On January 12, 2017, the Court of Appeals for the Federal Circuit handed Eli Lilly a win against Teva Pharmaceuticals that blocks Teva from selling its generic version of the cancer treatment drug Alimta.
The Court, following its precedent in Akamia V, found Teva’s proposed product labeling for its generic drug would induce infringement of U.S. Patent No. 7,772,209, which is owned by Eli Lilly. This patent claims a method of administering pemetrexed disodium to a patient and includes the step of administering an effective amount of folic acid before pemetrexed disodium. In practice, the folic acid is taken by the patient at the direction of the treating physician. The direction includes taking a prescribed amount of folic acid following specific schedule. After which, the pemetrexed disodium is given to the patient by the physician. But, if the folic acid is not taken as directed, pemetrexed disodium is not given to the patient.
Since completing the claimed method requires action by two separate people, the question of induced infringement was at issue concerning the step of administering folic acid, which is completed by the patient.
Under Akamia V, when no single actor performs all the steps of a method claim, infringement only occurs “if the acts of one are attributable to the other such that a single entity is responsible for the infringement.” In one circumstance, performance of method steps is attributable to a single entity when that entity “directs or controls” others in completing the steps. Directing or controlling of others performance includes an actor that (1) conditions participation in an activity or receipt of a benefit upon others’ performance of one or more steps of the patented method, and (2) establishes the manner or timing of that performance.
Here, the Court found treating a patient with Teva’s generic drug satisfied both prongs because the treatment is conditioned on the patient first taking folic acid by the patient following a specific regiment that was prescribed by the doctor. This decision provides further guidance on how multi-actor method claims can be infringed under Akamia V.