MEMORANDUM OPINION

COLM F. CONNOLLY, UNITED STATES DISTRICT JUDGE.

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 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-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:

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 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.

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 [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:

Id. at 74:6-25 (emphasis added).

Orexo's 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 occurred:

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:

Id. at 83:15-24. When I finished explaining my ruling, counsel stated:

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 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:

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 to permit the Zubsolv litigation to be mentioned in front of a jury," id. at 447:16-18, 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 "[f]or many years ... focus[ed] on sublingual medicines" and in "recent years ... focus[ed] more and more on improving [the] treatment of opioid dependence." Id. at 164:9-12. Sorensen 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 "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 PTX-250, 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:

Id. at 191:10-195:23.

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, 101 S.Ct. 188, 66 L.Ed.2d 193 (1980); Olefins 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 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." Roebuck v. 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. at 3-4.

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.

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:

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. Del. 1998). As Judge Hardiman explained in United States v. Dupree, 617 F.3d 724, 728 (3d Cir. 2010):

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-or-waive 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 omitted); see also Puckett v. United States, 556 U.S. 129, 134, 129 S.Ct. 1423, 173 L.Ed.2d 266 (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 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 non-infringement defenses:

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 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.

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 Subutex® 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 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 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 if I 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 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 ¶¶ 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. ¶ 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 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. 1F, Jones Dep. 338:9-339:16. Only one of those witnesses had knowledge about an "other publication," and Orexo questioned that witness about other publications without objection or limitation. See Tr. at 518:1-533:14.

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.