The Prometheus decision reflects that Supreme Court is obviously concerned about the possibility that a patent claim might preempt a law of nature and thereby broadly restrict use and application of the underlying principles. Perhaps the concern is heightened by the fact that the claimed method relates to treatment of disease, and the prospect of preempting such treatment is troubling. The reasoning set forth in the opinion, however, is anything but helpful.
The court dismisses a suggestion that virtually any step beyond a law of nature should transform an unpatentable law of nature into a potentially patentable application, sufficient to satisfy §101 whereby patentability could be determined under applicable novelty and obviousness analyses pursuant to 35 U.S.C. §102 and 103, saying that such an approach would render the “law of nature” exception to §101 a “dead letter.” The court, never the less, decides the status of the claimed subject matter under §101 under a point of novelty approach, leaving the reader to puzzle about which part of the opinion should be considered as determinative of what is proper under the law.
The opinion includes an extended comparison of the claims in the present case to the claimed subject matter in the Diehr and Flook decisions. The court noted that the claimed process in Diehr, a process of curing rubber based on the Arrhennius equation that expressed a law of nature, was deemed statutory because “nowhere [was it] suggested that all these steps, or at least the combination of these steps [otherwise recited in the claim] were in context obvious.” The process claimed in Flook related to a method for monitoring certain parameters of a process, using an apparently novel mathematical algorithm to calculate certain current alarm limits, and then adjusting the system/process to reflect new limit values. That method was deemed to be nonstatutory because, “putting the formula to the side, there was no ‘inventive concept’ in the application of the formula. The additional activity was deemed to be “conventional and obvious” and, thus, could not transform an unprotectable law of nature into a statutory process.
The court, thus, engaged in and based its decision on an analysis that it expressly described as inappropriate for the situation. What we are to make of that remains to be seen. It has long been accepted that methods of treatment of disease are statutory methods eligible for patent protection.
The exemplary claim discussed in the Prometheus decision recited:
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 8×108 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 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject. [emphasis supplied]
Suppose the claim had recited:
A method of treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug . . .
Conventionally, such a method of treatment would be considered to be statutory. Would the court have declared such a claim to now be ineligible under §101? That appears to be a prevalent fear, perhaps with good reason.
The court dismissed the recited step of “administering a drug” as not really a method step at all, but merely a reference “to the relevant audience, namely doctors, who treat patients with certain diseases with [the recited] drugs.” The basis for this is not clear, to say the least. It is doubtful that this unusual variation in lexicography can be found in the underlying patent disclosure. Must we now be concerned that words of a claim – consistently held to always have meaning; otherwise they would not be in the claim – might be ignored when inconsistent with a desired result or ruling?
Maybe the problem with the claims before the Prometheus court was that they were too specific, and might have passed under the §101 radar if the method had been recited more broadly. Suppose the claim in issue had read:
A method 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;
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, and
(c) increasing or decreasing the amount of said drug subsequently administered to said subject to maintain an efficacious level of 6-thioguanine in said subject.
Would the claim have been considered to be nonstatutory? Would the question have even been raised? From this perspective, (and setting aside considerations of novelty or obviousness) one might conclude that, rather than claiming some methods with reference to anything that looks like a law of nature in a claim, thus raising the specter of §101, it may be better to claim some methods more broadly so as to avoid such issues – maybe obtaining broader claim scope in any event.
What this all means is anything but clear. For the moment, it would seem that the Prometheus decision is just one more in a long series that will not resolve the question of what is or is not statutory subject matter.