Case: Mayo Collaborative Servs. V. Prometheus Labs., Inc., No. 10-1150 (Mar. 20, 2012).
In a unanimous decision the Supreme Court held that Prometheus’ patents claim a law of nature and are invalid. The patent claims relate to the use of thiopurine drugs to treat certain diseases. Specifically, the claims require “administering a drug,” “determining the level” of metabolites in the blood, and, depending on the level, either increasing or decreasing the dosage. Slip. Op. at 5-6. Whether doctors should increase or decrease the dosage is determined by comparing the concentration of metabolites in the blood with the correlations embodied in the patent claims.
As the Court explained, although a law of nature is not patentable, the application of a law of nature may claim a patent-eligible process: “If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.” Id. at 8-9. Reciting the law of nature and then adding the words “apply the law” do not transform the process into a patent-eligible application of the law of nature. The process needs additional elements “sufficient to ensure that the patent . . . amounts to significantly more than a patent upon the natural law itself.” Id. at 3 (citations omitted).
The Court first concluded that Prometheus’ patents claim laws of nature. The laws of nature present in the claims are the “relationships between correlations of certain metabolites in the blood and the likelihood that a dosage of thiopurine drug will prove ineffective or cause harm.” Id. at 8. The correlations are an attempt to articulate the bounds of wholly natural processes and exist independently of human action. Because the patents describe laws of nature, the patents must “add enough” to the processes “to qualify as patent-eligible processes that apply natural laws.” Id. at 8 (emphasis in original).
In determining the patent-eligibility of the patent claims, the Court addressed each of Prometheus’ claims and concluded that the additional steps in the claims “involve well-understood, routine, conventional activity previously engaged in by researchers in the field,” and, “when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.” Id. at 4, 11. “[U]pholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.” Id. at 4. The Court thus held that the additional steps in the claims do not transform the process into a patent-eligible application of the laws of nature.