. v. R.E.
Serv. Co., 285 F .3d 1046, 1052 (Fed. Cir. 2002) ("Infringement, either literally or

under the doctrine of equivalents, does not arise by comparing the accused product
with a preferred embodiment described in the specification, or with a
commercialized embodiment of the patent[]." (internal quotation marks and
citation omitted)). Indeed, when Actavis tried at trial to employ the other side of
this same coin-that is, to argue non-infringement of the #996 patent based on
testimony that Suboxone® and Subutex® differed from the patent's commercial
embodiment, Zubsolv®-Orexo cried foul, arguing that such "testimony is
irrelevant and ... misleading" and "not the appropriate analysis" for patent
infringement. Tr. at 488:21-25. I sustained Orexo's objection because the
Zubsolv® case involved a different drug-the same rationale I articulated when I
granted Actavis's motion in limine before trial.

22

Finally, had I been asked to revisit my pretrial ruling after Actavis withdrew
its invalidity defenses, I would still have granted Actavis's motion in limine. In
my view, litigation of issues related to Zubsolv® would have created a significant
risk of jury confusion about the relevance of Judge Robinson's decisions and
would have necessitated a trial-within-a-trial without any assurance that the jury
would have been able to sort through the irrelevancies to determine the only actual
issue in the case-i.e., whether Actavis' s sale of its generic Suboxone® and
Subutex® induced or contributed to the infringement of the #996 patent. That risk
substantially outweighs the probative value of Judge Robinson's decision in the
Zubsolv® case. As I acknowledged numerous times during the pretrial
conference, the Zubsolv® case is probative of Actavis' s knowledge and
willfulness. See Tr. of Mar. 11, 2019 Hr'g at 74:15-83:24. Actavis's participation
in the Zubsolv® case shows that it had knowledge of the #996 patent and
knowledge that a court decided that Zubsolv® infringes that patent. It arguably
shows-to the extent that Zubsolv® is similar to Suboxone® and Subutex®-that
Actavis had knowledge of the possibility that Suboxone® and Suputex® infringe
the patent. But the Zubsolv® case has limited probative weight, since ( 1) it was
undisputed that Actavis had knowledge of the #996 patent before the Zubsolv®
case, and (2) the Zubsolv® case involved a different drug than the accused

23

products in this case. 7 Thus, for the reasons stated above and at the pretrial
conference, the evidence's limited probative value is substantially outweighed by
the jury confusion and unfair prejudice its admission at trial would have caused.

2. Whether I Weighed The Necessity and Highly Probative
Nature of The Zubsolv® Case Evidence Against Any
Prejudice to Actavis
Orexo argues that "[w]hile the Court agreed that the Zubsolv action was
probative of 'willfulness, knowledge, [and] intent', the Court's analysis did not
consider the substantial impact that exclusion of this highly probative evidence
would have on Orexo's indirect infringement case." D.I. 284 at 4 (second
alteration in original) (citation omitted). According to Orexo, "[t]he Zubsolv
action is particularly probative given [Judge Robinson's] findings relating to dry
mixing and the [#]996 patent disclosures relating to bioadhesives." Id.
My oral pretrial ruling, see Tr. of Mar. 11, 2019 Hr'g at 74:15-83:24,
explains how I balanced the relevant Rule 403 factors and concluded that the
probative value of the Zubsolv® case was substantially outweighed by the

7

Although I did not state so explicitly at the pretrial conference ( due to time
constraints and the fact that I was dealing with experienced patent counsel), the
fact that Zubsolv® is a different drug means that Judge Robinson's ruling that
Zubsolv® infringes the #996 patent is not highly probative of Actavis's knowledge
that Suboxone® and Subutex® infringe the #996 patent. I think the ruling can at
least arguably be characterized as probative of Actavis' s knowledge of potential
infringement-to the extent the accused products in this case are similar to
Zubsolv®-but I think it an overstatement to call it highly probative.
24

significant risks of jury confusion and unfair prejudice to Actavis. I did not
mention in my oral ruling anything about Judge Robinson's "findings relating to
dry mixing and the [#] 996 patent disclosures relating to bioadhesives" because

Orexo did not mention those findings in its response to Actavis' s motion in limine
or during its arguments at the pretrial conference, or, for that matter, at any time
before or during trial in connection with Actavis's motion. D.I. 284 at 4. Orexo
first made this argument in its brief filed in support of its Rule 59 motion and its
14-page "Addendum of Evidence" attached thereto. Id Accordingly, Orexo has
waived the issue. But even ifl had considered the findings of Judge Robinson on
which Orexo now relies, for the reasons articulated above and in my oral ruling on
Actavis's motion in limine, I would still have precluded Orexo from putting in
front of the jury Judge Robinson's decision in the Zubsolv® case. And, as I do not
agree that Orexo suffered a miscarriage of justice from its inability to introduce at
trial evidence of the Zubsolv® case, I will deny its motion for new trial to the
extent it is based on my decision to preclude it from adducing at trial evidence of
Judge Robinson's rulings in the Zubsolv® case.

B.

Conditional Exclusion of The #910 Patent, Its Application, And
Unidentified "Other Publications"

Orexo argues that "[t]he Court's exclusion of evidence concerning Orexo's
other public disclosures besides the [#]996 patent issuance was an error." D.I. 284
at 10. The only "public disclosures" Orexo identified at trial besides the #996

25

patent and its application were the #910 patent and its application, which Orexo
sought to introduce as a combined exhibit during the direct examination of its
CEO. See Tr. at 190:21-191:6. Thus, Orexo appears to have waived its right to
seek a new trial based on the exclusion from evidence of any publication other than
the #910 patent and its application.
Orexo did make two passing references at trial to unidentified "other
publications." See id at 448:6-451: 15. And in the "Addendum of Evidence"
attached to its brief filed in support of its Rule 59 motion, Orexo identifies for the
first time at least some of these publications. See D.I. 284 ,I,I 10-14. But
consistent with its trial strategy of not squarely raising issues before the Court,
Orexo asserts in the Addendum that it "has numerous other publications" (of which
it merely provides "examples") that were erroneously excluded from evidence.
See id. ,I 14.

Leaving aside the question of waiver, Orexo's argument that the other
publications were erroneously excluded from evidence fails for the same reason
that its argument that the #910 patent and its application were erroneously
excluded from evidence fails: none of the publications are relevant unless Actavis
knew.about them.
Orexo argued at trial that the publications were relevant to Actavis's
willfulness because they disclosed that crospovidone was a bioadhesive. See id. at

26

448:6-451:15. As a matter of logic, Actavis can only have known about
disclosures in a publication if it was aware of the publication. Accordingly, I ruled
at trial that any publication that disclosed that crospovidone was a bioadhesive
would be admissible if it was established that an Actavis witness was aware of the
publication. As I explained to Orexo's counsel: "I already said if [an Actavis
witness] admits that he was aware of the existence of a particular patent or article
or an advertisement or [a] signed con[f]ession about what crospovidone is, you
can, once you get that, [']I'm aware of that,['] sure, you can put it now in ... the
case." Id. at 449:15-19.
Orexo argues that this ruling "left [it] unable to respond to Defendants'
arguments that they independently developed the accused products and could not
have known that use of the accused products would infringe the [#]996 patent."
D.I. 284 at 11. But that is not true. My ruling allowed Orexo to ask Actavis's
witnesses if they knew about any "other publication" and, if any witness did, to test
with that witness whether the disclosures in that publication undermined testimony
that Actavis developed its products independently and with no knowledge that the
accused products infringed the #996 patent. See Tr. at 449: 15-19. Orexo chose,
however, to ask only two Actavis witnesses about other publications. See Tr. at
518:1-533:14; D.I. 256, Ex. IF, Jones Dep. 338:9-339:16. Only one of those
witnesses had knowledge about an "other publication," and Orexo questioned that

27

witness about other publications without objection or limitation. See Tr. at 518: 1-

533: l 4.
Orexo cannot now complain that it was unable to introduce a publication for
which it failed or did not even try to lay a proper foundation. To this day, Orexo
has not identified a single publication that an Actavis witness was aware of that
was excluded from evidence. It was the lack of evidence, not my ruling, that
prevented Orexo from overcoming Actavis's defense that it independently
developed its products without knowledge that those products infringed the #996
patent. Thus, Orexo' s inability and unwillingness to adduce evidence of other
publications did not result in a miscarriage of justice and do not warrant a new
trial.

IV.

CONCLUSION
For the reasons stated above, I will deny Orexo' s motion for a new trial.
The Court will issue an order consistent with this Memorandum Opinion.

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