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Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward Pharmaceutical Corp.

United States District Court, D. Delaware

December 12, 2018


          Mary W. Bourke and Daniel M. Attaway, WOMBLE BOND DICKINSON (US) LLP, Wilmington, DE; Jeffrey I. Weinberger, Ted G. Dane, Heather E. Takahashi, Elizabeth L. Laughton (argued), and Hannah L. Dubina, MUNGER, TOLLES & OLSON LLP, Los Angeles, CA; Celia R. Choy, MUNGER, TOLLES & OLSON LLP, Washington, DC; Peter A. Detre, MUNGER, TOLLES & OLSON LLP, San Francisco, CA, attorneys for Plaintiff.

          Dominick T. Gattuso, HEYMAN ENERIO GATTUSO & HIRZEL LLP, Wilmington, DE; Charles B. Klein (argued) & Ilan Wurman, WINSTON & STRAWN LLP, Washington, DC, attorneys for Defendant.



         Currently pending before the Court is Defendants West-Ward Pharmaceutical, Hikma Americas, and Hikma Pharmaceuticals' Motion for Summary Judgment. (D.I. 347). The Parties have fully briefed the issues. (D.I. 349; D.I. 361; D.I. 368). The Court held oral argument on October 16, 2018. (D.I. 410). For the following reasons, Defendants' motion for summary judgment is GRANTED.

         I. Background

         Plaintiff Takeda Pharmaceuticals manufactures and markets Colcrys, a branded 0.6 mg colchicine tablet used for the treatment of gout prophylaxis and acute gout flares. (D.I. 362, Ex. 4). In 2010, Plaintiffs predecessor became the sole provider of colchicine on the pharmaceutical market, after receiving FDA authorization and the FDA removing all other colchicine products. (D.I. 362 Ex. 1 ¶¶ 32-38). Plaintiffs predecessor also owned several patents directed to a method of treating acute gout flares with colchicine by administering 1.2 mg oral colchicine at the onset of an acute flare, followed by 0.6 mg oral colchicine one hour later ("the Acute Gout Flare Patents"). (D.I. 133 ¶ 30); U.S. Patent No. 7, 964, 647 cl. 1; U.S. Patent No. 7, 981, 938 cl. 1; U.S. Patent No. 8, 415, 395 cl. 1.

         Hikma Pharmaceuticals received FDA approval of a paper New Drug Application ("paper NDA") for Mitigare on September 26, 2014. (D.I. 349 at 6-7). Mitigare is a 0.6 mg colchicine capsule indicated solely for the prophylaxis of gout. (D.I. 362, Ex. 5). Shortly thereafter, on October 3, 2014, Plaintiff filed suit against Defendants West-Ward Pharamaceutical, Hikma Americas, and Hikma Pharmaceuticals ("Defendants"). (D.I. 1). After the Federal Circuit affirmed the denial of a preliminary injunction on January 9, 2015, Takeda Pharm., U.S.A., Inc. v. West-WardPharm. Corp., 785 F.3d 625 (Fed. Cir. 2015), Defendants launched Mitigare and its authorized generic (Mitigare AG). (D.I. 349 at 7). Plaintiff also launched its competing authorized generic of Colcrys (Colcrys AG). (Id.).

         The Court later dismissed the suit for failure to state a claim on May 18, 2016. (D.I. 122). The Court then granted Plaintiffs Motion to Alter Judgment of Dismissal and for Leave to Amend its Complaint on December 15, 2016 (D.I. 124; D.I. 132) and implemented phased discovery. (D.I. 150).

         Plaintiffs Second Amended Complaint alleges Defendants induced infringement of the Acute Gout Flare Patents through post-launch marketing efforts for Mitigare. (D.I. 133). The Complaint asserted two different sets of patents: the Drug-Drug Interaction patents[1] and the Acute Gout Flare Patents. (D.I. 133 ¶ 28). Defendants filed a motion for summary judgment on May 4, 2018. (D.I. 347). After this filing, Plaintiff voluntarily dismissed its infringement claims under the Drug-Drug Interaction patents. (D.I. 376). Thus, only the Acute Gout Flare Patents remain at issue for the purposes of summary judgment.

         The parties do not dispute that Defendants (1) negotiated both exclusive and nonexclusive contracts with insurance payers (D.I. 349 at 17), (2) hired InVentiv Health as a pharmaceutical marketing force focused on encouraging prescribers to prescribe Mitigare or Mitigare AG (D.I. 361 at 9), (3) created promotional materials which direct readers to the American College of Rheumatology Guidelines for the treatment of gout (D.I. 133-14, Ex. N at 6 and 8 n.6), and (4) provided samples of Mitigare directly to prescribers. (D.I. 361 at 15). Mitigare's label also includes language that directs patients to consult their physician if they experience an acute gout flare. (D.I. 133, Ex. K). Defendants' exclusive contracts contain either a "block" or a "step edit." (D.I. 362, Ex. 13-15). A "block" is where Defendants have agreed to provide a manufacturer rebate to the insurance payer to cover only Mitigare/Mitigare AG and to exclude Colcrys/Colcrys AG from the payer's formulary. (D.I. 410 at 34:14-19). A formulary determines how much of the prescription cost will be the patient's responsibility. A "step edit" is where the insurance payer agrees to require that a patient has tried Mitigare or Mitigare AG and failed before the insurance payer will cover a prescription for Colcrys or Colcrys AG. (D.I. 361 at 10; D.I. 410 at 37:17-23).

         Plaintiff alleges that Defendants' post-launch marketing activities have induced infringement of the Acute Gout Flare Patents. (D.I. 133). Defendants now seek summary judgment on the induced infringement claims. (D.I. 347).

         II. Legal Standard

         A. Summary Judgment

         "The 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." Fed.R.Civ.P. 56(a). The moving party has the initial burden of proving the absence of a genuinely disputed material fact relative to the claims in question. Celotex Corp. v. Catrett,477U.S. 317, 330 (1986). Material facts are those "that could affect the outcome" of the proceeding, and "a dispute about a material fact is 'genuine' if the evidence is sufficient to permit a reasonable jury to return a verdict for the nonmoving party." Lamont v. New Jersey,637 F.3d 177, 181 (3d Cir. 2011) (quoting Anderson v. Liberty Lobby, Inc.,477 U.S. 242, 248 (1986)). The burden on the ...

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