Upon remand from the US Court of Appeals for the Federal Circuit, the US District Court for the District of Delaware dismissed Takeda’s claim of induced infringement, finding that the mere existence of direct infringement by physicians is not sufficient to support a claim of inducement. Instead, the accused infringer, Hikma, must encourage, recommend or promote infringement. Takeda Pharmas. v. West-Ward Pharma. Corp., 2016 WL 2904593 (D. Del., May 18, 2016) (Robinson, J.)
Takeda markets a colchicine drug product, Colcrys®, which was approved for the two separate indications of use: (1) prophylaxis of acute gout flares and (2) treatment of acute gout flares. Takeda is also the owner of several patents covering methods of use of its colchicine drug product, Colcrys. Hikma received FDA approval of the accused product, Mitigare®, under the Section 505(b)(2) pathway of the Hatch-Waxman Act, carving out of its label the uses for which Takeda has patent protection. Hikma’s Mitigare product was indicated for prophylaxis of gout flares in adults only. Upon launch of Hikma’s Mitigare product, Takeda moved for a temporary restraining order, which the court granted. Takeda then moved for a preliminary injunction. The court reviewed Takeda’s preliminary injunction motion and concluded that because Takeda has failed to demonstrate that it will likely prove induced infringement at trial or suffer irreparable harm, the extraordinary relief of a preliminary injunction is not warranted. Takeda appealed. The Federal Circuit affirmed the denial of Takeda’s motion for a preliminary injunction and remanded the case back to the District Court of Delaware whereby Hikma moved to dismiss Takeda’s claims of induced infringement under Fed. R. Civ. P. 12(b)(6).
In its complaint, Takeda alleged that Hikma’s Mitigare products induced infringement of its patents directed to the treatment of acute gout flares. To support its claim of induced infringement, Takeda relied primarily on: (1) the Mitigare product labels; (2) Hikma’s correspondence with the US Food and Drug Administration (FDA); and (3) Hikma’s sales and marketing activities. Takeda pointed out that the same 0.6 milligrams of colchicine can be used for either prophylaxis or treatment of gout flares and the Mitigare label instructs patients, “If you have a gout flare while taking Mitigare, tell your healthcare provider.” Takeda asserted that this instruction means that health care providers will prescribe Mitigare products for the treatment of acute gout flares according to the Colcrys product label and guidelines. As for the Hikma FDA correspondence, Takeda alleged that the FDA informed Hikma if Mitigare is being used for prophylaxis, it may be natural for the provider to use it for acute treatment as well. Takeda also contended that Hikma entered into at least two “sole-source contracts” with insurance providers that effectively guarantee for all patients covered by these insurance providers the only colchicine option available to them for the treatment of acute gout flares will be Hikma’s Mitigare product.
Addressing the allegations regarding the Mitigare label first, the court found that the label was not a sufficient catalyst to constitute active steps taken to encourage direct infringement as it requires consultation with a health care provider “who may (or may not) consult the Colcrys prescribing information, and who may (or may not) follow the patented method of use for treatment of the acute gout flare.” The court concluded this was an insufficient basis upon which to establish induced infringement. Next, the court found the allegations regarding third-party insurance providers “merely acknowledges potential infringement by others, not that Hikma has taken active steps to encourage direct infringement.” Finally, the court noted that the allegations in Takeda’s complaint stating Mitigare can be used for acute gout flares, including the FDA correspondence with Hikma, is not the same thing as stating Mitigare should be used, explaining how to infringe and showing patients follow those instructions. The court ultimately concluded that given the lack of factual allegations in the complaint, Takeda does not have a “plausible claim for relief” and granted Hikma’s motion to dismiss.
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