On March 20, 2012, the U.S. Supreme Court issued a decision in Mayo Collaborative Services, DBA Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc., No. 10-1150, holding that several claims drawn to measuring drug metabolite levels from patient samples were not patentable subject matter under 35 U.S.C. §101. Although the Court's decision may affect some diagnostics patents, the Court provided several clues on how to construct such claims so as to meet patentability requirements. This decision, however, represents a fundamental shift in the law of patent eligibility, and companies—especially diagnostics companies — that own or license patents and patent applications with claims incorporating "laws of nature" should review their claim strategies in light of Prometheus.

Overview

Section 101 of the Patent Act provides that "[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title."

Past U.S. Supreme Court cases addressing this part of the statute have ruled that the language is to be given broad scope and applicability, but that the scope of patentable subject matter is not unlimited. A longstanding limitation was provided in Diamond v. Chakrabarty, where the Supreme Court held that laws of nature, physical phenomena, and abstract ideas fall outside the scope of patentable subject matter. Thus, such things as unmodified living organisms, pure elements, and mathematical algorithms are not patentable.

The Supreme Court also addressed patentable processes more recently in Bilski v. Kappos. Specifically, the Court rejected the "machine-or-transformation" test developed by the Federal Circuit as the only test to define a patentable process. Under the machine-or-transformation test, a process was patentable if it was tied to a machine or apparatus, or had a transformative step. The Supreme Court, however, held that the machine-or-transformation test offers "a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under §101," but that it was not the only analytical tool for determining the patentability of process claims.