Guest Post by Robert R. Sachs of Fenwick & West LLP
?Not even wrong.? So said Wolfgang Pauli about a proposed analysis by a young physicist, meaning that the arguments were not subject to falsification, the basic tool of scientific analysis. So too it can be said about the Supreme Court?s decision in Mayo v. Prometheus. The Court?s analysis creates a framework for patent eligibility in which almost any method claim can be invalidated. Like so many pseudo-sciences in which every phenomenon can be rationalized and in which there is no test that can show the theory to be incorrect, under Prometheus seemingly anything can be ?explained? as being unpatentable subject matter.
Let me say at the outset that I?ve been a student of patent law, and patent eligibility in particular, since 1993. My clients have frequently been those whose inventions bumped up against the boundaries of patentable subject matter?in software, e-commerce, finance, business operations, user interfaces, and bio-informatics to name a few?so I have become intimately acquainted with both the legal and practical implications of this question. As such my personal reaction to this decision is very strong, and I will be quite blunt in what follows.
Over the next several days I will address just some of the logical and legal errors in the Court?s decision.
What?s a Law of Nature?
The first critical mistake is the Court?s assumption that Prometheus? claims recited a ?law of nature:? ?The claims purport to apply natural laws describing the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that the drug dosage will be ineffective or induce harmful side-effects.? The facile assumption that this relationship is a ?law of nature? is incorrect, and potentially the most damaging misstep by the Court.
First, let us assume for the moment that there are in fact such things as ?laws of nature.? What would their characteristics be? A first approximation would suggest that a law of nature is immutable and universal, that it is not subject to change, and it applies in all circumstances. See, Evidence Based Science. Thus, gravity and the speed light apply to you and me equally, and under all conditions. (I?m purposely using these two examples, for reasons that will become clear.) ?However, this is not the case with the toxicity of any drug, including thiopurines, as acknowledged by the Court: the amount of a toxic dose varies between individuals for two reasons. First, different people metabolize at different rates, thereby producing different metabolite levels for a given dose. Second, individuals have differential responses to a given amount of the metabolites; a given level of the metabolites may be toxic in one person and not toxic in another. Thus, while the patent sets forth metabolite levels for toxicity and effectiveness, these levels are necessarily probabilistic, as some patients could experience toxicity at levels below or above those specified in the patent claims. This is inherent in the way toxicity is determined using a median lethal dose, LD50. This is exactly the same reason that one person can be drop dead drunk after five drinks and another can be stone cold sober at the same level. Indeed, Mayo?s test used a higher threshold for toxicity?evidence that there is no ?law of nature? as to what is a toxic dose of thiopurine in all humans.
The ?natural relation? that Prometheus claims is, itself, not immutable in an even deeper sense. This relationship is a byproduct of human (or perhaps more generally mammalian) biology, which from a logical point of view is a contingent relationship that could have been otherwise: we could have evolved in such a way that the toxicity range was higher or lower, or the drug was entirely ineffective. That is, it?s an arbitrary and contingent fact that humans evolved so that thiopurine drugs were effective at all for treating immune-mediated gastrointestinal disorders, or that we metabolize them in a manner that makes them toxic at specific dosing ranges. Indeed, given that humans are not exposed to thiopurine in nature, it is hard to understand how it can even be argued that it is a ?natural law? that these drugs have a specific range of toxic or effective dosages at all. That these drugs are effective (or toxic) is a classic discovery in the truest sense of the term.
At best, the relationship between the dosage and toxicity level may be a ?natural phenomenon.? Let us assume that is the case. Natural phenomena are a different class of things than laws of nature. Lightning, mirages, tornadoes, superconductivity, rainbows, these are natural phenomena: events that take place in nature (or in the lab) under specific and contingent conditions. While these events are of course dependent on the laws of nature, they are different from them in kind. The prohibition of patent claims in this regard is for claims on the phenomenon itself, not on the specific application of a phenomenon. Indeed, most patents in the chemical, biological, and electrical arts are based precisely on this distinction, being able to induce, apply, or control a natural phenomenon for a particular purpose. For example, there are thousands of patents that expressly claim a particular use of the Hall effect, natural phenomena discovered in 1879. The Court?s failure to appreciate this distinction puts many patents that harness natural phenomena at risk.
In short, the relationship of thiopurine dosage to toxicity is a contingent, empirical fact and subject to discovery. Like other empirical facts, it is precisely the type of subject matter that has been patented in this country since the very first patent issued by the USPTO: Samuel Hopkins? patent on an improved method for making potash, based on the discovery that burning the raw ashes a second time increased their carbonate production. Hopkins? discovery is no different in kind from Prometheus? discovery: in both cases empirical ?scientific? facts about the world.
But let us return to the core assumption: that there are laws of nature in the first instance. The Court makes the obvious reference to Einstein?s E=mc2 equation as an example. But the great scientist would have readily dismissed this appellation, knowing full well that what he set forth was a theory, a model, a description that was subject to falsification. Indeed, Einstein?s work has been criticized as being incomplete, or valid only in limited circumstances.
The view that there are laws of nature reflects an 18th century view of the world, based no doubt upon the classical, Newtonian view of a reality of absolute space and time governed by the three ?laws of motion??laws that were thought to be immutable and universal?and which Einstein among others showed not to be ?laws? at all.
Most modern scientists do not view reality as defined by ?laws??indeed, the very idea that we could ?know? what the ?laws? are itself begs the very questions that philosophers since Plato have struggled with, the questions of epistemology (what is knowledge, what can we know) and ontology (what exists).
In several places, the Court lumps laws of nature together with ?abstract ideas,? for example by leaning on the analysis in Bilski and Benson. But again, this is a category error: abstract ideas are very different from laws of nature, and must be treated separately. ?Ideas,? classically speaking, are the ?impressions in your head? when you think about something?the thing you think about is a ?concept.? When you think about concepts that have instances in the world?cats, dogs, and thiopurine?you are thinking of ?concrete? concepts, and your ideas are ?concrete.? ?Even when you think of a unicorn or a flying purple people eater, you are thinking of a concrete concept because it could have an instance in the world. However, when you think about concepts that do not (or could not) have instances in the world?justice, eternity, infinitesimal, invisible green four sided triangles?or metaphors?All the world's a stage, and all the men and women merely players?the ?idea? in your head is ?abstract.? (Of course, I know that this is (1) a gloss, and (2) subject to debate as much as anything else in philosophy. Arguably, there are no ?abstract? concepts at all. I?ll leave that debate for another day).
To wit: the abstract idea of say, immortality, is clearly not a ?law of nature,? describing something that by definition cannot have examples in the world, since nothing can be immortal (there could be unicorns however, thus the concept of ?unicorn? is concrete). Conversely, Ohm?s Law?that the current through a conductor between two points is directly proportional to the potential difference across the two points?describes something inherently and entirely physical and real. Ohm?s Law is a description of the world (and it turns out, not always correct). That the Court attempts to put these two square pegs in the same round hole reveals just how little the Court understands the nuances of science, philosophy and language?let alone the patent law itself.
Tomorrow:? What?s a Claim? and Patent-Eligibility vs. Patentability
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