Split infringement is an important consideration for personalized medicine patents because often one entity performs the diagnostic step, and a second entity performs the treatment step. Avoiding split infringement issues are difficult as diagnostic method claims alone must contend with subject matter eligibility problems, as discussed in our previous post. Adding a treatment step may make the claim patent eligible, so long as it passes muster under the Supreme Court’s Mayo decision.1

Once patent eligibility was established, capturing infringing activity still may be challenging in light of the single entity requirement for direct infringement. Personalized medicine often involves at least two steps: diagnosis and therapy, with laboratories performing the first step, and clinicians performing the second step. Before the Akamai decision,2 a party could be liable for direct infringement only if (1) it performs all the steps itself, (2) it acts through an agent, or (3) it contracts with another to perform one or more steps of the claimed method. For categories (2) and (3), the inquiry is whether “a single entity directs or controls the acts of another.” In typical personalized medicine scenarios, the doctor and laboratory are usually not in a relationship that would fall under categories (2) and (3), and thus infringement of two-step claims might not be infringed under the old direct infringement standard.

Now, however, the Federal added another category for direct infringement: “when an alleged infringer conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance.”3

The Federal Circuit also explained that if two or more actors form a joint enterprise, all can be charged with the acts of the other.4 A joint enterprise requires proof of four elements:

(1) an agreement, express or implied, among the members of the group; (2) a common purpose to be carried out by the group; (3) a community of pecuniary interest in that purpose, among the members; and (4) an equal right to a voice in the direction of the enterprise, which gives an equal right of control.5

The Federal Circuit also found that “Section 271(a) is not limited solely to principal-agency relationships, contractual arrangements, and joint enterprise . . . . Rather, to determine direct infringement, we consider whether all method steps can be attributed to a single entity.”6

Akamai involved a business method claim, a network provider and its customers, making it difficult to draw parallels between those facts and those of a typical personalized medicine scenario. InAkamai, the infringing party was the network provider, Limelight, which was found to condition its customers’ use of its content delivery network upon its customers performance of the tagging and serving steps. Limelight was found to establish the manner or timing of its customers’ performance.7 In the context o personalized medicine, the laboratory carrying out the diagnostic testing could be considered the doctor’s customer, in the sense that the doctor is conditioning the laboratory’s services upon the performance of a particular diagnostic test. While testing laboratories are typically independent entities, in the sense that the patient is billed directly for their services, the patient sometimes does not choose the testing laboratory. Rather, the physician sends the patient to a particular laboratory of its choosing, or sends the patient’s sample to a testing laboratory of its choosing. Under such a scenario, the doctor may be found to directly infringe under the Akamaistandard.

In a related personalized scenario, the laboratory performing an allegedly infringing diagnostic service could potentially be found liable for infringement if it could be demonstrated that the laboratory provides detailed instructions to the physician based upon the results of diagnostic testing. For example, based on a measured level of an analyte, the clinician is directed to administer a particular therapy to a patient. Depending upon the level of instruction provided by the laboratory, it could be found that the manner and timing of the clinician’s performance was established by the laboratory. The benefit that would be received by the clinician, and the laboratory, would be reimbursement of the testing and treatment by a health insurance provider or the patient.

Depending on the courts’ interpretation of the Akamai standard, there may yet be more opportunities to capture infringement of personalized medicine claims.