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On Tuesday, March 20, the U.S. Supreme Court decided Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (U.S. March 20, 2012), holding that the patent at issue was an unpatentable law of nature and clarifying which applications of natural laws are eligible for patent protection. Under Prometheus, new patents involving correlations between natural phenomena must do more than simply recite the natural correlation and then tell the user to apply it. Rather, correlation patents must confine themselves to particular applications of these correlations applied in new ways and not simply using well-known steps. In addition to this important clarification on the patentability of natural phenomena, Prometheus is significant for its rejection of a “look ahead’ approach that would allow courts to sidestep the patentable subject matter question by fast forwarding to analysis of patentability under 35 U.S.C. Sections 102 or 103.
Case Background
The Prometheus patents at issue in the case claim methods for “(a) ‘administering’ a drug … to a subject, and (b) ‘determining’ the levels of the drug’s metabolites, … in the subject.” 628 F.3d 1347, 1350. These measured levels are then compared to predetermined levels “‘wherein’ the measured levels ‘indicate a need’ to increase or decrease the level of drug to be administered so as to minimize toxicity and maximize treatment efficacy.” Id. Some of the claimed methods only contain the determining step. In response to a patent infringement suit by Prometheus, Mayo sought summary judgment that the patents were invalid because they claim unpatentable subject matter under 35 U.S.C. Section 101. Mayo contended that the patents claim natural phenomena — the correlation between metabolite levels and drug toxicity — and that the claims wholly preempt use of that phenomena.
The district court found the patents invalid. The court held that the patents only claimed correlations and that these correlations resulted from a natural bodily process. The court reasoned that by claiming the correlations, the patent wholly pre-empted anyone from using these naturally occurring correlations.
The Federal Circuit reversed and found the claims valid under the — at the time definitive — machine-or-transformation test. The court found that the steps of administering and determining satisfied the transformation prong of the test. Subsequently, the Supreme Court decided Bilski, finding the machine-or-transformation test to be an important — but not necessarily the only — test for determining patentable subject matter. The Court then vacated the Federal Circuit’s Prometheus decision for consideration in light of Bilski. On remand, the Federal Circuit again found the patents valid. As before, the court found that the administering and determining steps were sufficiently transformative. The court further found that the determining step alone satisfied the machine-or-transformation test. The court also reasoned that the Prometheus patents did not preempt an entire law of nature, but simply an application of that law.
The Supreme Court’s Decision and Practical Guidance
The Court found that the patented steps were “not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.” Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150, slip op. at 11 (U.S. March 20, 2012). The Court pointed out that at the time of patenting, the correlation of certain metabolites and harmful dosage levels of thiopurine were known. Id. at 4. The main question was whether the steps of the patent itself and the precise levels listed in the patent added enough to be patentable. Id. at 5. The Court held that the administering and determining steps in the patent simply informed the scientific community of routine, conventional activity while the wherein step simply highlighted the law of nature. Id. at 10–11. These steps “add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field.” Id. at 13. The effect of these steps was “simply to tell doctors to apply the law [of nature] somehow when treating their patients.” Id. In its ruling, the Court highlighted that they were concerned about patents “improperly tying up the future use of laws of nature” and were worried that patents on simple applications of laws of nature could foreclose future innovation. Id. at 16–17.
The Court held that a process reciting a law of nature is unpatentable unless that process has assurances that the patent is not merely monopolizing a law of nature. Id. at 8. The Court also made clear that it doesn’t matter how broad or narrow the law of nature is for the patent to be found invalid under Section 101. Id. at 20. The Court provided some guidance to future patentees, saying that a “patent on a new drug” and “a new way of using an existing drug” would still be patent eligible. Id. at 18. These differ from the Prometheus patent because they “confine their reach to particular applications of [laws of nature].” Id. at 18. As such, new patentees should be wary of claiming broad laws of nature or drug applications. Patents on newly created drugs still should be allowed as well as patents on novel uses of existing drugs. The important factor for correlation patents will be not to reach too broadly and foreclose all uses of that correlation.
As for invalidating patents based on Section 101, the Court also rejected a “look ahead” approach for law of nature patentability stating that such an approach “would make the ‘law of nature’ exception to Section 101 patentability a dead letter.” Id. at 21. Although recognizing that there could be “some overlap” between Section 101 and other sections of the Patent Act, the Court found that it wouldn’t always be the case and that Section 101 still should be considered on its own. Id. at 21. As such, patents reciting laws of nature still can be invalidated simply on the basis of Section 101.
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