MEMORANDUM OPINION AND ORDER ON MOTIONS IN LIMINE BY DEFENDANT EPOCAL, INC.

LYNWOOD SMITH, District Judge.

This opinion addresses the following motions in limine filed by defendant, Epocal, Inc. ("Epocal"): i.e., (1) motion to exclude evidence and argument that plaintiff, Abbott Point of Care, Inc. ("Abbott" or, as plaintiff's counsel prefer, "APOC") has been harmed by Epocal's alleged conduct;1 (2) motion to exclude evidence and argument regarding Epocal's federal Food and Drug Administration 510(k) submissions;2 (3) motion to exclude documents that use certain claim terms outside the context of the patents-in-suit;3 and (4) motion to exclude arguments and evidence regarding solicitation of employees other than the five at issue in Abbott's tortious interference allegations.4

I. EPOCAL'S MOTION TO EXCLUDE EVIDENCE AND ARGUMENT THAT ABBOTT HAS BEEN HARMED BY EPOCAL'S ALLEGED CONDUCT

This court entered an order on March 22, 2010, granting the parties' joint motion to bifurcate the trial and to stay discovery on the bifurcated issues. That order stated, in pertinent part:

The order also stated that discovery should proceed with regard to all issues covered in Phase One, but that discovery on all issues reserved for consideration in Phase Two would be stayed, pending a determination on the issues covered in Phase One.6 Epocal now seeks to exclude from presentation to the jury "all evidence that Abbott has been harmed, or perceives that it has been harmed, in any way by Epocal's alleged infringement of the asserted patent claims or by Epocal's employment of five former APOC employees," because any such evidence would contravene the court's bifurcation order.7 More specifically, Epocal points to several items identified on Abbott's March 22, 2010 exhibit list, including

Epocal also points to two individuals named on Abbott's March 22, 2010 witness list: i.e., Lisa Reece, who "may have discoverable information regarding both the use and sale of Abbott and i-STAT products, as well as Abbott's competition with other entities, such as Epocal," and Greg Arnsdorf, who "is involved in marketing."9

Epocal asserts that this evidence could only be relevant to the issue of whether Abbott was harmed, or perceived that it was harmed, by Epocal's alleged misconduct, and for that reason it should be excluded from this phase of the trial, during which the jury will only be considering the issues of patent infringement liability, patent infringement willfulness, and tortious interference liability, exclusive of any element or proof related to the "fact of damages." Moreover, Epocal alleges that, even if some of the proposed evidence might be relevant to the issue of patent infringement injunctive relief, it should not be presented to the jury, because the issue of injunctive relief will be decided by the court, not the jury, and all evidence related to that issue will be presented at a later hearing, after the conclusion of the jury trial.

The court agrees that evidence of harm or perceived harm suffered by Abbott should not be presented to the jury during the "Phase One" trial, because any such evidence would contravene the court's bifurcation order, confuse the jury, and cause undue prejudice to Epocal's defense. Abbott does not even contest this central point.10 Indeed, Abbott admits that most of the exhibits cited by Epocal in its motion were only included in its trial exhibit list "for use at the post-trial injunctive hearing."11 Therefore, Epocal's motion will be granted as to those documents identified as Plaintiff's Exhibits ("PX") 273, 325-28, 354-56, 395, 403, 416, 418, 432, 438, and 449-51.

Even so, Abbott maintains that not all evidence "that might somehow involve `marketing,' `customers,' or `market competitive information'" should be excluded.12 Indeed, some of that evidence may be relevant to Epocal's intent to harm Abbott, which is an element of Abbott's tortious interference claim, or to Epocal's affirmative defense of unclean hands, which rests on the theory that Abbott filed this lawsuit in an effort to force Epocal out of the market.13 That may be, but is not necessarily, true. Thus, to preclude plaintiff's counsel from attempting to slip any of the excluded and prejudicial evidence through the back door of trial, counsel must first approach the bench and request a side-bar conference to discuss any of the foregoing evidence before it may be referred to or offered in the presence of the jury.

II. EPOCAL'S MOTION TO EXCLUDE ARGUMENTS AND EVIDENCE REGARDING EPOCAL'S FDA 510(k) SUBMISSIONS

In order to obtain approval from the federal Food and Drug Administration ("FDA") to market a new medical device, a company must submit a notification that the device is "substantially equivalent" to one that is already on the market (the "predicate device"). 21 U.S.C. § 360e(b)(1)(B). This notification is referred to as a "510(k) notification."14 The terms "substantially equivalent" and "substantial equivalence" have special meanings in the context of FDA 510(k) notifications. They mean that

21 U.S.C. § 360c(i)(1)(A).

Epocal submitted a 510(k) notification to the FDA regarding the "EPOC Blood Analysis System" in 2006.15 Epocal identified Abbott's i-Stat Analyzer as a predicate product, and it claimed that its own EPOC system was "substantially equivalent" to the i-Stat system.16 Epocal now seeks a ruling to prevent Abbott from using any evidence regarding Epocal's 510(k) submission. Epocal's primary argument is that Abbott should not be allowed to use such evidence to argue that Epocal's device infringes Abbott's patents under the Doctrine of . In response, Abbott makes clear that it will not be relying on the Doctrine of Equivalents to support its infringement claims at trial.17

Despite that concession, Abbott goes on to argue that, even if it cannot rely on Epocal's 510(k) notification to support a Doctrine of Equivalents theory, it should, nevertheless, be allowed to present evidence of factual statements made in Epocal's 510(k) submission — and, in particular, statements about how Epocal's device functions — for impeachment and other purposes. Abbott also argues that Epocal's characterization of the Epocal system as "substantially equivalent" to the i-Stat system is relevant, because Epocal's expert witnesses have been permitted to testify about comparisons between the i-Stat device and the EPOC system. According to Abbott,

Abbott does not cite any authority to support its argument, and, unfortunately for Abbott, there is ample authority supporting the opposite conclusion. The Federal Circuit has cautioned that evidence supporting a finding of "substantial equivalence" in the FDA 510(k) context should not be confused with the proof required to support a claim of patent infringement under the Doctrine of Equivalents. Indeed, as the Federal Circuit instructed in Abbott Laboratories v. Sandoz, Inc., 566 F.3d 1282 (Fed. Cir. 2009):

Id. at 1298 (footnote, alteration, and emphasis supplied). See also, e.g., The Johns Hopkins University v. Datascope Corp., 543 F.3d 1342, 1349 n.3 (Fed. Cir. 2008) ("FDA equivalence is irrelevant to patent law because it involves fundamentally different inquiries.").

Thus, as the district court noted in Ethicon Endo-Surgery, Inc. v. Hologic, Inc., 689 F.Supp.2d 929 (S.D. Ohio 2010), "[s]everal district courts have held that it is not proper to consider statements made in a FDA 510K notification." Id. at 936 (citing Abbott Laboratories. v. Sandoz, Inc., 486 F.Supp.2d 767, 776 (N.D. Ill. 2007); CardioVention, Inc. v. Medtronic, Inc., 483 F.Supp.2d 830, 840 (D. Minn. 2007); Sunrise Med. HHG, Inc. v. AirSep Corp., 95 F.Supp.2d 348, 405-06 (W.D. Pa. 2000); and Univ. of Fla. Research Foundation, Inc. v. Orthovita, Inc., No. 1:96-cv-82-MMP, 1998 WL 34007129 (N.D. Fla. Apr. 20, 1998)).

Abbott points out that all of the cited cases excluding evidence of FDA 510(k) submissions in patent infringement cases have done so in the context of a Doctrine of Equivalents analysis. None of the cases explicitly state that the same evidence could not be used for some other purpose, such as impeaching an expert witness, as Abbott proposes that the testimony be used here. Even so, the court concludes that the same reasons justifying exclusion of 510(k) evidence to support a theory of infringement under the Doctrine of Equivalents also support excluding the evidence for other purposes, including impeachment. Evidence of statements made and product descriptions given by Epocal in its 510(k) notifications might have some probative value for impeachment purposes, if Epocal attempts to offer a different description of the design or function of its device at trial. But the risk for prejudice and jury confusion as a result of that evidence is simply too high. There undoubtedly are similarities between Abbott's i-Stat device and Epocal's EPOC device. If there were not, Abbott's infringement claims in this suit probably would be frivolous. When Epocal was petitioning for FDA approval to market its device, it was in Epocal's best interest to highlight those similarities, so it could argue that its device and Abbott's i-Stat predicate device were "substantially equivalent." But the standard for "substantial equivalence" in the FDA-approval context is so different from the standards for evaluating the similarity of inventions in the patent infringement context that the jury could easily be confused about the significance of statements made to the FDA. Specifically, the jury could be misled into believing that Epocal's statements to the FDA — even descriptive statements about the design and function of Epocal's device — are supportive of patent infringement. The jury also could be misled into analyzing the evidence under something like a Doctrine of Equivalents theory, even though no such theory actually is being asserted here.

Accordingly, all evidence regarding Epocal's 510(k) submissions to the FDA — including both descriptive statements about the EPOC device, and statements about its "substantial equivalence" to Abbott's i-Stat predicate device — will be excluded. Abbott will not suffer undue prejudice as a result of this holding. If Epocal's expert witnesses testify that the EPOC system is different from the i-Stat device manufactured by Abbott, Abbott is free to cross-examine those witnesses using the testimony of its own expert witnesses, or the results of its own comparisons of the two devices. In other words, it will not be necessary, for impeachment purposes, for Abbott to show that Epocal gave a different description of its device, in a different context, to a different government agency. The parties' different analyses of the two competing products can speak for themselves.

III. EPOCAL'S MOTION TO EXCLUDE DOCUMENTS THAT USE CERTAIN CLAIM TERMS OUTSIDE THE CONTEXT OF THE PATENTS-IN-SUIT

Epocal next asks the court to exclude from evidence certain internal documents generated by Epocal during the design process for the EPOC device, as well as any deposition testimony regarding those documents.20 According to Epocal,

In response, Abbott argues that Epocal's own internal documentation is a valid source of information about the design of the EPOC device and how it works. Indeed, this court already decided in the memorandum opinion and order denying Epocal's Daubert motion to exclude the testimony of Dr. James Tusa, Abbott's expert witness, that Dr. Tusa was justified in relying upon Epocal's internal experimental data to form his opinions.22 Abbott also asserts that the internal Epocal documents could be relevant for impeachment of Dr. Imants Lauks, Epocal's founder, and Epocal's experts, Dr. William Olbricht and Dr. Ranil Wickramasinghe, who may offer testimony that contradicts the information contained in the internal documents.

The court recognizes both the probative value of this evidence to Abbott's case, and the potential for unfair prejudice that could result to Epocal if the jury disregards the court's claim constructions due to the use of key words like "equilibration" or "reservoir" in Epocal's internal documents. The court concludes that the best approach for balancing these two competing interests is that proposed by Epocal: i.e., Abbott will be permitted to present the contested documents to the jury, but the court will issue a limiting instruction explaining that the use of terms like "reservoir," "equilibrate," and "equilibration" in those documents is not necessarily consistent with the court's construction of those claim terms, and is not an admission by Epocal that its device meets any of the limitations of the asserted claims. The court also will remind the jury that they must apply the court's construction of the claim terms — not a construction of the terms that was used in some other context — to the Epocal device to decide infringement.23 Thus, Epocal's motion will be denied, and the court will address some of Epocal's concerns by use of a limiting instruction. Counsel for Epocal should present this court and opposing counsel a draft of a proposed limiting instruction on or before Friday, April 20, 2012. Any objection should be filed no later than the following Monday, April 23, 2012.

IV. EPOCAL'S MOTION TO EXCLUDE ARGUMENTS AND EVIDENCE REGARDING SOLICITATION OF EMPLOYEES OTHER THAN THE FIVE AT ISSUE IN ABBOTT'S TORTIOUS INTERFERENCE ALLEGATIONS

In support of its claim for tortious interference with contractual relationships, Abbott alleges that Epocal successfully solicited five employees — Dan McLain, Wendy Thompson, Mark Maund, Martin Bemer, and Peggy Wachowski — to terminate their employment with Abbott and begin working for Epocal.24 Epocal seeks to preclude Abbott from introducing evidence of any other employees who may also have been approached by Epocal, but who did not ultimately terminate their employment with Abbott.

Abbott uses its employee Lisa Reece as an example. On June 19, 2007, Jeff Baker, an Epocal employee, sent Reece an e-mail stating, in pertinent part: "We would like to try and recruit you to our company." Baker stated in another e-mail contents of the documents. The limiting instruction described above will be sufficient to eliminate any unfair prejudice or jury confusion. sent to Reece the following day, June 20, 2007: "Seriously, I would like to hire you. Things to think about? No company car, Large territory, Lower Base Salary but a larger upside and stock at the ground floor. You would do well working with all of us."25 During her September 10, 2010 deposition, Reece testified that Jeff Baker contacted her "periodically" to discuss her coming to work for Epocal. Reece sent her resume to Baker in late 2007, and the two individuals met in person to discuss the potential career move on three or four occasions. Epocal eventually made Reece a verbal job offer that included a higher salary than she earned at Abbott, but Reece rejected the offer because she felt Abbott was a good company to work for, and she believed in the i-Stat product.26

Epocal asserts that this evidence — and any similar evidence regarding other employees — should be excluded because it is not relevant to any fact in dispute, is improper character evidence, is unfairly prejudicial to Epocal, and would mislead the jury and confuse the issues. According to Epocal, any such evidence would "mislead the jury into inferring that Epocal also tried to recruit the five Abbott employees whom it hired."27

The essence of Epocal's arguments is Federal Rule of Evidence 404, which provides, in pertinent part, that: "Evidence of a person's character or character trait is not admissible to prove that on a particular occasion the person acted in accordance with the character or trait." Fed. R. Evid. 404(a). Under that rule, if Abbott was offering the evidence about Lisa Reece and other employees to suggest to the jury that, since Epocal (albeit unsuccessfully) attempted to recruit Reece, it must also have recruited McLain, Thompson, Maund, Bemer, and Wachowski, it would be inadmissible.

Abbott asserts, however, that evidence of Epocal's alleged attempts to lure other employees away from Abbott's employment falls under an exception to Rule 404(a), allowing such evidence to be admitted for the purpose of proving a matter — such as intent or motive — other than action in conformity with the actor's alleged character or prior bad actions. See Fed. R. Evid. 404(b)(2) ("This evidence may be admissible for another purpose, such as proving motive, opportunity, intent, preparation, plan, knowledge, identity, absence of mistake, or lack of accident."). The Eleventh Circuit has elaborated on that exception:

United States v. Calderon, 127 F.3d 1314, 1330-31 (11th Cir. 1997) (quoting United States v. Diaz-Lizaraza, 981 F.2d 1216, 1224 (11th Cir. 1993), and citing United States v. Beechum, 582 F.2d 898 (5th Cir.1978)28 (en banc), cert. denied, 440 U.S. 920 (1979)).

According to Abbott, evidence of Epocal's attempts to lure other employees away from Abbott could be relevant to prove Epocal's intent and motive, both of which are essential elements of its tortious interference claim. Under New Jersey law, which the parties agree applies to Abbott's tortious interference claim:

Printing Mart-Morristown v. Sharp Electronics Corp., 563 A.2d 31, 37 (N.J. 1989). See also Deluxe Bldg. Systems, Inc. v. Constructamax, Inc., No. 06-2996(ES), 2012 WL 967362, at * 3-4 (D. N.J. March 21, 2012) (slip copy) (citing the same elements); Gaelick v. Connecticut General Life Ins. Co., No. 11-2464(SRC), 2011 WL 3794228, at *2 (D. N.J. Aug. 25, 2011) (slip copy) (same).

In the tortious interference context, "`Interference is intentional "if the actor desires to bring it about or if he knows that the interference is certain or substantially certain to occur as a result of his action."'" Gaelick, 2011 WL 3794228, at *3 (quoting Cedar Ridge Trailer Sales, Inc. v. National Community Bank of New Jersey, 312 N.J.Super. 51, 711 A.2d 338, 345 (N.J. Super. Ct. App. Div. 1998)). Thus, implicit in the meaning of the term "malice" in the context of a tortious interference claim under New Jersey law is "acceptance of the principle that the requisite intent may be either a specific intent to interfere with the contract or the taking of improper action with knowledge that interference will probably result." Velop, Inc. v. Kaplan, 693 A.2d 917, 926 (N.J. Super. Ct. App. Div. 1997).

The court agrees with Abbott that evidence of Epocal's unsuccessful attempts to hire away Abbott's employees could be relevant to prove Epocal's "intent" to hire away the employees who actually are the subject of Abbott's claim. Therefore, the evidence could be admissible under Federal Rule of Evidence 404(b)(2), even if it would otherwise be inadmissible under Rule 404(a) or 404(b)(1). Furthermore, such evidence would be relevant to Abbott's tortious interference claim, in that Epocal's alleged solicitation of Lisa Reece occurred during approximately the same time period of its alleged solicitation of Dan McLain, Wendy Thompson, Mark Maund, Martin Bemer, and Peggy Wachowski, and it happened in a similar manner: i.e., Jeff Baker contacted some of the other employees on Epocal's behalf, just as he had contacted Lisa Reece. Finally, the court concludes that the risk of unfair prejudice to Epocal if the jury hears such evidence does not outweigh the probative value of the evidence to Abbott. If necessary, the jury can be provided with a limiting instruction that the evidence should only be considered in determining Epocal's intent, not to demonstrate that, just because Epocal may have attempted to hire away Reece, it also attempted to hire away McLain, Thompson, Maund, Bemer, and Wachowski. See Calderon, 127 F.3d at 1333 (holding that "any unfair prejudice that may have existed was mitigated by the district judge's limiting instruction"). Again, counsel for Epocal should present this court and opposing counsel a draft of a proposed limiting instruction on or before Friday, April 20, 2012. Any objection should be filed no later than the following Monday, April 23, 2012.

In summary, Abbott will be permitted to present evidence regarding Epocal's alleged attempts to hire away Lisa Reece, as well as similar evidence regarding other employees, as long as Epocal's alleged solicitation of other employees occurred during approximately the same time period, and in a similar manner, as the alleged solicitation of the five employees made the basis of Abbott's tortious interference claim.

V. CONCLUSION AND ORDERS

In accordance with the foregoing, Epocal's motion to exclude evidence and argument that Abbott has been harmed by Epocal's alleged conduct is GRANTED in part, with regard to PX 273, 325-28, 354-56, 395, 403, 416, 418, 432, 438, and 449-51. In all other respects, the motion is DENIED, but counsel are cautioned that they must comply with all imitations on the presentation of evidence set forth in this memorandum opinion and order.

Epocal's motion to exclude evidence and argument regarding its FDA 510(k) submissions is GRANTED. No evidence regarding Epocal's FDA 510(k) submissions will be allowed at trial by either party.

Epocal's motion to exclude documents that use certain claim terms outside the context of the patents-in-suit is DENIED, but a limiting instruction will be issued. Counsel for Epocal should present this court and opposing counsel a draft of a proposed limiting instruction on or before Friday, April 20, 2012. Any objection should be filed no later than the following Monday, April 23, 2012.

Epocal's motion to exclude arguments and evidence regarding solicitation of employees other than the five at issue in Abbott's tortious interference allegations is DENIED, but a limiting instruction may be issued if necessary. Again, counsel for Epocal should present this court and opposing counsel a draft of a proposed limiting instruction on or before Friday, April 20, 2012. Any objection should be filed no later than the following Monday, April 23, 2012.

DONE and ORDERED.