Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward Pharmaceutical Corp. et al. and Hikma Americas Inc. et al. (collectively “Hikma”)

Docket No. 2015-1139, 2015-1142

May 6, 2015

Brief Summary: DC denial of Takeda’s motion for preliminary injunction of “paper NDA” (“§ 505(b)(2) application”) holder because it could not show a likelihood of success on the merits of the induced infringement claim affirmed based in large part on the language of the alleged infringer’s label.

Summary: Takeda appealed DC denial of its motion for preliminary injunction to enjoin Hikima from continuing its launch of Mitigare, a colchicine product for prophylactic treatment of gout, and an authorized generic version thereof. The asserted patents are method of treatment (acute gout flares) patents US 7,964,648 and 7,981,938 and drug-drug interaction patents 8,097,655, 8,440,722, and 7,964,647 (reduced colchicine dosage with clarithromycin, ketoconazole or verapamil, respectively). Hikma filed a “paper NDA” (“§ 505(b)(2) application”) without a Paragraph IV certification because it relied on prior FDA findings of safety and efficacy concerning colchicine and did not seek approval for a use covered by Takeda’s patents (“indicated for prophylaxis” of gout…the safety and effectiveness of [it] for acute treatment of gout flares has not been studied…[i]f you have a gout flare while taking [Mitgare], tell your healthcare provider”) (“a generic manufacturer may avoid infringement by proposing a label that does not claim a patented method of use” (Caraco, US 2012 and 21 § USC 355(b)). The DC concluded Takeda could not show a likelihood of success on the merits of the induced infringement claim which cannot be shown if an alleged infringer raises a substantial question regarding either infringement or validity of the asserted patents (Genentech, FC 1997). The FC explained that “there is no indirect infringement ‘when a defendant merely sells a commercial product suitable for some lawful use” and “[i]nfringement only exists where there is evidence that ‘goes beyond a product’s characteristics or the knowledge that it may be put to infringing uses”; there needs to be evidence of an “intent to encourage infringement…[t]he label must encourage, recommend, or promote infringement” (Grokster, US 2005 (copyright)). Takeda acknowledged “that mere knowledge of off-label infringing uses of Mitigare’s product would not establish inducement.” The FC found that that facts the FDA told Hikma “it may be natural for the provider to use [Mitigare] for acute treatment” and the American College of Rheumatology (ACR) recommended prescribing [colchicine] for acute gout flares” only established “knowledge of infringing uses and does not establish inducement.” And Hikma’s stating “tell your healthcare provider” on the label was found to be “vague” and not combinable “with speculation about how physicians may act to find inducement.” The FC also found “no evidence that the label would necessarily lead doctors…to prescribe an off-label use” (“host of alternatives” available, “common knowledge” not enough). Arguments regarding the DDI patents (label warnings regarding co-administration, “likelihood of direct infringement, which is a prerequisite for indirect infringement” not shown) were also found to be insufficient. Thus, the DC decision was affirmed. Judge Newman’s dissent argued that the provider of a known drug product, with knowledge that it is likely to be used in direct infringement” should, in some instances, “be liable for induced infringement” and that the facts of this case should be considered in more detail.

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