Takeda Pharms. U.S.A., Inc. v. West-Ward Pharm. Corp.

Finding that a drug label’s language did not rise to the level of “active encouragement” that would induce doctors to infringe, the U.S. Court of Appeals for the Federal Circuit upheld the district court’s denial of a preliminary injunction. Takeda Pharms. U.S.A., Inc. v. West-Ward Pharm. Corp., Case Nos. 15-1139, -1142 (Fed. Cir., May 6, 2015) (Dyk, J.) (Newman, J., dissenting).

Both parties market colchicine drug formulations, which have been known for centuries to be useful in preventing and treating gout. Takeda’s patents are directed to specific methods of using colchicine for treatment of acute gout flares, whereas Hikma’s allegedly infringing product, Mitigare, is marketed for prevention of gout. According to Hikma’s drug label, Mitigare is “indicated for prophylaxis” and the “safety and effectiveness of Mitigare for acute treatment of gout flares during prophylaxis has not been studied.” The label also stated that “if you have a gout flare while taking [Mitigare], tell your healthcare provider.”

Takeda argues that the “tell your healthcare provider” instruction will “inevitably” lead to physicians who are consulted to advise patients taking Mitigare for prophylaxis to simply increase their dose of Mitigare to treat acute gout flares and that Hikma was aware of or willfully blind to this possibility. To support its argument, Takeda presented expert opinion and medical literature evincing that at least somephysicians would simply tell patients with acute gout, who are already using Mitigare, to simply increase their Mitigare dosage to match the acute gout dosing instructions from Takeda’s own competing colchicine treatment.

The Federal Circuit rejected Takeda’s argument, concluding that “vague label language cannot be combined with speculation about how physicians may act to find inducement.” According to the Federal Circuit, inducement in the context of pharmaceutical labeling requires that the Mitigare label expressly “encourage, recommend, or promote infringement.” Because a physician would have to “look outside the label” (e.g., to the label of Takeda’s own colchicine product) in order to know how to use Mitigare in an infringing way, the Mitigare label did not rise to the level of “active encouragement.”

Moreover, inducement requires that the label “necessarily” and “inevitably” lead to infringement. By contrast, here there is “no evidence that the label would necessarily lead doctors who are consulted by patients taking Mitigare to prescribe an off-label use of it to treat acute gout flares.” Although Takeda showed that some physicians would use Mitigare in an off-label (infringing) manner, according to the Court, “[s]peculation or even proof that some, or even many, doctors would prescribe Mitigare for acute flares is hardly evidence of inevitability.”

Judge Newman dissented, noting that the panel’s decision runs counter to the purpose of the Hatch-Waxman Act by “provid[ing] a disincentive by negative enforcement of improvement patents by the simple expedient of omitting the improvements from the label.”

Practice Note: When drafting method of treatment claims, think prospectively and seek claims for both on-label uses and potential off-label uses.