January 12, 2017

Instructions Induced Prescribing Physicians to Infringe

By Bryan K. Wheelock, Principal

In Eli Lilly and Company v. Teva Parenteral Medicines, Inc., [2015-2067] (January 12, 2017), the Federal Circuit affirmed judgment of inducement of infringement of U.S. Patent No. 7,772,209, and that the the asserted claims were not invalid for indefiniteness, obviousness, or obviousness-type double patenting.

The claims in suit all required pretreatment by administration of folic acid.  The parties agreed, for purposes of appeal, that no single actor performs all steps of the asserted claims.  Rather, the steps are divided between physicians and patients.  Though physicians administer vitamin B12 and pemetrexed, patients self-administer folic acid with guidance from physicians.  Specifically, the Physician Prescribing Information and the Patient Information accompanying the product instructed the patient to self-administer folic acid.

The Federal Circuit noted that where no single actor performs all steps of a method claim, direct infringement only occurs if the acts of one are attributable to the other such that a single entity is responsible for the infringement.  The performance of method steps is attributable to a single entity in two types of circumstances: (1) when that entity directs or controls others performance, or (2) when the actors form a joint enterprise.  In  Akamai V, the Federal Circuit held that directing or controlling others’ performance includes circumstances in which an actor: (1) conditions participation in an activity or receipt of a benefit upon others’ performance of one or more steps of a patented method, and (2) establishes the manner or timing of that performance.  The Federal Circuit, however, also said that other factual scenarios may arise which warrant attributing others’ performance of method steps to a single actor.

Regarding the first Akamai V prong, the district court found from the product labelling that “taking folic acid in the manner specified is a condition of the patient’s participation in [the] treatment.”  Regarding the second prong, the district court found that physicians would “prescrib[e] an exact dose of folic acid and direct[] that it be ingested daily.” The district court concluded that the performance of all steps of the asserted claims would be attributable to the prescribing physicians. The Federal Circuit agreed, finding the record replete with evidence that physicians delineate the step of folic acid administration that patients must perform if they wish to receive pemetrexed treatment.  The Federal Circuit further found that the evidence regarding the critical nature of folic acid pretreatment and physicians’ practices supported a finding that physicians cross the line from merely guiding or instructing patients to take folic acid to conditioning the treatment on their administration of folic acid.  The Federal Circuit rejected the argument that an actor can only condition the performance of a step by imposing a legal obligation to do so, by interposing that step as an unavoidable technological prerequisite to participation, or both.  Conditioning is not limited to legal obligations or technological prerequisites.

The Federal Circuit also found sufficient control over the manner and timing of performance, again relying upon the written instructions and the testimony.

Although the Federal Circuit found that the two-prong Akamai V test was met, it did not end the inquiry because the patent owner also has the burden of further proving “specific intent and action to induce infringement.”  Takeda argued that Lily did not show what physicians do, just what they may do.  The Federal Circuit rejected this argument, finding that the label simply must encourage, recommend, or promote infringement, and that it is irrelevant that some users may ignore the warnings in the proposed label.

The Federal Circuit rejected arguments that “Vitamin B12” made the claims indefinite, and arguments that the claims were obvious, and that they were invalid for obviousness type double patenting.