Carve-Out Of Patented Uses In Hikma’s Mitigare™ Label Avoids Induced Infringement

In Takeda Pharmaceuticals USA, Inc. v. West-Ward Pharmaceutical Corp., Judge Sue L. Robinson of Delaware denied Takeda’s motion for a preliminary injunction, finding no likelihood of success on its claim that Hikma induces infringement of Takeda’s method patents under 35 U.S.C. § 271(b). The five patents-in-suit cover methods of treating acute gout flare with colchicine and methods of prophylaxis of gout flares when colchicine is co-administered with other drugs.  Hikma launched its accused product, Mitigare™, under an approved NDA for the prophylaxis of gout flares. Mitigare™ has the same active ingredient, route of administration, and strength as Takeda’s colchicine product, Colcrys®, but Hikma’s approved label carves out the patented uses of colchicine.

Under established precedent, Takeda was required to show that Hikma had specific intent to, and acted to, induce infringement; where a product has substantial noninfringing uses, intent to induce infringement cannot be inferred. Judge Robinson found Takeda’s estimate of 44% non-infringing uses (i.e., the use of colchicine for the prophylactic treatment of gout flares) to be substantial, and so specific intent to induce infringement could not be inferred.  Rather, Takeda was required to show through record evidence that Hikma actively encouraged others to directly infringe the patents-in-suit.

In determining whether Hikma actively encouraged patients or healthcare providers to directly infringe the acute gout flare treatment patents, Judge Robinson considered Hikma’s approved label, which states that the safety and effectiveness of Mitigare™ for acute treatment of gout flares during prophylaxis has not been studied, and that “[i]f you have a gout flare while taking Mitigare™, tell your healthcare provider.”

While the parties agreed that Hikma’s label lacks affirmative directions for the treatment of acute gout flairs, Takeda argued that the label advises patients to consult with their healthcare providers if they suffer an acute gout flare, and that providers would refer to Colcrys® prescribing information for the treatment of acute gout flares, so Hikma’s label would inevitably lead doctors to follow the patented method.  In rejecting Takeda’s argument, Judge Robinson considered the Federal Circuit’s 2010 decision in AstraZeneca LP v. Apotex, Inc. and distinguished that case, stating:

Unlike the facts reviewed in AZ 2010, where the generic’s label itself gave the information needed to infringe (the downward titration language), Hikma’s label only ‘necessarily leads’ to consultation 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.

As to the drug-drug interaction patents, Judge Robinson found that Hikma’s label did not “recommend or suggest to a physician” that the patented methods of co-administration should be followed.  Rather, the label explicitly warned against it, stating that co-administration “should be avoided if possible.” Citing United Therapeutic Corp. v. Sandoz, analyzed in our post of October 1, Judge Robinson noted that “there is a rather significant difference between a warning and an instruction.” Takeda’s induced infringement theory relied on a “predictive course of conduct” requiring a healthcare provider to follow the patented methods only after determining that co-administration could not be avoided in a patient both prescribed one of the three drugs at issue and undergoing prophylactic colchicine treatment. Further, there was no evidence in the record that any healthcare provider directly infringed the patented methods. Thus, as in UTC v. Sandoz, Judge Robinson rejected the theory “that a scholarly scavenger hunt—which may be incited by [the label]—can constitute evidence of [defendant’s] intent to induce physicians to engage in infringing conduct.”

Takeda is yet another federal district court case finding that an accused generic drug product’s label does not instruct physicians or patients to infringe a patented method of treatment. Where substantial non-infringing uses exist for a drug, a patentee relying on the accused product’s label to establish intent to induce infringement must identify explicit instructions to infringe in the label. A patentee’s showing of specific intent to induce infringement apparently cannot rest on an attenuated, “scholarly scavenger hunt” theory wherein a prescriber must take a series of hypothetical steps after reading a drug label in order to arrive at the patented method.