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The Medicines Co. v. Mylan Inc.

United States District Court, N.D. Illinois, Eastern Division

March 27, 2014



AMY J. ST. EVE, District Judge.

Plaintiff The Medicines Company's ("TMC") has moved to preclude certain opinions of Dr. Ian McKeague offered by Defendant Mylan Inc., Mylan Pharmaceuticals Inc., and Bioniche Pharma USA, LLC (collectively, "Mylan"), pursuant to Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). For the reasons discussed below, the Court grants in part and denies in part TMC's motion.


This action arises out of a patent infringement case involving U.S. Patent No. 7, 582, 727 (R. 358-1, "the 727 Patent") The 727 patent "relates to a compounding process for preparing a pharmaceutical batch(es) of a drug product or a pharmaceutical formulation(s) comprising bivalirudin as an active ingredient." ( Id., 727 patent at col. 2 ll. 29-32) Bivalirudin is the active ingredient in TMC's Angiomax® drug product, an injectable anticoagulant used to prevent blood clotting during coronary procedures. TMC has sold Angiomax® since 2001. Before expiration of the patents-in-suit, Mylan submitted Abbreviated New Drug Application ("ANDA") No. 202471 to the U.S. Food and Drug Administration ("FDA"), seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of a generic equivalent to Angiomax®. TMC claimed that Mylan's ANDA No. 202471 infringes several claims of the patents-in-suit.

On June 21, 2013, Defendant moved for summary judgment of non-infringement or, in the alternative, invalidity, of the '727 patent. (R. 276, Mylan Open Br.) The Court granted in part and denied in part Defendants' motion for summary judgment of non-infringement, invalidity, and willful infringement.[1] (R. 309, Mem, Op, & Order) To support its invalidity theories as to the '727 patent, Mylan disclosed the Expert Report of Ian McKeague, Ph.D. (R. 330-1, McKeague Open Report) In the report, Dr. McKeague opined, in part, that the calculations provided in Table 6 of the '727 patent failed to disclose the true nature of the underlying data. Table 6 lists the mean, standard deviation, and maximum results for certain characteristics of 87 batches of bivalirudin manufactured using "inefficient mixing." (R. 358-1, the '727 patent, col. 22 ll. 10-20.) One of those characteristics is the level of a process impurity known as "Asp9." ( Id. at col. 22 l. 17.) Table 6 lists a maximum Asp9 level of 3.6% and a mean of 0.5% with a 0.4% standard deviation for prior art batches made using inefficient mixing. (R. 358-1, the '727 patent, col. 22 ll. 15-25.) The prosecution history provides no additional disclosures related to these values.

Dr. McKeague applied his expertise in statistics to determine what Table 6, from a statistical perspective, conveyed to the Patent Office Examiner concerning the percentage of prior art batches that satisfied the "about 0.6%" Asp9 maximum recited in the '727 patent claims. (R. 330-4, McKeague Open Expert Report ¶¶ 47-48) In Dr. McKeague's opinion, Table 6 conveyed that approximately 60% of the batches made via inefficient mixing had an Asp9 value of 0.6% or lower. He then compared this estimation to the actual Asp9 levels found in these prior art batches and was surprised to learn that 87% had Asp9 levels at or below 0.6%, and that 90% had Asp9 levels at or below "about 0.6%." ( Id. ¶ 48) Based on this, Dr. McKeague concluded that TMC's disclosure in Table 6 "tended to overstate the appearance of difference in the Asp9 results for TMC's old' and new' compounding processes." ( Id. ¶ 49)

On April 8, 2013, TMC served the Expert Report of Alan J. Salzberg, Ph.D. in Response to the Expert Report of Ian McKeague, Ph.D. (R. 364-5 Dr. Salzberg Rebuttal Expert Report) In that report, Dr. Salzberg criticized Dr. McKeague's decision to apply a normal distribution to the prior art inefficient mixing data. ( Id. ¶¶ 9-15) Dr. Salzberg did not dispute the accuracy of Dr. McKeague's calculation based on a normal distribution. Instead, he simply disagreed that it applied. In Dr. Salzberg's opinion, given the low probability that data in Table 6 follows a normal distribution, "conclusions... based solely on a calculation using an assumption of a Normal Distribution are unreliable." ( Id. ¶¶ 10-11) He did not provide an alternate or better method to calculate the expected Asp9 levels based on the information provided to the Patent Office.


"The admissibility of expert testimony is governed by Federal Rule of Evidence 702 and the Supreme Court's opinion in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993)." Lewis v. Citgo Petroleum Corp., 561 F.3d 698, 705 (7th Cir. 2009). Rule 702 provides, in relevant part, that "[i]f scientific, technical or other specialized knowledge will assist the trier of fact[, ]... a witness qualified as an expert by knowledge, skill, experience, training or education, may testify thereto in the form of an opinion...." Id . See also Happel v. Walmart Stores, Inc., 602 F.3d 820, 824 (7th Cir. 2010).

Under the expert-testimony framework, courts perform the gatekeeping function of determining whether the expert testimony is both relevant and reliable prior to its admission at trial. See id.; Power Integrations, Inc. v. Fairchild Semiconductor Intern., Inc., 711 F.3d 1348, 1373 (Fed. Cir. 2013); United States v. Pansier, 576 F.3d 726, 737 (7th Cir. 2009) ("To determine reliability, the court should consider the proposed expert's full range of experience and training, as well as the methodology used to arrive [at] a particular conclusion."). In doing so, courts "make the following inquiries before admitting expert testimony: first, the expert must be qualified as an expert by knowledge, skill, experience, training, or education; second, the proposed expert must assist the trier of fact in determining a relevant fact at issue in the case; third, the expert's testimony must be based on sufficient facts or data and reliable principles and methods; and fourth, the expert must have reliably applied the principles and methods to the facts of the case." Lees v. Carthage College, 714 F.3d 516, 521-22 (7th Cir. 2013); see also Stollings v. Ryobi Tech., Inc., 725 F.3d 753, 765 (7th Cir. 2013); Power Integrations, 711 F.3d at 1373; Pansier, 576 F.3d at 737.

It is clear that "genuine expertise may be based on experience or training." United States v. Conn, 297 F.3d 548, 556 (7th Cir. 2002) (quoting Tyus v. Urban Search Mgmt., 102 F.3d 256, 263 (7th Cir. 1996)). "[W]hile extensive academic and practical expertise in an area is certainly sufficient to qualify a potential witness as an expert, Rule 702 specifically contemplates the admission of testimony by experts whose knowledge is based on experience." Trustees of Chicago Painters & Decorators Pension, Health & Welfare, & Deferred Sav. Plan Tr. Funds v. Royal Int'l Drywall & Decorating, Inc., 493 F.3d 782, 787-88 (7th Cir. 2007) (citations and quotations omitted). As such, courts "consider a proposed expert's full range of practical experience, as well as academic or technical training, when determining whether that expert is qualified to render an opinion in a given area." Id. (quoting Smith v. Ford Motor Co., 215 F.3d 713, 718 (7th Cir. 2000)).

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 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, 619 F.3d 748, 760 (7th Cir. 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 and the judge will serve as the trier of fact at trial, the Court may choose to (1) allow the presentation of borderline testimony, (2) subject the ...

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