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Bone Care International LLC v. Pentech Pharmaceuticals

October 1, 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

Before the Court are several Daubert motions brought by the parties in this patent litigation: Defendants' Motion to Preclude Trial Testimony of Dr. Lee-Jen Wei [345], Plaintiffs' Motion to Preclude the Testimony of Michael Sofocleous [406], and Plaintiffs' Motion to Preclude Defendants' Experts from Providing Speculative Testimony on the Issues of Intent for Inequitable Conduct and the Facts Supporting Date of Conception [424]. For the reasons and to the extent stated below, each of the motions [345, 406, 424] is granted in part and denied in part.

I. Legal Framework for Rule 702 Analysis

Federal Rule of Evidence 702 and the Supreme Court's decision in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), provide the legal framework for the admissibility of expert testimony. See United States v. Pansier, 576 F.3d 726, 737 (7th Cir. 2009).*fn1 Rule 702 permits the admission of expert testimony if "scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue." Fed. R. Evid. 702. Rule 702 requires that the district court act as a "'gatekeeper' who determines whether proffered expert testimony is reliable and relevant before accepting a witness as an expert." Winters v. Fru-Con Inc., 498 F.3d 734, 741-42 (7th Cir. 2007) (quoting Autotech Tech. Ltd. P'ship v. Automationdirect.com, 471 F.3d 745, 749 (7th Cir. 2006)); see also Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 147-49 (1999); Daubert, 509 U.S. at 589.

In assessing a motion to exclude testimony under Rule 702, the Court must consider whether the proposed opinion witness (1) is qualified to offer opinion testimony under Rule 702, (2) has employed a reliable methodology, (3) proposes to offer opinions that follow rationally from the application of his "knowledge, skill, experience, training, or education," and (4) presents testimony on a matter that is relevant to the case at hand, and thus helpful to the trier of fact. See Kumho Tire, 526 U.S. at 151-53; Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997); Daubert, 509 U.S. at 589-93; see also Walker v. Soo Line R. R. Co., 208 F.3d 581, 586 (7th Cir. 2000). "The proponent of the expert bears the burden of demonstrating that the expert's testimony would satisfy the Daubert standard." Lewis v. CITGO Petroleum Corp., 561 F.3d 698, 705 (7th Cir. 2009).District judges possess considerable discretion in dealing with expert testimony. Carroll v. Otis Elevator Co., 896 F.2d 210, 212 (7th Cir. 1990); see also Gen. Elec. Co., 522 U.S. at 141-43 (holding that abuse of discretion standard applies in reviewing district court rulings on admissibility of proposed Rule 702 opinion testimony).

In regard to qualifications, Federal Rule of Evidence 702 allows parties to introduce expert opinions if the expert has the requisite "knowledge, skill, experience, training, or education." Anyone who has relevant expertise and can offer responsible opinion testimony that is helpful to a judge or jury may qualify as an expert witness. See Tuf Racing Prod., Inc. v. Am. Suzuki Motor Corp., 223 F.3d 585, 591 (7th Cir. 2000). In assessing an expert's qualifications, a court should consider the proposed expert's full range of education, experience, and training. LG Elec. U.S.A., Inc. v. Whirlpool Corp., 661 F. Supp. 2d 940, 951 (N.D. Ill. 2009). In addition, given that "[m]odern science is highly specialized," a court must take care to confirm that a proposed expert is qualified to offer opinion testimony in the specific area of his or her proposed testimony. Braun v. Lorrillard, Inc., 84 F.3d 230, 235 (7th Cir. 1996).

Daubert lists a number of relevant considerations in evaluating an expert's reasoning and methodology -- including testing, peer review, error rates, and acceptability in the relevant scientific community. Daubert at 593-94. "[T]he test of reliability is flexible," however, "and Daubert's list of specific factors neither necessarily nor exclusively applies to all experts or in every case." Kumho, 526 U.S. at 141 (internal quotation omitted). "Rather the law grants a district court the same broad latitude when it decides how to determine reliability as it enjoys in respect to its ultimate reliability determination." Id. at 142 (emphasis omitted); see also Pansier, 576 F.3d at 737 (the Seventh Circuit "gives the [district] court great latitude in determining not only how to measure the reliability of the proposed expert testimony but also whether the testimony is, in fact, reliable") (emphasis omitted) (citing Jenkins v. Bartlett, 487 f.3d 482, 489) (7th Cir. 2007); Lewis, 561 F.3d at 704-05 ("the law grants the district court great discretion regarding the manner in which it conducts that [Daubert] evaluation").

In assessing the admissibility of proposed expert testimony, the Court's "focus, of course, must be solely on principles and methodology, not on the conclusions that they generate." Daubert, 509 U.S. at 595. However, as the Supreme Court has recognized, "conclusions and methodology are not entirely distinct from one another," and while "[t]rained experts commonly extrapolate from existing data[,] * * * nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert." Gen. Elec., 522 U.S. at 146. In other words, "[a]n expert who supplies nothing but a bottom line supplies nothing of value to the judicial process." Wendler & Ezra, P.C. v. Am. Int'l Grp., Inc., 521 F.3d 790, 791-92 (7th Cir. 2008) (quoting Mid-State Fertilizer Co. v. Exch. Nat'l Bank, 877 F.2d 1333, 1339 (7th Cir. 1989)). To ensure that the expert's conclusions follow reliably from his or her methods, the Seventh Circuit has stressed that "the district court is responsible for making sure that when scientists testify in court they adhere to the same standards of intellectual rigor that are demanded in their professional work." Braun, 84 F.3d at 234. In short, "[i]t is critical under Rule 702 that there be a link between the facts or data the expert has worked with and the conclusion the expert's testimony is intended to support." United States v. Mamah, 332 F.3d 475, 478 (7th Cir. 2003). Where that link is missing, "[a] court may conclude that there is simply too great an analytical gap between the data and the opinion proffered." Gen. Elec.,522 U.S. at 146.

Finally, it is important to bear in mind the Seventh Circuit's teaching about the critical distinction between a jury trial and a bench trial with respect to the Rule 702 inquiry:

Where the gatekeeper and the factfinder are one and the same -- that is, the judge -- the need to make such decisions prior to hearing the testimony is lessened. See United States v. Brown, 415 F.3d 1257, 1268-69 (11th Cir. 2005). That is not to say that the scientific reliability requirement is lessened in such situations; the point is only that the court can hear the evidence and make its reliability determination during, rather than in advance of, trial. Thus, where the factfinder and the gatekeeper are the same, the court does not err in admitting the evidence subject to the ability later to exclude it or disregard it if it turns out not to meet the standard of reliability established by Rule 702.

In re Salem, 465 F.3d 767, 777 (7th Cir. 2006); see also Metavante Corp. v. Emigrant Sav. Bank, ___ F.3d ___, 2010 WL 3385961, at *7 (7th Cir. Aug. 30, 2010) (observing that "the court in a bench trial need not make reliability determinations before evidence is presented" because "the usual concerns of the rule -- keeping unreliable expert testimony from the jury -- are not present in such a setting"); Brown, 415 F.3d at 1269 ("There is less need for the gatekeeper to keep the gate when the gatekeeper is keeping the gate only for himself"). Under this sensible approach, where there is no jury demand, and therefore the judge will be the trier of fact at trial, the Court may choose to (1) allow the presentation of borderline testimony, (2) subject the testimony to the rigors of cross-examination, and (3) decide later whether the testimony is entitled to some consideration or whether it should be excluded as irrelevant, unreliable, or both. Nevertheless, at some point before disposition of the case, the court "must provide more than just conclusory statements of admissibility or inadmissibility to show that it adequately performed its gatekeeping function." Metavante Corp., 2010 WL 3385961, at *7.

II. Analysis

A. Defendant's Motion to Preclude Trial Testimony of Dr. Wei

Defendants have filed a motion in limine [345] to preclude Plaintiffs from presenting evidence at trial that pertains to biostatistical expert Dr. Lee-Jen Wei's report comparing the results of two clinical studies that administered different vitamin D analogs to patients suffering hyperparathyroidism secondary to end-stage renal failure. Defendants contend that Dr. Wei's report is the product of unreliable methodology and will not be helpful to the trier of fact.

By way of background, Defendants seek to prove that claim 7 of the '116 patent is invalid on the ground of, inter alia, obviousness under 35 U.S.C. § 103. Section 103 states that an issued patent may be invalid if the "subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains." 35 U.S.C. § 103(a). A patentee may rebut a claim of obviousness of the invention by putting forth evidence of so-called "secondary considerations" of non-obviousness. Graham v. John Deere, Co., 383 U.S. 1, 17-18 (1966). One such secondary consideration may be that the invention produced such "unexpected results" that it could not have been obvious to a person of ordinary skill in the art at the time of the invention. Sud-Chemie, Inc. v. Multisorb Tech., Inc., 554 F.3d 1001, 1009 (Fed. Cir. 2009).

Claim 7 of the '116 patent teaches a method of lowering levels of parathyroid hormone ("PTH") in patients with hyperparathyroidism secondary to end-stage renal failure by administering an effective amount of the drug doxercalciferol, a vitamin D2 analog. Defendants posit that prior art relating to use of the drug calcitriol, a vitamin D3 analog, made the claim 7 invention obvious, since calcitriol was known to persons skilled in the art at the time to reduce PTH. Plaintiffs counter that the invention of administering doxercalciferol to secondary hyperparathyroidism patients yielded results so unexpected that it was non-obvious. The alleged unexpected result was that, unlike calcitriol, doxercalciferol did not cause the side effect of hypercalcemia (elevated levels of calcium in the bloodstream, potentially so high as to be poisonous). In other words, doxercalciferol allegedly proved unexpectedly less toxic than other methods of treatment that a person of ordinary skill in the art would have been aware of at the time.

In support of the "unexpected results" secondary consideration, Plaintiffs retained Dr. Wei, a statistician, to provide an expert comparison of two clinical studies: (1) the "Sprague" study,*fn2 describing hypercalcemia levels in secondary hyperparathyroidism patients treated with calcitriol, and (2) an internal Bone Care clinical study, known as "H-114", describing hypercalcemia levels in secondary hyperparathyroidism patients treated with doxercalciferol. As Dr. Wei acknowledged, the scope of his assignment was quite narrow: he was simply to provide a statistical comparison of the incidence rates of hypercalcemia in patients treated with equipotent doses of calcitriol and doxercalciferol as shown by the Sprague and the H-114 studies, respectively. In carrying out that assignment, Dr. Wei undertook a comparative analysis of the two studies using "Poisson distribution," a method that counts the probability that a particular number of events will occur across a fixed period of time based on certain assumptions. In his expert report of October 30, 2009, Dr. Wei concluded that "treatment with doxercalciferol is significantly safer than treatment with calcitriol" due to the lower incidence of hypercalcemia with doxercalciferol treatment. (Dr. Lee-Jen Wei, Expert Report, at 6 (Oct. 30, 2009).)

After submitting the October 2009 report, Dr. Wei received electronic patient level data ("SAS" data) from Plaintiffs regarding the H-114 study that enabled him to confirm the results of his analysis. Also, subsequent to the submission of Dr. Wei's initial expert report, Dr. Langman, a nephrologist whom Plaintiffs had retained as an expert, accounted for clinically significant variables of the Sprague and H-114 studies, and thereby confirmed the results Dr. Wei had put forth in his October 2009 report. Dr. Wei acknowledged during his deposition that the confirmatory steps that the SAS data and Dr. Langman's review enabled were necessary to a reliable methodology. He further acknowledged that he had not taken either step as of the filing of his October 2009 report. Dr. Wei filed a second expert report after receiving the SAS data that, he contends, confirmed and provided further explanation of the results reported in his first report. The second report was stricken by Magistrate Judge Ashman as untimely on June 8, 2010. [372] Thus, Dr. Wei's October 2009 report is the only report that is properly before the Court for consideration in this trial.

Defendants ask the Court to preclude (1) Dr. Wei from testifying at trial as to the statistical analysis set forth in his expert report; and (2) Plaintiffs from offering any evidence, testimonial or otherwise, comparing the Sprague and H-114 studies unless Plaintiffs can lay a foundation that the methodologies are the same between the two studies.*fn3 Defendants submit that any evidence presented on the basis of Dr. Wei's comparison of the two studies is unreliable due to the allegedly flawed methodology that he employed in his analysis, and would not be helpful to the trier of fact.

1. Dr. Wei's Testimony

As a threshold matter, Defendants do not challenge Dr. Wei's credentials as an expert in statistics; Dr. Wei holds a Ph.D. in statistics and is a tenured professor of biostatistics at Harvard University. But Defendants argue that the methodology that Dr. Wei employed in the October 2009 report, based on the data and resources available to him at the time,*fn4 was so incomplete that the conclusions set forth in his report are unreliable and unhelpful to the Court (as the trier of fact). In short, Defendants submit that Dr. ...


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