101 issue for diagnostic method in Cleveland Clinic
From Holman's biotech blog:
Tuesday, November 24, 2015
The Cleveland Clinic Foundation v. True Health Diagnostics: Judge Denies Preliminary Injunction Based on Likelihood That Diagnostic Testing Method Is Patent Ineligible
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”).