On March 20, 2012, the Supreme Court issued a unanimous decision, authored by Justice Breyer, in Mayo Collaborative Services v. Prometheus Laboratories, Inc. The court held that the process patent that Prometheus Laboratories had obtained for correlations between blood test results and patient health is not eligible for a patent because it incorporates the laws of nature. The Court found that the claimed method merely restated a law of nature, specifically the correlation between the concentrations of certain metabolites in the blood and drug effectiveness or toxicity and, thus, it was not patentable subject matter under Section 101 of the Patent Act.
Here’s the gist of the decision’s underpinnings: Although “laws of nature, natural phenomena, and abstract ideas” are not patentable subject matter under §101 of the Patent Act, Diamond v. Diehr, 450 U. S. 175, 185 (1981), “an application of a law of nature . . . to a known structure or process may [deserve] patent protection,” id., at 187. But to transform an unpatentable law of nature into a patent eligible application of such a law, a patent must do more than simply state the law of nature while adding the words “apply it.” See, e.g., Gottschalk v. Benson, 409 U. S. 63, 71–72 (1972). It must limit its reach to a particular, inventive application of the law. Applying these principles to the claims in the plaintiff’s patent led the Court to a decision that the claims were not patentable subject matter.
The decision reversed the US Court of Appeals for the Federal Circuit’s earlier decision which held that the claims were patentable because they included additional limitations containing treatment steps involving a particular application of the natural correlations. The Supreme Court held that the additional limitations were routine, conventional steps that did not transform the natural correlations into patentable subject matter.
As you might imagine, this decision has caused some consternation in the world of pharmaceuticals and other goods and services that arguably rely on the laws of nature. The decision ratchets up uncertainty as to the viability of many existing patents and will likely increase patent litigation in this market sector.