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

188 F. Supp. 3d 367, 2016 U.S. Dist. LEXIS 65317, 2016 WL 2904593
CourtDistrict Court, D. Delaware
DecidedMay 18, 2016
DocketCiv. No. 14-1268-SLR
StatusPublished
Cited by1 cases

This text of 188 F. Supp. 3d 367 (Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward Pharmaceutical Corp.) is published on Counsel Stack Legal Research, covering District Court, D. Delaware primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward Pharmaceutical Corp., 188 F. Supp. 3d 367, 2016 U.S. Dist. LEXIS 65317, 2016 WL 2904593 (D. Del. 2016).

Opinion

MEMORANDUM OPINION

ROBINSON, District Judge

I. INTRODUCTION

On October 3, 2014, Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”) filed suit against West-Ward Pharmaceutical Corporation, Hikma Americas Inc., and Hikma Pharmaceuticals' PLC (collectively, “Hik-ma”), asserting induced infringement of five patents under 35 U.S.C. § 271(b).1 (D.I. 1) Takeda is the owner of the asserted patents, which contain one or more claims covering methods of use of Takeda’s colchicine product, Colerys®. (D.I. 109 at 8) Colerys® is used primarily for preventing and treating gout flares. (Id. at 5)

Hikma has launched the accused product, Mitigare™, an oral single-ingredient colchicine product, “indicated for prophylaxis of gout flares in adults.” (D.I; 1, ex. H at 1) Although Mitigare™ ‘ has the same active ingredient, route of administration, and strength as Colerys®, Hikma did not file its application with the Food and Drug Administration (FDA) as an Abbreviated New Drug Application (“ANDA”). Instead, Hikma sought approval through the New Drug Application (“NDA”) pathway under § 505(b)(2) of the Hatch-Waxman' Act. Moreover, in its proposed label, Hikma has omitted specific mention of uses for which Takeda has patent protection.

On October 5, 2014, Takeda requested a temporary restraining order (“TRO”) to preserve the status quo while the parties more fully briefed (and the court considered) Takeda’s motion for a preliminary injunction. (D.I. 5) On October 9, 2014, the court issued a memorandum order granting Takeda’s motion for a TRO. (D.I. 21) The parties jointly stipulated to extend the period for which the TRO was in force through the end of November 4, 2014. (D.I. 54) The court reviewed Takeda’s motion for a preliminary injunction and concluded that “[bjecause Takeda has failed to demonstrate that it will likely prove induced infringement at trial or suffer irreparable harm, the extraordinary relief sought is not warranted.” (D.I. 78 at 15) The court also concluded that, “given the significance of this dispute to both parties, [the court] will- maintain the status quo pending appeal if: (1) Takeda takes an immediate appeal and requested expedited review of both the merits and this ruling by the Federal Circuit; and (2) the conditions included in [the court’s] order of October 31, 2014 (D.I. 72) continue to govern the conduct of the parties, except that the bond shall increase $500,000 per day until further order of this court or the Federal Circuit.” (Id.)

On November 5, 2014, Takeda filed a notice of appeal to the United States Court of Appeals for the Federal Circuit, appealing the order denying its motion for preliminary injunction and seeking expedited review. (D.I. 80) Hikma then filed a notice of cross appeal to the Federal Circuit on November 10, 2014. (D.I. 82) On appeal, the Federal Circuit affirmed this court’s order denying Takeda’s motion for a preliminary injunction. Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward Pharmaceutical Corp., 785 F.3d 625, 627 (Fed.Cir.2015). On September 10,2015, Takeda filed [370]*370its first amended complaint, (D.I. 109) Presently before the court is Hikma’s motion to dismiss Takeda’s first amended complaint pursuant to Federal Rule of Civil Procedure 12(b)(6). (D.I. 112) The court has jurisdiction pursuant to 28 U.S.C. §§ 1331 and 1338(a).

II. BACKGROUND

A. Takeda’s Amended Complaint

■ In its amended complaint, Takeda alleges that Hikma’s MitigareTM products induce infringement of the Acute Flare Patents,- and suppoi’ts this claim with allegations related to the MitigareTM and Mi-tigareTM AG product labels, Hikma’s FDA correspondence, and Hikma’s marketing and sales activities. The amended complaint also alleges induced infringement of the DDI Patents and supports this claim ■with allegations related to the MitigareTM and MitigareTM AG product labels and Hikma’s FDA correspondence.

1. The Acute Flare Patents

In asserting that Hikma infringes its Acute Flare Patents, Takeda describes three aspects of Hikma’s MitigareTM product: the MitigareTM and MitigareTM AG product labels, Hikma’s correspondence with the FDA, and Hikma’s marketing and sales activities.

a. The MITIGARETM and MITIGAREtm AG product labels

Takeda states that “Colcrys® is .approved- for both prophylaxis and treatment of acute gout flares, while MitigareTM ⅛ approved only for prophylaxis. Nevertheless, the same 0.6 mg of colchicine can and is being used for either prophylaxis or treatment of acute gout flares.” (D.I. 109 at ¶35) Takeda then describes the Miti-gareTM product label which instructs patients: “If you have a gout flare while taking MitigareTM, tell your healthcare provider.” (Id. at ¶ 36) Takeda asserts that this instruction means that “[w]ith respect to acute treatment, upon information and belief, [Hikma] know[s] and intend[s] that healthcare providers will prescribe the Mi-tigareTM Products for the treatment of acute gout flares according to the Col-crys® product label and the [American College of Rheumatology] guidelines [].” (Id.) Further, Takeda states that the only reference in the product labels to the treatment of acute gout flares is a statement that “the safety and effectiveness of MitigareTM [or “colchicine capsules”] for acute treatment of gout flares during prophylaxis has not been studied.” (Id. at ¶ 37) (alterations in original). Takeda bolsters this statement by alleging that while Hikma “may not have performed studies” to examine the effect of its capsule product in treating acute gout flares, Hikma is aware that Mutual, a pharmaceutical company and former affiliate of Takeda, “did study the safety and effectiveness of its pharmacologically-identical 0.6 mg colchi-cine tablet product in treating acute gout flares, as described in the Colcrys® product labeling.” (Id.) Finally, Takeda states that the medication guides for ■ Hikma’s products “do not instruct patients to refrain from taking [MitigareTM] for treatment of acute gout flares[,] [n]or do they prescribe the proper dosage of [Mitigar-eTM].” (Id, at ¶ 38)

b. FDA correspondence

Takeda states that the FDA “recognized the high likelihood that a drug suitable both for the treatment and the prophylaxis of acute gout flares likely would be prescribed for both,” and that the FDA consequently informed Hikma that “if Mitigare is being used for prophylaxis, it may be natural for the provider to use it for acute treatment as well.” (Id. at ¶ 41) According to Takeda, Hikma’s product label stating “If you have a gout flare while taking MitigareTM, tell your healthcare provider” indicates that Hikma “intended to encourage and facilitate the use of [Mitigare] to [371]*371treat acute gout flares in accordance with Takeda’s patented methods.” (Id. at ¶ 42).

c. Marketing and sales activities

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Related

Takeda Pharmaceuticals U.S.A., Inc. v. Burwell
691 F. App'x 634 (D.C. Circuit, 2016)

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Bluebook (online)
188 F. Supp. 3d 367, 2016 U.S. Dist. LEXIS 65317, 2016 WL 2904593, Counsel Stack Legal Research, https://law.counselstack.com/opinion/takeda-pharmaceuticals-usa-inc-v-west-ward-pharmaceutical-corp-ded-2016.