By Thomas Long, J.D.
Takeda Pharmaceuticals U.S.A., Inc., cannot go forward with a patent infringement suit seeking to prevent West-Ward Pharmaceutical Corp., Hikma Americas Inc., and Hikma Pharmaceuticals PLC (collectively, “Hikma”) from launching a generic alternative to Takeda’s Colcrys®, a colchicine-based medication for treatment of gout flares, the federal district court in Wilmington, Delaware, has decided (Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward Pharmaceutical Corp., May 18, 2016, Robinson, S.). Because Hikma’s accused product was labeled only for the prevention of gout flares, and Hikma’s label did not address the treatment of acute gout flares, the product’s label could not induce infringement of Takeda’s asserted patents. An instruction on the label stating that “[i]f you have a gout flare while taking [Mitigare], tell your healthcare provider” did not constitute an active step encouraging direct infringement.
Patents-in-suit. Takeda asserted ownership of five patents covering several methods of administering colchicine products to treat gout: U.S. Patent Nos. 7,964,648, 8,097,655, and 8,440,722 (the “drug-drug interaction (DDI) patents”); and 7,964,647 and 7,981,938 (the “acute gout patents”). The DDI patents were directed to methods of administering reduced doses of colchicine for the prophylaxis of gout flares in patients who were concomitantly taking ketoconazole, clarithromycin, or verapamil. The acute gout patents recited methods of treating acute gout with a specific low-dose regimen of colchicine.
Accused products. In 2010, Hikma sought Food and Drug Administration approval of a colchicine product for prophylaxis of gout flares and submitted a New Drug Application (NDA). Although Hikma’s proposed Mitigare product had the same active ingredient, route of administration, and strength as Takeda’s brand-name product, Colcrys®, Hikma did not file its application with the FDA as an Abbreviated New Drug Application (ANDA), opting instead for the NDA pathway provided by Section 505(b)(2) of the Hatch-Waxman Act. Moreover, in its proposed label, Hikma omitted specific mention of uses for which Takeda had patent protection—namely, treatment of acute gout flares. On September 26, 2014, the FDA granted Hikma approval to market a colchicine capsule under the name Mitigare.
Infringement suit. Takeda filed suit against Hikma on October 3, 2014, asserting induced patent infringement based on Hikma’s labeling of the Mitigare product. The district court granted Takeda’s request for a temporary restraining order, preventing Hikma from selling Mitigare and from launching a generic colchicine product. On November 4, 2014, the district court denied Takeda’s motion for a preliminary injunction. The TRO was extended pending Takeda’s appeal to the Federal Circuit. On January 9, 2015, after oral argument, the Federal Circuit issued an order affirming the district court’s denial of preliminary injunction and vacating the TRO. In an opinion dated May 6, 2015, the Federal Circuit stated that Takeda failed to show that success on the merits of its induced infringement claim was likely. Hikma then filed a motion to dismiss the complaint.
Inducement of infringement—acute gout patents. Under Federal Circuit precedent, indirect infringement would not occur when a defendant merely sold a commercial product suitable for some lawful but off-label use. There was only infringement by inducement when there were active steps taken to encourage direct infringement, such as advertising an infringing use or instructing how to engage in an infringing use. Such instructions must evidence the specific intent to encourage infringement. In this case, the court noted that the Mitigare label warned that “[t]he safety and effectiveness of MITIGARE™ for acute treatment of gout flares during prophylaxis has not been studied.” Hikma had specified that Mitigare was for the prevention of gout flares and warned that its drug was not indicated for the treatment of acute gout flares. Allowing Takeda to proceed with its inducement claim would be akin to allowing Takeda to expand the scope of its exclusivity over the treatment of gout with colchicine, the court said.
The Mitigare label did not infringe on its face; the label only instructed patients to consult with a healthcare provider, who may or may not consult Colcrys® prescribing information, and who may or may not follow the patented method of use for treatment of the acute gout flare. This was an insufficient basis upon which to establish induced infringement, in the court’s view. The Mitigare label was not a sufficient catalyst to constitute “active steps taken to encourage direct infringement,” as it required consultation with a physician.
Takeda failed to present plausible factual allegations that Hikma’s marketing and sales activities induced infringement. Assertions that Mitigare sales representatives told a patient that Mitigare could be used for gout flares was not the same as stating that it should be used, explaining how to do so in an infringing manner, and establishing that patients had followed those instructions. Statements by Hikma to third-party insurance providers—which allegedly showed that Hikma knew that doctors could be prescribing Mitigare for gout flares—could not establish inducement to infringe; mere knowledge of infringement by others did not amount to inducement, in the absence of specific intent and active steps encouraging infringement.
Underlying direct infringement—DDI patents. Furthermore, Takeda failed to adequately allege underlying direct infringement of the DDI patents, according to the court. Takeda merely speculated that “at least some doctors and patients will consult the dose regimens set forth in the Colcrys® product labeling, and adjust the colchicine dosing according to the instructions in the FDA-approved Colcrys® label.” The allegations did not raise a reasonable inference of infringement because Takeda had pleaded only speculative future infringement.
Accordingly, the motion to dismiss was granted.
The case is No. 1:14-cv-01268-SLR.
Attorneys: Mary W. Bourke and Daniel M. Attaway (Womble Carlyle Sandridge & Rice, LLP) for Takeda Pharmaceuticals U.S.A., Inc. Dominick T. Gattuso (Proctor Heyman Enerio LLP) for West-Ward Pharmaceutical Corp., Hikma Americas Inc., and Hikma Pharmaceuticals PLC.
Companies: Takeda Pharmaceuticals U.S.A., Inc.; West-Ward Pharmaceutical Corp.; Hikma Americas Inc.; Hikma Pharmaceuticals PLC
MainStory: TopStory Patent DelawareNews
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