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GlaxoSmithKline LLC v. Glenmark Pharmaceuticals Inc.

United States District Court, D. Delaware

May 2, 2017

GLAXOSMITHKLINE LLC and SMITHKLINE BEECHAM (CORK) LIMITED, Plaintiffs,
v.
GLENMARK PHARMACEUTICALS INC., USA, Defendant. GLAXOSMITHKLINE LLC and SMITHKLINE BEECHAM (CORK) LIMITED, Plaintiffs,
v.
TEVA PHARMACEUTICALS USA, INC., Defendant.

          MEMORANDUM ORDER

          CHRISTOPHER J. BURKE UNITED STATES MAGISTRATE JUDGE.

         In these two patent infringement actions filed by Plaintiffs GlaxoSmithKline LLC and SmithKline Beecham (Cork) Limited (collectively, "GSK" or "Plaintiffs") against Defendants Glenmark Pharmaceuticals Inc., USA ("Glenmark") and Teva Pharmaceuticals USA, Inc. ("Teva") (collectively, "Defendants"), presently before the Court is Plaintiffs' Daubert motion ("Motion") to exclude testimony offered by Defendants' proffered expert, Sandra Kinsey, M.B.A., R.Ph. (D.I. 211)[1] For the following reasons, the Court DENIES the Motion.[2]

         I. BACKGROUND

         A. Procedural History

         On July 3, 2014, GSK commenced these actions. (D.I. 1) GSK alleges that Defendants induce infringement of United States Patent No. RE40, 000 by making, offering to sell, selling, importing, and otherwise promoting and distributing generic carvedilol tablets. (See, e.g., D.I. 59, 175)

         Briefing on the instant Motion was completed on March 3, 2017. (D.I. 270) The Court held oral argument on the Motion (and various other summary judgment and Daubert motions filed in the case) on March 24, 2017, (D.I. 296 (hereinafter, "Tr.")). A 5-day trial is set to begin in the Teva Action (Civil Action No. 14-878-LPS-CJB) on June 12, 2017. (Teva Action, D.I. 38, 329)

         B. Factual Background

         Ms. Kinsey is a currently a registered pharmacist in Arkansas and Kansas, and she works in stores with independent pharmacists on prescription filling, operational processes and related matters. (D.I. 256, ex. B ("Kinsey Report") at ¶ 2) She is also the president of her own retail healthcare consulting firm. (Id. at ¶ 1) From approximately 1997 to 2014, Ms. Kinsey held several positions at Walmart Store, Inc. ("Walmart"), including the title of Vice President of Pharmacy Merchandising, Health & Wellness. (Id. at ¶ 3) While at Walmart, she was responsible for all of the company's prescription product procurement, preferred formulary development, distribution and supply chain, pricing, and inventory management for over 5, 000 stores. (Id.)

         During her time at Walmart, Ms. Kinsey was "instrumental in building [the company's] propriety prescription management system, including the pharmacist interface and all product substitution logic." (Id.) In that regard, she worked to set a company-wide protocol for: (1)how drug prescriptions should be evaluated; (2) the circumstances in which generic drug substitution would occur; and (3) compliance with state-specific substitution laws. (D.I. 257, ex. 42 at 42-45)

         In her expert report, Ms. Kinsey explains that she was asked to "describe how the dispensing of prescription drugs occurs at pharmacy, and to discuss the factors that influence which product ultimately is dispensed for a particular prescription." (Kinsey Report at ¶ 10) Among her overarching conclusions were the following:

(1) For the entire period relevant to this suit, pharmacists were authorized in every state to substitute an "AB-rated" generic drug product (like Defendants' generic carvedilol products at issue in this case) when filling a prescription for the corresponding brand product (like Plaintiffs' branded drug COREG®, relevant here), without obtaining prior approval from the prescribing physician.;
(2) Even if a generic drug manufacturer were to communicate to pharmacies, insurers or others that a particular AB-rated generic product was approved for fewer than all of the United States Food & Drug Administration ("FDA")-approved indications in the brand label, this information would not reduce the frequency with which that product was dispensed in place of the corresponding brand.;
(3) Differences in approved indications for AB-rated generic products compared to the corresponding brand product play no role in generic substitution practices at the pharmacy.;
(4) The out-of-pocket expense that a patient incurs by filling a prescription plays an important role in determining which ...

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