On March 20, 2012, the Supreme Court published its opinion deciding Mayo v. Prometheus. In its decision, the Supreme Court cherry-picked ideas and principles from select cases to set forth a new analysis for determining patentable subject that is broad enough to have serious unintended consequences. The new analysis consists of two steps: 1) Determine if the patent describes a natural law; and 2) Determine if the patent claims add enough additional features to allow the processes they describe to qualify as patent-eligible processes that apply natural laws.
The invention at issue in Mayo v. Prometheus concerns a scientific discovery involving the relationship between a patient’s response to a drug and its effectiveness. Scientists already understood that when a patient ingests thiopurine drugs, the level of certain metabolites that form in the bloodstream is correlated with whether a particular dosage is too high to be safe or too low to be effective. Because every person metabolizes thiopurine differently, doctors had difficulty in determining the proper dosage. The invention at issue embodies researchers’ findings that identified the precise correlations between specified metabolite levels and likely harm or ineffectiveness. Claim 1 of the 6,355,623 Patent (“‘623 Patent”) is representative of the claims at issue and recites:
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 8108 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 8108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
The Court analyzed the ‘623 Patent using the new analysis and concluded that the ‘623 Patent sets forth a law of nature, namely a relation between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm. The Court trivialized the human actions (the administration of a thiopurine drug) required to trigger a manifestation of this relation in a particular person, stating that the relation itself exists in principle apart from any human action and that the relation is a consequence of the ways in which thiopurine compounds are metabolized by the body, which are entirely natural processes.
After finding that the ‘623 Patent describes a law of nature, the Court then determined whether the claims contained enough additional features to allow the process to qualify as a patent-eligible process that applies a natural law. The Court analyzed each element independently and concluded that the administering and determining steps were well known and that the wherein clauses are, at most, a suggestion to doctors and are not limiting features. In summary, the Court concluded that the claims inform a relevant audience about certain laws of nature; that any additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community; and that those steps, when viewed as a whole, add nothing significant beyond the sum of their parts when taken separately.
There are various problems with the Court’s analysis that may result in serious unintended consequences. First, the analysis seems to assume that a natural process is a natural law. A natural process relies on a natural law but is not the same as a natural law. Many patents that are not software or business method-type patents rely on natural processes, such as chemical patents, mechanical patents related to combustion and thermodynamics, circuit design patents related to interactions between current/voltage and materials, and communication patents related to optical and wireless data transmissions. The Court’s decision opens up potential subject matter challenges to all these types of patents.
Second, the Court dissects the claim and analyzes each element independently using Section 102 and 103 analyses to determine whether the steps provide some non-routine or unconventional activity, i.e., novel or non-obvious activity. This procedure is in direct contradiction to the precedent in Diamond v. Diehr, 450 U.S. 175 (1981), which states that the “novelty” of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the §101 categories of possibly patentable subject matter. This essentially makes a category decision—is the invention the kind of thing that is patentable—into a quality decision—is this invention different from the prior art and by how much. Furthermore, the Supreme Court gave little to no direction regarding how much an invention needs to differ from the prior art to be patentable subject matter, simply stating the difference needs to be “enough.” This leaves a gaping hole that will have to be defined in future litigation.
It will be interesting to see how the Federal Circuit applies this decision. In my opinion, I believe the decision will likely be narrowly applied by the Federal Circuit. As a result, the case will likely not have much of an effect going forward, but time will tell.
View the full presentation here: Where Do We Stand After Mayo v. Prometheus?