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Reckitt Benckiser LLC v. Aurobindo Pharma Ltd.

United States District Court, D. Delaware

March 7, 2017


          James M. Lennon and Pilar G. Kraman, YOUNG CONAWAY STARGATT & TAYLOR, LLP, Wilmington, DE John T. Gutkoski, Douglas J. Nash, Bella S. Satra, and F. Paul Vellano, EI, BARCLAY DAMON, LLP, Boston, MA, Attorneys for Plaintiff.

          Mary B. Matterer and Richard K. Herrmann, MORRIS JAMES LLP, Wilmington, DE Timothy H. Kratz, George J. Barry III, and Meghan M. Rachford, MCGUIREWOODS LLP, Atlanta, GA Attorneys for Defendants.



         I. BACKGROUND

         Plaintiff Reckitt Benckiser ("Reckitt") brought this patent infringement action under the Hatch-Waxman Act. Reckitt filed suit against Defendants Aurobindo Pharma Limited and Aurobindo Pharma USA, Inc. (collectively, "Aurobindo"), which had submitted an Abbreviated New Drug Application to market a generic version of Mucinex® DM, an extended-release tablet that contains dextromethorphan hydrobromide and guaifenesin. (See D.I. 1 at ¶ 23) Reckitt asserts claims 1, 2, 6-12, 14, 17, 29, 30, 41, and 42 of U.S. Patent No. 6, 955, 821 and claim 1 of U.S. Patent No. 7, 838, 032. (See D.I. 148 at 3 n.l) The patents claim controlled-release formulations of the drug guaifenesin, which contain both immediate-release and sustained-release portions or quantities.

         The Court issued a claim construction opinion on November 3, 2016. (See D.I. 134) In light of that claim construction, the Court granted Aurobindo's motion for leave to file a motion for summary judgment of non-infringement. (SeeD.l. 138) The parties briefed Aurobindo's summary judgment motion, as well as Aurobindo's motion to exclude certain expert testimony. The Court heard oral argument on the pending motions on February 23, 2017. A five-day bench trial is scheduled to begin on April 17, 2017.

         For the reasons stated below, the Court will deny Aurobindo's motion to exclude expert testimony and grant its motion for summary judgment of non-infringement.


         A. Motion to Exclude

         In Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 597 (1993), the Supreme Court explained that Federal Rule of Evidence 702 creates "a gatekeeping role for the [trial] judge" in order to "ensur[e] that an expert's testimony both rests on a reliable foundation and is relevant to the task at hand." Rule 702(a) requires that expert testimony "help the trier of fact to understand the evidence or to determine a fact in issue." Expert testimony is admissible only if "the testimony is based on sufficient facts or data, " "the testimony is the product of reliable principles and methods, " and "the expert has reliably applied the principles and methods to the facts of the case." Fed.R.Evid. 702(b)-(d).

         There are three distinct requirements for proper expert testimony: (1) the expert must be qualified; (2) the opinion must be reliable; and (3) the expert's opinion must relate to the facts. See Elcock v. Kmart Corp., 233 F.3d 734, 741 (3d Cir. 2000).

         B. Summary Judgment

         Under Rule 56(a) of the Federal Rules of Civil Procedure, "[t]he court shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." The moving party bears the burden of demonstrating the absence of a genuine issue of material fact. See Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 585-86 (1986). An assertion that a fact cannot be - or, alternatively, is - genuinely disputed must be supported either by "citing to particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or declarations, stipulations (including those made for purposes of the motion only), admissions, interrogatory answers, or other materials, " or by "showing that the materials cited do not establish the absence or presence of a genuine dispute, or that an adverse party cannot produce admissible evidence to support the fact." Fed.R.Civ.P. 56(c)(1)(A) & (B). If the moving party has carried its burden, the nonmovant must then "come forward with specific facts showing that there is a genuine issue for trial." Matsushita, 475 U.S. at 587 (internal quotation marks omitted). The Court will "draw all reasonable inferences in favor of the nonmoving party, and it may not make credibility determinations or weigh the evidence." Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133, 150 (2000).

         To defeat a motion for summary judgment, the nonmoving party must "do more than simply show that there is some metaphysical doubt as to the material facts." Matsushita, 475 U.S. at 586; see also Podobnik v. U.S. Postal Serv., 409 F.3d 584, 594 (3d Cir. 2005) (stating party opposing summary judgment "must present more than just bare assertions, conclusory allegations or suspicions to show the existence of a genuine issue") (internal quotation marks omitted). The "mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment;" a factual dispute is genuine only where "the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48 (1986). "If the evidence is merely colorable, or is not significantly probative, summary judgment may be granted." Id. at 249-50 (internal citations omitted); see also Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986) (stating entry of summary judgment is mandated "against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial"). Thus, the "mere existence of a scintilla of evidence" in support of the nonmoving party's position is insufficient to defeat a motion for summary judgment; there must be "evidence on which the jury could reasonably find" for the nonmoving party. Anderson, 477 U.S. at 252.


         A. Aurobindo's Motion to Exclude Testimony of Mario A. Gonzalez

         Aurobindo moves to exclude the expert opinions of Mario A. Gonzalez, Ph.D., FCP, regarding infringement and invalidity, specifically with respect to (1) the structure or physical make-up of Aurobindo's product and (2) the obviousness of the patents in suit. (See D.I. 148 at 1-2)[1] Aurobindo contends that Dr. Gonzalez is not qualified to opine on drug formulation science and that his opinions are neither reliable nor fit the issues in the case. The Court disagrees and will deny Aurobindo's motion.

         Dr. Gonzalez is qualified to offer opinions here. Although there is some disagreement as to the identity of a person of skill in the art, Dr. Gonzalez undisputedly meets both sides' definitions. (See D.I. 149 Ex. C at ¶¶ 131-32) Dr. Gonzalez has a Ph.D. in pharmacokinetics, with over 50 years of experience in the fields of pharmacy, pharmacology, and pharmacokinetics. (See D.I. 152 at ¶ 1) Dr. Gonzalez is not himself a formulator, but he has experience working in research and development of specialized drug-delivery systems, including immediate-release and modified-release dosage forms. (See D.I. 141 Ex. F at ¶ 10) Dr. Gonzalez's work includes collaborating with formulators to determine how drug products perform and how they release active ingredients. (See D.I. 141 Ex. D at 34-37)

         With respect to fit and reliability, Aurobindo contends that Dr. Gonzalez has failed "to particularize his opinions and to link Aurobindo's formulations to each limitation, " specifically the requirement for two distinct formulations. (D.I. 148 at 15) In particular, Aurobindo suggests that the in vitro and pharmacokinetic data Dr. Gonzalez discusses are not relevant to the structure of Aurobindo's product and cannot show that Aurpbindo's product has two distinct formulations. (See id.) But Aurobindo does not argue that the data Dr. Gonzalez relies on was collected using an unreliable methodology, and Dr. Gonzalez articulates his reasoning supporting the conclusions that he draws from the data. "The test of admissibility is not whether a particular scientific opinion ... is demonstrably correct. Rather, the test is whether the 'particular opinion is based on valid reasoning and reliable methodology.'" Oddi v. Ford Motor Co., 234 F.3d 136, 145-46 (3d Cir. 2000) (quoting Kannankeril v. Terminix Int'l Inc., 128 F.3d 802, 806 (3d Cir. 1997)). That Aurobindo disagrees with Dr. Gonzalez's conclusions is not reason to exclude his opinions. Dr. Gonzalez's testimony is sufficiently reliable and will assist the trier of fact. Accordingly, the Court will deny Aurobindo's motion.

         B. Other Evidence

         Aurobindo suggests that in deciding the motion for summary judgment, the Court should not consider any evidence other than the AND A. (See D.I. 140 at 11-12) The Court disagrees. "[S]ection 271(e)(2) 'requires an infringement inquiry focused on what is likely to be sold following FDA approval, ' an inquiry that 'must be based on all of the relevant evidence including the ANDA.'" Tyco Healthcare Grp. LP v. Mut. Pharm. Co., 762 F.3d 1338, 1344 (Fed. Cir. 2014) (quoting Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1568 (Fed. Cir. 1997)). Thus, for example, biobatch test data submitted with an ANDA - based on testing which falls into the safe harbor provision of 35 U.S.C. § 271(e)(1) and, therefore, cannot be a basis for infringement - may be irrelevant and, perhaps, should not be considered. See Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1249 (Fed. Cir. 2000). But where additional evidence supplements the record with respect to characteristics of the proposed commercial product made pursuant to the specifications of the AND A, courts may consider that evidence. See Bayer AG. v. Biovail Corp., 279 F.3d 1340, 1346-47 (Fed. Cir. 2002). The additional evidence that Reckitt provides here - a dissolution study conducted by a commercial laboratory on Aurobindo's ANDA drug product - falls into this latter category. This testing provides relevant evidence about characteristics of the product Aurobindo will likely sell, and is appropriate to consider.[2]

         Aurobindo also requests that the Court disregard statements in Dr. Gonzalez's expert report that contradict his deposition testimony. (See D.I. 158 at 8) Although Aurobindo identifies inconsistencies between Dr. Gonzalez's reports and testimony, the Court is not persuaded that Dr. Gonzalez's reports are shams - intended simply to generate a dispute of material fact and defeat summary judgment - ...

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