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Bone Care International, LLC v. PenTech Pharmaceuticals

September 30, 2010

BONE CARE INTERNATIONAL, LLC AND GENZYME CORPORATION, PLAINTIFFS,
v.
PENTECH PHARMACEUTICALS, INC., AND COBREK PHARMACEUTICALS, INC., DEFENDANTS.



The opinion of the court was delivered by: Judge Robert M. Dow, Jr.

MEMORANDUM OPINION AND ORDER

Pending before the Court are nine motions in limine filed by both parties [345, 399, 403, 406, 409, 412, 414, 417, 424], as well as Defendants' motion to file instanter a reply to one of Plaintiffs' motions in limine [471]. Several of these motions are addressed below [399, 409, 412, 414, 417, 471]. The Daubert-related motions, as well as the objection to Judge Ashman's ruling, will be addressed in a separate opinion. For the reasons set forth below, the Court denies four motions in limine [399, 412, 414, and 417], and grants in part and denies in part one motion in limine [409]. In addition, the Court grants Defendants' motion to file instanter a reply brief [471].

I. Legal Standard

A motion in limine is a motion "at the outset" or one made "preliminarily." BLACK'S LAW DICTIONARY 803 (8th ed. 2004). The power to rule on motions in limine inheres in the Court's role in managing trials. Luce v. United States, 469 U.S. 38, 41 n.4 (1984). Motions in limine may be used to eliminate evidence "that clearly ought not be presented to the jury because [it] clearly would be inadmissible for any purpose." Jonasson v. Lutheran Child & Family Svcs., 115 F.3d 436, 440 (7th Cir. 1997) (observing that, when used properly, the motions may sharpen the issues for trial). The party seeking to exclude evidence has the burden of demonstrating that the evidence would be inadmissible for any purpose. Robenhorst v. Dematic Corp., 2008 WL 1766525, at *2 (N.D. Ill. Apr. 14, 2008).

Because motions in limine are filed before the Court has seen or heard the evidence or observed the trial unfold, rulings in limine may be subject to alteration or reconsideration during the course of trial. United States v. Connelly, 874 F.2d 412, 416 (7th Cir. 1989); see also Luce, 469 U.S. at 41-42 (holding that "even if nothing unexpected happens at trial, the district judge is free, in the exercise of sound judicial discretion, to alter a previous in limine ruling"). In addition, if the in limine procedural environment makes it too difficult to evaluate an evidentiary issue, it is appropriate to defer ruling until trial. Jonasson, 115 F.3d at 440 (delaying until trial may afford the judge a better opportunity to estimate the evidence's impact on the jury).

These limiting principles apply in all trial settings, but they have even greater force in a bench trial, because the trial judge has flexibility to provisionally admit testimony or evidence and then discount or disregard it if upon further reflection it is entitled to little weight or should not have been admitted at all. See, e.g., SmithKlineBeecham Corp. v. Apotex, Corp., 247 F. Supp. 2d 1011, 1042 (N.D. Ill. 2003) (Posner, J.) ("In a bench trial it is an acceptable alternative to admit evidence of borderline admissibility and give it the (slight) weight to which it is entitled"), aff'd on other grounds, 403 F.3d 1331 (Fed Cir. 2005); Barna v. United States, 183 F.R.D. 235, 239 (N.D. Ill. 1998) ("motions in limine to strike party experts are of less importance in bench trials").

II. Analysis

A. Plaintiffs' Fourth Motion in Limine to Preclude Testimony Regarding Defendants' New and Abandoned Validity and Priority Connections

Plaintiffs' fourth motion in limine [409] asks the Court to bar Defendants from introducing evidence on the issue of whether claim 7 of the '116 patent is invalid for any ground other than obviousness, pursuant to 35 U.S.C. § 103. Plaintiffs contend that other defenses asserted by Defendants-namely, invalidity based on anticipation, insufficient written description, nonenablement, indefiniteness, and lack of utility-were abandoned and revived only at such a late date that Plaintiffs would be prejudiced by introduction of evidence of those defenses at trial. For the reasons set forth below, the Court grants Plaintiffs' motion in limine with respect to evidence of indefiniteness and lack of utility, and denies the motion with respect to evidence of anticipation, insufficient written description, and nonenablement.

In a suit for infringement of a patent, the party accused of infringement may raise a defense of invalidity of the patent. 35 U.S.C. § 282. The invalidity defense may rest on grounds of failure to satisfy the conditions of patentability set forth in 35 U.S.C. § 100-103or failure to comply with the conditions for claiming the benefit of a priority filing date under § 112. 35 U.S.C. §§ 101-103, 112 ¶ 1. Sections 101, 102, and 103set forth the conditions of patentability, including utility of the patent (§ 101), lack of anticipation of the invention (§ 102), and non-obviousness of the invention (§103). 35 U.S.C. §§ 101-03. Section 112 enumerates three requirements for claiming the benefit of the earlier filing date of a related, ancestor application under § 120: the ancestor application must (1) provide a written description of, (2) enable a person skilled in the art to make, and (3) set forth the best mode contemplated by the inventor for carrying out the same invention described in the later application.*fn1 35 U.S.C. §§ 112, ¶ 1, 120.

In their answer [227] to Plaintiffs' second amended complaint alleging infringement of the '116 patent [197], Defendants raised counterclaims of invalidity on several grounds. Specifically, Defendants alleged that: "[t]he '116 patent is invalid under one or more provisions of 35 U.S.C. § 101, et seq. including sections 103 and 112," "is invalid under 35 U.S.C. § 102", and "is obvious over the prior art under 35 U.S.C. § 103 and thus is invalid." Defs.' Ans. ¶¶ 35-37. Plaintiffs submitted contention interrogatories asking Defendants to specify the factual and legal bases for their allegations that the patents were invalid under §§ 101 (lack utility), 102 (anticipation), 103 (obviousness), and 112 and 120 (lack of entitlement to priority filing date based on insufficient written description and non-enablement). In their responses to the contention interrogatories, Defendants provided the factual and legal bases for their contentions of obviousness of claim 7 under § 103 and of insufficient written description of Example 4 in claim 7 under §§ 112 and 120. Defendants did not provide the bases for their invalidity arguments regarding claim 7 as to lack of utility under § 101 and anticipation under § 102. Plaintiffs state that Defendants' experts failed to address any defense theory except obviousness in their opening or rebuttal reports.

In light of the omissions in the interrogatory responses and experts' reports, Plaintiffs argue that Defendants have abandoned all of the defenses asserted in their answer with the exception of obviousness. See Advanced Cardiovascular Sys., Inc. v. Medtronic, Inc., 41 U.S.P.Q.2d 1770, 1773 (N.D. Cal. 1996) ("since [35 U.S.C.] sections 101, 102, 103, and 112 provide numerous grounds for finding a patent invalid, defendant must provide a more specific statement of the basis for this defense in order to give [plaintiff] fair notice of the claims being asserted"); Qarbon.com, Inc. v. eHelp Corp., 315 F. Supp. 2d 1046, 1050 (N.D. Cal. 2004) (same); TecSec, Inc. v. Protegrity, Inc., 2001 WL 802064 at *2 (E.D. Va. Jun. 27, 2001) (same); Daiichi Pharm. Co. v. Apotex, Inc., 2005 U.S. Dist. LEXIS 26059 (D.N.J. Nov. 1, 2005) (same). Plaintiffs further assert that, after abandoning those defenses, Defendants only raised anew the grounds of anticipation, insufficient written description, nonenablement, indefiniteness, and lack of utilityso late in the game that Plaintiffs lack sufficient time to prepare adequate responses.*fn2

Because none of those defenses were disclosed in Defendants' experts' reports, Plaintiffs contend that Defendants have violated Federal Rule of Civil Procedure 26(a)(2)(B), and that the proper sanction is to exclude all evidence of these grounds for invalidity pursuant to Rule 37(c)(1). Fed. R. Civ. P. 26(a)(2)(B), 37(c)(1).

Federal Rule of Civil Procedure 26(a)(2)(B) provides that experts whom a party may use at trial must prepare written reports that include "a complete statement of all opinions the witness will express and the basis and reasons for them; [and] the data or other information considered by the witness in forming them * * *." Fed. R. Civ. P. 26(a)(2)(B)(i)-(ii). The sanctions for violating Rule 26(a) and (e) are severe: "If a party fails to provide information or identify a witness as required by Rule 26(a) or 26(e), the party is not allowed to use that information or witness to supply evidence on a motion, at a hearing, or at a trial, unless the failure was substantially justified or is harmless." Fed. R. Civ. P. 37(c)(1). The Seventh Circuit has established a four-factor test for evaluating whether Rule 37 sanctions are warranted: (1) prejudice or surprise to party against whom evidence is offered; (2) ability of the party to cure the prejudice; (3) likelihood of disruption to the trial; (4) the proffering party's bad faith or willfulness in not disclosing evidence at an earlier date. David v. Caterpillar, Inc., 324 F.3d 851, 857 (Fed. Cir. 2003). Not all four factors need be met; preclusion of the untimely or insufficiently disclosed evidence is "automatic and mandatory" where the violation is unjustified and harms the party. Finley v. Marathon Oil Co., 75 F.3d 1225, 1230 (7th Cir. 1996).

Plaintiffs argue that preclusion of evidence on anticipation, insufficient written description, nonenablement, lack of utility, and indefiniteness is warranted under Rule 37 because all four of the David factors are met. Plaintiffs assert that they will be harmed at trial as a result of their inability to review the defenses and prepare responses in the short amount of time before trial. They further assert that the only cure for the prejudice-postponing the trial- could cause other harmful consequences, as they have specially sought an early trial date in order to forestall the possibility that Defendants will launch at risk their generic version of the '116 patent drug. Plaintiffs contend that introduction of evidence relevant to these defenses will disrupt the trial by diverting significant resources of the parties and the Court. Finally, they state that Defendants "have no good faith explanation" for failing to meet their Rule 26 obligations as to these defenses.

In response, Defendants do not point to any evidence that their experts addressed defenses other than obviousness in their reports-which is tantamount to conceding a Rule 26(a)(2)(B) violation. Defendants contend, however, that no sanction should be imposed under the four David factors. Preliminarily, Defendants state that they identified in their answer anticipation, insufficient written description, nonenablement, and lack of utility as grounds of invalidity-thus putting Plaintiffs on sufficient notice-and never abandoned them thereafter. Defendants then present an assortment of reasons why each of the allegedly abandoned defenses will not prejudice Plaintiffs.

Defendants argue that the defense of anticipation is so substantially related to the defense of obviousness as to be effectively indistinct from it. "Anticipation requires the presence in a single prior art disclosure of all elements of a claimed invention arranged as in the claim. A prior art disclosure that 'almost' meets that standard may render the claim invalid under § 103; it does not 'anticipate.'" Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1549 (Fed. Cir. 1983) (internal citations omitted). Defendants contend that if they can show anticipation, they also will succeed in showing obviousness. See Johns Hopkins University v. CellPro, Inc., 152 F.3d 1342, 1357 n.21 (Fed. Cir. 1998) (holding that "a disclosure that anticipates under § 102 [anticipation] also renders the claim invalid under § 103 [obviousness]") (citing Connell, 722 F.2d at 1549). The converse is not necessarily true, however: because the anticipation standard is stricter- requiring the presence in a prior art disclosure of all, not merely most, elements of a claimed invention arranged in the same way-a claim that is invalid as obvious under § 103 is not necessarily invalid as anticipated under § 102. Nevertheless, the Court notes that in this case the same prior art is at issue and the same analysis applies for both the anticipation and the obviousness defenses. To the extent that evidence as to anticipation at trial would prejudice Plaintiffs at all, the harm would be de minimus, and Plaintiffs would have had the opportunity to cure it by preparing a response to the defense during the approximately five months between the initial work on the pre-trial order and trial. Nor is the Court persuaded that presentation of evidence on anticipation will disrupt trial in light of its similarity to the evidence that the Court will consider as to obviousness. Finally, the Court does not find that there is any evidence that Defendants acted in bad faith in failing to discuss anticipation in their experts' reports. Plaintiffs' assertion that Defendants lack a good faith motive is insufficient to satisfy this factor of the David test. The Court therefore denies Plaintiffs' motion in limine with respect to evidence of anticipation.

Defendants also argue that Plaintiffs will not prejudiced by introduction of evidence purporting to show insufficient written description and nonenablement under § 112 to dispute Plaintiffs' claim to priority under § 120. The Court agrees. As discussed in its opinion denying summary judgment on Defendants' counterclaims and affirmative defenses F and G [498], Plaintiffs bear the burden of putting forth evidence showing that that the '116 patent is entitled to the benefit of its parent application's filing date under § 120 through satisfaction of the written description and enablement requirements of § 112. See Tech. Licensing Corp., v. Videotek, Inc., 545 F.3d 1316, 1327-29 (Fed. Cir. 2008). Defendants have the ultimate burden of proving by clear and convincing evidence that the '116 patent is entitled only to the later filing date of the application from which it issued because of insufficient written description and nonenablement. Id. The Court denied Plaintiffs' motion for summary judgment of Defendants' counterclaims and affirmative defenses F and G precisely because it determined that Defendants had shown the existence of genuine issues of material fact as to whether the written description and enablement requirements could be satisfied. (See also the related decision on Defendants' motion in limine to preclude evidence of Plaintiffs' claim of priority, infra Section II.C.) In light of the fact that the written description and enablement requirements will be key issues during Plaintiffs' case-in-chief, and thus also will be a focus during Defendants' cross-examination, the Court finds that Plaintiffs will not be prejudiced, nor will the trial be disrupted, by introduction of evidence on these issues. The Court therefore denies Plaintiffs' motion in limine with respect to evidence of insufficient written description and nonenablement.

Finally, Defendants argue that they are justified in raising new defenses of invalidity based on indefiniteness and lack of utility in light of the Court's construction of the claim "effective amount." [363, 468] Defendants state that Plaintiffs will not suffer prejudice by evidence of indefiniteness or lack of utility as the defenses are "uncomplicated" and will not require additional fact discovery. The Court finds that Defendants' argument as to indefiniteness of the construed term of the claim likely has been rendered moot by the Court's revised claim construction opinion. [468] To the extent that Defendants still intend to assert evidence as to indefiniteness, the Court grants Plaintiffs' motion in limine to preclude such evidence. Because the defense is not sufficiently enmeshed with other issues in the case as to overcome the prejudice to Plaintiffs or disruption of the trial from the late disclosure, the Court concludes that preclusion of the evidence under Rule 37(c)(1) is warranted.

The Court also finds that Plaintiffs may suffer prejudice with respect to the lack of utility defense. Defendants provide no justification as to why, aside from the boilerplate language in their answer, they addressed this defense only in their June 2010 reply to their first Daubert motion [376] and in their response [380] that same month to Plaintiffs' motion for summary judgment on counterclaims F, G, and IX [336]. Defendants have elsewhere explained that utility and enablement are related requirements for a patent, and that a patent that lacks utility also does not enable. See infra at II.C (discussing In re '318 Patent Infringement Litigation, 583 F.3d 1317, 1323-24 (Fed. Cir. 2009)); Defs.' Resp. to Pls.' Mot. for Summ. J. at 16 (same). Defendants do not provide a similar explanation-or indeed any description of what the defense of lack of utility entails-in their opposition to this motion in limine. Nor do they aver that the analysis for a claim of lack of utility is similar to that for nonenablement (in contrast to their assertion, discussed above, that Plaintiffs would not be prejudiced by evidence of anticipation because the analysis and evidence offered in support of the anticipation defense would be the same as that necessary for the defense of obviousness). Indeed, all that Defendants posit with respect to the defense of lack of utility is that it is "uncomplicated" and "would require no additional fact discovery for either party." Yet, even a defense so allegedly "uncomplicated" merits fuller explication and supporting information, and in a timelier manner, than Defendants have provided.

In light of the late and scant assertions of lack of utility, the Court concludes that Plaintiffs would suffer prejudice by introduction of evidence on this new defense that Plaintiffs would be forced to counter. Postponing the trial to cure the prejudice is an unavailable alternative in light of the imminence of trial and the desire of both parties to proceed on the current schedule. Although Plaintiffs have failed to show affirmative evidence of Defendants' bad faith in failing to present lack of utility in their experts' reports, the Court nevertheless finds that, on ...


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