Yesterday, the U.S. Supreme Court released its unanimous opinion in Mayo v. Prometheus. I was pleased to see the Court affirm and clarify the unpatentability of laws of nature.
Here’s a generalized statement of the law of nature at issue in this case: Certain concentrations of a specific drug metabolite in the blood indicate (a) toxic levels to humans (too high); or (b) ineffective therapeutic levels (too low).
The method claims included a step of (i) administering the drug; (ii) determining the level of the drug metabolites in the blood; and (iii) increasing or decreasing the administration dose in accordance with prescribed tolerances for efficacy and toxicity.
A long line of case law makes it clear that laws of nature, natural phenomena, mathematical algorithms, and abstract ideas are not patentable subject matter under 35 U.S.C. Section 101. This doesn’t mean that adding additional steps to natural phenomena, or applying a law of nature in a unique way may not be patented, but we now have guidance that says those steps must be more than just the run of the mill application of standard processes regularly used in the field of the claims.
In reversing the Federal Circuit Court and affirming the District Court’s ruling, the Supreme Court clarified why these claims were not directed to patentable subject matter:
[T]he claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.
In other words, you can’t add well understood, routine, conventional steps to a natural phenomenon or law of nature and have a valid patent claim. In explaining the rationale behind the conclusion, the court stated its concern and pointed out that Prometheus was in good company:
The Court has repeatedly emphasized this last mentioned concern, a concern that patent law not inhibit further discovery by improperly tying up the future use of laws of nature. Thus, in Morse the Court set aside as unpatentable Samuel Morse’s general claim for “‘the use of the motive power of the electric or galvanic current . . . however developed, for making or printing intelligible characters, letters, or signs, at any distances,’”
Great Job SCOTUS!
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