132 S.Ct. 1289, 182 L.Ed.2d 321, 80 USLW 4225, 101 U.S.P.Q.2d 1961, 12 Cal. Daily Op. Serv. 3236, 2012 Daily
`Journal D.A.R. 3618, 23 Fla. L. Weekly Fed. S 189
`(Cite as: 132 S.Ct. 1289)
`
`Page 1
`
`
`
`
`
`
`
`
`
`Supreme Court of the United States
`MAYO COLLABORATIVE SERVICES, dba Mayo
`Medical Laboratories, et al., Petitioners
`v.
`PROMETHEUS LABORATORIES, INC.
`
`No. 10–1150.
`Argued Dec. 7, 2011.
`Decided March 20, 2012.
`
`
`Background: Licensee of patents claiming methods
`for calibrating proper dosage of thiopurine drugs to
`treat autoimmune diseases filed infringement suit. The
`United States District Court for the Southern District
`of California, John A. Houston, J., 2008 WL 878910,
`granted summary judgment of invalidity of patents.
`Licensee appealed. The United States Court of Ap-
`peals for the Federal Circuit, 581 F.3d 1336, reversed.
`The Supreme Court granted certiorari, vacated the
`Court of Appeals decision, and remanded for recon-
`sideration. On remand, the Court of Appeals, Lourie,
`Circuit Judge, 628 F.3d 1347, again reversed. Certio-
`rari was granted.
`
`Holding: The Supreme Court, Justice Breyer, held
`that patents effectively claimed the underlying laws of
`nature themselves, and thus were invalid.
`
`
`Reversed.
`
`
`
`West Headnotes
`
`
`[1] Patents 291
`
`291 Patents
` 291I Subjects of Patents
`
`6
`
`16.2
`
` 291k4 Arts
` 291k6 k. Principles or laws of nature. Most
`Cited Cases
`
`Patents 291
`
`291 Patents
` 291II Patentability
` 291II(A) Invention; Obviousness
` 291k16.2 k. Ideas and abstract principles.
`Most Cited Cases
`
`Patents 291
`
`291 Patents
` 291II Patentability
` 291II(A) Invention; Obviousness
` 291k16.3 k. Natural or scientific phenomena
`or principles. Most Cited Cases
`
`
`16.3
`
`6
`
`Laws of nature, natural phenomena, and abstract
`ideas are not patentable. 35 U.S.C.A. § 101.
`
`[2] Patents 291
`
`291 Patents
` 291I Subjects of Patents
` 291k4 Arts
` 291k6 k. Principles or laws of nature. Most
`Cited Cases
`
`Patents 291
`
`291 Patents
` 291II Patentability
` 291II(A) Invention; Obviousness
` 291k16.2 k. Ideas and abstract principles.
`Most Cited Cases
`
`16.2
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`1
`
`SAMSUNG-1029
`
`

`
`
`
`132 S.Ct. 1289, 182 L.Ed.2d 321, 80 USLW 4225, 101 U.S.P.Q.2d 1961, 12 Cal. Daily Op. Serv. 3236, 2012 Daily
`Journal D.A.R. 3618, 23 Fla. L. Weekly Fed. S 189
`(Cite as: 132 S.Ct. 1289)
`
`Patents 291
`
`291 Patents
` 291II Patentability
` 291II(A) Invention; Obviousness
` 291k16.3 k. Natural or scientific phenomena
`or principles. Most Cited Cases
`
`
`16.3
`
`Page 2
`
`7.14
`
`
`[5] Patents 291
`
`291 Patents
` 291I Subjects of Patents
` 291k4 Arts
` 291k7.14 k. Particular processes or methods
`as constituting invention. Most Cited Cases
`
`
`7.12
`
`Phenomena of nature, though just discovered,
`mental processes, and abstract intellectual concepts
`are not patentable, as they are the basic tools of sci-
`entific and technological work. 35 U.S.C.A. § 101.
`
`[3] Patents 291
`
`291 Patents
` 291I Subjects of Patents
` 291k4 Arts
` 291k7.12 k. Law of nature. Most Cited
`Cases
`
`
`7.12
`
`To transform unpatentable law of nature into pa-
`tent-eligible application of such law, one must do
`more than simply state the law of nature while adding
`the words “apply it.” 35 U.S.C.A. § 101.
`
`[4] Patents 291
`
`291 Patents
` 291I Subjects of Patents
` 291k4 Arts
` 291k7.12 k. Law of nature. Most Cited
`Cases
`
`
`Patented process that focuses upon use of natural
`law must also contain other elements or combination
`of elements, sometimes referred to as “inventive
`concept,” sufficient to ensure that the patent in prac-
`tice amounts to significantly more than a patent upon
`the natural law itself. 35 U.S.C.A. § 101.
`
`Patent claims covering processes that helped
`doctors who used thiopurine drugs to treat patients
`with autoimmune diseases determine whether given
`dosage level was too low or too high, and purporting
`to apply natural laws describing relationships between
`concentration in the blood of certain thiopurine me-
`tabolites and likelihood that drug dosage would be
`ineffective or induce harmful side-effects, did not
`transform unpatentable natural
`laws
`into pa-
`tent-eligible applications of those laws; steps in
`claimed processes, apart from natural laws them-
`selves, involved well-understood, routine, conven-
`tional activity previously engaged in by researchers in
`the field. 35 U.S.C.A. § 101.
`
`[6] Patents 291
`
`291 Patents
` 291I Subjects of Patents
` 291k4 Arts
` 291k6 k. Principles or laws of nature. Most
`Cited Cases
`
`
`6
`
`Prohibition against patenting abstract ideas can-
`not be circumvented by attempting to limit use of the
`formula to a particular technological environment. 35
`U.S.C.A. § 101.
`
`[7] Patents 291
`
`291 Patents
` 291I Subjects of Patents
`
`6
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`2
`
`

`
`
`
`132 S.Ct. 1289, 182 L.Ed.2d 321, 80 USLW 4225, 101 U.S.P.Q.2d 1961, 12 Cal. Daily Op. Serv. 3236, 2012 Daily
`Journal D.A.R. 3618, 23 Fla. L. Weekly Fed. S 189
`(Cite as: 132 S.Ct. 1289)
` 291k4 Arts
` 291k6 k. Principles or laws of nature. Most
`Cited Cases
`
`
`Page 3
`
`ticular, inventive application of the law.
`
`
`Inc.
`Respondent, Prometheus Laboratories,
`(Prometheus), is the sole and exclusive licensee of the
`two patents at issue, which concern the use of thiopu-
`rine drugs to treat autoimmune diseases. When in-
`gested, the body metabolizes the drugs, producing
`metabolites in the bloodstream. Because patients me-
`tabolize 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 pa-
`tient's blood—and (3) a “wherein” step—describing
`the metabolite*1291 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 concentra-
`tions above or below 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 di-
`agnostic 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 judg-
`ment to Mayo, reasoning that the processes claimed by
`the patents effectively claim natural laws or natural
`phenomena—namely, the correlations between thio-
`purine metabolite levels and the toxicity and efficacy
`of thiopurine drugs—and therefore are not patentable.
`The Federal Circuit reversed, finding the processes to
`
`328(2)
`
`Purely conventional or obvious pre-solution ac-
`tivity is normally not sufficient to transform un-
`patentable law of nature into patent-eligible applica-
`tion of such a law. 35 U.S.C.A. § 101.
`
`Patents 291
`
`291 Patents
` 291XIII Decisions on the Validity, Construction,
`and Infringement of Particular Patents
` 291k328 Patents Enumerated
` 291k328(2) k. Original utility. Most Cited
`Cases
`
`
`6,355,623, 6,680,302. Invalid.
`
`*1290 Syllabus FN*
`
`FN* The syllabus constitutes no part of the
`opinion of the Court but has been prepared by
`the Reporter of Decisions for the conven-
`ience of the reader. See United States v. De-
`troit Timber & Lumber Co., 200 U.S. 321,
`337, 26 S.Ct. 282, 50 L.Ed. 499.
`
`
`
`
`
`
`
`Although “laws of nature, natural phenomena,
`and abstract ideas” are not patentable subject matter
`under § 101 of the Patent Act, Diamond v. Diehr, 450
`U.S. 175, 185, 101 S.Ct. 1048, 67 L.Ed.2d 155, “an
`application of a law of nature ... to a known structure
`or process may [deserve] patent protection,” id., at
`187, 101 S.Ct. 1048. But to transform an unpatentable
`law of nature into a patent-eligible application of such
`a law, a patent must do more than simply state the law
`of nature while adding the words “apply it.” See, e.g.,
`Gottschalk v. Benson, 409 U.S. 63, 71–72, 93 S.Ct.
`253, 34 L.Ed.2d 273. It must limit its reach to a par-
`
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`
`3
`
`

`
`Page 4
`
`
`
`132 S.Ct. 1289, 182 L.Ed.2d 321, 80 USLW 4225, 101 U.S.P.Q.2d 1961, 12 Cal. Daily Op. Serv. 3236, 2012 Daily
`Journal D.A.R. 3618, 23 Fla. L. Weekly Fed. S 189
`(Cite as: 132 S.Ct. 1289)
`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.
`593, 130 S.Ct. 3218, 177 L.Ed.2d 792, which clarified
`that the “machine or transformation test” is not a de-
`finitive test of patent eligibility, id., at –––– – ––––,
`130 S.Ct. at 3226–3227, the Federal Circuit reaffirmed
`its earlier conclusion.
`
`
`simply tells doctors to engage in well-understood,
`routine, conventional activity previously engaged in
`by scientists in the field. Such activity is normally not
`sufficient to transform an unpatentable law of nature
`into a patent-eligible application of such a law. Parker
`v. Flook, 437 U.S. 584, 590, 98 S.Ct. 2522, 57 L.Ed.2d
`451. Finally, considering 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. Pp. 1296 – 1298.
`
`
`(b) A more detailed consideration of the control-
`ling precedents reinforces this conclusion. Pp. 1298 –
`1303.
`
`
`*1292 (1) Diehr and Flook, the cases most di-
`rectly on point, both addressed processes using
`mathematical formulas that, like laws of nature, are
`not themselves patentable. In Diehr, the overall pro-
`cess was patent eligible because of the way the addi-
`tional steps of the process integrated the equation into
`the process as a whole. 450 U.S., at 187, 101 S.Ct.
`1048. These additional steps transformed the process
`into an inventive application of the formula. But in
`Flook, the additional steps of the process did not limit
`the claim to a particular application, and the particular
`chemical processes at issue 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. 437 U.S., at 594, 98 S.Ct. 2522. Here,
`the claim presents a case for patentability that is
`weaker than Diehr 's patent-eligible claim and no
`stronger than Flook 's unpatentable one. The three
`steps 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.
`Pp. 1298 – 1300.
`
`
`(2) Further support for the view that simply ap-
`pending conventional steps, specified at a high level of
`generality, to laws of nature, natural phenomena, and
`abstract ideas cannot make those laws, phenomena,
`
`Held: Prometheus' process is not patent eligible.
`Pp. 1296 – 1305.
`
`
`(a) Because the laws of nature recited by Prome-
`theus' patent claims—the relationships between con-
`centrations of certain metabolites in the blood and the
`likelihood that a thiopurine drug dosage will prove
`ineffective or cause harm—are not themselves pa-
`tentable, 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 “adminis-
`tering” 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 ––––, 130 S.Ct., at
`3230. 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 “deter-
`mining” step tells a doctor to measure patients' me-
`tabolite levels, through whatever process the doctor
`wishes to use. Because methods for making such
`determinations were well known in the art, this step
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`4
`
`

`
`
`
`132 S.Ct. 1289, 182 L.Ed.2d 321, 80 USLW 4225, 101 U.S.P.Q.2d 1961, 12 Cal. Daily Op. Serv. 3236, 2012 Daily
`Journal D.A.R. 3618, 23 Fla. L. Weekly Fed. S 189
`(Cite as: 132 S.Ct. 1289)
`and ideas patentable is provided in O'Reilly v. Morse,
`15 How. 62, 114–115, 14 L.Ed. 601; Neilson v. Har-
`ford, Webster's Patent Cases 295, 371; Bilski, supra, at
`–––– – ––––; and Benson, supra, at 64, 65, 67, 93
`S.Ct. 253. Pp. 1300 – 1301.
`
`
`patents; and that a principle of law denying patent
`coverage here will discourage investment in discov-
`eries of new diagnostic laws of nature—do not lead to
`a different conclusion. Pp. 1302 – 1305.
`
`
`Page 5
`
` 628 F.3d 1347, reversed.
`
`
`
`BREYER, J., delivered the opinion for a unani-
`mous Court.
`*1293 Stephen M. Shapiro, Los Angeles, CA, for
`Petitioners.
`
`Donald B. Verrilli, Jr., Solicitor General, for the
`United States, as amicus curiae, by special leave of the
`Court.
`
`Richard P. Bress for Respondent.
`
`Jonathan Singer, John Dragseth, Deanna Reichel, Fish
`& Richardson P.C., Minneapolis, MN, Stephen M.
`Shapiro, Counsel of Record, Timothy S. Bishop, Jef-
`frey W. Sarles, Mayer Brown LLP, Chicago, IL, Eu-
`gene Volokh, Los Angeles, CA, Joseph M. Colaiano,
`James A. Rogers, III, Mayo Clinic, Rochester, MN,
`Charles Rothfeld, Mayer Brown LLP, Washington,
`D.C., for Petitioners.
`
`Richard P. Bress, Counsel of Record, J. Scott Bal-
`lenger, Maximilian A. Grant, Matthew J. Moore, Ga-
`briel K. Bell, Latham & Watkins LLP, Washington,
`DC, for Respondent.
`
`For U.S. Supreme Court briefs, See:2011 WL
`5189089
`(Resp.Brief)2011 WL 5562514
`(Re-
`ply.Brief)
`
`Justice BREYER delivered the opinion of the Court.
`[1] Section 101 of the Patent Act defines patent-
`able subject matter. It says:
`
`
`“Whoever invents or discovers any new and
`
`(3) This Court has repeatedly emphasized a con-
`cern 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, 93 S.Ct.
`253. Rewarding with patents those who discover laws
`of nature might encourage their discovery. But be-
`cause those laws and principles are “the basic tools of
`scientific and technological work,” id., at 67, 93 S.Ct.
`253, 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 regardless of whether he changes his dosage
`in the light of the inference he draws using the corre-
`lations. And they threaten to inhibit the development
`of more refined treatment recommendations that
`combine Prometheus' correlations with later discov-
`eries. This reinforces the conclusion that the processes
`at issue are not patent eligible, while eliminating any
`temptation to depart from case law precedent. Pp.
`1301 – 1303.
`
`
`(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
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`5
`
`

`
`
`
`132 S.Ct. 1289, 182 L.Ed.2d 321, 80 USLW 4225, 101 U.S.P.Q.2d 1961, 12 Cal. Daily Op. Serv. 3236, 2012 Daily
`Journal D.A.R. 3618, 23 Fla. L. Weekly Fed. S 189
`(Cite as: 132 S.Ct. 1289)
`useful process, machine, manufacture, or composi-
`tion 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.
`
`Page 6
`
`
`
`The Court has long held that this provision con-
`tains an important implicit exception. “[L]aws of
`nature, natural phenomena, and abstract ideas” are not
`patentable. Diamond v. Diehr, 450 U.S. 175, 185, 101
`S.Ct. 1048, 67 L.Ed.2d 155 (1981); see also Bilski v.
`Kappos, 561 U.S. 593, ––––, 130 S.Ct. 3218,
`3233–3234, 177 L.Ed.2d 792 (2010); Diamond v.
`Chakrabarty, 447 U.S. 303, 309, 100 S.Ct. 2204, 65
`L.Ed.2d 144 (1980); Le Roy v. Tatham, 14 How. 156,
`175, 14 L.Ed. 367 (1853); O'Reilly v. Morse, 15 How.
`62, 112–120, 14 L.Ed. 601 (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 cele-
`brated law that E=mc 2; nor could Newton have pa-
`tented the law of gravity. Such discoveries are ‘man-
`ifestations of ... nature, free to all men and reserved
`exclusively to none.’ ” Chakrabarty, supra, at 309,
`100 S.Ct. 2204 (quoting Funk Brothers Seed Co. v.
`Kalo Inoculant Co., 333 U.S. 127, 130, 68 S.Ct. 440,
`92 L.Ed. 588 (1948)).
`
`
`[2] “Phenomena of nature, though just discov-
`ered, mental processes, and abstract intellectual con-
`cepts are not patentable, as they are the basic tools of
`scientific and technological work.” Gottschalk v.
`Benson, 409 U.S. 63, 67, 93 S.Ct. 253, 34 L.Ed.2d 273
`(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 na-
`ture or a mathematical algorithm.’ ” 450 U.S., at 187,
`101 S.Ct. 1048 (quoting Parker v. Flook, 437 U.S.
`584, 590, 98 S.Ct. 2522, 57 L.Ed.2d 451 (1978)). It
`added that “an application of a law of nature or
`mathematical*1294 formula to a known structure or
`process may well be deserving of patent protection.”
`Diehr, supra, at 187, 101 S.Ct. 1048. And it empha-
`sized Justice Stone's similar observation in Mackay
`Radio & Telegraph Co. v. Radio Corp. of America,
`306 U.S. 86, 59 S.Ct. 427, 83 L.Ed. 506 (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, 101 S.Ct. 1048 (quoting Mackay Radio, supra,
`at 94, 59 S.Ct. 427).
`
`
`
`See also Funk Brothers, supra, at 130, 68 S.Ct.
`440 (“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”).
`
`
`[3] Still, as the Court has also made clear, to
`transform an unpatentable law of nature into a pa-
`tent-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, 93 S.Ct. 253.
`
`
`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 like-
`
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`
`6
`
`

`
`Page 7
`
`
`
`132 S.Ct. 1289, 182 L.Ed.2d 321, 80 USLW 4225, 101 U.S.P.Q.2d 1961, 12 Cal. Daily Op. Serv. 3236, 2012 Daily
`Journal D.A.R. 3618, 23 Fla. L. Weekly Fed. S 189
`(Cite as: 132 S.Ct. 1289)
`lihood that the drug dosage will be ineffective or in-
`duce harmful side-effects. We must determine
`whether the claimed processes have transformed these
`unpatentable natural laws into patent-eligible appli-
`cations of those laws. We conclude that they have not
`done so and that therefore the processes are not pa-
`tentable.
`
`
`I
`A
`The patents before us concern the use of thiopu-
`rine drugs in the treatment of *1295autoimmune dis-
`eases, 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 pa-
`tents were made, scientists already understood that the
`levels in a patient's blood of certain metabolites, in-
`cluding, in particular, 6–thioguanine and its nucleo-
`tides
`(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 metab-
`olite levels can be used to predict clinical efficacy and
`tolerance to azathioprine or 6–MP” (citing Cuffari,
`Théorêt, Latour, & Seidman, 6–Mercaptopurine Me-
`tabolism in Crohn's Disease: Correlation with Effi-
`cacy 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
`8x10 8 red blood cells, respectively) indicate that the
`
`[4] 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 ref-
`erence to the “principles underlying the prohibition
`against patents for [natural laws].” Flook, supra, at
`593, 98 S.Ct. 2522. 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, 93 S.Ct. 253. 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 prac-
`tice amounts to significantly more than a patent upon
`the natural law itself. Flook, supra, at 594, 98 S.Ct.
`2522; see also Bilski, supra, at 3218, 130 S.Ct. at 3230
`(“[T]he prohibition against patenting abstract ideas
`‘cannot be circumvented by attempting to limit the use
`of the formula to a particular technological environ-
`ment’ or adding ‘insignificant postsolution activity’ ”
`(quoting Diehr, supra, at 191–192, 101 S.Ct. 1048)).
`
`
`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, con-
`ventional activity previously engaged in by research-
`ers in the field. At the same time, upholding the pa-
`tents would risk disproportionately tying up the use of
`the underlying natural laws, inhibiting their use in the
`making of further discoveries.
`
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`7
`
`

`
`
`
`132 S.Ct. 1289, 182 L.Ed.2d 321, 80 USLW 4225, 101 U.S.P.Q.2d 1961, 12 Cal. Daily Op. Serv. 3236, 2012 Daily
`Journal D.A.R. 3618, 23 Fla. L. Weekly Fed. S 189
`(Cite as: 132 S.Ct. 1289)
`dosage is likely too high for the patient, while con-
`centrations in the blood of 6–TG metabolite lower
`than a certain level (about 230 picomoles per 8x10 8
`red blood cells) indicate that the dosage is likely too
`low to be effective.
`
`
`Page 8
`
`'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. *1296 But in 2004 Mayo an-
`nounced that it intended to begin using and selling its
`own test—a test using somewhat higher metabolite
`levels to determine toxicity (450 pmol per 8x10 8 for
`6–TG and 5700 pmol per 8x10 8 for 6–MMP). Pro-
`metheus then brought this action claiming patent in-
`fringement.
`
`
`The District Court found that Mayo's test in-
`fringed 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 de-
`creases (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 im-
`proving ... treatment ... by using individualized me-
`tabolite 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 rea-
`soned that the patents effectively claim natural laws or
`natural phenomena—namely the correlations between
`thiopurine metabolite levels and the toxicity and ef-
`ficacy of thiopurine drug dosages—and so are not
`patentable. App. to Pet. for Cert. 50a–83a.
`
`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 gastro-
`intestinal disorder; and
`
`“(b) determining the level of 6–thioguanine in said
`subject having said immune-mediated gastrointes-
`tinal disorder,
`
`“wherein the level of 6–thioguanine less than about
`230 pmol per 8x10 8 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 8x10 8 red blood cells indicates
`a need to decrease the amount of said drug subse-
`quently 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
`Inc.
`Respondent, Prometheus Laboratories,
`(Prometheus), is the sole and exclusive licensee of the
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`8
`
`

`
`
`
`132 S.Ct. 1289, 182 L.Ed.2d 321, 80 USLW 4225, 101 U.S.P.Q.2d 1961, 12 Cal. Daily Op. Serv. 3236, 2012 Daily
`Journal D.A.R. 3618, 23 Fla. L. Weekly Fed. S 189
`(Cite as: 132 S.Ct. 1289)
`
`
`Page 9
`
`tion 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 thio-
`purine
`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 re-
`searchers discovered. In doing so, it recites an “ad-
`ministering” step, a “determining” step, and a
`“wherein” step. These additional steps are not them-
`selves natural laws but neither are they sufficient to
`
`On appeal, the Federal Circuit reversed. It pointed
`out that in addition to these natural correlations, the
`claimed processes specify the steps of (1) “adminis-
`tering a [thiopurine] drug” to a patient and (2) “de-
`termining 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 trans-
`formation 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.
`593, 130 S.Ct. 3218, 177 L.Ed.2d 792, which clarified
`that the “machine or transformation test” is not a de-
`finitive test of patent eligibility, but only an important
`and useful clue. Id., at –––– – ––––, 130 S.Ct., at
`32