In Eli Lilly and Company v. Teva Parenteral Medicines, Appeal No. 2015-2067, the Federal Circuit affirmed a finding of direct infringement attributable to physicians under the Akamai V divided infringement standard, which supported the district court’s finding of induced infringement of a pharmaceutical method claim.
The district court determined that Teva induced infringement of Eli Lilly’s patent covering the method of administering a chemo therapy drug. Doctors performed the underlying direct infringement. On appeal, Teva argued that there was no direct infringement by a single actor because patients self-administer vitamins prior to the doctors’ administering of the drug. Teva also argued that there was no attribution of the accused conduct to a single actor because a single entity did not direct or control the asserted method steps.
The Federal Circuit held that that Eli Lilly had satisfied the two-prong test—outlined in Akamai v. Limelight, 797 F.3d 1020 (Fed. Cir. 2015) (Akamai V)—to prove direct infringement by more than one actor. The product labeling instructed doctors and patients on dosage ranges and schedules. Doctors would also discontinue treatment if they discovered patients were not following the prescribed regimen. The Court held that this was sufficient evidence that the doctors (1) conditioned the patient’s participation in the activity, and (2) controlled the manner and timing of that performance.
Teva also argued that there was insufficient evidence of inducement. But the Court found that self-administration of the vitamins was not merely a suggestion but rather a critical step in the doctors’ treatment regimen. The Court also held that there was no requirement that Eli Lilly prove the general prevalence of the induced activity. It was irrelevant that some users ignored label warnings.