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Takeda Pharmaceuticals,USA, Inc. v. West-Ward Pharmaceutical Corp.

United States District Court, D. Delaware

November 4, 2014

TAKEDA PHARMACEUTICALS USA, INC., Plaintiff,
v.
WEST-WARD PHARMACEUTICAL CORPORATION, HIKMA AMERICAS INC., and HIKMA PHARMACEUTICALS PLC, Defendants

Page 540

Mary W. Bourke, Esquire and Daniel M. Attaway, Esquire of Womble Carlyle Sandridge & Rice, LLP, Wilmington, Delaware. Counsel for Plaintiff. Of 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 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.

Page 541

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 patents[1] under 35 U.S.C. § 271 (b).[2]

Page 542

(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[TM], an oral single-ingredient colchicine product, " indicated for prophylaxis of gout flares in adults" (D.I. 1, ex. Hat 1), and intends to launch a generic version of such at a price significantly below that of Takeda's pricing structure. Although Mitigare[TM] 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 Pharms, 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. 2011); Antares Pharma, Inc. v. Medac Pharma, Inc., Civ. No. 14-270, 55 F.Supp.3d 526, 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

Page 543

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 downward-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 ...


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