This is a pre-copyedited, author-produced version of an article accepted for publication in the Journal of Intellectual Property Law and Practice following peer review.
In the wake of Mayo and Myriad, life science patent drafters may consider coupling method claim treatment steps with sampling and diagnosing steps to overcome subject matter eligibility rejections raised by the USPTO. While these approaches may be effective for overcoming §101 rejections, this may result in divided-actor method claims where more than one entity is involved in performing the patented steps. This creates enforcement problems under Akamai V, 797 F.3d 1020 (Fed. Cir. 2015), which confirmed 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.” Id. at 1022.
Courts hold one entity responsible for another’s performance of patented steps in two situations:
(1) where one entity directs or controls another’s actions, and
(2) where multiple actors form a joint enterprise.
In Akamai V, the Federal Circuit expanded prong (1) above, explaining that directing or controlling another’s actions can include situations in which an actor:
(a) conditions participation in an activity or receipt of a benefit upon another’s performance, and
(b) establishes the manner or timing of that performance.
The Federal Circuit recently applied the holdings of Akamai V in Eli Lilly v. Teva, 845 F.3d 1357 (Fed. Cir. 2017) and Medgraph v. Medtronic, 843 F.3d 942 (Fed. Cir. 2016), reaching different conclusions regarding the infringement of two life science patents where divided-actor method claims were asserted.
In Eli Lilly, the Federal Circuit affirmed the district court’s finding of direct infringement of a divided-actor method claim based on the theory that one entity (a doctor) directed or controlled another’s actions (a patient). The claim recited a method for administering a lung cancer chemotherapeutic to a patient. On appeal the parties agreed that no single actor performed all steps of the claim, but rather that the steps were divided between physicians and patients. The prescribing label instructed patients to self-administer supplements at least one week prior to chemotherapy.
The court relied on the label and expert testimony to find that with respect to prong (a) physicians conditioned chemotherapy on the step of folic acid administration. Defendants argued that simple instructions from the product label did not rise to the level of “conditioning” because physicians did not verify patient compliance, enter into a contractual agreement with the patient, or threaten to deny treatment. The court disagreed, stating that the ability of doctors to withhold chemotherapy based on low serum folic acid levels crossed the line from merely guiding patients, to conditioning treatment on patient-administration of the supplements. Eli Lilly at 1366.
With respect to prong (b), the court again looked to the product label and relied on expert testimony confirming that it is the doctor who decides how much folic acid the patient will take and when, thereby “establishing the manner and timing of performance.” Eli Lilly at 1367. In their defense, Teva and Barr Laboratories contended that the product label actually gave patients discretion to select their own dose and form of folic acid, as well as the liberty to consult with outside experts on vitamin deficiency. But the court was not persuaded, finding that “manner and timing of performance” was established by a daily regimen at a particular dose for a set duration. Thus, the patient’s actions could be attributed to the physician, establishing direct infringement by the physician as the sole actor performing the patented method. Once direct infringement was found, the court considered the question of inducement and held that defendants’ proposed distribution of a generic version of Eli Lilly’s chemotherapeutic, in the manner described on the proposed generic product label, would induce physicians to infringe the patented methods.
The Federal Circuit applied Akamai V to find attribution in Eli Lilly, but declined to find attribution in another medical treatment case, Medgraph v. Medtronic. The asserted claims in Medgraph were “directed to a method for improving and facilitating diagnosis and treatment of patients, whereby data relating to ‘medically important variable[s],’ for example, blood sugar levels of a diabetic patient, measured from a patient’s body, are uploaded onto a computer and transmitted to a central storage device, from which they can be accessed remotely by medical professionals treating the patient. Medgraph, 843 F.3d at 944 citing U.S. Patent No. U.S. Patent 5,974,124. Patentee Medgraph asserted divided-actor method claims against Medtronic, arguing that Medtronic’s CareLink® product˗˗a diabetes management system˗˗instructed users to practice the patented steps.
The accused product, Medtronic’s CareLink® , collects blood glucose levels directly from a patient to generate reports that patients share with their doctors to monitor their diabetes. Medtronic succeeded in arguing non-infringement before the district court because the asserted claims required the actions of more than one entity˗˗Medtronic, a patient and a doctor˗˗and neither the patient nor the doctor was an agent of, or under a contractual obligation to Medtronic to perform all of the steps. The district court entered judgment of non-infringement “because there had not been any showing that Medtronic itself directly infringed the method claims or that it acted as a ‘mastermind’ by controlling or directing anyone else’s direct infringement.” Medgraph at 946-47.
The Federal Circuit agreed, stating that even under the broadened Akamai V standard, Medgraph could not attribute the action of the patient or the physician to Medtronic, to unify the divided steps. Medgraph could only have used the enlarged standard of Akamai V to show attribution if it proved that Medtronic conditioned the use of, or receipt of a benefit from CareLink® , based on performance of Medgraph’s patented steps. The court found that Medtronic did not deny users access to CareLink® if they did not perform a step of the claim involving detaching the measurement device after the measurement was taken. There was also no incentive for detachment. Rather, Medtronic benefits when CareLink® patients continuously use glucose monitoring devices by keeping them attached to the body. Likewise, Medtronic did not deny a benefit to its users if they chose not to perform the step of synchronizing blood glucose data to allow their physicians to access the data remotely. Instead of remote synchronization, patients could locally synchronize their devices at a clinic, perform data extraction and report-printing onsite, and still benefit from the product. Thus, Medgraph’s divided patent steps could not be attributed to a single entity and the Federal Circuit affirmed summary judgment of non-infringement.
So far, these are the only two examples of how life science divided-actor method claims have fared when asserted under the new Akamai V attribution standard. A key difference appears to be the number of divided actors and claim simplicity. Eli Lilly involved two discrete actors rather than three or more potential actors as seen in Medgraph (where a Medtronic computer system carried out multiple patented steps in addition to a patient and physician). The most resilient attribution theories may be built around method claims that refer to a preferred actor based on a client’s business strategy. For example, method claims drafted from the vantage point of a treating physician (as seen in Eli Lilly), who is following step-wise instructions from the prescribing label, may allow for consolidation of actions and support induced infringement.
Method claims that make use of adjectives rather than verbs may also be preferable. For example, the following claim combines steps under the work of one actor: “administering chemotherapeutic X to a patient determined to have an allelic polymorphism…”. In contrast, a less preferable construction divides the same concept between two potentially different actors: “determining that a patient has an allelic polymorphism … and then administering chemotherapeutic X.”
Elizabeth Flanagan is a Principal in the Delaware office of Fish & Richardson. Her practice focuses on complex patent litigation, with an emphasis on life sciences, biotechnology and pharmaceutical litigation, including Hatch-Waxman litigation. Betsy has worked on a variety of...
Gina Nellesen is a Patent Fellowship Attorney in Fish & Richardson’s Silicon Valley office. Ms. Nellesen drafts and prosecutes patents for academic institutions, corporations and emerging companies pursuing life sciences. She collaborates with scientists to capture new intellectual property and builds patent landscapes to help clients...
Tasha Francis, Ph.D. is an associate in Fish & Richardson’s Twin Cities office, practices intellectual property litigation with an emphasis on patent litigation. Dr. Francis has represented plaintiffs and defendants in cases involving medical devices, biotechnology...