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Prometheus’s Brief – Don’t Confuse Us With “LabCorp”

It took me a while to get around to reading Prometheus’s brief to the Supreme Court in Mayo v. Prometheus Labs., No. 10-1150 (S. Ct. Oct. 31, 2011), because I was pretty sure how it would read and, in fact, there are no major surprises. Prometheus argues that their claims must be considered as a whole, and that section 101 does not categorically exclude processes that end by providing useful information – what I called a “thinking step” in an earlier post. Prometheus argues that “Mayo’s categorical rule that all claims must end with an action step would just multiply byzantine claim drafting…This Court has routinely recognized that patents can properly leave ample room for ‘the judgment of the operator.” Res. Brief at 35. Prometheus also reaches into the Bilski opinion for one of the few helpful quotations: “Nothing in Bilski was intended to ‘create uncertainty as to the patentability of …advanced diagnostic medicine techniques.’ [130 S. Ct. at 3227[ let alone all processes provided valuable information.” Res. brief at 36.

Prometheus also takes the reader along the well-worn path of Morse, Benson, Flook and Grams to argue that the monitoring patents do not preempt all practical use of any “relevant principle” but then neatly circles back to Tilghman, 102 U.S. at 709, to argue that the patent in question “wholly preempted the ‘natural phenomenon’ that water applied at high temperature and pressure would have the stated effect on fatty bodies. But it did not preempt the broader natural principle that high temperature and pressure tend to break chemical bonds, and it did not preclude the use of other methods to separate fat acids and glycerine from fatty bodies, such as sulfuric acid distillation or steam distillation.”

Prometheus then argues, as it must, that the patents do not recite  natural phenomena, and they use some good images:

“Combustion inside an automobile engine is surely mediated by natural laws, but both the engine itself and an improved method for tuning the engine are nonetheless patentable….Ironically, what Mayo considers the body’s ‘natural’ response is, in fact, an artificial suppression of the body’s natural immune system…..The correlations discovered and utilized by the inventors are, for 101 purposes, entirely unnatural.”

Res. Brief at 41.

Prometheus could have ended its “unnatural phenomenon” arguments here, as far as I am concerned. But the drafters could see that Mayo was going to try to piggyback its defense onto the LabCorp dissent, 548 U.S. at 125, in which three Justices suggested that a diagnostic claim to detecting a vitamin deficiency by measuring total homocysteine in the blood of a subject was an unpatentable natural phenomenon. Here are Prometheus’ words:

“The claims in this case are also drawn far more narrowly than the diagnostic method that the dissenters found objectionable in [LabCorp. 548 U.S. 124, 125-39 (2006)]. Unlike Prometheus’s claims, the claim in LabCorp was not limited to improving a specific medical treatment; instead it recited a ‘method for detecting’ a vitamin taught that ‘elevated’ total homocysteine levels correlates [sic] to a particular vitamin deficiency…And unlike Prometheus’s claims, the claim in LabCorp did not involve synthetic drugs and non-natutrally occurring synthetic correlations; instead it was based on a ‘natural relationship between homocysteine and vitamin deficiency’ that exists without any human intervention.”

The problem, of course, is that the Supreme Court is going to be considering the patent-eligibility of such claims in the  near future, and such “biomarker claims” are much more important to the development of personalized medicine than the monitoring claims in suit. Ironically, Prometheus recognizes this as well, albeit later in the brief:

“[A] ruling for Mayo…would mark a significant change in the law that would dramatically alter the status quo and upset settled expectations. The impact, moreover, would be widespread because essential features of Prometheus’s methods—the application of scientific knowledge to identified and measured biomarkers to produce information useful for clinical diagnosis and treatment—describe the core of personalized medicine and underlie thousands of existing patents in the field of personalized medicine [ed. note: Except for that pesky LabCorp patent?]”.

Res. brief at 50-51.



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