On June 20, 2011, the Supreme Court granted certiorari for the second time in Prometheus Labs., Inc. v. Mayo Collaborative Servs., after having already granted certiorari last year, vacating and remanding to the Federal Circuit for further consideration in light of Bilski.  The patent claims at issue in Prometheus are medical method claims directed at administering a drug to treat autoimmune disorders, and determining whether the metabolite level of the drug falls within a range correlated with efficacy but not toxicity. 

One could speculate as to why the Supreme Court granted certiorari-and in fact many are guessing that it is a second chance at some of the same questions presented by Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc.,[1] where the Supreme Court dismissed the writ as improvidently granted on procedural grounds, and the dissent rendered a substantive opinion.  However, speculation as to the reasons the Supreme Court chose to weigh in is likely unproductive, particularly after Microsoft v. i4i, where assumptions about the Court's purpose for granting certiorari did not hold true. 

While it remains to be seen how the high Court will handle the issues presented, it is clear that the case provides the potential for the Court to clarify the patentable subject matter analysis, while at the same time hopefully avoiding the frequent problem of conflation between the threshold test for patentable subject matter and the separate requirement of novelty in patent law. 

Potential for Clarification

Prometheus will present the Supreme Court with an opportunity to clarify the proper application of and relationship between the "machine-or-transformation" test and the "preemption" analysis for determining what falls within patentable subject matter under 35 U.S.C. §101.  Are the two tests truly separate, or is the machine-or-transformation test merely a "useful and important clue" to inform the overarching preemption test?  While the interplay between these tests was not fully addressed in Bilski,[2] both were addressed in the Federal Circuit's decision in Prometheus[3] and are also a strong focus of the briefing on petition for certiorari.

The Federal Circuit held that Prometheus's patent claims satisfied the machine-or-transformation test because the steps preceding use of the natural correlations (between metabolite levels and efficacy or toxicity) involve "transformations" of the human body (because enzymes transform the drug into metabolites whose concentrations can be determined).  The Federal Circuit also held under the preemption test that Prometheus's method claims recite a patent-eligible application (constituting specific treatment steps) of the correlations, and that this application is sufficiently limiting so that all uses of the naturally occurring correlation are not preempted.

In its certiorari petition, Mayo argued that the Federal Circuit got it wrong-that Prometheus's claims monopolize all uses of the natural correlations, and fail the preemption standard even if specific steps and natural "transformations" of body chemistry may lead up to those correlations.[4]  Addressing the Federal Circuit's treatment of the two tests, Mayo's petition argues that the "transformations" found by the Federal Circuit would only be relevant if they impose meaningful limitations on the claims such that the claims do not preempt all uses of the natural correlation, and that here "[t]hose bodily transformations in no way limit the uses that may be made of the admittedly natural correlations."[5]   

Mayo's arguments should require the Supreme Court to expand upon Bilski and further address the three Supreme Court precedents discussed therein (Benson,[6] Flook,[7] and Diehr[8]) to clarify the relationship between the preemption standard and the machine-or-transformation test.  While an abstract idea or law of nature cannot be patented, the Court has recognized that an application may deserve protection if it imposes meaningful limits.  For example, in Benson the Court stated, in reversing the court below, that "The mathematical formula involved here has no substantial practical application except in connection with a digital computer, which means that if the judgment below is affirmed, the patent would wholly pre-empt the mathematical formula and in practical effect would be a patent on the algorithm itself."[9]  Thus, in Benson, tethering the claim to an application using a digital computer did not reduce the preemptive footprint of the claim because it did not provide meaningful limits.  Mayo's petition attempts to draw parallels to Benson, noting that the transformation steps recited provide no meaningful limitation because there is no utility for the correlation outside an application involving the human body.

Mayo will also seek to rely on Flook, where the applicant attempted to patent a procedure for monitoring the conditions during the catalytic conversion process in the petrochemical and oil-refining industries.  In Flook, the only innovation was reliance on a mathematical algorithm, and the Court "rejected ‘[t]he notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process," concluding that "the process at issue there was ‘unpatentable under § 101, not because it contain[ed] a mathematical algorithm as one component, but because once that algorithm [wa]s assumed to be within the prior art, the application, considered as a whole, contain[ed] no patentable invention.'"[10] 

Mayo will seek to distinguish Diehr, also discussed in Bilski, where the patent at issue claimed a method for molding uncured synthetic rubber into cured precision products, using a mathematical formula to complete some of its steps using a computer.  The Court in Diehr concluded that the claim fell within patentable subject matter because it was not an attempt to patent a mathematical formula, but instead a patent on the process of curing synthetic rubber that did not preempt all uses of the formula: "Their process admittedly employs a well-known mathematical equation, but they do not seek to pre-empt the use of that equation.  Rather, they seek only to foreclose from others the use of that equation in conjunction with all of the other steps in their claimed process..."[11] 

The central policy behind § 101 is to prevent monopoly over natural phenomena or abstract ideas and keep these dedicated to the public domain.  It is this concern with over-breadth that is at the heart of the § 101 inquiry, and drives the requirement that the patentee tether the abstract idea or natural phenomenon to a real-world application that limits the scope of the claims.  It therefore makes sense that the preemption analysis, which focuses directly on this over-breadth concern, should be the dominant analysis, and that the machine-or-transformation test is relevant only to the extent it informs the overarching preemption analysis by providing limitations on claims involving abstract ideas or natural phenomena.  This use of the machine-or-transformation test to determine whether the claims are sufficiently limited so as to not monopolize all uses of a natural phenomenon is also consistent with the Court's statement in Bilski that the machine-or-transformation inquiry, while not the sole test, serves as a "useful and important clue" to determine whether a claimed invention is a patent-eligible process.[12] 

The application of these analyses and the interplay between them as applied to particular facts remain unclear and present difficult issues for the lower courts.  The decision in Prometheus has the potential to provide welcome clarification regarding the relationship between the preemption and "machine-or-transformation" tests following Bilski.

Potential for Confusion

Prometheus is also important because it presents the potential for confusion between the threshold patentable subject matter analysis under § 101 and the novelty analysis under  §§ 102 and 103.  As Justice Kennedy stated in Bilski, the § 101 patent-eligibility inquiry is a threshold condition on patentability separate from novelty and nonobviousness.[13]  Similarly, as former Chief Judge Michel noted in the Federal Circuit Bilski opinion, "Congress did not intend the ‘new and useful' language of § 101 to constitute an independent requirement of novelty or non-obviousness distinct from the more specific and detailed requirements of §§ 102 and 103, respectively....  [I]t is irrelevant to the § 101 analysis whether Applicants' claimed process is novel or non-obvious."[14]

There is no doubt, however, that the issues of patentable subject matter and novelty are easily and frequently confused.  Indeed, the question presented in Prometheus highlights this potential for confusion as it appears to conflate the threshold test for patentable subject matter under § 101 with what should be the separate requirement of novelty:

"Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve ‘transformations' of body chemistry." (emphasis added). 

Notably, some of the Supreme Court's own precedents, including Flook, contribute to the potential for confusion between the novelty and patentable subject matter analyses.  For instance, Flook states that because the "algorithm [wa]s assumed to be within the prior art, the application, considered as a whole, contain[ed] no patentable invention."[15]  Comparison of the patent claims to the prior art, however, is generally the purview of the novelty analysis, not patentable subject matter. 

Admittedly, the preemption analysis invites a cursory, and likely necessary, inquiry into how commonplace the use of an application is, to determine whether that application provides sufficient limitation to avoid preemption.  That is, if the real-world application of an abstract idea is so widespread that it effectively provides no real limitation, such as the use of the computer in Benson, then all uses are preempted.   Mayo argues along these lines that "those steps [relied upon by the Federal Circuit in upholding the patent] are well-known, are performed every day by countless medical personnel, and owe nothing at all to Prometheus"[16] and thus that the recited steps provide no limitation to a monopoly on the natural correlation.

However, Mayo's arguments extend beyond this inquiry regarding limitation and go further to question the level of innovation, which unquestionably invites further confusion.  In its petition for certiorari, Mayo argues that the steps needed to elicit the correlation, which the Federal Circuit found to be transformative, are not innovative:

"But these steps are simply the administration of the drug and the measurement of metabolite levels, both of which had been known in the art for decades. This was enough for the Federal Circuit to find patent-eligibility for a process that--far from constituting any innovation-- is nothing more than the body's natural reaction to the ingestion of drugs, and a mental recognition of that natural reaction."[17]

Prometheus points out the potential for confusion in its opposition to the petition, stating, "Mayo and its amici repeatedly try to import novelty analysis into §101 by arguing that the physical, transformative steps of the patents should be disregarded because those steps were previously well known in the art--and that without those steps all that remains is a mental step."[18] 

Prometheus thus poses an important question, which if left unanswered will lead to further confusion, and if answered without clarity could lead to further conflation of the doctrines:  Does the specific application merely have to be limiting so as to avoid preemption, or does it also need to be novel, and non-obvious in order to constitute eligible patentable subject matter, so that it is not merely "post-solution activity"?  Hopefully the Supreme Court will not succumb to the invitation to conflate the two questions and will instead answer this question so as to avoid further confusion. 

It is difficult to know why the Supreme Court granted certiorari in Prometheus.  However, the potential for the Court to answer critical questions about the interrelationship of the tests for patentable subject matter, and to either avoid further conflation or add to the confusion of the separate §101 and novelty inquiries, means this opinion will be one to watch for.

Published on Law360.com