Diagnostic Correlations Under Review
With respect to diagnostic method claims, in Laboratory Corp v. Metabolite Labs the claimed method of correlating homocysteine levels and vitamin deficiency was initially upheld by the Federal Circuit, prior to the issuance of Bilski. While the Supreme Court dismissed LabCorp’s appeal, a dissent questioned whether the diagnostic method was improperly claiming a natural phenomenon.
In September 2009, the Federal Circuit decided in Prometheus Labs v. Mayo that the claimed methods of optimizing therapeutic efficacy for treatment of immune-mediated gastrointestinal disorder, which included steps for both administrative treatment and diagnosis, qualified as patentable subject matter.
The Federal Circuit noted that both steps were transformative, since therapeutic administration necessarily affects the body and determining the levels of analyte cannot be performed by mere inspection. However, the Supreme Court has now remanded Prometheus to be reconsidered in view of Bilski.
To the extent that diagnostic method claims involve only mental correlative steps, they are at risk for being characterized as merely an unpatentable “abstract idea.” On the other hand, for claims that involve multiple steps of the medical continuum, in order to capture a more clearly patentable transformation step along with the diagnostic mental correlation step, it is more likely that a single entity will not infringe the claim, precluding any remedy.
In July 2010 the Federal Circuit further strengthened the single infringer requirement in Golden Hour Data Sys v. emsCharts, where the patent holder failed to prove that one party exercised the requisite “mastermind” control over the entire process, even though the two defendants were in a strategic partnership and joint distribution agreement to accomplish the claimed process. Therefore, “separate entities” may contract to infringe a method patent by simply performing different claimed steps.