By Rachel Sachs
Regular readers of this blog will recall that I often think and write about the interaction between the induced infringement doctrine in patent law and medical method patents of various kinds (previous blog posts are here and here). Until the recent en banc decision in Akamai v. Limelight, courts had been extremely reluctant to attribute the actions of multiple parties to a single actor for purposes of assigning infringement liability. These cases have largely involved business method or software patents, but I had hypothesized in prior work that this analysis would extend to medical method patents, making them difficult to enforce.
Last week, Judge Tanya Walton Pratt of the U.S. District Court for the Southern District of Indiana provided evidence for the opposite proposition. Eli Lilly had sued a set of generic drug companies for patent infringement, arguing that they had induced physicians to infringe a set of method-of-treatment claims involving a chemotherapy drug. The problem for Lilly was that its claims require action by both physicians and patients, who must take certain other medications, including folic acid, before the physician administers the chemotherapy drug. Judge Pratt was tasked with determining whether the actions of the patient in preparing for their chemotherapy could be attributed to the physician. She ruled that because the physician “directs or controls the patient’s administration of folic acid,” “the performance of all the claimed steps … can be attributed to a single person, i.e. the physician.” As a result, the generic companies could be held liable for infringement.
One problem with Judge Pratt’s ruling is that it fails to confront the single Federal Circuit opinion to have considered and rejected this argument. McKesson Technologies, Inc. v. Epic Systems Corporation dealt with a patent on electronic communication between physicians and their patients. In that case, the Federal Circuit had occasion to consider how the doctor-patient relationship fits into the induced infringement paradigm. Judge Linn’s opinion concluded that “[a] doctor-patient relationship does not by itself give rise to an agency relationship or impose on patients a contractual obligation such that the voluntary actions of patients can be said to represent the vicarious actions of their doctors,” declining to attribute the patients’ actions to their physicians for purposes of assigning liability.
McKesson is not controlling precedent: the decision has since been vacated, as it was coupled with Akamai for en banc review, and the parties settled before further opinions could be rendered. Further, there are of course differences in the two fact patterns that may be used to distinguish the cases. But to my knowledge McKesson provides the only statement on this subject from the Federal Circuit, and Judge Pratt’s failure to address it in her opinion, even though the generic drug companies specifically cited it in their briefing, is puzzling.
More generally, though, neither Judge Pratt’s ruling nor McKesson spends substantial time considering the nature of the doctor-patient relationship. Going forward, there is an opportunity for judges to consider whether the doctor-patient relationship is just like any other relationship between a company and its customers (as in Akamai) or whether it is qualitatively different, as much (though certainly not all) of the voluminous sociological and ethical literature argues.