Determining Patentable Subject Matter In The United States And Canada

As reported in our March 21, 2012, Spring Alert, the United States Supreme Court recently held in Prometheus v. Mayo that certain personalized medicine claims were directed to laws of nature and were thus unpatentable despite containing both an administering step and a determining step. The decision has raised concern amongst biotechnology patent seekers and holders especially in the area of diagnostic methods.

The Prometheus claims were based on the identification of particular ranges of metabolites that are associated with drug efficacy and toxicity. Prior to this, it was known that the levels of the metabolites were correlated with efficacy and toxicity. However, the particular ranges recited in the claims were not known to correlate. The Court was asked to consider whether the method claims contained statutory subject matter although many commentators think the issue of inventiveness appeared more relevant. The Court, in rejecting the claims, pointed to the