MAYO COLLABORATIVE SERVICES v. PROMETHEUS LABORATORIES, INC.

NOTICE: This opinion is subject to formal revision before publication in the preliminary print of the United States Reports. Readers are requested to notify the Reporter of Decisions, Supreme Court of the United States, Washington, D. C. 20543, of any typographical or other formal errors, in order that corrections may be made before the preliminary print goes to press.

SUPREME COURT OF THE UNITED STATES

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No. 10–1150

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MAYO COLLABORATIVE SERVICES, dba MAYO MEDICAL LABORATORIES, et al., PETITIONERS v. PROMETHEUS LABORATORIES, INC.

on writ of certiorari to the united states court of appeals for the federal circuit

[March 20, 2012]

Justice Breyer delivered the opinion of the Court.

Section 101 of the Patent Act defines patentable subject matter. It says:

“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” 35 U. S. C. §101.

The Court has long held that this provision contains an important implicit exception. “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable. Diamond v. Diehr, 450 U. S. 175, 185 (1981) ; see also Bilski v. Kappos, 561 U. S. ___, ___ (2010) (slip op., at 5); Diamond v. Chakrabarty, 447 U. S. 303, 309 (1980) ; Le Roy v. Tatham, 14 How. 156, 175 (1853); O’Reilly v. Morse, 15 How. 62, 112–120 (1854); cf. Neilson v. Harford, Webster’s Patent Cases 295, 371 (1841) (English case discussing same). Thus, the Court has written that “a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity. Such discoveries are ‘manifestations of . . . nature, free to all men and reserved exclusively to none.’ ” Chakrabarty, supra, at 309 (quoting Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U. S. 127, 130 (1948) ).

“Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U. S. 63, 67 (1972) . And monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it.

The Court has recognized, however, that too broad an interpretation of this exclusionary principle could eviscerate patent law. For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas. Thus, in Diehr the Court pointed out that “ ‘a process is not unpatentable simply because it contains a law of nature or a mathematical algorithm.’ ” 450 U. S., at 187 (quoting Parker v. Flook, 437 U. S. 584, 590 (1978) ). It added that “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.” Diehr, supra, at 187. And it emphasized Justice Stone’s similar observation in Mackay Radio & Telegraph Co. v. Radio Corp. of America, 306 U. S. 86 (1939) :

“ ‘While a scientific truth, or the mathematical expression of it, is not a patentable invention, a novel and useful structure created with the aid of knowledge of scientific truth may be.’ ” 450 U. S., at 188 (quoting Mackay Radio, supra, at 94).

See also Funk Brothers, supra, at 130 (“If there is to be invention from [a discovery of a law of nature], it must come from the application of the law of nature to a new and useful end”).

Still, as the Court has also made clear, to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words “apply it.” See, e.g., Benson, supra, at 71–72.

The case before us lies at the intersection of these basic principles. It concerns patent 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. 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. We must determine whether the claimed processes have transformed these unpatentable natural laws into patent-eligible applications of those laws. We conclude that they have not done so and that therefore the processes are not patentable.

Our conclusion rests upon an examination of the particular claims before us in light of the Court’s precedents. Those cases 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].” Flook, supra, at 593. They warn us against upholding patents that claim processes that too broadly preempt the use of a natural law. Morse, supra, at 112–120; Benson, supra, at 71–72. And they insist that 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. Flook, supra, at 594; see also Bilski, supra, at ___ (slip op., at 14) (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment’ or adding ‘insignificant postsolution activity’ ” (quoting Diehr, supra, at 191–192)).

We find that the process claims at issue here do not satisfy these conditions. In particular, 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. 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.

I A

The patents before us concern the use of thiopurine drugs in the treatment of autoimmune diseases, such as Crohn’s disease and ulcerative colitis. When a patient ingests a thiopurine compound, his body metabolizes the drug, causing metabolites to form in his bloodstream. Because the way in which people metabolize thiopurine compounds varies, the same dose of a thiopurine drug affects different people differently, and it has been difficult for doctors to determine whether for a particular patient a given dose is too high, risking harmful side effects, or too low, and so likely ineffective.

At the time the discoveries embodied in the patents were made, 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. See U. S. Patent No. 6,355,623, col. 8, ll. 37–40, 2 App. 10. (“Previous studies suggested that measurement of 6–MP metabolite levels can be used to predict clinical efficacy and tolerance to azathioprine or 6–MP” (citing Cuffari, Théorêt, Latour, & Seidman, 6-Mercaptopurine Metabolism in Crohn’s Disease: Correlation with Efficacy and Toxicity, 39 Gut 401 (1996))). But those in the field did not know the precise correlations between metabolite levels and likely harm or ineffectiveness. The patent claims at issue here set forth processes embodying researchers’ findings that identified these correlations with some precision.

More specifically, the patents—U. S. Patent No. 6,355,623 (’623 patent) and U. S. Patent No. 6,680,302 (’302 patent)—embody findings that concentrations in a patient’s blood of 6–TG or of 6–MMP metabolite beyond a certain level (400 and 7000 picomoles per 8x108 red blood cells, respectively) indicate that the dosage is likely too high for the patient, while concentrations in the blood of 6–TG metabolite lower than a certain level (about 230 picomoles per 8x108 red blood cells) indicate that the dosage is likely too low to be effective.

The patent claims seek to embody this research in a set of processes. Like the Federal Circuit we take as typical claim 1 of the ’623 Patent, which describes one of the claimed processes as follows:

“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.” ’623 patent, col. 20, ll. 10–20, 2 App. 16.

For present purposes we may assume that the other claims in the patents do not differ significantly from claim 1.

B

Respondent, Prometheus Laboratories, Inc. (Prometheus), is the sole and exclusive licensee of the ’623 and ’302 patents. It sells diagnostic tests that embody the processes the patents describe. For some time petitioners, Mayo Clinic Rochester and Mayo Collaborative Services (collectively Mayo), bought and used those tests. But in 2004 Mayo announced that it intended to begin using and selling its own test—a test using somewhat higher metabolite levels to determine toxicity (450 pmol per 8x108 for 6–TG and 5700 pmol per 8x108 for 6–MMP). Prometheus then brought this action claiming patent infringement.

The District Court found that Mayo’s test infringed claim 7 of the ’623 patent. App. to Pet. for Cert. 110a–115a. In interpreting the claim, the court accepted Prometheus’ view that the toxicity-risk level numbers in Mayo’s test and the claim were too similar to render the tests significantly different. The number Mayo used (450) was too close to the number the claim used (400) to matter given appropriate margins of error. Id., at 98a–107a. The District Court also accepted Prometheus’ view that a doctor using Mayo’s test could violate the patent even if he did not actually alter his treatment decision in the light of the test. In doing so, the court construed 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. Id., at 107a–109a; see also Brief for Respondent i (describing claimed processes as methods “for improving . . . treatment . . . by using individualized metabolite measurements to inform the calibration of . . . dosages of . . . thiopurines” (emphasis added)).

Nonetheless the District Court ultimately granted summary judgment in Mayo’s favor. The court reasoned that the patents effectively claim natural laws or natural phenomena—namely the correlations between thiopurine metabolite levels and the toxicity and efficacy of thiopurine drug dosages—and so are not patentable. App. to Pet. for Cert. 50a–83a.

On appeal, the Federal Circuit reversed. It pointed out that in addition to these natural correlations, the claimed processes specify the steps of (1) “administering a [thiopurine] drug” to a patient and (2) “determining the [resulting metabolite] level.” These steps, it explained, involve the transformation of the human body or of blood taken from the body. Thus, the patents satisfied the Circuit’s “machine or transformation test,” which the court thought sufficient to “confine the patent monopoly within rather definite bounds,” thereby bringing the claims into compliance with §101. 581 F. 3d 1336, 1345, 1346–1347 (2009) (internal quotation marks omitted).

Mayo filed a petition for certiorari. We granted the petition, vacated the judgment, and remanded the case for reconsideration in light of Bilski, 561 U. S. ___, which clarified that the “machine or transformation test” is not a definitive test of patent eligibility, but only an important and useful clue. Id., at ___–___ (slip op., at 7–8). On remand the Federal Circuit reaffirmed its earlier conclusion. It thought that the “machine-or-transformation test,” understood merely as an important and useful clue, nonetheless led to the “clear and compelling conclusion . . . that the . . . claims . . . do not encompass laws of nature or preempt natural correlations.” 628 F. 3d 1347, 1355 (2010). Mayo again filed a petition for certiorari, which we granted.

II

Prometheus’ patents set forth laws of nature—namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm. Claim 1, for example, states that if the levels of 6–TG in the blood (of a patient who has taken a dose of a thiopurine drug) exceed about 400 pmol per 8x108 red blood cells, then the administered dose is likely to produce toxic side effects. While it takes a human action (the administration of a thiopurine drug) to trigger a manifestation of this relation in a particular person, the relation itself exists in principle apart from any human action. The relation is a consequence of the ways in which thiopurine compounds are metabolized by the body—entirely natural processes. And so a patent that simply describes that relation sets forth a natural law.

The question before us is whether the claims do significantly more than simply describe these natural relations. To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws? We believe that the answer to this question is no.

A

If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. A patent, for example, could not simply recite a law of nature and then add the instruction “apply the law.” 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.

What else is there in the claims before us? The process that each claim recites tells doctors interested in the subject about the correlations that the researchers discovered. In doing so, it recites an “administering” step, a “determining” step, and a “wherein” step. These additional steps are not themselves natural laws but neither are they sufficient to transform the nature of the claim.

First, the “administering” step simply refers to the relevant audience, namely doctors who treat patients with certain diseases with thiopurine drugs. That audience is a pre-existing audience; doctors used thiopurine drugs to treat patients suffering from autoimmune disorders long before anyone asserted these claims. In any event, the “prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment.’ ” Bilski, supra, at ___ (slip op., at 14) (quoting Diehr, 450 U. S., at 191–192).

Second, the “wherein” clauses simply tell a doctor about the relevant natural laws, at most adding a suggestion that he should take those laws into account when treating his patient. That is to say, these clauses tell the relevant audience about the laws while trusting them to use those laws appropriately where they are relevant to their decisionmaking (rather like Einstein telling linear accelerator operators about his basic law and then trusting them to use it where relevant).

Third, the “determining” step tells the doctor to determine the level of the relevant metabolites in the blood, through whatever process the doctor or the laboratory wishes to use. As the patents state, methods for determining metabolite levels were well known in the art. ’623 patent, col. 9, ll. 12–65, 2 App. 11. Indeed, scientists routinely measured metabolites as part of their investigations into the relationships between metabolite levels and efficacy and toxicity of thiopurine compounds. ’623 patent, col. 8, ll. 37–40, id., at 10. Thus, this step tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists who work in the field. Purely “conventional or obvious” “[pre]-solution activity” is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law. Flook, 437 U. S., at 590; see also Bilski, 561 U. S., at ___ (slip op., at 14) (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by’ . . . adding ‘insignificant post-solution activity’ ” (quoting Diehr, supra, at 191–192)).

Fourth, to consider the three steps as an ordered combination adds nothing to the laws of nature that is not already present when the steps are considered separately. See Diehr, supra, at 188 (“[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”). Anyone who wants to make use of these laws must first administer a thiopurine drug and measure the resulting metabolite concentrations, and so the combination amounts to nothing significantly more than an instruction to doctors to apply the applicable laws when treating their patients.

The upshot is that the three steps simply tell doctors to gather data from which they may draw an inference in light of the correlations. To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.

B 1

A more detailed consideration of the controlling precedents reinforces our conclusion. The cases most directly on point are Diehr and Flook, two cases in which the Court reached opposite conclusions about the patent eligibility of processes that embodied the equivalent of natural laws. The Diehr process (held patent eligible) set forth a method for molding raw, uncured rubber into various cured, molded products. The process used a known mathematical equation, the Arrhenius equation, to determine when (depending upon the temperature inside the mold, the time the rubber had been in the mold, and the thickness of the rubber) to open the press. It consisted in effect of the steps of: (1) continuously monitoring the temperature on the inside of the mold, (2) feeding the resulting numbers into a computer, which would use the Arrhenius equation to continuously recalculate the mold-opening time, and (3) configuring the computer so that at the appropriate moment it would signal “a device” to open the press. Diehr, 450 U. S., at 177–179.

The Court pointed out that the basic mathematical equation, like a law of nature, was not patentable. But it found the overall process patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole. Those steps included “installing rubber in a press, closing the mold, constantly determining the temperature of the mold, constantly recalculating the appropriate cure time through the use of the formula and a digital computer, and automatically opening the press at the proper time.” Id., at 187. It nowhere suggested that all these steps, or at least the combination of those steps, were in context obvious, already in use, or purely conventional. And so the patentees did not “seek to pre-empt the use of [the] equation,” but sought “only to foreclose from others the use of that equation in conjunction with all of the other steps in their claimed process.” Ibid. These other steps apparently added to the formula something that in terms of patent law’s objectives had significance—they transformed the process into an inventive application of the formula.

The process in Flook (held not patentable) provided a method for adjusting “alarm limits” in the catalytic conversion of hydrocarbons. Certain operating conditions (such as temperature, pressure, and flow rates), which are continuously monitored during the conversion process, signal inefficiency or danger when they exceed certain “alarm limits.” The claimed process amounted to an improved system for updating those alarm limits through the steps of: (1) measuring the current level of the variable, e.g., the temperature; (2) using an apparently novel mathematical algorithm to calculate the current alarm limits; and (3) adjusting the system to reflect the new alarm-limit values. 437 U. S., at 585–587.

The Court, as in Diehr, pointed out that the basic mathematical equation, like a law of nature, was not patentable. But it characterized the claimed process as doing nothing other than “provid[ing] a[n unpatentable] formula for computing an updated alarm limit.” Flook, supra, at 586. Unlike the process in Diehr, it did not “explain how the variables used in the formula were to be selected, nor did the [claim] contain any disclosure relating to chemical processes at work or the means of setting off an alarm or adjusting the alarm limit.” Diehr, supra, at 192, n. 14; see also Flook, 437 U. S., at 586. And so the other steps in the process did not limit the claim to a particular application. Moreover, “[t]he chemical processes involved in catalytic conversion of hydrocarbons[,] . . . the practice of monitoring the chemical process variables, the use of alarm limits to trigger alarms, the notion that alarm limit values must be recomputed and readjusted, and the use of computers for ‘automatic monitoring-alarming’ ” were all “well known,” to the point where, putting the formula to the side, there was no “inventive concept” in the claimed application of the formula. Id., at 594. “[P]ost-solution activity” that is purely “conventional or obvious,” the Court wrote, “can[not] transform an unpatentable principle into a patentable process.” Id., at 589, 590.

The claim before us presents a case for patentability that is weaker than the (patent-eligible) claim in Diehr and no stronger than the (unpatentable) claim in Flook. Beyond picking out the relevant audience, namely those who administer doses of thiopurine drugs, the claim simply tells doctors to: (1) measure (somehow) the current level of the relevant metabolite, (2) use particular (unpatentable) laws of nature (which the claim sets forth) to calculate the current toxicity/inefficacy limits, and (3) reconsider the drug dosage in light of the law. These instructions add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field. And since they are steps that must be taken in order to apply the laws in question, the effect is simply to tell doctors to apply the law somehow when treating their patients. The process in Diehr was not so characterized; that in Flook was characterized in roughly this way.

2

Other cases offer further support for the view that simply appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable. This Court has previously discussed in detail an English case, Neilson, which involved a patent claim that posed a legal problem very similar to the problem now before us. The patent applicant there asserted a claim

“for the improved application of air to produce heat in fires, forges, and furnaces, where a blowing apparatus is required. [The invention] was to be applied as follows: The blast or current of air produced by the blowing apparatus was to be passed from it into an air-vessel or receptacle made sufficiently strong to endure the blast; and through or from that vessel or receptacle by means of a tube, pipe, or aperture into the fire, the receptacle be kept artificially heated to a considerable temperature by heat externally applied.” Morse, 15 How., at 114–115.

The English court concluded that the claimed process did more than simply instruct users to use the principle that hot air promotes ignition better than cold air, since it explained how the principle could be implemented in an inventive way. Baron Parke wrote (for the court):

“It is very difficult to distinguish [Neilson’s claim] from the specification of a patent for a principle, and this at first created in the minds of some of the court much difficulty; but after full consideration, we think that the plaintiff does not merely claim a principle, but a machine embodying a principle, and a very valuable one. We think the case must be considered as if the principle being well known, the plaintiff had first invented a mode of applying it by a mechanical apparatus to furnaces; and his invention then consists in this—by interposing a receptacle for heated air between the blowing apparatus and the furnace. In this receptacle he directs the air to be heated by the application of heat externally to the receptacle, and thus he accomplishes the object of applying the blast, which was before of cold air, in a heated state to the furnace.” Neilson v. Harford, Webster’s Patent Cases, at 371.

Thus, the claimed process included not only a law of nature but also several unconventional steps (such as inserting the receptacle, applying heat to the receptacle externally, and blowing the air into the furnace) that confined the claims to a particular, useful application of the principle.

In Bilski the Court considered claims covering a process for hedging risks of price changes by, for example, contracting to purchase commodities from sellers at a fixed price, reflecting the desire of sellers to hedge against a drop in prices, while selling commodities to consumers at a fixed price, reflecting the desire of consumers to hedge against a price increase. One claim described the process; another reduced the process to a mathematical formula. 561 U. S., at ___–___ (slip op., at 2–3). The Court held that the described “concept of hedging” was “an unpatentable abstract idea.” Id., at ___ (slip op., at 15). The fact that some of the claims limited hedging to use in commodities and energy markets and specified that “well-known random analysis techniques [could be used] to help establish some of the inputs into the equation” did not undermine this conclusion, for “Flook established that limiting an abstract idea to one field of use or adding token postsolution components did not make the concept patentable.” Id., at ___, ___ (slip op., at 16, 15).

Finally, in Benson the Court considered the patentability of a mathematical process for converting binary-coded decimal numerals into pure binary numbers on a general purpose digital computer. The claims “purported to cover any use of the claimed method in a general-purpose digital computer of any type.” 409 U. S., at 64, 65. The Court recognized that “ ‘a novel and useful structure created with the aid of knowledge of scientific truth’ ” might be patentable. Id., at 67 (quoting Mackay Radio, 306 U. S., at 94). But it held that simply implementing a mathematical principle on a physical machine, namely a computer, was not a patentable application of that principle. For the mathematical formula had “no substantial practical application except in connection with a digital computer.” Benson, supra, at 71. Hence the claim (like the claims before us) was overly broad; it did not differ significantly from a claim that just said “apply the algorithm.”

3

The Court has repeatedly emphasized this last mentioned concern, a concern that patent law not inhibit further discovery by improperly tying up the future use of laws of nature. Thus, in Morse the Court set aside as unpatentable Samuel Morse’s general claim for “ ‘the use of the motive power of the electric or galvanic current . . . however developed, for making or printing intelligible characters, letters, or signs, at any distances,’ ” 15 How., at 86. The Court explained:

“For aught that we now know some future inventor, in the onward march of science, may discover a mode of writing or printing at a distance by means of the electric or galvanic current, without using any part of the process or combination set forth in the plaintiff’s specification. His invention may be less complicated—less liable to get out of order—less expensive in construction, and in its operation. But yet if it is covered by this patent the inventor could not use it, nor the public have the benefit of it without the permission of this patentee.” Id., at 113.

Similarly, in Benson the Court said that the claims before it were “so abstract and sweeping as to cover both known and unknown uses of the [mathematical formula].” 409 U. S., at 67, 68. In Bilski the Court pointed out that to allow “petitioners to patent risk hedging would pre-empt use of this approach in all fields.” 561 U. S., at ___ (slip op., at 15). And in Flook the Court expressed concern that the claimed process was simply “a formula for computing an updated alarm limit,” which might “cover a broad range of potential uses.” 437 U. S., at 586.

These statements reflect the fact that, even though rewarding with patents those who discover new laws of nature and the like might well encourage their discovery, those laws and principles, considered generally, are “the basic tools of scientific and technological work.” Benson, supra, at 67. And so there is a danger that the grant of patents that tie up their use will inhibit future innovation premised upon them, a danger that becomes acute when a patented process amounts to no more than an instruction to “apply the natural law,” or otherwise forecloses more future invention than the underlying discovery could reasonably justify. See generally Lemley, Risch, Sichelman, & Wagner, Life After Bilski, 63 Stan. L. Rev. 1315 (2011) (hereinafter Lemley) (arguing that §101 reflects this kind of concern); see also C. Bohannan & H. Hovenkamp, Creation without Restraint: Promoting Liberty and Rivalry in Innovation 112 (2012) (“One problem with [process] patents is that the more abstractly their claims are stated, the more difficult it is to determine precisely what they cover. They risk being applied to a wide range of situations that were not anticipated by the patentee”); W. Landes & R. Posner, The Economic Structure of Intellectual Property Law 305–306 (2003) (The exclusion from patent law of basic truths reflects “both . . . the enormous potential for rent seeking that would be created if property rights could be obtained in them and . . . the enormous transaction costs that would be imposed on would-be users [of those truths]”).

The laws of nature at issue here are narrow laws that may have limited applications, but the patent claims that embody them nonetheless implicate this concern. They tell a treating doctor to measure metabolite levels and to consider the resulting measurements in light of the statistical relationships they describe. In doing so, 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. And they 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. The “determining” step too is set forth in highly general language covering all processes that make use of the correlations after measuring metabolites, including later discovered processes that measure metabolite levels in new ways.

We need not, and do not, now decide whether were the steps at issue here less conventional, these features of the claims would prove sufficient to invalidate them. For here, as we have said, the steps add nothing of significance to the natural laws themselves. Unlike, say, a typical patent on a new drug or a new way of using an existing drug, the patent claims do not confine their reach to particular applications of those laws. The presence here of the basic underlying concern that these patents tie up too much future use of laws of nature simply reinforces our conclusion that the processes described in the patents are not patent eligible, while eliminating any temptation to depart from case law precedent.

III

We have considered several further arguments in support of Prometheus’ position. But they do not lead us to adopt a different conclusion. First, the Federal Circuit, in upholding the patent eligibility of the claims before us, relied on this Court’s determination that “[t]ransformation and reduction of an article ‘to a different state or thing’ is the clue to the patentability of a process claim that does not include particular machines.” Benson, supra, at 70–71 (emphasis added); see also Bilski, supra, at ___ (slip op., at 6–7); Diehr, 450 U. S., at 184; Flook, supra, at 588, n. 9; Cochrane v. Deener, 94 U. S. 780, 788 (1877) . It reasoned that the claimed processes are therefore patent eligible, since they involve transforming the human body by administering a thiopurine drug and transforming the blood by analyzing it to determine metabolite levels. 628 F. 3d, at 1356–1357.

The first of these transformations, however, is irrelevant. As we have pointed out, the “administering” step simply helps to pick out the group of individuals who are likely interested in applying the law of nature. See supra, at 9. And the second 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. See supra, at 18. Regardless, in stating that the “machine-or-transformation” test is an “important and useful clue” to patentability, we have neither said nor implied that the test trumps the “law of nature” exclusion. Bilski, supra, at ___ (slip op., at 6–7) (emphasis added). That being so, the test fails here.

Second, Prometheus argues that, because the particular laws of nature that its patent claims embody are narrow and specific, the patents should be upheld. Thus, it encourages us to draw distinctions among laws of nature based on whether or not they will interfere significantly with innovation in other fields now or in the future. Brief for Respondent 42–46; see also Lemley 1342–1344 (making similar argument).

But the underlying functional concern here is a relative one: how much future innovation is foreclosed relative to the contribution of the inventor. See supra, at 17. A patent upon a narrow law of nature may not inhibit future research as seriously as would a patent upon Einstein’s law of relativity, but the creative value of the discovery is also considerably smaller. And, as we have previously pointed out, even a narrow law of nature (such as the one before us) can inhibit future research. See supra, at 17–18.

In any event, our cases have not distinguished among different laws of nature according to whether or not the principles they embody are sufficiently narrow. See, e.g., Flook, 437 U. S. 584 (holding narrow mathematical formula unpatentable). And this is understandable. Courts and judges are not institutionally well suited to making the kinds of judgments needed to distinguish among different laws of nature. And so the cases have endorsed a bright-line prohibition against patenting laws of nature, mathematical formulas and the like, which serves as a somewhat more easily administered proxy for the underlying “building-block” concern.

Third, the Government argues that virtually any step beyond a statement of a law of nature itself should transform an unpatentable law of nature into a potentially patentable application sufficient to satisfy §101’s demands. Brief for United States as Amicus Curiae. The Government does not necessarily believe that claims that (like the claims before us) extend just minimally beyond a law of nature should receive patents. But in its view, other statutory provisions—those that insist that a claimed process be novel, 35 U. S. C. §102, that it not be “obvious in light of prior art,” §103, and that it be “full[y], clear[ly], concise[ly], and exact[ly]” described, §112—can perform this screening function. In particular, it argues that these claims likely fail for lack of novelty under §102.

This approach, however, would make the “law of nature” exception to §101 patentability a dead letter. The approach is therefore not consistent with prior law. The relevant cases rest their holdings upon section 101, not later sections. Bilski, 561 U. S. ___; Diehr, supra; Flook, supra; Benson, 409 U. S. 63 . See also H. R. Rep. No. 1923, 82d Cong., 2d Sess., 6 (1952) (“A person may have ‘invented’ a machine or a manufacture, which may include anything under the sun that is made by man, but it is not necessarily patentable under section 101 unless the conditions of the title are fulfilled” (emphasis added)).

We recognize that, in evaluating the significance of additional steps, the §101 patent-eligibility inquiry and, say, the §102 novelty inquiry might sometimes overlap. But that need not always be so. And to shift the patent-eligibility inquiry entirely to these later sections risks creating significantly greater legal uncertainty, while assuming that those sections can do work that they are not equipped to do.

What role would laws of nature, including newly discovered (and “novel”) laws of nature, play in the Government’s suggested “novelty” inquiry? Intuitively, one would suppose that a newly discovered law of nature is novel. The Government, however, suggests in effect that the novelty of a component law of nature may be disregarded when evaluating the novelty of the whole. See Brief for United States as Amicus Curiae 27. But §§102 and 103 say nothing about treating laws of nature as if they were part of the prior art when applying those sections. Cf. Diehr, 450 U. S., at 188 (patent claims “must be considered as a whole”). And studiously ignoring all laws of nature when evaluating a patent application under §§102 and 103 would “make all inventions unpatentable because all inventions can be reduced to underlying principles of nature which, once known, make their implementation obvious.” Id., at 189, n. 12. See also Eisenberg, Wisdom of the Ages or Dead-Hand Control? Patentable Subject Matter for Diagnostic Methods After In re Bilski, 3 Case W. Res. J. L. Tech. & Internet 1, ___ (forthcoming, 2012) (manuscript, at 85–86, online at http://www.patentlyo.com/ files/eisenberg.wisdomordeadhand.patentlyo.pdf (as visited Mar. 16, 2012, and available in Clerk of Court’s case file)); 2 D. Chisum, Patents §5.03[3] (2005).

Section 112 requires only a “written description of the invention . . . in such full, clear, concise, and exact terms as to enable any person skilled in the art . . . to make and use the same.” It does not focus on the possibility that a law of nature (or its equivalent) that meets these conditions will nonetheless create the kind of risk that underlies the law of nature exception, namely the risk that a patent on the law would significantly impede future innovation. See Lemley 1329–1332 (outlining differences between §§101 and 112); Eisenberg, supra, at ___ (manuscript, at 92–96) (similar). Compare Risch, Everything is Patentable, 75 Tenn. L. Rev. 591 (2008) (defending a minimalist approach to §101) with Lemley (reflecting Risch’s change of mind).

These considerations lead us to decline the Government’s invitation to substitute §§102, 103, and 112 inquiries for the better established inquiry under §101.

Fourth, Prometheus, supported by several amici, argues that a principle of law denying patent coverage here will interfere significantly with the ability of medical researchers to make valuable discoveries, particularly in the area of diagnostic research. That research, which includes research leading to the discovery of laws of nature, is expensive; it “ha[s] made the United States the world leader in this field”; and it requires protection. Brief for Respondent 52.

Other medical experts, however, argue strongly against a legal rule that would make the present claims patent eligible, invoking policy considerations that point in the opposite direction. The American Medical Association, the American College of Medical Genetics, the American Hospital Association, the American Society of Human Genetics, the Association of American Medical Colleges, the Association for Molecular Pathology, and other medical organizations tell us that if “claims to exclusive rights over the body’s natural responses to illness and medical treatment are permitted to stand, the result will be 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.” Brief for American College of Medical Genetics et al. as Amici Curiae 7; see also App. to Brief for Association Internationale pour la Protection de la Propriété Intellectuelle et al. as Amici Curiae A6, A16 (methods of medical treatment are not patentable in most of Western Europe).

We do not find this kind of difference of opinion surprising. Patent protection is, after all, a two-edged sword. On the one hand, the promise of exclusive rights provides monetary incentives that lead to creation, invention, and discovery. On the other hand, that very exclusivity can impede the flow of information that might permit, indeed spur, invention, by, for example, raising the price of using the patented ideas once created, requiring potential users to conduct costly and time-consuming searches of existing patents and pending patent applications, and requiring the negotiation of complex licensing arrangements. At the same time, patent law’s general rules must govern inventive activity in many different fields of human endeavor, with the result that the practical effects of rules that reflect a general effort to balance these considerations may differ from one field to another. See Bohannan & Hovenkamp, Creation without Restraint, at 98–100.

In consequence, we must hesitate before departing from established general legal rules lest a new protective rule that seems to suit the needs of one field produce unforeseen results in another. And we 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.

*  *  *

For these reasons, we conclude that the patent claims at issue here effectively claim the underlying laws of nature themselves. The claims are consequently invalid. And the Federal Circuit’s judgment is reversed.

It is so ordered.

Print this transcript Transcript: 

ORAL ARGUMENT OF STEPHEN M. SHAPIRO ON BEHALF OF THE PETITIONERS

Chief Justice John G. Roberts: We will hear argument first this morning in Case 10-1150, Mayo Collaborative Services v. Prometheus Laboratories.

Mr. Shapiro.

Stephen M. Shapiro: Thank you, Mr. Chief Justice, and may it please the Court:

We're here today to urge the Court to reinstate the district court's decision, which faithfully applied this Court's precedents under section 101 of the Patent Act.

The problem with the Prometheus patent is its broad preemption of a physical phenomenon, which prevents others like Mayo Clinic from offering a better metabolite test with more accurate numbers.

And this is a huge practical problem for patients.

These thiopurine drugs are strong medicine.

Too much of this can be fatal; too little can leave -- leave a chronic lingering disease in the patient.

Justice Sonia Sotomayor: I'm sorry.

I didn't think that this patent covered the actual machine.

Mayo is free to develop a new machine.

Stephen M. Shapiro: Well, what it can't do is use any number from 400 up until infinity, and it believes that's the wrong number.

And it can't have a -- a different standard for a legion of autoimmune diseases, and there are dozens and dozens of them.

And that's a broad field to preempt the natural phenomenon.

Justice Sonia Sotomayor: It -- it actually is much narrower than that.

It's within a range, two ranges actually.

And so it has already changed one range, and that's not the subject of the district court's finding that the lower number it's proposing is infringing.

So it's not as broad as you are stating.

Stephen M. Shapiro: Well, you -- you see, Your Honor, we believe the correct number is 450 to 700.

And that's necessary to cure various autoimmune diseases.

And Prometheus took the position that its patent preempts everything above 400, all the way up to infinity, it said, for all autoimmune diseases, dozens and dozens of them.

Justice Sonia Sotomayor: Well, it took that position, but the district court narrowed it to 15 percent, to 15--

Stephen M. Shapiro: Well, you know, actually it didn't, Your Honor.

You will see in that opinion, there are two rulings: one is the 15 percent ruling, which lowers the number; but it said 400 and above all the way to infinity.

There's no upper limit on this.

So as a practical matter, there's no room for anybody else to offer a metabolite test.

And what this means for patients is one opinion in the United States.

If you have one of these life-threatening diseases--

Justice Sonia Sotomayor: --It can offer the test.

Stephen M. Shapiro: --you get one opinion.

Pardon me?

Justice Sonia Sotomayor: It can offer the test.

It just can't recommend the dosage to the doctor.

Stephen M. Shapiro: Well, it -- it can't have a test that has a different therapeutic range, because that's a preemption.

They take the position--

Justice Sonia Sotomayor: Tests do two things: they measure something--

Stephen M. Shapiro: --Yes.

Justice Sonia Sotomayor: --And therapeutic range does something else.

The tests can happen.

The doctor gets a number.

What the doctor does with that number is a different issue.

Stephen M. Shapiro: And -- and what -- what Prometheus submitted and the court agreed is if you are notified, if you are aware of their range when you're drawing blood, that's an infringement right then and there, if -- if you're aware or warned by their number.

So any doctor in the United States that draws blood and is aware of this range of theirs is preempting.

And the practical result is we haven't been able to offer this competing test now for 7 years.

Justice Anthony Kennedy: When -- when the Respondent addresses this, will they take issue with the way you describe what has been preempted, or as you read their -- we'll ask them -- but as you read their brief, is this crystal-clear?

Stephen M. Shapiro: Well, you'll see, Justice Kennedy, in the district court, they argued for any number above 400.

That's -- it's 400 and above is what it says.

And they said there's no upper limit on that.

The district court found that.

That was their position that was accepted.

Justice Anthony Kennedy: In thinking about what's preempted, I looked at the Diehr case involving the rubber molding and the constant monitoring.

And if you could take an analogy from that: let's -- let's suppose that there was a system of measurements that you take every half-hour which constantly monitor how a drug is being retained in the tissues, and that there is a protocol for the admission of some two or three different drugs to get the balance right.

In other words, it's much more complicated.

Is there some point at which that is patentable, even though this preempts a -- a whole range of -- of different choices?

Stephen M. Shapiro: Well, it may be patentable.

Justice Anthony Kennedy: And it's hard for you to answer -- you know, there's a million hypotheticals.

But I'm just trying to--

Stephen M. Shapiro: The -- the key is--

Justice Anthony Kennedy: --see what the process is.

Stephen M. Shapiro: --the specificity.

If it leaves room for others to have their own tests with different numbers and different procedures so that it isn't just one test for the whole country, then yes, if it's specific enough.

The specificity is the key.

What -- what the Court said in Bilski, of course, is that you can't preempt a whole field, a broad field with -- with your -- your patent, which this one does.

And if you look at the diseases that are covered--

Justice Antonin Scalia: I'm -- I'm not comfortable with that.

I mean, it depends on how -- how broad it is?

Stephen M. Shapiro: --Yes.

If -- if you -- if you preempt all the numbers up to infinity and all autoimmune diseases, that's a vast field.

It's much bigger than -- than the field--

Justice Antonin Scalia: What about up to 700?

Is that okay?

Stephen M. Shapiro: --Well, no.

I -- I think--

Justice Antonin Scalia: 550?

Stephen M. Shapiro: --No.

I -- I think--

Justice Antonin Scalia: 830?

Stephen M. Shapiro: --No.

Justice Antonin Scalia: How are we supposed to apply that kind of a rule?

Stephen M. Shapiro: I think doctors have to have freedom to make their own judgments about these natural phenomena.

Justice Antonin Scalia: Above 830 or below 830?

Which?

Stephen M. Shapiro: Well, I -- no.

I think--

Justice Antonin Scalia: It just seems to me not a -- not a patent rule that we could possibly apply.

Stephen M. Shapiro: --Well, it's the rule I believe adopted in Bilski and in Flook, that you can't wipe out a whole field so no one else can have a competing test.

The result for the public is that these numbers would be frozen for 20 years and a very serious person couldn't get a second opinion from Mayo Clinic, which uses different numbers.

That's why we think--

Justice Antonin Scalia: But doesn't -- doesn't any -- any medical patent rely on natural processes?

I mean, even if you invent a new drug, what that new drug does is -- is natural.

It affects the -- the human physiognomy in a certain natural way.

Stephen M. Shapiro: --Oh, yes.

Justice Antonin Scalia: Is it -- is it therefore precluded from patentability?

Stephen M. Shapiro: No, it's not.

And in fact, this drug was patented.

Justice Antonin Scalia: What is different here?

Stephen M. Shapiro: The difference is the specificity.

If you invent a drug which has a particular chemical formula, others can invent other drugs.

There's room for competing drugs in the medical world.

And you'll -- many, many patented drugs--

Justice Anthony Kennedy: I thought your answer to Justice Scalia would be -- and please correct me -- the difference is, is that what the Respondent is claiming is a -- a patent on the measurement of the result.

Stephen M. Shapiro: --Yes, it -- it is a patent--

Justice Anthony Kennedy: But they're giving a different answer.

I mean, that's how I would have answered the question.

But -- but that's obviously not the right way to do it.

Stephen M. Shapiro: --I think that's -- that's one -- one part of it.

Justice Antonin Scalia: Well, that's another one of your arguments, but one of your arguments says you can't patent nature.

Stephen M. Shapiro: You can't patent nature, that's correct.

Justice Antonin Scalia: Right, and that relates to the question that I asked.

Stephen M. Shapiro: But--

Justice Antonin Scalia: Now, tell me why you can't patent nature, then?

Stephen M. Shapiro: --Because -- because of the law of nature doctrine that has existed for 150 years in this Court.

Congress has never disagreed with that.

Pieces of nature can't be monopolized.

Neither can formulas.

Justice Stephen G. Breyer: Nature--

Justice Anthony Kennedy: But nature always has a reaction to the drug.

Stephen M. Shapiro: Pardon me?

Justice Anthony Kennedy: Nature always has a reaction to the drug.

Stephen M. Shapiro: Yes.

So all doctors -- that's part of the storehouse of information.

All doctors can look at that reaction.

They can calibrate it the way they see fit.

They have different opinions.

And it's important for all of us that they have those different opinions.

We found that the numbers that they were using were way off for skin disorders, dangerously high.

400 is the wrong number.

The correct number is 150 to 300.

Now, it's very important for patients to be -- with life-threatening conditions, to be able to get that information.

Justice Stephen G. Breyer: --All right.

So how do you -- that's -- I see that.

I will spare you the reasons why I think the law of nature doctrine exists, because they are not relevant to my question.

My question is, I think it's hornbook law that the law of nature cannot be patented.

Stephen M. Shapiro: Yes.

Justice Stephen G. Breyer: It is also hornbook law that the application of a law of nature can be patented.

Stephen M. Shapiro: Right.

Justice Stephen G. Breyer: All right.

So in this case, what I think the claim is is that we are applying a law of nature.

Now, we read the words of applying it: Administer a drug, determine the level.

And then it uses the word "wherein", which I will ask them what that means.

But -- but -- so they say those two words, administer the drug, determine the level, are the application of the law of nature that they found.

Now, there's something odd about that in your view--

Stephen M. Shapiro: Yes.

Justice Stephen G. Breyer: --at least.

And I want to know what.

Stephen M. Shapiro: For us, the real oddity is that this numerical calibration that they've given extends up to infinity, and it precludes every other blood test.

Justice Stephen G. Breyer: All right.

Suppose it didn't.

Suppose I discover that if I take aspirin, someone takes aspirin, I discover they have to take aspirin for a headache and, you know, I see an amazing thing: if you look at a person's little finger, and you notice the color of -- it shows the aspirin, you need a little more, unless it's a different color, you need a little less.

Now, I've discovered a law of nature and I may have spent millions on that.

And I can't patent that law of nature, but I say: I didn't; I said apply it.

I said: Look at his little finger.

Stephen M. Shapiro: Sure.

Justice Stephen G. Breyer: Okay?

Is that a good patent or isn't it?

Stephen M. Shapiro: No, it's not.

Justice Stephen G. Breyer: Why not?

Stephen M. Shapiro: It's not a good patent.

Justice Stephen G. Breyer: If you can tell me why not, I'll have an understanding of where you are coming from.

Stephen M. Shapiro: Well, because you -- you've added to a law of nature just -- just a simple observation of the man's little finger.

Justice Stephen G. Breyer: Ah.

Now, we're into the problem.

And that is the problem of how much you have to add.

Stephen M. Shapiro: Yes.

Justice Stephen G. Breyer: If you look at the Court's cases, they seem to say Flook, one thing, and Diehr another thing.

And so what is your view about how much has to be added to make it an application of a law of nature?

And how would you put that in words?

Stephen M. Shapiro: There are several things that it can't be.

After Bilski, which reaffirmed what was said in Flook, a conventional step isn't sufficient, because that's just adding a law of nature to prior art, and prior art plus prior art equals nothing that is patentable under the Flook decision.

And also, the step that you add has to narrow your preemption--

Justice Antonin Scalia: Well, excuse me.

Does that render it nonpatentable because it's not novel?

Is that the reason why it -- it renders it nonpatentable?

Stephen M. Shapiro: --Well--

Justice Antonin Scalia: That's not what we're talking about here; we are not talking about novelty, are we?

Stephen M. Shapiro: --No, we are really not.

What the Court -- what the Court said in Bilski is that a conventional step plus a law of nature isn't sufficient, and what the Court explained in Flook is that the law of nature is part of the common domain, it's part of prior art.

So if you are adding prior art to prior art it's nothing under section 101.

Justice Ruth Bader Ginsburg: Mr. Shapiro, on that question and the question Justice Scalia just raised, the government, you know, has taken the position that you are under the wrong section.

It's not a question of patentability, but you used the -- the example of the finger, you said it's obvious.

So why didn't you raise the sections that the government says would have been the appropriate ones on the novelty or anticipation of prior art and obviousness?

Stephen M. Shapiro: That's a very important question for the medical community.

They need a robust section 101 standard because under 102 and 103 you could patent E equals mc-squared.

That's new, it's nonobvious; but you can't patent it under 101 because it's a law of nature.

And it's important to keep this -- this common domain, the storehouse of information that medical researchers need to have access to--

Justice Anthony Kennedy: It's hard to resist the temptation to peek into the obvious component or the nonobvious component and then go back and apply it to 101.

Stephen M. Shapiro: --Yes.

Justice Anthony Kennedy: You want us to discipline ourselves to talk just about 101 in this.

Stephen M. Shapiro: Well, no, I think -- we have two arguments on this point.

The first is both Flook and Bilski peeked and -- and they looked at the conventional nature of the additional step, and that's--

Justice Antonin Scalia: But once you say conventional nature, you are saying it's not novel.

If -- if the step is not conventional, it's okay.

Why?

Stephen M. Shapiro: --Well--

Justice Antonin Scalia: Because it's novel.

Stephen M. Shapiro: --this -- this is the Court's 101 analysis in both Flook and in Bilski.

So we rely on the latest decision, Bilski, which took exactly that peek.

But the other part of our answer is you don't even have to peek.

If the step doesn't narrow the preemption of the natural phenomenon, if it's just an incidental step that you need to use to observe the natural phenomenon, which this blood test is, you can't see the natural phenomenon.

Justice Stephen G. Breyer: You are getting warmer, but--

[Laughter]

But the -- the words, look, "a simple conventional step".

Hmmm.

You see, whether it's true in this case or not, discovering natural laws is often a very expensive process.

Stephen M. Shapiro: Oh, yes.

Justice Stephen G. Breyer: And there's lots of investment to be protected.

Stephen M. Shapiro: Oh, sure.

Justice Stephen G. Breyer: But they can't, okay?

So now you are going to say, well, what do they have to add to that?

And now we run into problems, because if you have to just not look at the law of nature, don't look at it when you decide whether it's novel, that not only runs into conflict with prior cases, but it doesn't make much sense because really the novel thing is often the law of nature.

But you say you have to add something.

Stephen M. Shapiro: Yes.

Justice Stephen G. Breyer: What?

Stephen M. Shapiro: Our view--

Justice Stephen G. Breyer: Now that -- what do you have to add?

And it can't be that you take the law of nature out and look to whether the rest of it meets the patent criteria.

It's -- it's pretty clear in the law and I can give you reasons why, but forget the reasons.

But look, what do you want to say the rest of it has to add up to?

Stephen M. Shapiro: --In our view, the rest of it has to add up to some step that limits the natural phenomenon, so that you have a concrete, specific--

Justice Stephen G. Breyer: You are going on a limitation thing.

You are going to say reject all the 15 fancy hypotheticals I will also spare you.

Stephen M. Shapiro: --Well, in the Diehr--

Justice Stephen G. Breyer: But it's pretty easy to think of the same problem you have, you know, which doesn't have this infinity in it.

Stephen M. Shapiro: --In the Diehr case--

Justice Stephen G. Breyer: Which unfortunately we have to deal with.

Stephen M. Shapiro: --In the Diehr case the natural phenomenon was limited with steps that confined the invention to a specific machine with doors opening and closing, temperature being monitored so a product was cured.

It was a very specific, concrete invention.

Justice Sonia Sotomayor: I -- I don't know what -- you keep saying you have to limit the product.

Stephen M. Shapiro: Yes.

Justice Sonia Sotomayor: But you told me that there is a different range for the treatment of skin diseases.

Stephen M. Shapiro: --Yes.

Justice Sonia Sotomayor: So presumably there are different ranges for treatment of other diseases.

Stephen M. Shapiro: Absolutely.

Justice Sonia Sotomayor: So this patent has not limited exploration in there.

You are claiming it has.

That's an issue that your adversary can speak to.

I think they say no in their briefs.

But the point is, there's still a limit to their range.

You are claiming at one point they said it was limitless, but if we disagree with that--

Stephen M. Shapiro: Well, here's what--

Justice Sonia Sotomayor: --how do you answer Justice Breyer's question?

Stephen M. Shapiro: --Here's what they say, joint appendix pages 13 through 14, the second volume.

This is their patent.

This is what it covers.

It covers hepatitis, lupus, Hashimoto's disease, Graves' disease, Addison's disease, diabetes, arthritis; and they say it even covers organ transplants.

It covers heart, kidney and liver transplants.

So it covers every autoimmune disease, and there are dozens and dozens of them--

Justice Sonia Sotomayor: Mr. Shapiro--

Stephen M. Shapiro: --and they do have different numbers.

That's the key point.

Justice Sonia Sotomayor: --So we -- so do we add up all of the diseases in the world, all the potential diseases, and pick a percentage that this covers within that range?

Stephen M. Shapiro: Well, this--

Justice Sonia Sotomayor: I think Justice Breyer is asking you for something that doesn't involve that.

Stephen M. Shapiro: --Well--

Justice Sonia Sotomayor: That involves some greater answer to the issue of limitation.

Stephen M. Shapiro: --I -- I think what the Court did in Flook and what it did in Bilski is ask if a broad field is being preempted.

This is broad numerically.

It goes up to infinity.

It covers dozens and dozens of autoimmune diseases.

Justice Antonin Scalia: What if -- what if they -- what if they just split up the patent?

They -- they got one patent number for arthritis, another patent number for transplants, another patent number for each one of the autoimmune diseases you are talking about?

Stephen M. Shapiro: Well--

Justice Antonin Scalia: Would each of them be okay, because--

Stephen M. Shapiro: --No, it wouldn't.

That would be LabCorp, where there was just one malady in the patent; it was a vitamin deficiency with a natural correlation.

And Justice Breyer's opinion explained that -- that is too preemptive of the natural phenomenon.

Justice Stephen G. Breyer: Yeah, but what my opinion lacked, frankly, and sometimes that's the virtue of a dissent in such a case, it lacked -- and Novartis points this out very well in their brief -- it lacked an explanation as to why what I thought was a patent just said, observe the correlation--

Stephen M. Shapiro: Yes.

Justice Stephen G. Breyer: --why isn't that an application of the law of nature?

And if you look to LabCorp's dissent to find an answer to that question, you are better than I, because I couldn't find it.

Stephen M. Shapiro: Well, if -- if -- observe the -- that's another area of the breadth of this patent, because there is no specific action the doctor has to take.

If a doctor has been informed of their range and draws blood and thinks about it, that -- that is -- that is infringement, and the doctor here was accused of infringement, treble damages sought against this hospital in an injunction, because she thought about this correlation, and she had completely different numbers.

Justice Elena Kagan: Is there -- Mr. Shapiro, is there a patent that Prometheus could have written that you think would have met the 101 test.

Stephen M. Shapiro: Certainly.

They could have said: When you reach 400, a real number, a specific number, you adjust the dosage by 20 percent.

That's a treatment patent.

Justice Elena Kagan: So if they had added a treatment protocol that would have been a completely different case?

Stephen M. Shapiro: Yes.

Justice Elena Kagan: And what makes it a completely different case?

Stephen M. Shapiro: What makes it different is that leaves room for Mayo Clinic to come up with different numbers that it believes are more accurate and more helpful for patients that are suffering from these life-threatening diseases.

We shouldn't require Americans to get one opinion from Prometheus when they want an opinion from Mayo Clinic.

Justice Elena Kagan: Well, I think I'm not sure I understand that.

You said a specific number.

But suppose it uses ranges, but it also attaches treatment decisions to those ranges?

Stephen M. Shapiro: Well, that could be specific enough again that others could have a rival test that -- that used a different treatment protocol.

You would have to look at that.

Justice Elena Kagan: So if the idea--

Justice Anthony Kennedy: But then why didn't you answer her first question that it was -- that it was not patentable?

I have the same--

Stephen M. Shapiro: Well, I think--

Justice Anthony Kennedy: --I think I am having the same problem as Justice Kagan.

Stephen M. Shapiro: --I think it would be patentable.

Justice Anthony Kennedy: Why can't you just go -- the hypothetical was -- was one range, one result -- pardon me, one measurement, one result.

Suppose that just continued over a range.

And they said if it's 40 then you have this; if it's 50 you have this.

Stephen M. Shapiro: Well, I don't think they can -- they can wipe out the entire field so that others can't have rival tests that use different numbers.

They tried to do that, by the way.

They have a total of eight patents here which use different numbers.

But you can't preempt the whole field so others can't make any use of the natural phenomenon.

Justice Elena Kagan: --I guess the question -- the question I'm asking is, in your response to me is the difference the -- the extent of the ranges, or is the difference that there would be clear treatment decisions attached to those ranges?

Stephen M. Shapiro: I think you would need both.

You would have to look at it in practical terms.

Is there room for somebody else to make use of this natural correlation, so that they could come up with different numbers, different ranges and different treatments?

And if there's room left then there is no preemption of the natural phenomenon.

That's a vastly different case and that's what is missing here.

I -- I do see my time -- yes?

Justice Sonia Sotomayor: How many patents of this type are out there?

Stephen M. Shapiro: My view is there are only a couple of them.

LabCorp is like this, this one is like this.

The others that are referred to in these amicus briefs are vastly different.

They are specific patents with specific treatment protocols.

And by the way, the government admits this particular patent is invalid because it just attaches a mental step to prior art.

There are only a couple of them to our knowledge that would be affected by a decision in our favor.

But a decision in our favor would protect the storehouse of information that doctors really need.

They have to be able to look at the body's reaction to injections, pills, chemotherapy, radiation; and different hospitals have to have different opinions to safeguard the health of our people.

So we urge the Court to reverse, and I would reserve the balance of our time.

Chief Justice John G. Roberts: Thank you, counsel.

General Verrilli.

ORAL ARGUMENT OF DONALD B. VERRILLI, JR., ON BEHALF OF THE UNITED STATES, AS AMICUS CURIAE

Donald B. Verrilli Jr: Mr. Chief Justice and may it please the Court:

Each party in this case has got a valid point.

Mayo is correct that you can't get a patent by tacking a mental step onto an utterly conventional process for administering drugs and testing their effects.

But that is an issue under sections 102 and 103 of the Patent Act.

Justice Ruth Bader Ginsburg: Mr. Shapiro just told us, when I asked him that question based on your brief, that people need to know up front that this is not a patentable subject matter; very important that it be 101 and not 102 and 103.

So how do you answer his rejection of the adequacy of prior -- as it's anticipating prior art or obviousness?

Donald B. Verrilli Jr: I think the answer, Justice Ginsburg, is that from the perspective of the United States and the PTO, it's exactly the opposite; that importing these -- taking, as Justice Kennedy suggested, taking up the temptation to import a look into novelty and nonobviousness into the 101 inquiry is going to be very destabilizing; 101, as Bilski said, is a threshold eligibility test and the question is whether there is a process.

Here there is a process.

It's the administration of a drug that changes the body chemistry and there is then a test to determine the extent of the change and then there is an end of the test.

That's a process.

Chief Justice John G. Roberts: That -- in your test for that -- I see on page 9 of your brief you say:

"A classic patent-eligible process recites a series of acts performed in the physical world that transforms the subject of the process to achieve a useful result. "

So I have a great idea.

You take wood, you put it on a grate, you light it, and you get heat.

That is -- recites a series of acts performed in the physical world that transforms the subject of the process, the wood, to achieve a useful result, which is heat.

So I can get a patent for that?

Donald B. Verrilli Jr: No.

It's not novel, and it's obvious.

Chief Justice John G. Roberts: No, no, no, no.

Well, let me put it--

Donald B. Verrilli Jr: You can't get a patent for it.

Chief Justice John G. Roberts: --That's patent-eligible?

Donald B. Verrilli Jr: But that's our -- that's our point, Mr. Chief Justice, that the right way to look at this issue is under 102 and under 103, and I think--

Justice Stephen G. Breyer: Why?

Why is the question.

Donald B. Verrilli Jr: --Because--

Justice Stephen G. Breyer: Look: Anything can be transformed into a process.

Look at those real estate ones, lawyers ones.

I have a way of making a great argument in the Supreme Court.

You know, you could patent some of your arguments.

[Laughter]

Donald B. Verrilli Jr: --Most are pretty obvious.

Justice Stephen G. Breyer: Why not cut them off at the pass?

That is, if you're really prepared to say -- it has to do with process, not machines.

In the 19th century not many patent processes were granted, so they are rather special because of the special problem the Chief just noticed.

So why not cut them off at the pass, if you are prepared to say--

Donald B. Verrilli Jr: I'm sorry.

Justice Stephen G. Breyer: --Well, I will add a little bit to this because I am questioning what you say here in the other direction.

You say if you just look at everything minus the law of nature, hmm, and that is a process that's otherwise known or obvious in light of the prior art, you can't patent it.

That seems to me maybe it goes too far in the other direction, because we know that a lot of work goes into these laws of nature.

Donald B. Verrilli Jr: Our position is a little different.

Justice Stephen G. Breyer: All right.

So there are both parts, but I'm more interested in--

Donald B. Verrilli Jr: Your Honor, if I could, if I could.

I do think that one has to think about what -- this seems like a straightforward case on these facts, but if one thinks about the principles that Mayo is advocating and applying them in a different set of circumstances I think you will see the problems.

Take for example nuclear stress tests that cardiologists use.

That's a process.

The patient gets on a treadmill, the heart rate gets elevated, radioactive dye gets put into the body, it allows an image to be taken of the heart with an x-ray machine.

That improves treatment.

Now, the transformation there is, as in this case, incidental to the process, it's not the point of the process.

But I don't think anyone would suggest that that's not a patentable process, but under Mayo's process it's not a patentable process.

Similarly I think -- I'm sorry, Mr. Chief Justice.

Chief Justice John G. Roberts: I was just going to say, what is the great advantage you see of putting this critical question off until the 102, 103 analysis, rather than cutting it off at the beginning, 101, which I understand your friend to say is very important because you don't want people to have to pause terribly long to see if this is something they can do?

Donald B. Verrilli Jr: As a practical matter, at the PTO, Mr. Chief Justice, it doesn't make any difference, because the PTO examiner gets a patent application and answers every question, 101, 102, 103, 112, and makes a decision about all of them.

So it's not going to lead to any benefit at the PTO.

Chief Justice John G. Roberts: What about litigation?

It is easier to throw something out at the threshold level, isn't it, than to move further down the line?

Donald B. Verrilli Jr: Not if one moves the novelty and obviousness inquiries from 102 and 103 into 101.

You've just taken the complexity of 102 and 103 and moved it into 101.

Justice Anthony Kennedy: Well, I'm not so sure.

We're talking about summary judgment.

It seems to me, rough rule, that summary judgment would be much more easy -- much easier under 101 than 102 and 103.

Donald B. Verrilli Jr: I think this case is a pretty good illustration, Justice Kennedy, of why that's not true.

Think of, if I may pick up on the question Justice Scalia asked my friend, think of all the trouble we are having in this case figuring out what the standard is: How much preemption is too much?

How do you even figure out the scope of preemption?

What you are actually doing here is multiplying a whole new set of very difficult, complex questions that you don't have to answer.

Justice Elena Kagan: But, General, I read you in part as saying: Don't worry, because if something strikes you as wrong with this patent, we are going to catch it under 102.

And I guess I'm not sure why that's true.

There was novelty here.

There were some doctors who figured out some new things, which was new ranges of effective drug treatment.

And so why do you think you are going to catch this as a 102 matter?

If there is a problem here, it seems to me not the fact that there was something new.

There was something new.

It's that -- it's something else.

Donald B. Verrilli Jr: But there was no new process, Justice Kagan.

There is exactly the same process that already exists, with a new inference drawn at the end, and that's why you can capture this under 102.

And I do think it's important to think about in terms of the points Mr. Shapiro is making, if this patent had involved, instead of standard old blood tests, had involved a breakthrough new test that allowed one to measure metabolite levels in a way that could never have been done before, of course the person who invented that could get this patent, even though it would have the excluding effect that Mr. Shapiro has identified.

Similarly, if the drug is a breakthrough drug and a patentable drug, any use of the drug during its patented period, including a use in a test like this, would be an infringement under 271.

Justice Antonin Scalia: What about--

Chief Justice John G. Roberts: Justice Scalia?

Justice Antonin Scalia: --What about the discovery of a new physical change in the body caused by an old drug?

You -- you find that it affects another part of the human system.

Is it -- is that discovery patentable?

Donald B. Verrilli Jr: Well, I think that's a harder question, but there are, for example -- and I think the Court was looking at some of this in the Caraco case on Monday, follow-on patents with respect to pharmaceutical products, where you patent it originally for one use and then you can later patent it when you discover a different use.

And in fact there is an entire regulatory system set up to deal with that.

So I do think there are circumstances in which that can be patentable, yes.

Justice Samuel Alito: Could I ask you about your argument that the correlations that were discovered and that are involved here are not natural phenomenon because the thiopurine drugs are synthetic products of human ingenuity?

I found that a little difficult to understand.

Suppose someone discovers the level at which a human pollutant that is present in the atmosphere or in the air or the water has an adverse effect on human health.

Is that not a natural phenomenon?

Donald B. Verrilli Jr: The existence of a pollutant in the air and its effect probably is a natural phenomenon, but the difference here is that there is a conversion of the natural body chemistry.

The metabolites wouldn't be in the body but for the administration of these drugs.

And I do think if one were to say that that's an unpatentable natural phenomenon -- and this is what I mean about the destabilizing risk of thinking about this as a 101 issue rather than 102 or 103 -- you're going to call into question lots and lots, thousands in fact, of medical use patents where the patent is: Administer a therapeutically effective dosage of this drug in order to treat this disease.

Justice Stephen G. Breyer: --Yes, but this drug is patentable because it's a -- what is the third word.

You know, it's combination of nature.

What's the -- it's a composition of matter.

Donald B. Verrilli Jr: Yes, Justice Breyer.

But those patents are not on the composition of matter.

Those are process patents.

Justice Stephen G. Breyer: They don't have to be.

You'd say that where it's a new use there were some specifications and the specifications limited the area to over here, I think -- and tell me if I'm wrong because I'm really asking just a question -- they limit it over here, you see.

And now we have a new use and we are saying this composition of matter is being used over here.

So aren't you getting a -- simply a different area where you are using a composition of matter?

Donald B. Verrilli Jr: Well, but that's a use patent.

That's not a composition-of-matter patent and--

Justice Stephen G. Breyer: That isn't a process patent.

Donald B. Verrilli Jr: --Yes, it's a process patent.

It is a process patent, and the problem would be if one says--

Justice Stephen G. Breyer: All right.

Chief Justice John G. Roberts: Finish your sentence.

Donald B. Verrilli Jr: --If one says that it's nonpatentable because all you are doing is patenting the application of a law of nature, you're invalidating all those process patents.

Thank you.

Chief Justice John G. Roberts: Thank you, General.

Mr. Bress.

ORAL ARGUMENT OF RICHARD P. BRESS ON BEHALF OF THE RESPONDENT

Richard P. Bress: Mr. Chief Justice, and may it please the Court:

I would like to start out, I think, with answering the question about what these patents cover and what they don't.

And I'm going to answer that really not because I think it has any relevance to the 101 issue.

I actually don't think it has any relevance to 101.

And I will explain that it does perhaps have relevance under 102 and 103 and why the difference matters, if I may.

So the district -- my friend is correct that in the district court at the initial infringement stage, before the Court decided the validity of the patent, we argued that the right way to look at our numbers was that we were claiming that if a doctor correlated or associated a number greater than 400 with toxicity, that's what we were claiming, that would be within our claim.

And if the doctor correlated under 230 with not enough drug, well, we were claiming that as well.

Now, the district court agreed with that and said that those were the ranges.

But then it confused things a bit, and that's where we get to the 15 percent plus or minus point.

The court also said -- and by the way, I think this is a correct reading -- that when we said about 400, that means plus or minus 15 percent of 400, and about 230 plus or minus 230.

And then the court held that there was infringement, but it held it for two different reasons.

It said that -- that the patent for Mayo -- or the -- I'm sorry, not patent, the product Mayo had, which by the way was awfully close -- it was 235 to 450 -- fell within the 15 percent on the top side.

It didn't look at the bottom side for purposes of this decision.

But 450 was within 15 percent of 400.

And it also said it violated it because 450 is greater than 400.

At the court of appeals we argued that the right way to read the district court's opinion was that you had to actually do that comparison, that the ranges, the 15 percents, mattered and that the doctor, in order to infringe, would have to look at the result and say: Is this or isn't this greater than 400 and compare it to 400, or 230.

The court of appeals accepted that reading of it, and that reading wasn't disputed by Mayo, and on page 38 of the court of appeals opinion, the court of appeals says it has to be compared to a predetermined number.

I think you could go either way on this.

I think, frankly, the Court could go back to the district court and look at that, perhaps.

But the problem with that is that there was no objection at the court of appeals.

And I think any objection to how the court of appeals understood it is probably waived at this point.

Now for why it doesn't matter.

If there is a problem with the broad ranges here, in other words if there is a problem with the fact that we're saying over 400 indicates toxicity, let's think about what is that problem.

Suppose we are right.

I mean, at this stage the Court certainly can't presume we are wrong in that.

So let's suppose that we are right.

If we are right, then we are simply claiming the fact that we found, that after you administer the drugs and determine the metabolite level, if it's over 400, it indicates toxicity.

Justice Samuel Alito: And that's a natural phenomenon.

Richard P. Bress: It is a -- It's according to a law of nature, and I will agree with that, Your Honor.

The term J.E.M. has referred to the difference between things that exist in nature with the intervention of man and things that exist without the intervention of man.

So, for example, photosynthesis would be a process that is a natural phenomenon.

On the other hand, cross-breeding plants to create a new variety, that wasn't the natural phenomenon.

Justice Samuel Alito: Yes, but if photosynthesis is induced by a lamp inside a building, then it's not a natural phenomenon?

Richard P. Bress: I think you could probably get a patent.

I think you could get a patent, Your Honor, on the use of a lamp to induce photosynthesis, but you couldn't claim the underlying process, is all I'm saying, of photosynthesis.

Justice Stephen G. Breyer: I thought of two examples that will try to get you to talk about the problem that's really bothering me here, anyway.

Richard P. Bress: I would love to, Your Honor.

Justice Stephen G. Breyer: Well.

A patent for -- we've discovered, at some extent, what counts as too little fertilizer and what counts as too much to make plants grow, a certain kind of fertilizer, very common.

Less than an quarter of an inch, forget it; more than half an inch, you are going to burn the plant.

Imagine that.

Law of nature, absolutely, about the chemicals in the fertilizer.

Patent: A method for determining when there is too little or too much fertilizer.

Put some fertilizer in a field and measure how much there is, wherein less than a quarter of an inch is too little and wherein more than half an inch is too much.

Second example.

Einstein never lived, but at vast expense you invented E equals mc-squared, a method for measuring energy which is very useful that comes out of a cyclotron.

Put some stuff in a cyclotron, measure the stuff in and measure how much comes out, and keep -- wherein, wherein, the missing part is -- think about -- wherein -- it says: Wherein the missing part will be calculated as an amount of energy according to a formula E equals mc-squared.

If your patent is valid, why aren't the two I just mentioned?

And if you -- if the two I just mentioned are valid, there is something wrong with this picture.

Richard P. Bress: Okay, You Honor.

I will answer them in turn and then hopefully I'll get back to my range and explain what the 102 and 103 problems are with that for you all as well.

The first patent you've discussed, which is how best to use fertilizer essentially for plants.

Patent-eligible subject matter, but clearly novel and novel in a way that you could get rid of on summary judgment just as fast as you could get rid of it on 101.

There is no advantage, in other words, to saying: I am going to label my summary judgment motion 101 and import lack of novelty into that versus saying I'm going to label--

Justice Stephen G. Breyer: Where is lack of novelty?

Nobody has these numbers before.

They always thought it was a quarter, an eighth of an inch.

It's huge novelty.

Richard P. Bress: --Your Honor, the law, as you well know, recognizes that under section 103, if something would have been obvious to someone with ordinary skill in the art--

Justice Stephen G. Breyer: I mean, my point -- assume with me the eighth versus quarter of an inch which is the law of nature part is not obvious.

Richard P. Bress: --Your Honor, the first person who came up 10,000 years ago with the best way to do -- to use fertilizer in a way that nobody had ever done before would presumably get it.

If your question is at what level of sort of microns you can draw a line between obviousness and novelty, there are questions of fact embedded in that.

Justice Stephen G. Breyer: No, no.

My question is, what has to be added to a law of nature to make it a patentable process?

Richard P. Bress: To make--

Justice Stephen G. Breyer: And if you put too little in the answer to that question, I believe I can take things that like E equals mc-squared and make them patentable.

And if you put too much in, you are going to wreck your own case.

Richard P. Bress: --Your Honor, I will try very hard not to do either.

Your Honor, this Court has looked at two different ways to try to limit what are laws of nature, abstract ideas, etcetera.

One way it has looked at is to say we need something physical; it has to be in the world.

In other words, you have to move things, you've got to transform them, you have to apply machinery to them, that sort of thing.

So we just know off the bat you are not literally claiming just a principle in the air.

So in your example, if you used, you know, machines, implements, et cetera, to do it, at least we would know that much.

I think the problem that Your Honor's raising is more in the second stage, which is, okay, it isn't just a mere principle.

I get that.

But are we as a practical matter preempting an abstract idea in such a way that we are going to too greatly suppress follow-on invention.

And the classic example of that, Your Honor, is the Morse case, of course.

In Morse there were two different claims that were being discussed, actually eight different claims being discussed.

But one of the claims had to do with the actual invention of how you can make a telegraph work.

And Morse described a working telegraph system and he got a patent for that.

And the second one that he tried to claim was the use of electricity to write at a distance.

AND the reason he didn't get that one is that it was expressed at such a level -- high level of abstraction, that it would preempt many, many things that he had never invented and never thought of.

In fact, the Court's words were wonderful in that case: "For aught we now know", the Court said, somebody may come up with wonderful inventions in the future.

And of course now we have the fax machine, e-mail, et cetera.

That's the right way to think about it, which is, is the -- for the second step, which is, is what's being claimed at such a high level of generality that it's going to inhibit future innovation.

Justice Anthony Kennedy: Why couldn't someone come up with the idea that at a level which is in the range that is within your patent, that if at a certain level for a certain -- a person of a certain age, you administer a new drug, you have a new result?

Why isn't that like the fax machine?

Richard P. Bress: Your Honor, in that case they could get an improvement patent on it, first of all, no question about it, that they could apply for an improvement patent.

Justice Anthony Kennedy: But the--

Richard P. Bress: They're building on it.

Justice Anthony Kennedy: --Petitioner is saying that if you think about that, it's an infringement.

Richard P. Bress: Well, there's a -- let me explain why I think there is not a problem with that, Your Honor.

If you looked at the process for vulcanizing rubber, which Firestone patented many, many years ago, that involved you heat India rubber to a high temperature, you add sulfur and mineral salts, and that way you cure rubber into a usable way of using it.

Now, many years later in Diehr this Court looked at an improved process, if you will, for making rubber which involved continuous measurement and the use of the Arrhenius equation to know when the rubber was cured.

Now, there is no doubt that if somebody came out with a second one 10 years after Firestone had gotten the patent on vulcanization, they would have had to pay patent royalties for 10 years before their second one would have been free of patent royalties, right, because they would have had to respect the patent that Firestone got.

So the simple fact, in other words, that there may be further improvements to what you've done isn't where the court has ever drawn the line.

And I do think that in conceptualizing where to draw these lines, because at the edges they're indeterminant, they're elusive and they're going to be somewhat arbitrary.

This is judge-made law.

I think that what you've got to look to is what you've done before.

And if we take this case in the spectrum of what this Court has looked at, where you've got Morse on one side, on that same side you've got Benson, which was simply a formula for converting binary coded decimals to pure binary, which the court said you could use for an infinite number of uses.

It was way too broad.

If you look at Bilski, a general way of -- a general -- the concept of hedging.

Now Bilski was limited, admittedly and this Court discussed it and said, well, they tried to limit it with the conventional step of having the inputs determined by random analysis techniques.

I would like to focus on that for a second, because the Court said that was not significant extra solution activity.

It wasn't enough to either render the process a physical one in the world or to narrow its scope.

Well, why is that?

Because random analysis techniques are themselves just an abstract idea.

So you were adding one abstract idea to another one and it's no wonder that the Court found that it didn't narrow it to a patentable scope.

Now on the other side of the line we have cases Tilghman.

Now if you look at Tilghman, Tilghman was a patent on the fact that if you use water at a high heat and high pressure, you can separate out from fat bodies, the fatty acids on the one hand and the glycerin on the other.

And this Court approved a process -- a patent process on that.

Now that's of course a natural law, Justice Alito, no question about it, in terms of is it a law of nature that makes you do that, yes.

But the Court was comforted in that case by the fact that the patent wasn't trying to generally patent monopolize the idea that water at high pressure and temperature is going to in general break bonds of chemicals.

And it wasn't trying to either monopolize the whole idea of how you can separate fat acids and glycerin from fat bodies.

There are other ways, including the use of sulfuric acid.

Let's place this case in the continuum.

Now, we are not trying to pass the general broad idea that you can use metabolite readings after you administer the drug to determine what the likely, what the best level of the next administration might be.

That would be kind of like the Morse patent, and that's not what we are doing.

What we are talking about here is A, a very specific class of drugs, the thiopurines used for--

Justice Elena Kagan: But, Mr. Bress, here's what you have not done.

What you haven't done is say at a certain number you should use a certain treatment, at another number you should use another treatment.

I guess the first question is why didn't you file a patent like that?

Because that clearly would have been patentable.

Everybody agrees with that.

Richard P. Bress: --I agree it would, Your Honor.

Two responses if I may.

Justice Elena Kagan: And I think that the difference that people are noting or some people are noting is that this is not a treatment protocol, it's not a treatment regimen, all you have done is pointed out a set of facts that exist in the world, that exist in the world, and are claiming protection for something that anybody can try to make use of in any way and you are saying you have to pay us.

Richard P. Bress: Right.

Your Honor, I don't agree with that description, but let me explain--

Justice Elena Kagan: I thought you might not.

Richard P. Bress: --why.

All right, Your Honor, first of all most of the claims here have three steps.

So you have an administering step which clearly carries its own benefits with it.

It's not novel, but it's certainly a process step that in and of itself could be a process.

We couple that with determining -- you determine the amount of metabolites and the next step gives the doctor valuable information in order to decide what to do next.

Now why didn't we say, if it's over 400 you must decrease because that doesn't correspond with how doctors practice medicine, Your Honor.

So for example, you've got a patient for whom you've got a particularly sharp outbreak of Crohn's disease.

You may well be willing to go above the normal 400 level if your other tests, your liver toxicities, your white blood cell counts etc.

, tell you that for this patient at this time given that condition I am willing to risk some additional toxicity.

On the lower end of the scale you may have somebody under 230 who seems to be improving, they seem to be moving towards remission, why push it, why increase.

And this is not unusual.

And that's one of the things I think I've got to stress here is the notion of a patent only in the end producing information is old in this country.

And by the way to produce the information you are always going to have a step at the end that is some kind of an algorithm.

Like a very simple one.

But it takes the data, the raw data and turns it into something useful.

So for example, in the 19th century there were patents on the use of electricity to locate veins of ore and valuable minerals in the ground.

Now that patent didn't say after you found it, you have got to dig it out.

And according to Mayo, that would have to be the next step.

But of course you might have reasons for digging it out or not digging it out depending on your finances, depending on how deep it is and depending on what kind of ore it is, etc.

There were patents on how to navigate your boat in the fog, it was a primitive sonar based method.

And it didn't tell you in the end you had must steer your boat to X and go there.

It just told you a likely way to go.

There was not--

Justice Stephen G. Breyer: What about a process that all the steps are -- it's a process to -- to generate some useful information.

Richard P. Bress: --Yes.

Justice Stephen G. Breyer: Fine.

And the only new thing about it is the useful information.

Richard P. Bress: Yes.

Justice Stephen G. Breyer: Anything like that in history, any patent case that comes to mind that you say that was okay?

Can you think of one?

Richard P. Bress: Actually, Your Honor, yes.

Justice Stephen G. Breyer: What?

Good.

That's what I would like to know.

Richard P. Bress: Certainly.

For example, there was a patent on the -- and I can talk about modern ones too, of course, but a patent on how to find the -- where there is a leak in a water main and it was using vibration of--

Justice Stephen G. Breyer: No, no.

That's not what I'm thinking of.

I'm thinking of a patent to find useful information that chickens can only eat so much chicken food.

That nobody has ever known before, you know.

Okay.

Now there's something like that.

But they tell you the useful information that's going to be found right in the patent.

In other words, we have a patent to discover some useful information and here is the useful information.

And now here's -- see, that's what they're complaint--

Richard P. Bress: --I'm not sure that I am understanding, Your Honor, because the patent that tells you where to find the ore is telling you what you're going to--

Justice Stephen G. Breyer: --But you don't know what you are going to find because you don't know how much ore you are going to find?

Let's see, okay.

Let me think about it.

Richard P. Bress: --Well, and if we talk about modern days because I think it's helpful now to move this forward, the court has never suggested that there is an extra statutory limitation that prevents patents on developing useful information, even if they have a mental step at the end.

And what do we have today?

We've got inventions out there that through identification of biomarkers or measuring the biomarkers allow us to know which of 10 particular cancer drugs is going to work for a particular patient.

We have got patents on methods that allow us to identify the likely location and size of the next earthquake in the San Andreas fault.

We have got patents that allow us to determine where there is a crack and what type of crack in a nuclear reactor core.

Now, according to Mayo, because all of these patents end with a mental step that produces information, they're no good.

Or perhaps if you look at them and say everything up to that algorithm at the end is old, you can't get a patent because you lack novelty.

Now, it may be to -- it may be in fact, depending on the particular invention, that you should lose for lack of novelty on one or other of those, or that you should lose for lack -- for obviousness.

But under 101, these are precisely--

Justice Stephen G. Breyer: What's your view?

What's your view?

Richard P. Bress: --Okay, Your Honor, I'm happy to address that, too.

The answer is no, and here's why.

Justice Stephen G. Breyer: You should not lose it.

Richard P. Bress: You should not lose.

And this is why -- and I'll use my case as a wonderful example.

So in our case, what existed before in the prior art, so to speak, was people knew that you could administer thiopurines for these particular diseases, and by the way, they're not all diseases, just -- we do specifically exclude in these patents, for example, Host-versus-graft disease.

We exclude leukemia, et cetera.

They're not in the asserted patents in this case.

But in any event, administration of thiopurines to address certain diseases: old in the art.

Different methods for finding analytes in blood cells such as high pressure liquid chromatography?

Old in the art, no doubt.

They were used together before we did them, but why were they used?

They were used by people who were trying to come up with what we came up with.

They weren't doing it for fun.

They were administering.

They were determining in order to try to find a new treatment method, a new way of calibrating the right dose for each individual patient based on their metabolism, and help seriously ill patients.

And the idea that we are not novel because people took some of the same steps along the way to invention that we actually succeeded in is wrong.

And in fact, this Court said so in American Wood-Paper, where it said that

"incomplete and unsuccessful attempts to invent will not render not novel the successful inventor. "

And in Bell, the Court said the difference between those who -- those who did not get the patents in Bell was only the difference between failure and success, and didn't say that because many of them had used similar methods but had not understood that continuous electrical lines as opposed to intermittent or pulsing electrical lines was going to be the difference for a working telephone.

Similar here.

I don't think we ought to lose on novelty to that ground.

But let's put that to the side, because that's for remand, and it's something that hopefully--

Justice Antonin Scalia: Suppose somebody thinks you're wrong, that the numbers you've come up with are wrong.

And they want to develop better numbers that will -- will help the medical profession.

Your -- your patent occludes them from doing that.

Am I right?

Richard P. Bress: --No, Your Honor.

Justice Antonin Scalia: No?

Richard P. Bress: And let's explain why not.

And I will even take for purposes of this explanation my brother's example of over 400 and under 230, because I don't think it matters.

So you've got Dr. el-Azhary, who believes that the right ceiling level is 300.

Okay?

So if she sees a patient and says,

"I'm going to -- you know, I associate 290 with toxicity. "

that won't violate our patent in the least.

Our patent says if you associate over 400 with toxicity, that's within our range.

If she associates 290 with toxicity, no violation.

Now, getting more to the point, though, if we're totally wrong -- let's assume we're off base and -- and this doesn't work at all.

There's another participant of section 101 that addresses that, and that's utility.

And certainly Mayo would be able to come into court and say that patent has no utility, it's completely wrong.

In fact it's killing patients.

And try to invalidate us on that ground.

Similarly, suppose at the very edges of the spectrums that we're claiming, the answer is obvious, the answer is not novel.

They can seek to try to invalidate our patents on that basis as well.

This -- these aren't 101 problems.

Chief Justice John G. Roberts: Well, it seems to me that's your -- the problem with your whole approach is that every time you're pressed on 101, your answer is to fall back to 102 or 103 or the utility part of 101.

And I'm just wondering why it's beneficial to essentially eliminate 101 and say oh, we'll catch everything later on.

Richard P. Bress: Thank you, Mr. Chief Justice; I appreciate the question.

I -- I think that the answer is that when the problem is lack of novelty, when the problem is obviousness, the right place to go are the sections that actually have very clear rules on how to apply those, and that the problem with taking a short cut in that instance is, essentially, the Court would just imbue its own notions or pre-conceived notions of what should be patentable and pour it into it as opposed to following those rules.

And of course, if you're going to follow these rules, you might as well follow them under that section.

Now, it doesn't completely leave 101 bereft.

This Court has said 101's very broad, but it does have limitations.

And if you look at a case like Morse--

Chief Justice John G. Roberts: Well, just as -- I'm sorry to interrupt.

Your friend's point is that if you don't do this -- if you don't give 101 some more content, then the doctor is going to have to start worrying right from the get-go, and they say well, is there an exception that I might be able to rely on, as opposed to being able to say right away this -- I don't have to worry about this patent; I can treat the patient in this way.

Richard P. Bress: --Well, Your Honor, again, if -- if it's very clear that we're not novel.

For example, if -- if the government is correct here that facially, we lack novelty, it's no harder to proceed under 102 to achieve that goal than it is under 101.

If you're going to proceed under 101, then we'll talk about principles that 101 speaks to.

So 101 -- I think the primary -- the two things explored: it has to be a process in the physical world, a hands-on process.

And it can't be so broad that it preempts all follow-on innovation.

Those are the two things -- you know, this Court speaks about statutory language, and it has to do some work.

That's the work that--

Justice Sonia Sotomayor: So that's novel.

What's your answer about why this is novel?

Richard P. Bress: --Right.

Your Honor, before Prometheus -- actually, the inventors in this case in Montreal came up with this method -- doctors had no way to tailor for each individual based on their metabolism the right dosage of these powerful but potentially toxic drugs.

Chief Justice John G. Roberts: Thank you, counsel.

Mr. Shapiro, you have 4 minutes remaining.

REBUTTAL ARGUMENT OF STEPHEN M. SHAPIRO ON BEHALF OF THE PETITIONERS

Stephen M. Shapiro: Justice Scalia asked the critical question here: what if you think these numbers are wrong?

What happens with patients around the country?

Well, that's just what we concluded: these numbers were wrong.

They say you go up to 400, and above 400, it's bad, it's harmful.

We found that the right range was 450 up to 700 -- and sometimes above 700 -- to cure some of these very serious diseases.

And that different opinion was blockaded by this treble damages lawsuit, and request for an injunction.

So the -- the wrong information is--

Justice Antonin Scalia: He says the solution to that is that -- you're saying their patent is not useful.

That would be your defense.

Stephen M. Shapiro: --It's important that 101 be the robust test here.

This is the only provision under which this Court has issued decision after decision for 150 years protecting the public domain.

It's not some rough gauge; it's the critical test defining what's in the storehouse of information for medical researchers to use.

And reduce it to a dead letter here would be just contrary to this Court's precedence, and very harmful to the medical community.

This is very important to -- to doctors around the country.

Now, is this a natural process?

The question was raised.

Of course it's a natural process.

These metabolites come from the liver.

They don't come from a test tube.

They don't come from a syringe.

It's just like cholesterol.

If I eat in a French restaurant, there's some human intervention there that gives me high cholesterol.

And if I eat wild strawberries, there's no human intervention.

But either way, the doctors get to look at my cholesterol and hypothesize ranges that they think are essential.

It's the very same phenomenon.

Entirely natural.

Now, this is a clean legal issue.

Under section 101, it's always been a legal issue.

They say section 102 and 103 are the most elusive questions in the field of patent law.

This is a seven year old lawsuit against a hospital; it's cost millions of dollars to defend.

Two trips to this Court, two trips to the Federal circuit.

We're still litigating this treble damages case.

It should be terminated under this Court's precedence, as the district court did giving summary judgment.

Justice Sonia Sotomayor: I guess my problem is, if we call this just simply a application of natural phenomenon or of a natural process, why are treatment patents at all--

Stephen M. Shapiro: Well, because--

Justice Sonia Sotomayor: --permissible, meaning if someone finds out that at level 300, it's bad, and tells doctors to stop, that's natural, too.

Stephen M. Shapiro: --Yes.

Well, I think that's right.

That's -- that is a second issue.

But the first issue is the breadth of the preemption, which precludes anyone else in the country, from saying as Justice Scalia did -- those numbers are wrong.

And patients can't use those numbers safely or they won't get cured of this disease.

For 20 years, the public is stuck with the erroneous information.

Now, counsel suggests that it's narrow preemption because it doesn't cover Host-versus-Graft or leukemia.

Those are not autoimmune diseases.

Every autoimmune disease is swept in here.

And there are dozens and dozens of them.

They have different characteristics.

You don't take a "one size fits all" approach to autoimmune disease.

There are different numbers for different diseases.

That's what Mayo is trying to do, to have some personalized medicine for skin disorders.

And they said that -- that is an infringement and we're entitled to treble damages and an injunction.

Now, is this like the Morse case?

Yes, it is like the Morse case.

Prometheus is trying to preempt diseases it never researched, and it's trying to preempt numbers that differ from its numbers fundamentally.

They have the number 7000 in their patented number.

We thought the number should be 5700.

This is a very dangerous toxic drug.

If you get the wrong number set in concrete for 20 years, that is a huge problem for patients.

And there are millions and millions of patients suffering from autoimmune disease.

So we urge the Court to protect the research process here that's so fundamental to American health and to the economy and the healthcare industry.

We thank the Court.

Chief Justice John G. Roberts: Thank you, counsel.

Counsel.

The case is submitted.

Print this transcript Transcript: 

Justice Elena Kagan: In Case Number 10-1150, Mayo Collaborative Services versus Prometheus Laboratories. Justice Breyer has our opinion.

Justice Stephen G. Breyer: Section 101 of the Patent Act says, in relevant part, “Whoever invents or discovers any new and useful process, machine, manufacture or composition of matter may obtain a patent.”

The Court has long held, however, that the provision contains an important implicit exception.

Laws of nature, natural phenomena and abstract ideas are not patentable.

Thus, Einstein could not have patented his formula, E=mc2, nor could Archimedes have patented his principle of flotation.

Such discoveries, the Court has said, are manifestations of nature, free to all men and reserved exclusively to none.

The underlying concern is that since laws of nature are the basic tools of scientific work allowing them to be patented would pose to great a threat to future innovation, but the exception cannot go too far.

Virtually, every invention relies to some degree on some law of nature, so the Court has also said that inventions that apply a law of nature in a useful and inventive way are patentable.

But what must a claim do to leave the unpatentable law of nature category and enter the patentable application of the law of nature category?

To count as an application, a claim cannot simply state a law of nature and then add the words “apply it.”

Einstein could not get a patent on his law by telling people, “Apply my law as you think fit.”

This case raises these questions.

The patent claims here focus upon doctors who use drugs called thiopurine drugs to treat patients with certain kinds of autoimmune diseases.

Doctors have used these drugs for some time.

And they know that after a patient receives a dose, the drug has to be metabolized in order to work.

They also know that different patients metabolize the drug to different degrees in different ways and they know how to determine by examining a patient’s bloodstream to metabolize drug level.

But before the invention at issue here came along, they did not know just what metabolized level in the blood meant too much drug, so lower the dose and what level meant too little drug, so raise the dose.

The process claims here embody more recent discoveries that answer these last questions.

In case you would like to know, a level of less than 230 picomoles of metabolized drug per 800,000,000 red blood cells shows need to increase the dosage while a level of 400 shows a need to reduce the dosage.

I thought you'd like to know that.

These correlations, however, are unpatentable natural laws even though the relationship they describe arise only after a drug is administered to a patient and that is a human action, the relationships themselves are natural ones caused by the natural interactions of the drug with the human body.

So, we have to look beyond the correlations themselves and ask whether the process that the patent applicant seeks to claim embodies something more than just those natural laws.

We conclude that the claims before us do not contain anything significant beyond the natural law of correlations themselves.

The processes, as I'll summarize them, consist, in effect, of three steps.

Those steps tell doctors, one, administer a thiopurine drug to your patient.

Two, determine, i.e., measure the resulting metabolite levels in the patient's blood, and then three, consider the resulting measurements in the light of the correlations.

The first step, the administering step, simply identifies a set of people who may be interested in applying the relevant laws, namely, doctors who treat their patients with thiopurine drugs.

Our case law makes clear that you cannot patent a natural law just by limiting use of the patented process to those in a certain technological environment as if, for example, Archimedes had limited use of the flotation principle to boat builders, that isn't good enough.

The second step, the determining step, simply tells the doctors to measure metabolite levels in the blood, but measuring metabolites is something that researchers in the field were doing before the correlations at issue here were found and doing so is a necessary precursor to applying those correlations.

Our cases tell us that a process cannot be rendered patentable simply by adding conventional pre-solution activity to the statement of a natural law.

The third step, the consider step, simply adds to these first two steps a statement of the natural laws with, at most, a suggestion that doctors should take those laws into account when treating their patients, perhaps, by modifying the drug dosage they subsequently administer if they decide that doing so makes sense all things considered.

Insofar as the claim set forth additional steps beyond the law of nature itself, those steps consist of well understood routine, conventional activity already engaged in by the scientific community.

We consequently conclude that the patent claims say nothing significantly more than apply the law, i.e., apply the natural laws that they describe and that simple additional instruction, by itself, is insufficient to transform an otherwise patentable claim into a -- unpatentable claim into a patentable one.

We discuss these matters further in our opinion, but we also describe the relevant case law and explain why we cannot accept the respondents and the Government's counter arguments.

We hold that the patents are invalid under Section 101 of the Patent Act, and we reverse the Federal Circuit's contrary determination.

The decision is unanimous.