The patentee sued under 35 U.S.C. § 271(e) in the Southern District of Indiana alleging that the defendants’ ANDA filings infringed certain claims of the patent-in-suit related to a method of treating cancer. The district court found that the alleged infringer would be liable for induced infringement under the standard set forth in Akamai V, even though there was no single entity that could be called a direct infringer. The alleged infringer appealed.

The Federal Circuit examined under the “clear error” standard whether the district court had erred in finding direct infringement by the physicians of the patent-in-suit. The parties did not dispute that the steps of the method in question were performed separately by the patients and the physicians but disputed whether the physicians “direct or control” the actions of the patients. Citing the instructions in the packaging that accompanies the drugs themselves, the Federal Circuit found that (1) the physicians “conditioned participation” in the treatment on the activities of the patients—namely taking folic acid prior to administration of the drug, and (2) the physicians “established the manner or timing” of that performance.

The Federal Circuit then examined whether the alleged infringer induced infringement by the direct infringer through “specific intent and action.” The alleged infringers submitted that, even if there is direct infringement, their product labeling does not induce such infringement and that the patent holder failed to offer any evidence of what physicians do “in general,” but instead offer “speculation about how physicians may act.” The Federal Circuit instead found that the specificity of the instructions supported a finding that the product labeling sought would inevitably lead some physicians to act in a particular way that established the requisite intent for inducement.