In Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., Appeal No. 2015-2067 (Fed. Cir. Jan. 12, 2017), the Federal Circuit held that the generic pharmaceutical companies induced infringement despite some of the steps of the patented method claim being performed by a physician and some by a patient.
Eli Lilly & Co. (“Eli Lilly”) is the owner of U.S. Patent No. 7,772,209 (“’209 patent”). It filed suit to prevent several pharma companies from launching a generic version of a chemotherapy drug ALIMTA. The asserted claims stated a method for administering pemetrexed disodium with three different steps, two of which were performed by a physician and one of which was performed by a patient:
12. An improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment, wherein the improvement comprises: a) administration of between about 350 μg and about 1000 μg of folic acid prior to the first administration of pemetrexed disodium; b) administration of about 500 μg to about 1500 μg of vitamin B12, prior to the first administration of pemetrexed disodium; and c) administration of pemetrexed disodium.
The parties all agreed that no single actor performed all steps of the asserted claims; rather, the steps were divided between physicians and patients. Though physicians administer vitamin B12 and pemetrexed, patients self-administer folic acid with guidance from physicians. Eli Lilly’s theory of infringement therefore required first establishing direct infringement based on actions of two different actors.
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: when that entity “directs or controls” others’ performance, or when the actors “form a joint enterprise.” Akamai Techs., Inc. v. Limelight Networks, Inc., 797 F.3d 1020 (Fed. Cir. 2015) (en banc) (Akamai V). Eli Lilly did not pursue a joint enterprise theory, so the question of direct infringement was whether physicians direct or control their patients’ administration of folic acid.
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 district court had relied in part on Defendants’ proposed product labeling as evidence of infringement: The Physician Prescribing Information provides, among other things:
Instruct patients to initiate folic acid 400 μg to 1000 μg orally once daily beginning 7 days before the first dose of pemetrexed . . . . Instruct patients on the need for folic acid and vitamin B12 supplementation to reduce treatment-related hematologic and gastrointestinal toxicity . . . .
The Patient Information included similar information:
To lower your chances of side effects of pemetrexed, you must also take folic acid . . . prior to and during your treatment with pemetrexed. It is very important to take folic acid and vitamin B12 during your treatment with pemetrexed to lower your chances of harmful side effects. You must start taking 400–1000 micrograms of folic acid every day for at least 5 days out of the 7 days before your first dose of pemetrexed. . . .
With respect to the first prong— conditions participation in an activity upon others’ performance —the Federal Circuit held that the district court’s finding that physicians “condition” pemetrexed treatment on the administration of folic acid was supported by the record evidence. The Physician Prescribing Information, which is “directed to the physician,” explains that folic acid is a “requirement for premedication” in order “to reduce the severity of hematologic and gastrointestinal toxicity of pemetrexed.” Consistent with the importance of folic acid pretreatment, the product labeling repeatedly states that physicians should “instruct patients” to take folic acid and includes information about folic acid dosage ranges and schedules
With respect to the second prong—establishing the manner or timing of performance—the Federal Circuit again relied in the product labeling, stating that the Physician Prescription Information instructs physicians not only to tell patients to take folic acid orally, but also to take “400 μg to 1000 μg of folic acid once daily beginning 7 days before the first dose of pemetrexed,” accompanied with warnings about the consequences of non-compliance. In addition, Eli Lilly’s expert testified that “it’s the doctor” who “decides how much folic acid the patient will take and when the patient takes it.”
After finding direct infringement by the physician, the Federal Circuit analyzed whether the pharma companies induced the physician’s direct infringement. The intent for inducement must be with respect to the actions of the underlying direct infringer, here physicians. When the alleged inducement relies on a drug label’s instructions, “the question is not just whether those instructions describe the infringing mode, . . . but whether the instructions teach an infringing use such that we are willing to infer from those instructions an affirmative intent to infringe the patent.” “The label must encourage, recommend, or promote infringement.” For purposes of inducement, “it is irrelevant that some users may ignore the warnings in the proposed label.” The Federal Circuit held that the product labeling includes repeated instructions and warnings regarding the importance of and reasons for folic acid treatment, and there is testimony that the Physician Prescribing Information, as the name indicates, is directed at physicians. The instructions are unambiguous on their face and encourage or recommend infringement.
The case can be accessed here: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/15-2067.Opinion.1-10-2017.1.PDF