By Kevin E. Noonan --
In a decision he has waited six years to write (having dissented from the Court's decision not to decide similar issues in Laboratory Corp. v. Metabolite Labs., Inc. in 2006), Justice Breyer (and a unanimous Court) overturned the Federal Circuit's decision that diagnostic method claims are eligible for patenting under 35 U.S.C. § 101. Before discussing the reasons for the Court's decision and its possible impact, it is best to attempt to discern the reason why the Court believes its judgment on patent-eligibility is superior to the court specifically created by Congress to make patent law its particular area of expertise.
As a reminder, the case involves claims directed to methods for determining whether an effective amount of a drug is being administered to a patient. The claims of the patents-in-suit (U.S. Patent Nos. 6,355,623 and 6,680,302) were held invalid by the District Court as being outside the scope of patent-eligible subject matter under 35 U.S.C. § 101, based on its application of the "machine or transformation" test enunciated in In re Bilski. These claims included claims that affirmatively recited an "administrative" step, exemplified by Claim 1 of the '623 patent:
1. 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 8x108 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 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
And claims that did not recite such a step, exemplified by Claim 46 of the '302 patent:
46. A method of optimizing therapeutic efficacy and reducing toxicity associated with treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) determining the level of 6-thioguanine or 6-methylmercaptopurine in a subject administered a drug selected from the group consisting of 6-mercaptopurine, azathiop[u]rine, 6-thioguanine, and 6-methyl-mercaptoriboside, said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8x108 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 8x108 red blood cells or a level of 6-methylmercaptopurine greater than about 7000 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
The Federal Circuit reversed, finding that the claims recited sufficiently transformative steps that they satisfied the Bilski "machine or transformation" test. The Federal Circuit interpreted the entirety of Supreme Court precedent on patent eligibility to construe patent-eligibility broadly, limiting eligibility to exclude only laws of nature, physical phenomena, and abstract idea (based, the panel suggested, on historical precedent extending back to the 19th century; Le Roy v. Tatham, 55 U.S. (14 How.) 156, 174-75 (1853), continuing in the Court's most recent opinion on this issue (Bilski v. Kappos). In the appellate court's opinion, the Prometheus claims are merely a particular application of a natural phenomon, alá Diehr, rather than an attempt to preempt a natural phenomenon, alá Benson and Flook.
The Supreme Court disagreed. Beginning with its decision in Diamond v. Diehr, the Court's opinion set out the terms of the debate: to pass Constitutional muster, 35 U.S.C. § 101 must contain an "implicit exception": laws of nature, natural phenomena, and abstract ideas. Citations of the Court's prior precedent (bolstered by citation of English law, curiously post-independence) are followed in the opinion by the overriding policy assumption behind the Court's decision: that "monopolization of [the basic tools of scientific and technological work] through the grant of a patent might tend to impede innovation more than it would tend to promote it." In this context, of course, the Court recognizes the uncertainty of the policy conundrum, and suggests that evidence that "monopolization" would not impede innovation should be important in deciding that such claims would or would not transgress the Court's policy imperatives.
Fortunately, the Court also recognizes that there must be a balance, since "too broad an interpretation of this exclusionary principle could eviscerate patent law [because] all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas." That balance is appropriately struck, accordingly, by determining whether a claim embodies an application of a natural phenomenon or a law of nature; however, the Court warns that transforming a law of nature into a "patent-eligible application of such a law [requires that] one . . . do more than simply state the law of nature while adding the words 'apply it.'"
This case, the Court says, is at the "intersection of these basic principles." How the Court frames the issue goes a long way towards understanding their decision: according to the opinion, the case is about "claims covering processes that help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage level is too low or too high," illustrating another issue central to Justice Breyer's concerns: interference by patents with the practice of medicine. The Court then announces the fundamental reason it decided that the Prometheus claims are not patent-eligible: the "claimed processes have [not] transformed these unpatentable natural laws into patent-eligible applications of those laws."
Citing Parker v. Flook, the Court immediately takes its decision outside Judge Rich's adage about how to interpret patent law: while that eminent jurist realized that "the name of the game is the claim," the Court here states that its precedent "warn us against interpreting patent statutes in ways that make patent eligibility 'depend simply on the draftsman's art' without reference to the 'principles underlying the prohibition against patents for [natural laws].'" Doing so requires that claims to "a process that focuses upon the use of a natural law also contain other elements or a combination of elements, sometimes referred to as an 'inventive concept,' sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself." In this the Court continues its historical tendency to conflate patent-eligibility under § 101 with patentability under, inter alia, § 103. (Because this is a tendency apparently incapable of correction, it is perhaps best to accept it.) This does lead to another quirk of the Court's interpretation of patent law: rather than consider the claims as a whole (which, after all, is mandated by § 103), the Court then arrives at its decision by considering that "the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field" (albeit not applied to this method), and that "at the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries" (seemingly ignoring the portion of the patent statute that limits patent term to 20 years from the earliest effective filing date).
Having set forth the grounds for its decision, the Court then directed its attention to the claims at issue. In its opinion, "scientists already understood that the levels in a patient's blood of certain metabolites, including, in particular, 6-thioguanine and its nucleotides (6–TG) and 6-methyl-mercaptopurine (6–MMP), were correlated with the likelihood that a particular dosage of a thiopurine drug could cause harm or prove ineffective" (taking this understanding from the '623 patent specification). The opinion acknowledges that the patentees determined the "precise correlations between metabolite levels and likely harm or ineffectiveness." But the Court also noted (in agreement with the Federal Circuit) that "the claim's language, 'indicates a need to decrease' (or 'to increase'), as not limited to instances in which the doctor actually decreases (or increases) the dosage level where the test results suggest that such an adjustment is advisable."
The Court disagreed with the Federal Circuit, however, that the recited steps of the claim involved a transformation sufficient to render the claims patent-eligible. The Court starts with its interpretation that the Prometheus claims "set forth laws of nature," and then determines that the claims do not "so significantly more that simply describe these natural relations." Specifically, the Court says that the patent claims do not do "enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws."
The Court next explicates why it comes to this conclusion. The opinion returns to its concerns over the efforts of the artful claim drafter seeking to "monopolize the law of nature itself." The Court illustrates situations where such efforts should be unavailing (interestingly, taking its examples from the physical rather than the chemical or biological/medical arts):
Einstein, we assume, could not have patented his famous law by claiming a process consisting of simply telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced (or vice versa). Nor could Archimedes have secured a patent for his famous principle of flotation by claiming a process consisting of simply telling boat builders to refer to that principle in order to determine whether an object will float.
For the Court, the Prometheus claims provide no more than in these hypothetical situations. The claims "administering" steps "simply refer to the relevant audience, namely doctors who treat patients" with thiopurine drugs. But this audience is "preexisting" since these drugs have been used to treat certain diseases (and impliedly to be subject to the same limitations on ascertaining the proper dose of a drug for a particular patient) before the patented invention. The "determining" step is indeterminate: no particular method for making the determination is specified, and thus the entirety of prior art methods for making the determination is encompassed by the claim, in the Court's opinion. This is the basis for the Court's opinion that the step embodies "well-understood, routine, conventional activity previously engaged in by scientists who work in the field." Hieing back to Flook, the Court states that such "pre-solution activity" is "not enough to transform an unpatentable law of nature into a patent-eligible application of such a law." And the Court does not believe that these claims embody the "exception to the exception" recognized in Diehr that "a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made" because "[a]nyone who wants to make use of these laws must first administer a thiopurine drug and measure the resulting metabolite concentrations."
For the Court, "[t]he upshot is that the three steps simply tell doctors to gather data from which they may draw an inference in light of the correlations," merely "inform[ing] a relevent audience of certain laws of nature."
The Court also states that the cases "most directly on point" to their decision are Flook and Diehr; this choice suggests philosophical as well as practical possibilities that will be discussed elsewhere. In the opinion, the Court found the "way the additional steps of the process [recited in Diehr] integrated the equation into the process as a whole" rendered those claims patent-eligible, while in Flook all that was provided by the claim was the patent-ineligible algorithm to calculate alarm limits in pre-existing processes. (While this portion of the opinion also [re]introduces language concerning whether these additional steps, in both Flook and Diehr, were "obvious, already in use or purely conventional," this conflation is an invariant part of any § 101 analysis by the Court.) Applying this precedent, the Court finds that the Prometheus claims present a case for patent-eligibility that is "weaker than the (patent-eligible) claim in Diehr and no stronger than the (patent-ineligible) claim in Flook."
The Court then takes a brief excursion beyond the boundaries of its own precedent, considering a 19th Century English case regarding blast furnaces (which the Court must have considered the closest other precedent raising "a legal problem very similar to the problem now before [the Court])" and to its own Bilski and Benson opinions before arriving at a concern raised in Benson: that "patent law not inhibit further discovery by improperly tying up the future use of laws of nature" (citing Benson, Flook, Bilski, and O'Reilly v. Morse). Curiously, in view of the Chief Justice's recent statements on the general lack of usefulness provided by the legal academy, the opinion cites law review articles by Mark Lemley, Bohannan & Hovencamp, and Rebecca Eisenberg (whose "tragedy of the anticommons" is still anticipated 14 years after its possibility was perceived). The Court recognizes that the laws of nature encompassed by the Prometheus claims are "narrow laws," but their transgression is that they "tie up the doctor's subsequent treatment decision whether that treatment does, or does not, change in light of the inference he has drawn using the correlations" as well as "threaten to inhibit the development of more refined treatment recommendations (like that embodied in Mayo's test), that combine Prometheus' correlations with later discovered features of metabolites, human physiology or individual patient characteristics." While these concerns seem to implicate claim scope as much as subject-matter eligibility, the Court seems content with making its decision on § 101 grounds.
The opinion does leave some room for hope (or for more artful patent claim drafting), stating that the Justices do not "now decide whether were the steps at issue here less conventional, these features of the claims would prove sufficient to invalidate them." The "basic underlying concern" is that "these patents tie up too much future use of laws of nature."
Finally, the opinion considers and rejects the views of the Federal Circuit, Prometheus, the U.S. government, and relevant (and informed) amici such as the Biotechnology Industry Organization. Regarding the Federal Circuit, any transformation associated with the "administering" step is "irrelevant" according to the opinion, since this step merely selects the group of patients "who are likely interested in applying the law of nature." The Court also finds no transformation in the determining step, because such a step "could be satisfied without transforming the blood, should science develop a totally different system for determining metabolite levels that did not involve such a transformation." In rejecting Prometheus' argument that the narrowness of the laws of nature encompassed by the claims argues in favor of patent-eligibility, the opinion states that "[c]ourts and judges are not institutionally well suited to making the kinds of judgments needed to distinguish among different laws of nature, . . . the cases have endorsed a bright-line prohibition" against patenting such laws per se.
The government's position is rejected by the Court because relying on the other sections of the patent statute to invalidate claims such as the Prometheus claim would turn § 101 into a "dead letter" and is inconsistent with the Court's prior precedent (which perhaps the government was trying to modify). The Court also explicates its reasons why the other sections are not up to the task of policing the patent-eligibility question regarding laws of nature.
The last group of advocates whose views are rejected by the Court, amici with relevant experience, are counterbalanced by other amici, like the AMA and other medical groups, who advocate little or no patent protection to avoid "a vast thicket of exclusive rights over the use of critical scientific data that must remain widely available if physicians are to provide sound medical care." In doing so, the Court finds more persuasive the opinions of consumers of this technology rather than its providers. The Court also sees these differences of opinion as reflecting the "double-edged sword" of patent protection, reiterating Justice Breyer's long-standing opinion that too much patent protection is as bad as too little.
In the end, the Court suggests that those who disagree with their decision have recourse elsewhere:
[W]e must recognize the role of Congress in crafting more finely tailored rules where necessary. Cf. 35 U.S.C. §§161–164 (special rules for plant patents). We need not determine here whether, from a policy perspective, increased protection for discoveries of diagnostic laws of nature is desirable.
Clearly suggesting little chance of a change of heart from the Court.