Separate Doctor, Patient Steps = Direct Infringement Under Akamai V, Fed. Cir. Says in Eli Lilly ALI

On January 12, 2017, the Federal Circuit affirmed a bench ruling from the U.S. District Court for the Southern District of Indiana that certain generic drug makers induced infringement of U.S. Patent No. 7,772,209 (the “‘209 patent”) directed to methods of administration of pemetrexed, a chemotherapy drug marketed by Eli Lilly & Co. under the brand name ALIMTA®. Also in this Hatch-Waxman-based case, the Federal Circuit affirmed the lower court’s ruling that the asserted claims were not invalid for, inter alia, obviousness, indefiniteness, or obviousness-type double patenting.

The claims at issue involved steps to be separately performed by patients and doctors. Exemplary claim 1 is recited as follows (emphasis added):

1. A method of administering pemetrexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium, wherein

the methylmalonic acid lowering agent is se- lected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanoco- balamin, or chlorocobalamin.

Here, it was determined that the patent requires the patient to administer the folic acid and the physician to administer the pemetrexed disodium. Under well-established law, in order to be liable for inducing patent infringement, there must be an underlying direct infringement (as well as the requisite intent to induce infringement). In the case of method steps, establishing direct infringement normally requires showing that a single actor performed each of the steps in the claimed method.

Given that multiple actors (patients and physicians) were involved in the alleged direct infringement in the case at bar, the Court relied on the direct infringement standard articulated under Akamai Technologies, Inc. v. Limelight Networks, Inc. (Akamai V), 797 F.3d. 1020 (Fed. Cir. 2015) (en banc) (per curiam), which allows for the finding of direct infringement when multiple actors, under certain circumstances, perform separate steps in the claimed method. The Akamai V standard had developed during the pendency of the underlying subject case.

In affirming the lower court’s ruling, the Court analyzed the generic drug makers’ product labels and found that, under Akamai V, the performance of the claimed method was attributable to the “same entity.” Under Akamai V, the Court explained, “[t]he performance of method steps in is attributable to a single entity when that entity ‘directs or controls’ others’ performance,” and that such direction and control is found when the actor (1) “conditions participation . . . in an activity or receipt of a benefit" and (2) “establishes the manner or timing of that performance.” The Court found direction and control in this case because the “physicians condition patient participation in an activity or receipt of a benefit (pemetrexed treatment) on folic acid administration and also establish the manner or timing or performance.” The Court therefore found the requisite underlying direct infringement. Completing the analysis, the Court also held that the requisite “specific intent and action to induce infringement” existed, and therefore the generic makers were liable for inducement.

The full case opinion can be found here:

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