Takeda Pharm. USA, Inc. v. West-Ward Pharm. Corp.

• Decision Date: 04 November 2014
• Docket Number: Civ. No. 14–1268–SLR
• Citation: 72 F.Supp.3d 539
• Court: U.S. District Court — District of Delaware
• Parties: Takeda Pharmaceuticals USA, Inc., Plaintiff, v. West–Ward Pharmaceutical Corporation, Hikma Americas Inc., and Hikma Pharmaceuticals PLC, Defendants.

72 F.Supp.3d 539

Takeda Pharmaceuticals USA, Inc., Plaintiff

v.West–Ward Pharmaceutical Corporation, Hikma Americas Inc., and Hikma Pharmaceuticals PLC, Defendants.

Civ. No. 14–1268–SLR

United States District Court, D. Delaware.

Signed November 4, 2014

Mary W. Bourke, Esquire and Daniel M. Attaway, Esquire of Womble Carlyle Sandridge & Rice, LLP, Wilmington, Delaware. Counsel for Plaintiff. Of Counsel: Tryn T. Stimart, Esquire of Womble Carlyle Sandridge & Rice, LLP, Jeffrey I. Weinberger, Esquire, Ted G. Dane, Esquire, Elizabeth Laughton, Esquire, Eric K. Chiu, Esquire and Amy L. Greywitt, Esquire of Munger, Tolles & Olson LLP.

Dominick T. Gattuso, Esquire of Proctor Heyman LLP, Wilmington, Delaware. Counsel for Defendants. Of Counsel: John T. Bennett, Esquire, Elaine H. Blais, Esquire, William G. James, Esquire and Elizabeth J. Holland, Esquire of Goodwin Procter LLP, and John K. Hsu, Esquire, James F. Hurst, Esquire, Steffen N. Johnson, Esquire, Charles B. Klein, Esquire and Samuel S. Park, Esquire of Winston & Strawn LLP.

MEMORANDUM OPINION

SUE L. 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, “Hikma”), asserting induced infringement of five patents¹ under 35 U.S.C. § 271(b).²

(D.I. 1) Takeda is the owner of the asserted patents, all of which cover methods of administering colchicine

products for the treatment of acute gout flares, as well as for concomitant administration of colchicine with other drugs for prophylaxis (prevention) of gout flares.

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), and intends to launch a generic version of such at a price significantly below that of Takeda's pricing structure. Although Mitigare™ has the same active ingredient, route of administration, and strength as Takeda's colchicine product (Colcrys®), 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) Presently before the court is Takeda's motion for a preliminary injunction. (D.I. 5) The court has jurisdiction pursuant to 28 U.S.C. §§ 1331 and 1338(a). For the reasons discussed more fully below, the court denies Takeda's motion for a preliminary injunction.

II. STANDARD OF REVIEW

“The decision to grant or deny ... injunctive relief is an act of equitable discretion by the district court.” eBay, Inc. v. MercExchange, LLC, 547 U.S. 388, 391, 126 S.Ct. 1837, 164 L.Ed.2d 641 (2006). The grant of such relief is considered an “extraordinary remedy” that should be granted only in “limited circumstances.” See Kos Pharma . , Inc. v. Andrx Corp., 369 F.3d 700, 708 (3d Cir.2004) (citation omitted). A party seeking preliminary injunction relief must demonstrate: (1) a reasonable likelihood of success on the merits; (2) the prospect of irreparable harm in the absence of an injunction; (3) that this harm would exceed harm to the opposing party; and (4) the public interest favors such relief. See, e.g., Sciele Pharma Inc. v. Lupin Ltd., 684 F.3d 1253, 1259 (Fed.Cir.2012) ; Antares Pharma . , Inc. v. Medac Pharma . , Inc., Civ. No. 14–270, 55 F.Supp.3d 526, 529–30, 2014 WL 3374614, at *2 (D.Del. July 10, 2014). The burden lies with the movant to establish every element in its favor or the grant of a preliminary injunction is inappropriate. See P.C. Yonkers, Inc. v. Celebrations, the Party and Seasonal Superstore, LLC, 428 F.3d 504, 508 (3d Cir.2005). If either or both of the fundamental requirements—likelihood of success on the merits and probability of irreparable harm if relief is not granted—are absent, an injunction cannot issue. See McKeesport Hosp. v. Accreditation Council for Graduate Med. Educ., 24 F.3d 519, 523 (3d Cir.1994).

III. DISCUSSION

A. Likelihood of Success

As noted, Takeda has asserted inducement of infringement under 35 U.S.C. § 271(b). Under § 271(b), “[w]hoever actively induces infringement of a patent shall be liable as an infringer.” It is a plaintiff's burden to demonstrate that the accused infringer's “actions induced infringing acts and that [the accused infringer] knew or should have known [its] actions would induce actual infringements.” Manville Sales Corp. v. Paramount Sys., Inc., 917 F.2d 544, 553 (Fed.Cir.1990). “[M]ere knowledge of possible infringement by others does not amount to inducement; specific intent and action to induce infringement must be proven.” Warner – Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1364 (Fed.Cir.2003). Therefore, If an entity offers a product with the object of promoting its use to infringe, as shown by clear expression or other affirmative steps taken to foster infringement, it is liable for the resulting acts of infringement by third parties.... ‘The inducement rule ... premises liability on purposeful, culpable expressions and conduct....’ ” DSU Med. Corp. v. JMS Co., 471 F.3d 1293, 1305–1306 (Fed.Cir.2006) (quoting Metro–Goldwyn–Mayer Studios, Inc. v. Grokster, Ltd., 545 U.S. 913, 937, 125 S.Ct. 2764, 162 L.Ed.2d 781 (2005) ). “[W]here a product has substantial noninfringing uses, intent to induce infringement cannot be inferred even when [the accused infringer] has actual knowledge that some users of its product may be infringing the patent.” Warner Lambert, 316 F.3d at 1365.³

In addition to the above precedent, the parties addressed two subsequent Federal Circuit decisions, AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042 (Fed.Cir.2010) (“AZ 2010 ”), and AstraZeneca Pharmaceuticals LP v. Apotex Corp., 669 F.3d 1370 (Fed.Cir.2012) (“AZ 2012 ”). In AZ 2010, the Federal Circuit affirmed the grant of a preliminary injunction barring defendant Apotex from launching a generic version of a budesonide drug made and distributed by plaintiff AstraZeneca and covered under method and kit claims disclosed in several of AstraZeneca's patents. It was AstraZeneca's contention, inter alia, that Apotex's proposed label would induce consumers to infringe the asserted method claims “because the label implicitly instructed users to administer the generic drug once daily” by advising that, “[i]n all patients, it is desirable to down ward-titrate to the lowest effective dose” once “the desired clinical effect is achieved.” AZ 2010, 633 F.3d at 1057. Given the available strengths (0.25 mg and 0.5 mg per 2 ml vial) and the recommended starting dose (0.5 mg total daily dose administered twice daily in divided doses, i.e., 0.25 mg administered twice daily) of the generic, the district court reasoned that “the first step in titrating down from [the starting] dose would have to be 0.25 mg once daily.” The district court concluded that the downward titration language included in the proposed label “would necessarily lead patients” to infringe the asserted method claims which disclosed once-daily administration. Id. (emphasis added). By my reading, the district court found more in the label than an “implicit” instruction.

The Federal Circuit, for its part, acknowledged that when evidence of substantial noninfringing uses exists, a court may not infer intent from the mere knowledge of possible infringing uses, but must find affirmative intent from “[e]vidence of active steps ... taken to encourage direct infringement, such as advertising an infringing use or instructing how to engage in an infringing use.” Id. at 1059 (quoting Grokster, 545 U.S. at 935, 125 S.Ct. 2764 ). In other words, the evidence of specific intent must go “ ‘beyond a product's characteristics or the knowledge that it may be put to infringing uses, and [instead show] statements or actions directed to promoting infringement.’ ” Id. at 1059 (quoting Grokster, 545 U.S. 913 at 936, 125 S.Ct. 2764, 162 L.Ed.2d 781 ). According to the Court, then, “[t]he pertinent question is whether the proposed label instructs users to perform the patented method.” Id. at 1060. Based on the proposed label under review and Apotex's decision to proceed with its plan to distribute its generic “despite being aware that the label presented infringement problems,”⁴ the Federal Circuit found that is was “not left with a definite and firm conviction that a mistake [had] been made,” thus affirming the district court's determination that AstraZeneca would likely prove induced infringement at trial. Id. at 1061. Not exactly a ringing endorsement of the decision to enjoin Apotex.

In AZ 2012, defendants—all generic drug manufacturers—only sought approval in their ANDAs for unpatented methods of using rosuvastatin

calcium and, consequently, submitted section viii statements⁵ regarding AstraZeneca's use patents. AstraZeneca filed a § 271(e)(2)(A) action⁶ against defendants based on its belief that the FDA would require the defendants to make labeling amendments explicitly incorporating the indications covered by the use patents. The Federal Circuit affirmed dismissal of AstraZeneca's claims, based on the nature of the ANDA regime. More specifically, § 271(e)(2)(A) confines the scope of the infringement analysis in the context of ANDA litigation to the scope of approval sought in the ANDA. Because generic manufacturers...