On December 18, 2015, in The Cleveland Clinic Foundation v. True Health Diagnostics, LLC, a district court judge in Ohio issued an order denying the Cleveland Clinic Foundation’s (“CCF’s”) Motion for Temporary Restraining Order and Preliminary Injunction after concluding that CCF had failed to establish a likelihood of success on the merits. In particular, the court found that CCF had “fail[ed] to make a clear showing that the patents-in-suit” are directed towards patent eligible subject matter. This is yet another example of the challenges facing the developers of diagnostic tests in the wake of Mayo v. Prometheus.
The patents at issue in the case, U.S. Patent No. 7,223,552 (“the ’552 patent”); U.S. Patent No. 7,459,286 (“the ’286 patent”); and U.S. Patent No. 8,349,581 (“the ’581 patent”), relate to methods of analyzing Myeloperoxidase (“MPO”) biomarkers in a patient’s blood sample to predict a patient’s potential for heart disease, by comparing the level of MPO found in the patient’s blood sample with levels of MPO in control subjects to see if the patient has elevated levels of MPO. MPO is an enzyme released by white blood cells when an artery wall is damaged or becomes inflamed, and its presence is thus an early symptom of many types of cardiovascular disease (“CVD”).
Applying the Mayo/Alice two-step test for patent eligibility, the court concluded that “it appears that the correlation between MPO levels and cardiovascular disease is more akin to a law of nature,” and that, “[m]easuring a sample of blood or blood product1 appears to be a “’well-understood, routine and conventional activity’ known in the scientific community.” As a consequence, at least “at this point in the litigation,” the court was “not convinced that plaintiff has demonstrated that the patents-in-suit contain ‘an element or combination of elements’ sufficient to satisfy step two of the Mayo/Alice test.” The court rejected CCF’s argument that its patents require “measurement of a closed set of specific bodily samples” and, therefore, that its patents apply a “phenomenon in a combination of steps that has never been done before.”
Interestingly, the judge’s Order denying preliminary relief expounds in great detail on the important role the patents played in allowing CCF to translate the patented discovery into a successful commercial product. It describes how in 2009, CCF launched HeartLab as the exclusive licensee of the patents to commercialize MPO testing. CCF and HeartLab reportedly invested millions of dollars in their effort to build the MPO testing market, which has involved conducting ongoing medical and scientific studies, application for FDA approvals, and establishment of Medicare reimbursement status for MPO testing. In addition, they “have focused considerable effort on developing stringent manufacturing and quality standards and also invested in educational programs about MPO testing.”
To illustrate the success of CCF’s and HeartLab’s efforts to develop and commercialize MPO testing, the Order notes that at its “inception, HeartLab had eight employees who performed only a few hundred MPO tests. It now has 140 employees who will perform hundreds of thousands of MPO tests in 2015.”