U.S. Supreme Court
Mayo Collaborative Services v. Prometheus Laboratories, Inc.
566 U.S. 66
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, 101 S.Ct. 1048, 67 L.Ed.2d 155 (1981); see also Bilski
v. Kappos, 561 U.S. 593, 601, 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 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, 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)).
"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, 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 nature 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 formula to a known structure or process may well be deserving
of patent protection." Diehr, supra, at 187, 101 S.Ct. 1048. And it
emphasized 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").
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, 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 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, 98 S.Ct. 2522. They warn us against
upholding patents that claim processes that too broadly pre-empt 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
practice amounts to significantly more than a patent upon the natural law
itself. Flook, supra, at 594, 98 S.Ct. 2522; see also Bilski, 561 U.S., at
610-611, 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 environment' 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, 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-mercaptopurine
(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 7,000 picomoles (pmol) per
8×108 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 pmol per 8×108 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 8×108 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 8×108 red blood cells indicates a need to
decrease the amount of said drug subsequently administered to said
subject." 623 patent, col.20, ll.10-25, 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 8×108 for 6-TG and 5,700 pmol per 8×108 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. Prometheus Labs., Inc. v. Mayo
Collaborative Services, 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 definitive test of patent eligibility, but only an important and useful clue,
id., at 603-604, 130 S.Ct., at 3234-3235. 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 8×108 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 610-611, 130 S.Ct., at 3230 (quoting
Diehr, 450 U.S., at 191-192, 101 S.Ct. 1048).
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, 98 S.Ct. 2522; see also Bilski, 561 U.S., at 610-611,
130 S.Ct., at 3230 ("[T]he prohibition against patenting abstract ideas
`cannot be circumvented by'... adding `insignificant postsolution
activity'" (quoting Diehr, 450 U.S., at 191-192, 101 S.Ct. 1048)).
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 id., at 188, 101 S.Ct.
1048 ("[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, 101 S.Ct. 1048.
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, 101
S.Ct. 1048. 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, 98
S.Ct. 2522.
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, 98 S.Ct. 2522. 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, 101 S.Ct. 1048; see also Flook, 437
U.S., at 586, 98 S.Ct. 2522. 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 procesś 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, 98 S.Ct. 2522. "[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, 98 S.Ct. 2522.
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 599, 130 S.Ct., at
3223-3224. The Court held that the described "concept of hedging" was
"an unpatentable abstract idea." Id., at 611, 130 S.Ct., 3239. 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 612, 130 S.Ct., at 3231.
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, 93
S.Ct. 253. The Court recognized that "`a novel and useful structure
created with the aid of knowledge of scientific truth'" might be
patentable. Id., at 67, 93 S.Ct. 253 (quoting Mackay Radio, 306 U.S., at 94, 59
S.Ct. 427). 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, 93 S.Ct. 253. 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 (history of the case). 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, 93
S.Ct. 253. 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 612, 130 S.Ct., at 3231. 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, 98 S.Ct. 2522.
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, 93 S.Ct. 253. 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, 93 S.Ct. 253
(emphasis added); see also Bilski, supra, at 602-603, 130 S.Ct., at 3225-3227;
Diehr, 450 U.S., at 184, 101 S.Ct. 1048; Flook, supra, at 588, n. 9, 98 S.Ct.
2522; Cochrane v. Deener, 94 U.S. 780, 788, 24 L.Ed. 139 (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 1297. 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 1302. 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 "la[w] of nature" exclusion. Bilski, 561 U.S., at 603, 130
S.Ct., at 3225-3227 (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 1301-1302. 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 1301-1302.
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,
98 S.Ct. 2522, 57 L.Ed.2d 451 (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 § 101, not later sections. Bilski, supra; Diehr, supra;
Flook, supra; Benson, 409 U.S. 63, 93 S.Ct. 253, 34 L.Ed.2d 273. 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, 101 S.Ct. 1048 (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, 101 S.Ct. 1048. 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, 54-55
(2012); 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 59-61
(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 Propriete
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.