Cleveland Clinic Found. v. True Health Diagnostics LLC, No. 2016-1766, 2017 (Fed. Cir. June 16, 2017) (Before Lourie, Reyna, and Wallach, J.) (Opinion for the court, Reyna, J.)
The Federal Circuit affirmed a finding of Section 101 ineligibility and a failure by plaintiff to state a claim of contributory or induced infringement.
Cleveland Clinic’s diagnostic or “testing” patents at issue dealt with a process by which an enzyme was measured and correlated against known levels of the enzyme in patients who were healthy or had cardiovascular disease. The Court applied the two step Alice analysis. First, the Court found that the patents were directed to “multistep methods for observing the law of nature that [the enzyme] correlates to cardiovascular disease.” Second, the claims were not transformative and “merely tell those interested in the subject about the correlations that the researchers discovered,” using “only conventional [enzyme] detection methods and compare[ing] those values to predetermined or control values derived from conventional statistical methods.”
The Court also held that claims of contributory and induced infringement were properly dismissed for the “method of treatment” patent. It was not an abuse of discretion to deny the patentee leave to amend the complaint. On the facts of record, True Health does not provide a “material or apparatus,” which is required for contributory infringement. Cleveland Clinic also did not show that there was “specific intent and action” between True Health and doctors that may prescribe drugs based on the patented method, and could not show induced infringement.
Observed statistical correlations between healthy and diseased populations, such as correlating levels of an enzyme to cardiovascular disease, is not patentable subject matter. A defendant does not “contribute” to infringing a method of treatment when no material or apparatus is involved. A defendant does not “induce” infringement by knowing others might infringe; there must be evidence showing a “specific intent and action” to encourage infringing conduct. Absent such facts of record, it is not an abuse of discretion to deny amending a complaint to add allegations of contributory or induced infringement.