On March 20, 2012 the United States Supreme Court declared in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Prometheus) that a method of optimizing a dosage for treatment of an immune-mediated gastrointestinal disorder was not patentable subject matter under 35 U.S.C. § 101. The Court held that the method was not patentable because the claims essentially claimed a natural law. Although the claim recited additional steps that were clearly not natural laws, the additional steps were not sufficient to overcome the barrier of 35 U.S.C. § 101. The claim that the Court reviewed was:
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.
Section 101 of the Patent Act defines the boundaries of patentable subject matter. It 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.” The scope of Section 101, however, is limited. For example, the Court has consistently held that “[L]aws of nature, natural phenomena, and abstract ideas are not patentable.” (Prometheus, quoting Diamond v. Diehr, 450 U. S. 175, 185 (1981)). Thus, the patent laws do not allow discovery of a new mineral in the earth or a new plant in nature to be patented. Famously, the Court has declared that “Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity.” Prometheus at p. 2-3. The reasoning behind such an interpretation is that “such discoveries are ‘manifestations of ... nature, free to all men and reserved exclusively to none.’” (Prometheus, quoting Diamond v. Chakrabarty, 447 U. S. 303, 309 (1980)). Id. Although patents by their very nature provide the right to exclude and create a legal form of a monopoly, the Court in Prometheus explains that the “monopolization of [the natural laws] through the grant of a patent might tend to impede innovation more than it would tend to promote it.” Prometheus at 2. The Court recognized that “too broad an interpretation of this exclusionary principle could eviscerate patent law,” but “to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words ‘apply it.’” Id. at 2-3.
The Court was, therefore, faced with what they termed the “intersection” of two principles: issuing patents while respecting everyone’s right to a natural law. That is, whether “patent claims covering processes that help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage level is too low or too high” are eligible for patent protection, which the Court characterized as an application of a natural law. Id. at 3. The Court framed its role as having to “determine whether the claimed processes have transformed these unpatentable natural laws into patent-eligible applications of those laws.” Id. The answer in this case was a resounding NO! (The vote was 9-0).
The Court characterized the claim at issue as a natural law because the metabolite “is a consequence of the ways in which thiopurine compounds are metabolized by the body—entirely natural processes. And so a patent that simply describes that relation sets forth a natural law.” Id. at 8. This statement of what is a natural law could have far-reaching implications. Many, if not all, diagnostic tests rely upon a process that occurs in the body. Whether the process involves how a gene is expressed in a body, how a drug is metabolized, or the effect of a drug itself on the body, each of these actions could be considered a mere “consequence” of how the body functions. As the Court explained, the effect of a drug is an “entirely natural process” once the drug is administered to an individual. Id. “While it takes a human action ... to trigger a manifestation of this relation in a particular person, the relation itself exists in principle apart from any human action.” Id. One may ponder how a method of treatment is different than a diagnostic test if a broad view is taken of this reasoning.
In analyzing the patentee’s claim, the Court explained, “apart from the natural laws themselves [the claim] involve[s] well-understood, routine, conventional activity previously engaged in by researchers in the field.” Id. at 10. According to the Court, its precedent insists that “a process that focuses upon the use of a natural law [must] also contain other elements or a combination of elements, sometimes referred to as an ‘inventive concept,’ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.” Id. The Court's choice of the phrase “well-understood, routine, conventional activity” would be expected to be seen in a finding of obviousness. Thus, the Court appears to have taken obviousness factors and injected them into determining patent eligibility under 35 U.S.C. § 101. Therefore, the question patentees now face is if “the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as [a] patent-eligible processes.” Id. at 8. What will be considered “enough” is still a very open question, but will appear to require some unconventional activity.
Prometheus was unable to show that its application of a natural law was not based upon “well-understood, routine, conventional activity” because, according to the Court, scientists already understood that the thiopurine metabolites could be used to determine whether a dosage of the drug would be harmful or ineffective, but the field did not know the exact amounts that were relevant. The determining of the exact levels, however, was found to be routine and, therefore, not enough to be eligible for patent protection under Section 101. If the steps are merely “routine, conventional activity previously engaged in by scientists who work in the field” then the steps cannot be used to turn an unpatentable natural law into patent-eligible subject matter. The Court further emphasized, “Purely ‘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. The Court also explained that the additional steps in this case “add[ed] nothing specific to the laws of nature other than what [was] well-understood, routine, conventional activity, previously engaged in by those in the field.” Id. at 13. There was no explanation of what would be considered unconventional.
As many diagnostic methods use “conventional” methodology (e.g., arrays or PCR) it is unclear where the bar will be set for patent eligibility. For example, it is unknown whether the fact that scientists already knew the metabolites of thiopurine were relevant to making treatment decisions makes the rest of the claim “conventional” or whether it was the steps themselves (e.g., measuring metabolite levels) that made the steps conventional. The Court gave no indication of which standard will ultimately be used. This apparent entanglement between patentable subject matter and obviousness creates a cloud of uncertainty as to whether other diagnostics that recite a correlation of some kind are patent eligible.
The patentee had argued that it would be bad policy to invalidate the patent under Section 101 because such a decision “would interfere significantly with the ability of medical researchers to make valuable discoveries, particularly in the area of diagnostic research.” Id. at 22. The Court appeared unconcerned with the possible effect that this decision could have on diagnostic research and instead recognized “the role of Congress in crafting more finely tailored rules where necessary” and that the Court did not need to determine whether it is good policy to protect “diagnostic laws of nature.” Id. at 24.
The impact of this case will not be completely understood until other cases concerning unknown correlations or using nonobvious steps are challenged in court. One such case that may help elucidate the boundaries of Section 101 is Association for Molecular Pathology v. Myriad Genetics (Myriad), which involves the patenting of isolated fragments of genes associated with breast cancer (BRCA1 and BRCA2) and its use in identifying subjects at risk for breast cancer. Today, the Supreme Court vacated the Federal Circuit’s holding that isolated gene fragments are patent eligible and ordered the lower court to review the case again in view of its Prometheus decision. Therefore, the Myriad case may give the first indication of how Prometheus will be interpreted and its implications. This decision will likely come later this year if not in 2013.
Thus, the Court has declared that diagnostic claims that use a “natural law” with only conventional steps are not patent eligible. Unfortunately, the Court did not explain the difference between conventional and unconventional. Thus, its precedent-setting decision has likely created uncertainty for an entire industry that will likely take years to navigate.
A complete copy of the decision can be found here: http://www.supremecourt.gov/opinions/11pdf/10-1150.pdf.