Digest of Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward Pharmaceutical Corp. (Fed. Cir. May 6, 2015) (precedential). On appeal from the District of Delaware. Before Newman, Dyk, and Hughes.

Procedural posture: Plaintiff appealed the district court’s denial of a preliminary injunction against continuing its launch of a pharmaceutical product and against the launch of an authorized generic version of that product. CAFC affirmed.

  • Induced infringement: Where drug was marketed as a preventative treatment for gout flares, a statement on the label was not sufficient to show induced infringement of claims directed to treatment of acute gout flares, for which the product was used off-label. Inducement requires conduct that encourages infringement, not merely knowledge of infringing activity. The plaintiff argued that there was inducement because (i) the label directed patients to tell their physicians if they had an acute flare (“if you have a gout flare while taking [the drug], tell your healthcare provider”), (ii) defendants and physicians knew that the drug was also appropriate for treating acute flares, and therefore (iii) physicians who had already prescribed the drug would “inevitably” direct the patients to use the same drug, at higher doses, during the gout flare. The CAFC disagreed; the evidence did not show it to be “inevitable” that doctors would use that particular product to treat the acute flares, and evidence that “some, or even many, doctors” would do so was not sufficient to show induced infringement.
  • Induced infringement: The CAFC also found no induced infringement by the same product of patents directed to interaction between the claimed drug and other drugs. General statements on the label indicating that, if co-administration of the drug and other drugs was necessary, the dose or dose frequency should be reduced, were insufficient to induce infringement of claims requiring specific dosages of the drug and/or specific dosages of another drug. The district court correctly found that direct infringement was unlikely because (i) the claimed dosage was difficult to achieve using the product, and (ii) they did not direct co-administration with a particular dosage of a particular product. It was not sufficient that the particular dosage of the other product was the “usual” dose.

Judge Newman, dissenting:

  • Induced infringement: The majority panel misinterprets the Hatch-Waxman Act and announces a bright-line rule “that inducement cannot be found, whatever the particular medicament and use,” in cases like this one (i.e., where the label does not specifically direct the patented use). Because the defendant gives instructions to “tell your healthcare provider” about acute flares and the plaintiff introduced evidence that physicians would prescribe the infringing protocol, the issue of inducement should not be decided against the plaintiff at a preliminary injunction hearing but should be more fully developed and decided on a fact-specific basis.