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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....

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.

You can use laws of nature to invent on top of them, so to speak, but you cannot own them, I guess is what they are saying. You can't claim laws of nature and then sit back and rent-seek the world. You have to do something inventive using the laws of nature, but the laws of nature themselves belong to the world to use. Einstein, they point out, couldn't patent E=mc². To allow it would be to foreclose innovation, instead of encouraging it. And he also couldn't do this, the court explains:

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).

Here's an interesting sentence:

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...

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....

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....

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.

Indeed, Breyer’s decision is the most intellectually dishonest decision I have ever read, which is saying a lot given the utter contemptuous understanding of patent law displayed by the Supreme Court over the years. It is truly troubling that all 9 of the Justices concurred in what history will regard as one of the worst decisions in the patent space EVER!

Yes, Congress will be asked to step in and rectify this absurd ruling, and they should. Knowing how the legislative branch operates I cringe at the thought of Congress coming to the rescue. The only thing that gives me solace is that the industries summarily executed this morning have an A+ lobbying game, which in Washington, DC means everything.

To arms… to arms… the Supreme Court has come! Rally all the lawyers, collect all the lobbyists and march on Congress!

Although no action has been taken yet, I presume that the Supreme Court will now vacate and remand the pending Myriad case with instructions to the Federal Circuit to reconsider its holding that isolated human DNA is patentable. Following Mayo, the court could logically find that the information in the DNA represents a law of nature, that the DNA itself is a natural phenomenon, that the isolation of the DNA simply employs an isolation process already well known and expected at the time of the invention, and ultimately that the isolated DNA is unpatentable because it effectively claims a law of nature or natural phenomenon. One distinguishing point is that Prometheus claimed a process while Myriad claims a composition of matter. As we have seen in recent cases, the Federal Circuit already largely rejects formalistic distinctions between process and composition claims. Here, that distinction is further minimized by the reality that the claimed DNA is functionally characterized by the already well known process of isolating human DNA.

And here's SCOTUSblog's Lyle Denniston's recap of the ruling, "Opinion recap: Freeing doctors to practice", including this small taste:

Although the Court’s new decision focused very closely upon the two specific patents directly at issue, some of the language in Justice Stephen G. Breyer’s opinion swept more broadly and amounted to a caution to the Patent Office — and to the special appeals court that reviews patents — to be more skeptical about these moves to obtain medical practice monopolies....

In the concluding pages of the opinion, Breyer suggested that the Court had sided — in an energetic debate over whether patent monopolies were critical to generate new discoveries in medical diagnosis — with those who contended that such monopolies threaten to “impede the flow of information that might permit, indeed spur, invention.” Among the negative effects that might flow from this, Breyer wrote, is raising the price of using patented ideas, requiring potential users “to conduct costly and time-consuming searches of existing patents and pending patent applications, and requiring the negotiation of complex licensing agreements.”

"[U]pholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries."

That was one of Mayo's main arguments in fighting the infringement charge. The Rochester-based medical facility also said doctors might be afraid to make treatment recommendations based on commonly used, longstanding medical measurements for fear of being sued.

Mayo welcomed the decision and said it would free up effective treatment of patients and important research.

"It's essentially about the everyday interaction between a doctor and a patient," Mayo president and chief executive Dr. John Noseworthy said in an interview. "The ability of the physician to measure a patient's response to a drug and adjust and tailor the dose to optimize the patient's response to the drug to keep the patient safe. We think this will insure that the pressures in the marketplace come to bear to stimulate new and innovative tests. I think this will spur innovation, not impede it."

The Washington Post has a statement from Prometheus:

Personalized medicine is becoming big business in the United States, with companies trying to find the best way to use a person’s genetic makeup to help tailor care and find the most effective individualized treatments for cancer and other illnesses.

Officials at Prometheus Laboratories Inc., in San Diego said they were disappointed in the court’s ruling. “We believe that strong patent protection is important to encourage the investment of energy and resources to develop lifesaving diagnostic tests and treatment protocols,” a company statement said. “Without the availability of patent protection, future healthcare will suffer as companies may opt out of new research and development. This decision will, in our view, encourage imitation, not innovation.”

[Update 2: This record would be incomplete without hearing from the law professors whose article, Life After Bilski, was heavily relied upon by the court. As it happens, one of the authors (there were four -- Mark A. Lemley, Stanford Law School, who famously wrote Don't Break the Internet; Michael Risch, Villanova University School of Law; Ted M. Sichelman, University of San Diego School of Law; and R. Polk Wagner, University of Pennsylvania Law School), Michael Risch, also was cited for another article, Everything is Patentable, but the arguments in it were firmly rejected. So imagine how he's feeling today. We don't need to imagine, because he writes about it, and I think you'll enjoy his thoughtful response, even though he surely loves patents a lot more than we do. And it's a beautiful example of how to disagree with a court decision without becoming abusive. Probably that's why the court reads his articles, methinks.

As for the threats I've read in quotes in media articles and in comments on the rather hilarious comment thread on Dennis Crouch's article that now companies will hide their inventions as trade secrets because of this decision, I'd like to say: Please. Do. It. By all means. Keep your secrets, since you clearly don't care about the welfare of patients. That would at least leave those who *do* care free to practice medicine. - End update 2.]

[ Update 3: I found the ACLU's amicus brief [PDF] fascinating in one respect:

These cases make clear that, though the machine-or-transformation test is “a useful and important clue” as to process patentability, it is far from an “exhaustive or exclusive test.” Bilski, 130 S.Ct. at 3226-27. The Court in Bilski chose to reject the Federal Circuit’s adoption of the machine-or-transformation test as the sole test for process patents under Section 101, a ruling it need not have reached given the circuit court’s finding of invalidity. Such a rigid test, however, could not be reconciled with the analysis of Benson, Flook, and Diehr, particularly because it is entirely possible for a natural phenomenon to inherently involve transformation – e.g., aging. Indeed, chemical “transformations” occurred during the claimed catalytic chemical conversion of hydrocarbons in the Flook method found invalid by the Court. 437 U.S. at 586, 596-98.

Dissecting a claim to determine whether a “transformation” exists in one or more steps, and ending the Section 101 inquiry at that point, departs from this Court’s focus on the essence of what is claimed. Patents must be examined to determine whether, once extrasolution steps and technological field limitations are stripped away, abstract ideas or natural phenomena are the essence of the claim, and whether the claim’s practical effect is to preempt what is unpatentable.

[Update 4: Now this is up our alley, an article on SCOTUSblog noticing the connection between this decision and the software industry, Ronald Mann's "Court’s biotech case sends stern warning to Federal Circuit and software designers":

Because the Court’s cases regard algorithms as natural laws akin to the metabolic process at issue in Mayo, many software patents have the same conceptual structure as the Mayo patent: a patent on a software program that applies an algorithm often claims the software necessary to make the algorithm practically useful. But if the invention is discovery of the algorithm – a simpler, faster, or more elegant arrangement of steps to manipulate data or make calculations – a patent claiming the software that implements the algorithm is highly dubious after Mayo. To put it another way, if the purpose of the patent is to control use of the newly discovered algorithm, the offhand tone of Mayo suggests the patent is an easy and obvious case for invalidity. But that easy and obvious case surely extends to a large share of the software patents that have been enforced in litigation over the last two decades of the Federal Circuit’s developing tolerance for patents in that area.

So here it is, the court's ruling today, as text.

As always, for anything important, go by the PDF. We aim for accuracy in our text versions, but we are merely human:

******************

(Slip Opinion)

OCTOBER TERM, 2011

Syllabus

NOTE: Where it is feasible, a syllabus (headnote) will be released, as is being done in connection with this case, at the time the opinion is issued. The syllabus constitutes no part of the opinion of the Court but has been prepared by the Reporter of Decisions for the convenience of the reader. See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337.

SUPREME COURT OF THE UNITED STATES

Syllabus

MAYO COLLABORATIVE SERVICES, DBA MAYO
MEDICAL LABORATORIES, ET AL. v. PROMETHEUS
LABORATORIES, INC.

CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR
THE FEDERAL CIRCUIT

No. 10-1150.

Argued December 7, 2011--Decided March 20, 2012

Respondent, Prometheus Laboratories, Inc. (Prometheus), is the sole and exclusive licensee of the two patents at issue, which concern the use of thiopurine drugs to treat autoimmune diseases. When ingested, the body metabolizes the drugs, producing metabolites in the bloodstream. Because patients metabolize these drugs differently, doctors have found it difficult to determine whether a particular patient's dose is too high, risking harmful side effects, or too low, and so likely ineffective. The patent claims here set forth processes embodying researchers' findings that identify correlations between metabolite levels and likely harm or ineffectiveness with precision. Each claim recites (1) an "administering" step--instructing a doctor to administer the drug to his patient--(2) a "determining" step--telling the doctor to measure the resulting metabolite levels in the patient's blood--and (3) a "wherein" step--describing the metabolite concentrations above which there is a likelihood of harmful side-effects and below which it is likely that the drug dosage is ineffective, and informing the doctor that metabolite concentrations above or below

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Syllabus

these thresholds "indicate a need" to decrease or increase (respectively) the drug dosage.

Petitioners Mayo Collaborative Services and Mayo Clinic Rochester (Mayo) bought and used diagnostic tests based on Prometheus' patents. But in 2004 Mayo announced that it intended to sell and market its own, somewhat different, diagnostic test. Prometheus sued Mayo contending that Mayo's test infringed its patents. The District Court found that the test infringed the patents but granted summary judgment to Mayo, reasoning that the processes claimed by the patents effectively claim natural laws or natural phenomena--namely, the correlations between thiopurine metabolite levels and the toxicity and efficacy of thiopurine drugs--and therefore are not patentable. The Federal Circuit reversed, finding the processes to be patent eligible under the Circuit's "machine or transformation test." On remand from this Court for reconsideration in light of Bilski v. Kappos, 561 U. S. ___, which clarified that the "machine or transformation test" is not a definitive test of patent eligibility, id., at ___-___, the Federal Circuit reaffirmed its earlier conclusion.

Held: Prometheus' process is not patent eligible. Pp. 8-24.
(a) Because the laws of nature recited by Prometheus' patent claims--the relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or cause harm--are not themselves patentable, the claimed processes are not patentable unless they have additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations. The three additional steps in the claimed processes here are not themselves natural laws but neither are they sufficient to transform the nature of the claims. The "administering" step simply identifies a group of people who will be interested in the correlations, namely, doctors who used thiopurine drugs to treat patients suffering from autoimmune disorders. Doctors had been using these drugs for this purpose long before these patents existed. And a "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 ___. The "wherein" clauses simply tell a doctor about the relevant natural laws, adding, at most, a suggestion that they should consider the test results when making their treatment decisions. The "determining" step tells a doctor to measure patients' metabolite levels, through whatever process the doctor wishes to use. Because methods for making such determinations were well known in the art, this step simply tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists in the field. Such

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Syllabus

(2) 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 is provided in O'Reilly v. Morse, 15 How. 62, 114-115; Neilson v. Harford, Webster's Patent Cases 295, 371; Bilski, supra, at ___-___; and Benson, supra, at 64, 65, 67. Pp. 14-16.

(3) This Court has repeatedly emphasized a concern that patent law not inhibit future discovery by improperly tying up the use of laws of nature and the like. See, e.g., Benson, 409 U. S., at 67, 68. Rewarding with patents those who discover laws of nature might encourage their discovery. But because those laws and principles are "the basic tools of scientific and technological work," id., at 67, there is a danger that granting patents that tie up their use will inhibit future innovation, a danger that becomes acute when a patented process is no more than a general instruction to "apply the natural law," or otherwise forecloses more future invention than the underlying discovery could reasonably justify. The patent claims at issue implicate this concern. In telling a doctor to measure metabolite levels and to consider the resulting measurements in light of the correlations they describe, they tie up his subsequent treatment decision re-

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Syllabus

gardless of whether he changes his dosage in the light of the inference he draws using the correlations. And they threaten to inhibit the development of more refined treatment recommendations that combine Prometheus' correlations with later discoveries. This reinforces the conclusion that the processes at issue are not patent eligible, while eliminating any temptation to depart from case law precedent. Pp. 16-19.

(c) Additional arguments supporting Prometheus' position--that the process is patent eligible because it passes the "machine or transformation test"; that, because the particular laws of nature that the claims embody are narrow and specific, the patents should be upheld; that the Court should not invalidate these patents under §101 because the Patent Act's other validity requirements will screen out overly broad patents; and that a principle of law denying patent coverage here will discourage investment in discoveries of new diagnostic laws of nature--do not lead to a different conclusion. Pp. 19-24.

628 F. 3d 1347, reversed.

BREYER, J., delivered the opinion for a unanimous Court.

3

Cite as: 566 U. S. ____ (2012)

Opinion of the Court

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, Wash ington, 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

_________________

No. 10-1150

_________________

MAYO COLLABORATIVE SERVICES, DBA MAYO
MEDICAL LABORATORIES, ET AL., PETITION-
ERS 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.

"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.

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Opinion of the Court

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 pa tentable, as they are the basic tools of scientific and tech nological 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 pro tection." 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 ex pression 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).

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Opinion of the Court

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.,

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Opinion of the Court

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 post-solution 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

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. ("Previ-

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Opinion of the Court

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

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Opinion of the Court

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.

B

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 Prome theus' 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

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Opinion of the Court

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,

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Opinion of the Court

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

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

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Opinion of the Court

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

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Opinion of the Court

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 combi nation adds nothing to the laws of nature that is not al ready 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

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Opinion of the Court

B
1

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

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Opinion of the Court

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 im proved 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

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Opinion of the Court

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.

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Opinion of the Court

“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.

“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 val uable one. We think the case must be considered as if the principle being well known, the plaintiff had first

14

Opinion of the Court

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.

In BilskiId., at ___ (slip op., at 15). The fact that some of the claims limited hedging to use in commod ities 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).

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Opinion of the Court

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

“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 elec tric or galvanic current, without using any part of the process or combination set forth in the plaintiff ’s spec ification. His invention may be less complicated—less liable to get out of order—less expensive in construc tion, and in its operation. But yet if it is covered by

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Opinion of the Court

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.

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, Sichel man, & 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 Struc-

17

Opinion of the Court

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

18

Opinion of the Court

III

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

19

Opinion of the Court

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

20

Opinion of the Court

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

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Opinion of the Court

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

22

Opinion of the Court

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 &

23

Opinion of the Court

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.

* * *

It is so ordered.

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