Supreme Court Decides Methods Applying Laws of Nature Not Patentable
The United States Supreme Court issued a unanimous decision on March 20, 2012 in the case Mayo Collaborative Services, dba Mayo Medical Laboratores, et al. v. Prometheus Laboratories, Inc., 566 U.S. _____ (2012). The Court held that a claim applying a law of nature, without more, is not patentable: “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.’” Mayo, slip opinion at 3. In Mayo, Prometheus Laboratories, Inc. (“Prometheus”) licensed two patents, United States Patent Numbers 6,680,302 and 6,355,625, concerning the use of thiopurine drugs in treating certain autoimmune diseases. Thiopurine is metabolized differently in different people, and so the inventors developed a method of testing a patient’s blood for certain metabolites and using this information to decide how much thiopurine to use. A typical claim is Claim 1 of the ‘623 Patent: A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject. Mayo Clinic Rochester and Mayo Collaborative Services (“Mayo”) developed a similar test with slightly different levels, and Prometheus accused Mayo of patent infringement. The District Court found that Mayo infringed, but that the patents were invalid because they claimed natural phenomena. Thus, the District Court granted judgment in favor of Mayo. Prometheus appealed, and the Federal Circuit reversed, finding that the steps of administering the drug and determining the level were sufficient to distinguish the claims from laws of nature, rendering the claims patentable. Mayo petitioned for certiorari, which the Supreme Court granted. In its opinion, the Supreme Court discusses Section 101 of the Patent Act, which states: Whoever 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 therefor, subject to the conditions and requirements of this title. 35 U.S.C. § 101. The Court, like English courts before it, “has long held that this provision contains an important implicit exception. Laws of nature, natural phenomena, and abstract ideas are not patentable.” Id. at 1. Laws of nature, such as the law of gravity or E=mc2, are “manifestations of nature, free to all men and reserved exclusively to none.” Id. at 2, quoting Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) (quoting Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948)). Indeed, the Court has recognized that such concepts are the basic tools of scientific work and that “monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it.” Id. On the other hand, the Court also recognizes that “all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.” Id. Thus, “[w]hile a scientific truth, or the mathematical expression of it, is not a patentable invention, a novel and useful structure created with the aid of knowledge of scientific truth may be.” Id., quoting Mackay Radio & Telegraph Co. v. Radio Corp. of America, 306 U.S. 86, 94 (1939). Transforming an unpatentable law of nature into a patentable claim, however, requires more than merely applying the law of nature. Id. at 3. According to the Court, “Prometheus’ patents set forth laws of nature – namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.” Id. at 8. The Court considered whether “the patent claims add enough to their statements of the correlations to allow the process they describe to qualify as patent-eligible processes that apply natural laws,” and decided that they did not. Id. The Court held, “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. The Court notes that the claims at issue recite an “administering” step, a “determining” step, and a “wherein” step, and that “[t]hese additional steps are not themselves natural laws but neither are they sufficient to transform the nature of the claim.” Id. at 9. The Court found that “the ‘administering’ step simply refers to the relevant audience” and “the ‘wherein’ clauses simply tell a doctor about the relevant natural laws.” Id. The “determining” step “tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists who work in the field,” and “[p]urely conventional or obvious pre-solution activity is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law.” Id. at 10 (internal quotation marks omitted). The Court considered whether the particular order in which the steps were presented rendered the laws of nature patentable, but found that it did not. Id. Thus, the Court found “that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.” Id. The Court summarized the analysis as follows: Beyond picking out the relevant audience, namely those who administer doses of thiopurine drugs, the claim simply tells doctors to: (1) measure (somehow) the current level of the relevant metabolite, (2) use particular (unpatentable) laws of nature (which the claim sets forth) to calculate the current toxicity/inefficacy limits, and (3) reconsider the drug dosage in light of the law. These instructions 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. And since they are steps that must be taken in order to apply the laws in question, the effect is simply to tell doctors to apply the law somehow when treating their patients. Id. at 13. The Court reasoned that the patents would “tie up too much future use of laws of nature,” and while “rewarding with patents those who discover new laws of nature and the like might well encourage their discovery, … there is a danger that the grant of patents that tie up their use will inhibit future innovation premised upon them.” Id. at 18, 17. The Court concluded “that the patent claims at issue here effectively claim the underlying laws of nature themselves [and] are consequently invalid.” Id. at 24. It remains to be seen what impact the Mayo decision will have on existing patents and on future patent applications, particularly those directed to methods. A narrow reading of Mayo would primarily impact the field of diagnostic testing; a broader reading, however, could impact a wide variety of fields since, as the Court noted, “all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.” Following the Mayo decision, the United States Patent and Trademark Office issued a memorandum to its Patent Examining Corps setting forth preliminary guidance in determining subject matter eligibility under 35 U.S.C. § 101. Basically, the USPTO has advised examiners to continue to evaluate subject matter eligibility as they have in the past, but with the additional consideration of whether the claims monopolize a law of nature, natural phenomenon, or abstract idea itself, or rather the claims “include other elements or combination of elements such that, in practice, the claimed product or process amounts to significantly more than a law of nature, a natural phenomenon, or an abstract idea with conventional steps specified at a high level of generality appended thereto.” Additional guidance is expected to be issued in the near future.