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\u00a0No. 7,772,209, and that the\u00a0the asserted claims were not invalid for\u00a0indefiniteness, obviousness, or obviousness-type\u00a0double patenting.<\/p>\n
The claims in suit all required pretreatment by administration of folic acid. \u00a0The parties agreed, for purposes of appeal, that no\u00a0single actor performs all steps of the asserted claims. \u00a0Rather, the steps are divided between physicians and\u00a0patients. Though physicians administer vitamin B12 and
\npemetrexed, patients self-administer folic acid with\u00a0guidance from physicians. \u00a0Specifically,\u00a0the Physician Prescribing Information and the Patient Information accompanying the product instructed the patient to self-administer folic acid.<\/p>\n
The Federal Circuit noted that\u00a0where no single actor performs all steps of a\u00a0method claim, direct infringement only occurs if the acts\u00a0of one are attributable to the other such that a single\u00a0entity is responsible for the infringement. \u00a0The performance of method steps is\u00a0attributable to a single entity in two types of circumstances: (1)\u00a0when that entity directs or controls others\u00a0performance, or (2) when the actors form a joint enterprise. \u00a0In\u00a0\u00a0Akamai V, the Federal Circuit held that directing or controlling\u00a0others\u2019 performance includes circumstances in which an
\nactor: (1) conditions participation in an activity or receipt\u00a0of a benefit upon others\u2019 performance of one or more\u00a0steps of a patented method, and (2) establishes the manner\u00a0or timing of that performance. \u00a0However the Federal Circuit also said that\u00a0other factual scenarios may arise\u00a0which warrant attributing others\u2019 performance of method\u00a0steps to a single actor.<\/p>\n
Regarding the first Akamai V prong, the district court found from the product labelling that \u201ctaking folic acid in\u00a0the manner specified is a condition of the patient\u2019s participation\u00a0in [the] treatment.\u201d \u00a0Regarding the
\nsecond prong, the district court found that physicians would\u00a0\u201cprescrib[e] an exact dose of folic acid and direct[] that it\u00a0be ingested daily.\u201d The district court concluded that the performance of all steps of the
\nasserted claims would be attributable to the prescribing physicians. The Federal Circuit agreed, finding\u00a0the record replete with evidence that physicians\u00a0delineate the step of folic acid administration that\u00a0patients must perform if they wish to receive pemetrexed\u00a0treatment. \u00a0The Federal Circuit further found that\u00a0the evidence regarding the critical nature of folic acid\u00a0pretreatment and physicians\u2019 practices supported a finding\u00a0that physicians cross the line from merely guiding or\u00a0instructing patients to take folic acid to conditioning the treatment on their administration of folic
\nacid. \u00a0The Federal Circuit rejected the argument that an actor
\ncan only condition the performance of a step by imposing\u00a0a legal obligation to do so, by interposing that step as an\u00a0unavoidable technological prerequisite to participation, or both. \u00a0Conditioning is not limited to legal obligations or technological\u00a0prerequisites.<\/p>\n
The Federal Circuit also found sufficient control over the manner and timing of performance, again relying upon the written instructions and the testimony.<\/p>\n
Although the Federal Circuit found that the two-prong Akamai V
\ntest was met, it did not end the inquiry because the patent owner also has the burden\u00a0of further proving \u201cspecific intent and action to induce
\ninfringement.\u201d \u00a0Takeda argued that Lily did not show what physicians do, just what they may do. \u00a0The Federal Circuit rejected this argument, finding taht the label simply must encourage,\u00a0recommend, or promote infringement, and that it is irrelevant that some users may\u00a0ignore the warnings in the proposed label.<\/p>\n
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.<\/p>\n
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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\u00a0No. 7,772,209, and that the\u00a0the asserted claims were not invalid for\u00a0indefiniteness, obviousness, or obviousness-type\u00a0double patenting. … Continue reading