2 Week 5: Patentable Subject Matter 2 Week 5: Patentable Subject Matter

2.1 BILSKI v. KAPPOS 2.1 BILSKI v. KAPPOS

130 S.Ct. 3218 (2010)

Bernard L. BILSKI and Rand A. Warsaw, Petitioners,
v.
David J. KAPPOS, Under Secretary of Commerce for Intellectual Property and Director, Patent and Trademark Office.

No. 08-964.

Supreme Court of United States.

Argued November 9, 2009.
Decided June 28, 2010.

 

[3223] J. Michael Jakes, Washington, DC, for petitioners.

Malcolm L. Stewart, Washington, DC, for respondent.

J. Michael Jakes, Counsel of Record, Erika H. Arner, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., Washington, DC, Ronald E. Myrick, Denise W. DeFranco, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., Cambridge, Massachusetts, for petitioner.

Cameron F. Kerry, General Counsel, Quentin A. Palfrey, Associate General Counsel, Joan Bernott Maginnis, Assistant General Counsel, U.S. Department of Commerce, Washington, DC, Raymond T. Chen, Solicitor and Deputy General Counsel, Thomas W. Krause, Scott C. Weidenfeller, Associate Solicitors, Alexandria, VA, Elena Kagan, Solicitor General, Counsel of Record, Malcolm L. Stewart, Deputy Solicitor General, Tony West, Assistant Attorney General, Ginger D. Anders, Assistant to the Solicitor General, Scott R. McIntosh, Mark R. Freeman, Attorneys, Department of Justice, Washington, DC, for respondent.

Justice KENNEDY delivered the opinion of the Court, except as to Parts II-B-2 and II-C-2.[*]

The question in this case turns on whether a patent can be issued for a claimed invention designed for the business world. The patent application claims a procedure for instructing buyers and sellers how to protect against the risk of price fluctuations in a discrete section of the economy. Three arguments are advanced for the proposition that the claimed invention is outside the scope of patent law: (1) it is not tied to a machine and does not transform an article; (2) it involves a method of conducting business; and (3) it is merely an abstract idea. The Court of Appeals ruled that the first mentioned of these, the so-called machine-or-transformation test, was the sole test to be used for determining the patentability of a "process" under the Patent Act, 35 U.S.C. § 101.

I

Petitioners' application seeks patent protection for a claimed invention that explains how buyers and sellers of commodities in the energy market can protect, or hedge, against the risk of price changes. The key claims are claims 1 and 4. Claim 1 describes a series of steps instructing how to hedge risk. Claim 4 puts the concept articulated in claim 1 into a simple mathematical formula. Claim 1 consists of the following steps:

"(a) initiating a series of transactions between said commodity provider and consumers of said commodity wherein said consumers purchase said commodity [3224] at a fixed rate based upon historical averages, said fixed rate corresponding to a risk position of said consumers;
"(b) identifying market participants for said commodity having a counter-risk position to said consumers; and
"(c) initiating a series of transactions between said commodity provider and said market participants at a second fixed rate such that said series of market participant transactions balances the risk position of said series of consumer transactions." App. 19-20.

The remaining claims explain how claims 1 and 4 can be applied to allow energy suppliers and consumers to minimize the risks resulting from fluctuations in market demand for energy. For example, claim 2 claims "[t]he method of claim 1 wherein said commodity is energy and said market participants are transmission distributors." Id., at 20. Some of these claims also suggest familiar statistical approaches to determine the inputs to use in claim 4's equation. For example, claim 7 advises using well-known random analysis techniques to determine how much a seller will gain "from each transaction under each historical weather pattern." Id., at 21.

The patent examiner rejected petitioners' application, explaining that it "`is not implemented on a specific apparatus and merely manipulates [an] abstract idea and solves a purely mathematical problem without any limitation to a practical application, therefore, the invention is not directed to the technological arts.'" App. to Pet. for Cert. 148a. The Board of Patent Appeals and Interferences affirmed, concluding that the application involved only mental steps that do not transform physical matter and was directed to an abstract idea. Id., at 181a-186a.

The United States Court of Appeals for the Federal Circuit heard the case en banc and affirmed. The case produced five different opinions. Students of patent law would be well advised to study these scholarly opinions.

Chief Judge Michel wrote the opinion of the court. The court rejected its prior test for determining whether a claimed invention was a patentable "process" under § 101—whether it produces a "`useful, concrete, and tangible result'"—as articulated in State Street Bank & Trust Co. v. Signature Financial Group, Inc., 149 F.3d 1368, 1373 (1998), and AT & T Corp. v. Excel Communications, Inc., 172 F.3d 1352, 1357 (1999). See In re Bilski, 545 F.3d 943, 959-960, and n. 19 (C.A.Fed. 2008) (en banc). The court held that "[a] claimed process is surely patent-eligible under § 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing." Id., at 954. The court concluded this "machine-or-transformation test" is "the sole test governing § 101 analyses," id., at 955, and thus the "test for determining patent eligibility of a process under § 101," id., at 956. Applying the machine-or-transformation test, the court held that petitioners' application was not patent eligible. Id., at 963-966. Judge Dyk wrote a separate concurring opinion, providing historical support for the court's approach. Id., at 966-976.

Three judges wrote dissenting opinions. Judge Mayer argued that petitioners' application was "not eligible for patent protection because it is directed to a method of conducting business." Id., at 998. He urged the adoption of a "technological standard for patentability." Id., at 1010. Judge Rader would have found petitioners' claims were an unpatentable abstract idea. Id., at 1011. Only Judge Newman disagreed with the court's conclusion that petitioners' application was outside of the reach of § 101. She did not say that the application should have been granted but [3225] only that the issue should be remanded for further proceedings to determine whether the application qualified as patentable under other provisions. Id., at 997.

This Court granted certiorari. 556 U.S. ___, 129 S.Ct. 2735, 174 L.Ed.2d 246 (2009).

II

A

Section 101 defines the subject matter that may be patented under the Patent Act:

"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."

Section 101 thus specifies four independent categories of inventions or discoveries that are eligible for protection: processes, machines, manufactures, and compositions of matter. "In choosing such expansive terms . . . modified by the comprehensive `any,' Congress plainly contemplated that the patent laws would be given wide scope." Diamond v. Chakrabarty, 447 U.S. 303, 308, 100 S.Ct. 2204, 65 L.Ed.2d 144 (1980). Congress took this permissive approach to patent eligibility to ensure that "`ingenuity should receive a liberal encouragement.'" Id., at 308-309, 100 S.Ct. 2204 (quoting 5 Writings of Thomas Jefferson 75-76 (H. Washington ed. 1871)).

The Court's precedents provide three specific exceptions to § 101's broad patent-eligibility principles: "laws of nature, physical phenomena, and abstract ideas." Chakrabarty, supra, at 309, 100 S.Ct. 2204. While these exceptions are not required by the statutory text, they are consistent with the notion that a patentable process must be "new and useful." And, in any case, these exceptions have defined the reach of the statute as a matter of statutory stare decisis going back 150 years. See Le Roy v. Tatham, 14 How. 156, 174-175, 14 L.Ed. 367 (1853). The concepts covered by these exceptions are "part of the storehouse of knowledge of all men . . . free to all men and reserved exclusively to none." Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 68 S.Ct. 440, 92 L.Ed. 588 (1948).

The § 101 patent-eligibility inquiry is only a threshold test. Even if an invention qualifies as a process, machine, manufacture, or composition of matter, in order to receive the Patent Act's protection the claimed invention must also satisfy "the conditions and requirements of this title." § 101. Those requirements include that the invention be novel, see § 102, nonobvious, see § 103, and fully and particularly described, see § 112.

The present case involves an invention that is claimed to be a "process" under § 101. Section 100(b) defines "process" as:

"process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material."

The Court first considers two proposed categorical limitations on "process" patents under § 101 that would, if adopted, bar petitioners' application in the present case: the machine-or-transformation test and the categorical exclusion of business method patents.

B

1

Under the Court of Appeals' formulation, an invention is a "process" only if: "(1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing." 545 [3226] F.3d, at 954. This Court has "more than once cautioned that courts `should not read into the patent laws limitations and conditions which the legislature has not expressed.'" Diamond v. Diehr, 450 U.S. 175, 182, 101 S.Ct. 1048, 67 L.Ed.2d 155 (1981) (quoting Chakrabarty, supra, at 308, 100 S.Ct. 2204; some internal quotation marks omitted). In patent law, as in all statutory construction, "[u]nless otherwise defined, `words will be interpreted as taking their ordinary, contemporary, common meaning.'" Diehr, supra, at 182, 101 S.Ct. 1048 (quoting Perrin v. United States, 444 U.S. 37, 42, 100 S.Ct. 311, 62 L.Ed.2d 199 (1979)). The Court has read the § 101 term "manufacture" in accordance with dictionary definitions, see Chakrabarty, supra, at 308, 100 S.Ct. 2204 (citing American Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1, 11, 51 S.Ct. 328, 75 L.Ed. 801 (1931)), and approved a construction of the term "composition of matter" consistent with common usage, see Chakrabarty, supra, at 308, 100 S.Ct. 2204 (citing Shell Development Co. v. Watson, 149 F.Supp. 279, 280 (DDC 1957)).

Any suggestion in this Court's case law that the Patent Act's terms deviate from their ordinary meaning has only been an explanation for the exceptions for laws of nature, physical phenomena, and abstract ideas. See Parker v. Flook, 437 U.S. 584, 588-589, 98 S.Ct. 2522, 57 L.Ed.2d 451 (1978). This Court has not indicated that the existence of these well-established exceptions gives the Judiciary carte blanche to impose other limitations that are inconsistent with the text and the statute's purpose and design. Concerns about attempts to call any form of human activity a "process" can be met by making sure the claim meets the requirements of § 101.

Adopting the machine-or-transformation test as the sole test for what constitutes a "process" (as opposed to just an important and useful clue) violates these statutory interpretation principles. Section 100(b) provides that "[t]he term `process' means process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material." The Court is unaware of any "`ordinary, contemporary, common meaning,'" Diehr, supra, at 182, 101 S.Ct. 1048, of the definitional terms "process, art or method" that would require these terms to be tied to a machine or to transform an article. Respondent urges the Court to look to the other patentable categories in § 101—machines, manufactures, and compositions of matter—to confine the meaning of "process" to a machine or transformation, under the doctrine of noscitur a sociis. Under this canon, "an ambiguous term may be given more precise content by the neighboring words with which it is associated." United States v. Stevens, 559 U.S. ___, ___, 130 S.Ct. 1577, 1587, 176 L.Ed.2d 435 (2010) (internal quotation marks omitted). This canon is inapplicable here, for § 100(b) already explicitly defines the term "process." See Burgess v. United States, 553 U.S. 124, 130, 128 S.Ct. 1572, 170 L.Ed.2d 478 (2008) ("When a statute includes an explicit definition, we must follow that definition" (internal quotation marks omitted)).

The Court of Appeals incorrectly concluded that this Court has endorsed the machine-or-transformation test as the exclusive test. It is true that Cochrane v. Deener, 94 U.S. 780, 788, 24 L.Ed. 139 (1877), explained that a "process" is "an act, or a series of acts, performed upon the subject-matter to be transformed and reduced to a different state or thing." More recent cases, however, have rejected the broad implications of this dictum; and, in all events, later authority shows that it was not intended to be an exhaustive or exclusive test. Gottschalk v. Benson, 409 U.S. [3227] 63, 70, 93 S.Ct. 253, 34 L.Ed.2d 273 (1972), noted 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." At the same time, it explicitly declined to "hold that no process patent could ever qualify if it did not meet [machine or transformation] requirements." Id., at 71, 93 S.Ct. 253. Flook took a similar approach, "assum[ing] that a valid process patent may issue even if it does not meet [the machine-or-transformation test]." 437 U.S., at 588, n. 9, 98 S.Ct. 2522.

This Court's precedents establish that the machine-or-transformation test is a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under § 101. The machine-or-transformation test is not the sole test for deciding whether an invention is a patent-eligible "process."

2

It is true that patents for inventions that did not satisfy the machine-or-transformation test were rarely granted in earlier eras, especially in the Industrial Age, as explained by Judge Dyk's thoughtful historical review. See 545 F.3d, at 966-976 (concurring opinion). But times change. Technology and other innovations progress in unexpected ways. For example, it was once forcefully argued that until recent times, "well-established principles of patent law probably would have prevented the issuance of a valid patent on almost any conceivable computer program." Diehr, 450 U.S., at 195, 101 S.Ct. 1048 (STEVENS, J., dissenting). But this fact does not mean that unforeseen innovations such as computer programs are always unpatentable. See id., at 192-193, 101 S.Ct. 1048 (majority opinion) (holding a procedure for molding rubber that included a computer program is within patentable subject matter). Section 101 is a "dynamic provision designed to encompass new and unforeseen inventions." J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc., 534 U.S. 124, 135, 122 S.Ct. 593, 151 L.Ed.2d 508 (2001). A categorical rule denying patent protection for "inventions in areas not contemplated by Congress . . . would frustrate the purposes of the patent law." Chakrabarty, 447 U.S., at 315, 100 S.Ct. 2204.

The machine-or-transformation test may well provide a sufficient basis for evaluating processes similar to those in the Industrial Age—for example, inventions grounded in a physical or other tangible form. But there are reasons to doubt whether the test should be the sole criterion for determining the patentability of inventions in the Information Age. As numerous amicus briefs argue, the machine-or-transformation test would create uncertainty as to the patentability of software, advanced diagnostic medicine techniques, and inventions based on linear programming, data compression, and the manipulation of digital signals. See, e.g., Brief for Business Software Alliance 24-25; Brief for Biotechnology Industry Organization et al. 14-27; Brief for Boston Patent Law Association 8-15; Brief for Houston Intellectual Property Law Association 17-22; Brief for Dolby Labs., Inc., et al. 9-10.

In the course of applying the machine-or-transformation test to emerging technologies, courts may pose questions of such intricacy and refinement that they risk obscuring the larger object of securing patents for valuable inventions without transgressing the public domain. The dissent by Judge Rader refers to some of these difficulties. 545 F.3d, at 1015. As a result, in deciding whether previously unforeseen inventions qualify as patentable [3228] "process[es]," it may not make sense to require courts to confine themselves to asking the questions posed by the machine-or-transformation test. Section 101's terms suggest that new technologies may call for new inquiries. See Benson, supra, at 71, 93 S.Ct. 253 (to "freeze process patents to old technologies, leaving no room for the revelations of the new, onrushing technology[,] . . . is not our purpose").

It is important to emphasize that the Court today is not commenting on the patentability of any particular invention, let alone holding that any of the above-mentioned technologies from the Information Age should or should not receive patent protection. This Age puts the possibility of innovation in the hands of more people and raises new difficulties for the patent law. With ever more people trying to innovate and thus seeking patent protections for their inventions, the patent law faces a great challenge in striking the balance between protecting inventors and not granting monopolies over procedures that others would discover by independent, creative application of general principles. Nothing in this opinion should be read to take a position on where that balance ought to be struck.

C

1

Section 101 similarly precludes the broad contention that the term "process" categorically excludes business methods. The term "method," which is within § 100(b)'s definition of "process," at least as a textual matter and before consulting other limitations in the Patent Act and this Court's precedents, may include at least some methods of doing business. See, e.g., Webster's New International Dictionary 1548 (2d ed.1954) (defining "method" as "[a]n orderly procedure or process . . . regular way or manner of doing anything; hence, a set form of procedure adopted in investigation or instruction"). The Court is unaware of any argument that the "`ordinary, contemporary, common meaning,'" Diehr, supra, at 182, 101 S.Ct. 1048, of "method" excludes business methods. Nor is it clear how far a prohibition on business method patents would reach, and whether it would exclude technologies for conducting a business more efficiently. See, e.g., Hall, Business and Financial Method Patents, Innovation, and Policy, 56 Scottish J. Pol. Econ. 443, 445 (2009) ("There is no precise definition of . . . business method patents").

The argument that business methods are categorically outside of § 101's scope is further undermined by the fact that federal law explicitly contemplates the existence of at least some business method patents. Under 35 U.S.C. § 273(b)(1), if a patent-holder claims infringement based on "a method in [a] patent," the alleged infringer can assert a defense of prior use. For purposes of this defense alone, "method" is defined as "a method of doing or conducting business." § 273(a)(3). In other words, by allowing this defense the statute itself acknowledges that there may be business method patents. Section 273's definition of "method," to be sure, cannot change the meaning of a prior-enacted statute. But what § 273 does is clarify the understanding that a business method is simply one kind of "method" that is, at least in some circumstances, eligible for patenting under § 101.

A conclusion that business methods are not patentable in any circumstances would render § 273 meaningless. This would violate the canon against interpreting any statutory provision in a manner that would render another provision superfluous. See Corley v. United States, [3229] 556 U.S. ___, ___, 129 S.Ct. 1558, 1566, 173 L.Ed.2d 443 (2009). This principle, of course, applies to interpreting any two provisions in the U.S.Code, even when Congress enacted the provisions at different times. See, e.g., Hague v. Committee for Industrial Organization, 307 U.S. 496, 529-530, 59 S.Ct. 954, 83 L.Ed. 1423 (1939) (opinion of Stone, J.). This established rule of statutory interpretation cannot be overcome by judicial speculation as to the subjective intent of various legislators in enacting the subsequent provision. Finally, while § 273 appears to leave open the possibility of some business method patents, it does not suggest broad patentability of such claimed inventions.

2

Interpreting § 101 to exclude all business methods simply because business method patents were rarely issued until modern times revives many of the previously discussed difficulties. See supra, at 3227-3228. At the same time, some business method patents raise special problems in terms of vagueness and suspect validity. See eBay Inc. v. MercExchange, L.L. C., 547 U.S. 388, 397, 126 S.Ct. 1837, 164 L.Ed.2d 641 (2006) (KENNEDY, J., concurring). The Information Age empowers people with new capacities to perform statistical analyses and mathematical calculations with a speed and sophistication that enable the design of protocols for more efficient performance of a vast number of business tasks. If a high enough bar is not set when considering patent applications of this sort, patent examiners and courts could be flooded with claims that would put a chill on creative endeavor and dynamic change.

In searching for a limiting principle, this Court's precedents on the unpatentability of abstract ideas provide useful tools. See infra, at 3229-3231. Indeed, if the Court of Appeals were to succeed in defining a narrower category or class of patent applications that claim to instruct how business should be conducted, and then rule that the category is unpatentable because, for instance, it represents an attempt to patent abstract ideas, this conclusion might well be in accord with controlling precedent. See ibid. But beyond this or some other limitation consistent with the statutory text, the Patent Act leaves open the possibility that there are at least some processes that can be fairly described as business methods that are within patentable subject matter under § 101.

Finally, even if a particular business method fits into the statutory definition of a "process," that does not mean that the application claiming that method should be granted. In order to receive patent protection, any claimed invention must be novel, § 102, nonobvious, § 103, and fully and particularly described, § 112. These limitations serve a critical role in adjusting the tension, ever present in patent law, between stimulating innovation by protecting inventors and impeding progress by granting patents when not justified by the statutory design.

III

Even though petitioners' application is not categorically outside of § 101 under the two broad and atextual approaches the Court rejects today, that does not mean it is a "process" under § 101. Petitioners seek to patent both the concept of hedging risk and the application of that concept to energy markets. App. 19-20. Rather than adopting categorical rules that might have wide-ranging and unforeseen impacts, the Court resolves this case narrowly on the basis of this Court's decisions in Benson, Flook, and Diehr, which show that petitioners' claims are not patentable processes because they [3230] are attempts to patent abstract ideas. Indeed, all members of the Court agree that the patent application at issue here falls outside of § 101 because it claims an abstract idea.

In Benson, the Court considered whether a patent application for an algorithm to convert binary-coded decimal numerals into pure binary code was a "process" under § 101. 409 U.S., at 64-67, 93 S.Ct. 253. The Court first explained that "`[a] principle, in the abstract, is a fundamental truth; an original cause; a motive; these cannot be patented, as no one can claim in either of them an exclusive right.'" Id., at 67, 93 S.Ct. 253 (quoting Le Roy, 14 How., at 175, 14 L.Ed. 367). The Court then held the application at issue was not a "process," but an unpatentable abstract idea. "It is conceded that one may not patent an idea. But in practical effect that would be the result if the formula for converting . . . numerals to pure binary numerals were patented in this case." 409 U.S., at 71, 93 S.Ct. 253. A contrary holding "would wholly pre-empt the mathematical formula and in practical effect would be a patent on the algorithm itself." Id., at 72, 93 S.Ct. 253.

In Flook, the Court considered the next logical step after Benson. The applicant there attempted to patent a procedure for monitoring the conditions during the catalytic conversion process in the petrochemical and oil-refining industries. The application's only innovation was reliance on a mathematical algorithm. 437 U.S., at 585-586, 98 S.Ct. 2522. Flook held the invention was not a patentable "process." The Court conceded the invention at issue, unlike the algorithm in Benson, had been limited so that it could still be freely used outside the petrochemical and oil-refining industries. 437 U.S., at 589-590, 98 S.Ct. 2522. Nevertheless, Flook rejected "[t]he notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process." Id., at 590, 98 S.Ct. 2522. The Court concluded that the process at issue there was "unpatentable under § 101, not because it contain[ed] a mathematical algorithm as one component, but because once that algorithm [wa]s assumed to be within the prior art, the application, considered as a whole, contain[ed] no patentable invention." Id., at 594, 98 S.Ct. 2522. As the Court later explained, Flook stands for the proposition that the 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." Diehr, 450 U.S., at 191-192, 101 S.Ct. 1048.

Finally, in Diehr, the Court established a limitation on the principles articulated in Benson and Flook. The application in Diehr claimed a previously unknown method for "molding raw, uncured synthetic rubber into cured precision products," using a mathematical formula to complete some of its several steps by way of a computer. 450 U.S., at 177, 101 S.Ct. 1048. Diehr explained that while an abstract idea, law of nature, or mathematical formula could not be patented, "an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection." Id., at 187, 101 S.Ct. 1048. Diehr emphasized the need to consider the invention as a whole, rather than "dissect[ing] the claims into old and new elements and then . . . ignor[ing] the presence of the old elements in the analysis." Id., at 188, 101 S.Ct. 1048. Finally, the Court concluded that because the claim was not "an attempt to patent a mathematical formula, but rather [was] an industrial process for the molding of rubber products," it fell within § 101's patentable subject matter. Id., at 192-193, 101 S.Ct. 1048.

[3231] In light of these precedents, it is clear that petitioners' application is not a patentable "process." Claims 1 and 4 in petitioners' application explain the basic concept of hedging, or protecting against risk: "Hedging is a fundamental economic practice long prevalent in our system of commerce and taught in any introductory finance class." 545 F.3d, at 1013 (Rader, J., dissenting); see, e.g., D. Chorafas, Introduction to Derivative Financial Instruments 75-94 (2008); C. Stickney, R. Weil, K. Schipper, & J. Francis, Financial Accounting: An Introduction to Concepts, Methods, and Uses 581-582 (13th ed.2010); S. Ross, R. Westerfield, & B. Jordan, Fundamentals of Corporate Finance 743-744 (8th ed.2008). The concept of hedging, described in claim 1 and reduced to a mathematical formula in claim 4, is an unpatentable abstract idea, just like the algorithms at issue in Benson and Flook. Allowing petitioners to patent risk hedging would pre-empt use of this approach in all fields, and would effectively grant a monopoly over an abstract idea.

Petitioners' remaining claims are broad examples of how hedging can be used in commodities and energy markets. Flook established that limiting an abstract idea to one field of use or adding token postsolution components did not make the concept patentable. That is exactly what the remaining claims in petitioners' application do. These claims attempt to patent the use of the abstract idea of hedging risk in the energy market and then instruct the use of well-known random analysis techniques to help establish some of the inputs into the equation. Indeed, these claims add even less to the underlying abstract principle than the invention in Flook did, for the Flook invention was at least directed to the narrower domain of signaling dangers in operating a catalytic converter.

* * *

Today, the Court once again declines to impose limitations on the Patent Act that are inconsistent with the Act's text. The patent application here can be rejected under our precedents on the unpatentability of abstract ideas. The Court, therefore, need not define further what constitutes a patentable "process," beyond pointing to the definition of that term provided in § 100(b) and looking to the guideposts in Benson, Flook, and Diehr.

And nothing in today's opinion should be read as endorsing interpretations of § 101 that the Court of Appeals for the Federal Circuit has used in the past. See, e.g., State Street, 149 F.3d, at 1373; AT & T Corp., 172 F.3d, at 1357. It may be that the Court of Appeals thought it needed to make the machine-or-transformation test exclusive precisely because its case law had not adequately identified less extreme means of restricting business method patents, including (but not limited to) application of our opinions in Benson, Flook, and Diehr. In disapproving an exclusive machine-or-transformation test, we by no means foreclose the Federal Circuit's development of other limiting criteria that further the purposes of the Patent Act and are not inconsistent with its text.

The judgment of the Court of Appeals is affirmed.

It is so ordered.

Justice STEVENS, with whom Justice GINSBURG, Justice BREYER, and Justice SOTOMAYOR join, concurring in the judgment.

In the area of patents, it is especially important that the law remain stable and clear. The only question presented in this case is whether the so-called machine-or-transformation test is the exclusive test for what constitutes a patentable "process" under 35 U.S.C. § 101. It would be possible [3232] to answer that question simply by holding, as the entire Court agrees, that although the machine-or-transformation test is reliable in most cases, it is not the exclusive test.

I agree with the Court that, in light of the uncertainty that currently pervades this field, it is prudent to provide further guidance. But I would take a different approach. Rather than making any broad statements about how to define the term "process" in § 101 or tinkering with the bounds of the category of unpatentable, abstract ideas, I would restore patent law to its historical and constitutional moorings.

For centuries, it was considered well established that a series of steps for conducting business was not, in itself, patentable. In the late 1990's, the Federal Circuit and others called this proposition into question. Congress quickly responded to a Federal Circuit decision with a stopgap measure designed to limit a potentially significant new problem for the business community. It passed the First Inventors Defense Act of 1999 (1999 Act), 113 Stat. 1501A-555 (codified at 35 U.S.C. § 273), which provides a limited defense to claims of patent infringement, see § 273(b), for "method[s] of doing or conducting business," § 273(a)(3). Following several more years of confusion, the Federal Circuit changed course, overruling recent decisions and holding that a series of steps may constitute a patentable process only if it is tied to a machine or transforms an article into a different state or thing. This "machine-or-transformation test" excluded general methods of doing business as well as, potentially, a variety of other subjects that could be called processes.

The Court correctly holds that the machine-or-transformation test is not the sole test for what constitutes a patentable process; rather, it is a critical clue.[1] But the Court is quite wrong, in my view, to suggest that any series of steps that is not itself an abstract idea or law of nature may constitute a "process" within the meaning of § 101. The language in the Court's opinion to this effect can only cause mischief. The wiser course would have been to hold that petitioners' method is not a "process" because it describes only a general method of engaging in business transactions—and business methods are not patentable. More precisely, although a process is not patent-ineligible simply because it is useful for conducting business, a claim that merely describes a method of doing business does not qualify as a "process" under § 101.

I

Although the Court provides a brief statement of facts, ante, at 3220-3223, a more complete explication may be useful for those unfamiliar with petitioners' patent application and this case's procedural history.

Petitioners' patent application describes a series of steps for managing risk amongst buyers and sellers of commodities. The general method, described in Claim 1, entails "managing the consumption risk costs of a commodity sold by a commodity provider at a fixed price," and consists of the following steps:

"(a) initiating a series of transactions between said commodity provider and consumers of said commodity wherein said consumers purchase said commodity at a fixed rate based upon historical [3233] averages, said fixed rate corresponding to a risk position of said consumers;
"(b) identifying market participants for said commodity having a counter-risk position to said consumers; and
"(c) initiating a series of transactions between said commodity provider and said market participants at a second fixed rate such that said series of market participant transactions balances the risk position of said series of consumer transactions." App. 19-20.

Although the patent application makes clear that the "method can be used for any commodity to manage consumption risk in a fixed bill price product," id., at 11, it includes specific applications of the method, particularly in the field of energy, as a means of enabling suppliers and consumers to minimize the risks resulting from fluctuations in demand during specified time periods. See id., at 20-22. Energy suppliers and consumers may use that method to hedge their risks by agreeing upon a fixed series of payments at regular intervals throughout the year instead of charging or paying prices that fluctuate in response to changing weather conditions. The patent application describes a series of steps, including the evaluation of historical costs and weather variables and the use of economic and statistical formulas, to analyze these data and to estimate the likelihood of certain outcomes. See id., at 12-19.

The patent examiner rejected petitioners' application on the ground that it "is not directed to the technological arts," insofar as it "is not implemented on a specific apparatus and merely manipulates [an] abstract idea and solves a purely mathematical problem without any limitation to a practical application." App. to Pet. for Cert. 148a.

The Board of Patent Appeals and Interferences (Board) affirmed the examiner's decision, but it rejected the position that a patentable process must relate to "technological arts" or be performed on a machine. Id., at 180a-181a. Instead, the Board denied petitioners' patent on two alternative, although similar, grounds: first, that the patent involves only mental steps that do not transform physical subject matter, id., at 181a-184a; and, second, that it is directed to an "abstract idea," id., at 184a-187a.

Petitioners appealed to the United States Court of Appeals for the Federal Circuit. After briefing and argument before a three-judge panel, the court sua sponte decided to hear the case en banc and ordered the parties to address: (1) whether petitioners'"claim 1 . . . claims patent-eligible subject matter under 35 U.S.C. § 101"; (2) "[w]hat standard should govern in determining whether a process is patent-eligible subject matter"; (3) "[w]hether the claimed subject matter is not patent-eligible because it constitutes an abstract idea or mental process"; (4) "[w]hether a method or process must result in a physical transformation of an article or be tied to a machine to be patent-eligible subject matter"; and (5) whether the court's decisions in State Street Bank & Trust Co. v. Signature Financial Group, Inc., 149 F.3d 1368 (1998) (State Street), and AT & T Corp. v. Excel Communications, Inc., 172 F.3d 1352 (1999), should be overruled in any respect. App. to Pet. for Cert. 144a-145a.

The en banc Court of Appeals affirmed the Board's decision. Eleven of the twelve judges agreed that petitioners' claims do not describe a patentable "process," § 101. Chief Judge Michel's opinion, joined by eight other judges, rejected several possible tests for what is a patent-eligible process, including whether the patent produces a "`useful, concrete and tangible result,'" whether the process relates to [3234] "technological arts," and "categorical exclusions" for certain processes such as business methods. In re Bilski, 545 F.3d 943, 959-960 (2008). Relying on several of our cases in which we explained how to differentiate a claim on a "fundamental principle" from a claim on a "process," the court concluded that a "claimed process is surely patent-eligible under § 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing." Id., at 954-955. The court further concluded that this "machine-or-transformation test" is "the sole test governing § 101 analyses," id., at 955 (emphasis added), and therefore the "test for determining patent eligibility of a process under § 101," id., at 956. Applying that test, the court held that petitioners' claim is not a patent-eligible process. Id., at 963-966.

In a separate opinion reaching the same conclusion, Judge Dyk carefully reviewed the history of American patent law and English precedents upon which our law is based, and found that "the unpatentability of processes not involving manufactures, machines, or compositions of matter has been firmly embedded . . . since the time of the Patent Act of 1793." Id., at 966. Judge Dyk observed, moreover, that "[t]here is no suggestion in any of this early consideration of process patents that processes for organizing human activity were or ever had been patentable." Id., at 972.

Three judges wrote dissenting opinions, although two of those judges agreed that petitioners' claim is not patent eligible. Judge Mayer would have held that petitioners' claim "is not eligible for patent protection because it is directed to a method of conducting business." Id., at 998. He submitted that "[t]he patent system is intended to protect and promote advances in science and technology, not ideas about how to structure commercial transactions." Ibid. "Affording patent protection to business methods lacks constitutional and statutory support, serves to hinder rather than promote innovation[,] and usurps that which rightfully belongs in the public domain." Ibid.

Judge Rader would have rejected petitioners' claim on the ground that it seeks to patent merely an abstract idea. Id., at 1011.

Only Judge Newman disagreed with the court's conclusion that petitioners' claim seeks a patent on ineligible subject matter. Judge Newman urged that the en banc court's machine-or-transformation test ignores the text and history of § 101, id., at 977-978, 985-990, is in tension with several of decisions by this Court, id., at 978-985, and the Federal Circuit, id., at 990-992, and will invalidate thousands of patents that were issued in reliance on those decisions, id., at 992-994.

II

Before explaining in more detail how I would decide this case, I will comment briefly on the Court's opinion. The opinion is less than pellucid in more than one respect, and, if misunderstood, could result in confusion or upset settled areas of the law. Three preliminary observations may be clarifying.

First, the Court suggests that the terms in the Patent Act must be read as lay speakers use those terms, and not as they have traditionally been understood in the context of patent law. See, e.g., ante, at 3226 (terms in § 101 must be viewed in light of their "`ordinary, contemporary, common meaning'"); ante, at 3228 (patentable "method" is any "orderly procedure or process," "regular way or manner of doing anything," or "set form of procedure adopted in investigation or instruction" (internal quotation marks omitted)). [3235] As I will explain at more length in Part III, infra, if this portion of the Court's opinion were taken literally, the results would be absurd: Anything that constitutes a series of steps would be patentable so long as it is novel, nonobvious, and described with specificity. But the opinion cannot be taken literally on this point. The Court makes this clear when it accepts that the "atextual" machine-or-transformation test, ante, at 3229, is "useful and important," ante, at 3227, even though it "violates" the stated "statutory interpretation principles," ante, at 3226; and when the Court excludes processes that tend to pre-empt commonly used ideas, see ante, at 3230-3231.

Second, in the process of addressing the sole issue presented to us, the opinion uses some language that seems inconsistent with our centuries-old reliance on the machine-or-transformation criteria as clues to patentability. Most notably, the opinion for a plurality suggests that these criteria may operate differently when addressing technologies of a recent vintage. See ante, at 3227-3228 (machine-or-transformation test is useful "for evaluating processes similar to those in the Industrial Age," but is less useful "for determining the patentability of inventions in the Information Age"). In moments of caution, however, the opinion for the Court explains —correctly—that the Court is merely restoring the law to its historical state of rest. See ante, at 3227 ("This Court's precedents establish that the machine-or-transformation test is a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under § 101"). Notwithstanding this internal tension, I understand the Court's opinion to hold only that the machine-or-transformation test remains an important test for patentability. Few, if any, processes cannot effectively be evaluated using these criteria.

Third, in its discussion of an issue not contained in the questions presented— whether the particular series of steps in petitioners' application is an abstract idea—the Court uses language that could suggest a shift in our approach to that issue. Although I happen to agree that petitioners seek to patent an abstract idea, the Court does not show how this conclusion follows "clear[ly]," ante, at 3230-3231, from our case law. The patent now before us is not for "[a] principle, in the abstract," or a "fundamental truth." Parker v. Flook, 437 U.S. 584, 589, 98 S.Ct. 2522, 57 L.Ed.2d 451 (1978) (internal quotation marks omitted). Nor does it claim the sort of phenomenon of nature or abstract idea that was embodied by the mathematical formula at issue in Gottschalk v. Benson, 409 U.S. 63, 67, 93 S.Ct. 253, 34 L.Ed.2d 273 (1972), and in Flook.

The Court construes petitioners' claims on processes for pricing as claims on "the basic concept of hedging, or protecting against risk," ante, at 3231, and thus discounts the application's discussion of what sorts of data to use, and how to analyze those data, as mere "token postsolution components," ante, at 3231. In other words, the Court artificially limits petitioners' claims to hedging, and then concludes that hedging is an abstract idea rather than a term that describes a category of processes including petitioners' claims. Why the Court does this is never made clear. One might think that the Court's analysis means that any process that utilizes an abstract idea is itself an unpatentable, abstract idea. But we have never suggested any such rule, which would undermine a host of patentable processes. It is true, as the Court observes, that petitioners' application is phrased broadly. See ante, at 3230-3231. But claim specification is covered by § 112, not § 101; and if a series of steps constituted an [3236] unpatentable idea merely because it was described without sufficient specificity, the Court could be calling into question some of our own prior decisions.[2] At points, the opinion suggests that novelty is the clue. See ante, at 3230. But the fact that hedging is "`long prevalent in our system of commerce,'" ibid., cannot justify the Court's conclusion, as "the proper construction of § 101 . . . does not involve the familiar issu[e] of novelty" that arises under § 102. Flook, 437 U.S., at 588, 98 S.Ct. 2522. At other points, the opinion for a plurality suggests that the analysis turns on the category of patent involved. See, e.g., ante, at 3229 (courts should use the abstract-idea rule as a "too[l]" to set "a high enough bar" "when considering patent applications of this sort"). But we have never in the past suggested that the inquiry varies by subject matter.

The Court, in sum, never provides a satisfying account of what constitutes an unpatentable abstract idea. Indeed, the Court does not even explain if it is using the machine-or-transformation criteria. The Court essentially asserts its conclusion that petitioners' application claims an abstract idea. This mode of analysis (or lack thereof) may have led to the correct outcome in this case, but it also means that the Court's musings on this issue stand for very little.

III

I agree with the Court that the text of § 101 must be the starting point of our analysis. As I shall explain, however, the text must not be the end point as well.

Pursuant to its power "[t]o promote the Progress of . . . useful Arts, by securing for limited Times to . . . Inventors the exclusive Right to their . . . Discoveries," U.S. Const., Art. I, § 8, cl. 8, Congress has passed a series of patent laws that grant certain exclusive rights over certain inventions and discoveries as a means of encouraging innovation. In the latest iteration, the Patent Act of 1952 (1952 Act), Congress has provided that "[w]hoever 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, which include that the patent also be novel, § 102, and nonobvious, § 103. The statute thus authorizes four categories of subject matter that may be patented: processes, machines, manufactures, and compositions of matter. Section 101 imposes a threshold condition. "[N]o patent is available for a discovery, however useful, novel, and nonobvious, unless it falls within one of the express categories of patentable subject matter." Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 483, 94 S.Ct. 1879, 40 L.Ed.2d 315 (1974).

Section 101 undoubtedly defines in "expansive terms" the subject matter eligible for patent protection, as the statute was meant to ensure that "`ingenuit[ies] receive a liberal encouragement.'" Diamond v. Chakrabarty, 447 U.S. 303, 308-309, 100 S.Ct. 2204, 65 L.Ed.2d 144 (1980); see also J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc., 534 U.S. 124, 130, 122 S.Ct. 593, 151 L.Ed.2d 508 (2001). Nonetheless, not every new invention or discovery [3237] may be patented. Certain things are "free for all to use." Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 151, 109 S.Ct. 971, 103 L.Ed.2d 118 (1989).[3]

The text of the Patent Act does not on its face give much guidance about what constitutes a patentable process. The statute defines the term "process" as a "process, art or method [that] includes a new use of a known process, machine, manufacture, composition of matter, or material." § 100(b). But, this definition is not especially helpful, given that it also uses the term "process" and is therefore somewhat circular.

As lay speakers use the word "process," it constitutes any series of steps. But it has always been clear that, as used in § 101, the term does not refer to a "`process' in the ordinary sense of the word," Flook, 437 U.S., at 588, 98 S.Ct. 2522; see also Corning v. Burden, 15 How. 252, 268, 14 L.Ed. 683 (1854) ("[T]he term process is often used in a more vague sense, in which it cannot be the subject of a patent"). Rather, as discussed in some detail in Part IV, infra, the term "process" (along with the definitions given to that term) has long accumulated a distinctive meaning in patent law. When the term was used in the 1952 Patent Act, it was neither intended nor understood to encompass any series of steps or any way to do any thing.

With that understanding in mind, the Government has argued that because "a word" in a statute "is given more precise content by the neighboring words with which it" associates, United States v. Williams, 553 U.S. 285, 294, 128 S.Ct. 1830, 170 L.Ed.2d 650 (2008), we may draw inferences from the fact that "[t]he other three statutory categories of patent-eligible subject matter identified in Section 101—`machine, manufacture, or composition of matter'—all `are things made by man, and involve technology.'" Brief for Respondent 26. Specifically, the Government submits, we may infer "that the term `process' is limited to technological and industrial methods." Ibid. The Court rejects this submission categorically, on the ground that "§ 100(b) already explicitly defines the term `process.'" Ante, at 3226. But § 100(b) defines the term "process" by using the term "process," as well as several other general terms. This is not a case, then, in which we must either "follow" a definition, ante, at 3226, or rely on neighboring words to understand the scope of an ambiguous term. The definition itself contains the very ambiguous term that we must define.

In my view, the answer lies in between the Government's and the Court's positions: The terms adjacent to "process" in § 101 provide a clue as to its meaning, although not a very strong clue. Section 101's list of categories of patentable subject matter is phrased in the disjunctive, suggesting that the term "process" has content distinct from the other items in the [3238] list. It would therefore be illogical to "rob" the word "process" of all independent meaning. Reiter v. Sonotone Corp., 442 U.S. 330, 338, 99 S.Ct. 2326, 60 L.Ed.2d 931 (1979). Moreover, to the extent we can draw inferences about what is a "process" from common attributes in § 101, it is a dangerous endeavor to do so on the basis of a perceived overarching theme. Given the many moving parts at work in the Patent Act, there is a risk of merely confirming our preconceived notions of what should be patentable or of seeing common attributes that track "the familiar issues of novelty and obviousness" that arise under other sections of the statute but are not relevant to § 101, Flook, 437 U.S., at 588, 98 S.Ct. 2522. The placement of "process" next to other items thus cannot prove that the term is limited to any particular categories; it does, however, give reason to be skeptical that the scope of a patentable "process" extends to cover any series of steps at all.

The Court makes a more serious interpretive error. As briefly discussed in Part II, supra, the Court at points appears to reject the well-settled proposition that the term "process" in § 101 is not a "`process' in the ordinary sense of the word," Flook, 437 U.S., at 588, 98 S.Ct. 2522. Instead, the Court posits that the word "process" must be understood in light of its "ordinary, contemporary, common meaning," ante, at 3228 (internal quotation marks omitted). Although this is a fine approach to statutory interpretation in general, it is a deeply flawed approach to a statute that relies on complex terms of art developed against a particular historical background.[4] Indeed, the approach would render § 101 almost comical. A process for training a dog, a series of dance steps, a method of shooting a basketball, maybe even words, stories, or songs if framed as the steps of typing letters or uttering sounds—all would be patent-eligible. I am confident that the term "process" in § 101 is not nearly so capacious.[5]

So is the Court, perhaps. What is particularly incredible about the Court's stated method of interpreting § 101 (other than that the method itself may be patent-eligible under the Court's theory of § 101) is that the Court deviates from its own professed commitment to "ordinary, contemporary, common meaning." As noted earlier, the Court accepts a role for the "atextual" machine-or-transformation "clue." Ante, at 3229, 3234. The Court also accepts that we have "foreclose[d] a purely literal reading of § 101," Flook, 437 U.S., at 589, 98 S.Ct. 2522, by holding that claims that are close to "laws of nature, natural phenomena, and abstract ideas," Diamond v. Diehr, 450 U.S. 175, 185, 101 S.Ct. 1048, 67 L.Ed.2d 155 (1981), do not count as "processes" under § 101, even if [3239] they can be colloquially described as such.[6] The Court attempts to justify this latter exception to § 101 as "a matter of statutory stare decisis." Ante, at 3225. But it is strange to think that the very same term must be interpreted literally on some occasions, and in light of its historical usage on others.

In fact, the Court's understanding of § 101 is even more remarkable because its willingness to exclude general principles from the provision's reach is in tension with its apparent willingness to include steps for conducting business. The history of patent law contains strong norms against patenting these two categories of subject matter. Both norms were presumably incorporated by Congress into the Patent Act in 1952.

IV

Because the text of § 101 does not on its face convey the scope of patentable processes, it is necessary, in my view, to review the history of our patent law in some detail. This approach yields a much more straightforward answer to this case than the Court's. As I read the history, it strongly supports the conclusion that a method of doing business is not a "process" under § 101.

I am, of course, mindful of the fact that § 101 "is a dynamic provision designed to encompass new and unforeseen inventions," and that one must therefore view historical conceptions of patent-eligible subject matter at an appropriately high level of generality. J.E.M. Ag Supply, 534 U.S., at 135, 122 S.Ct. 593; see also Chakrabarty, 447 U.S., at 315-316, 100 S.Ct. 2204. But it is nonetheless significant that while people have long innovated in fields of business, methods of doing business fall outside of the subject matter that has "historically been eligible to receive the protection of our patent laws," Diehr, 450 U.S., at 184, 101 S.Ct. 1048, and likely go beyond what the modern patent "statute was enacted to protect," Flook, 437 U.S., at 593, 98 S.Ct. 2522. It is also significant that when Congress enacted the latest Patent Act, it did so against the background of a well-settled understanding that a series of steps for conducting business cannot be patented. These considerations ought to guide our analysis. As Justice Holmes noted long ago, sometimes, "a page of history is worth a volume of logic." New York Trust Co. v. Eisner, 256 U.S. 345, 349, 41 S.Ct. 506, 65 L.Ed. 963 (1921).

English Backdrop

The Constitution's Patent Clause was written against the "backdrop" of English patent practices, Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 5, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966), and early American patent law was "largely based on and incorporated" features of the English patent system, E. Walterscheid, To Promote the Progress of Useful Arts: American Patent Law and Administration, 1789-1836, p. 109 (1998) (hereinafter Walterscheid, To Promote the Progress).[7] The [3240] governing English law, the Statute of Monopolies, responded to abuses whereby the Crown would issue letters patent, "granting monopolies to court favorites in goods or businesses which had long before been enjoyed by the public." Graham, 383 U.S., at 5, 86 S.Ct. 684. The statute generally prohibited the Crown from granting such exclusive rights, 21 Jam. 1, c. 3, § 1 (1623), in 4 Statutes of the Realm 1213 (reprint 1963), but it contained exceptions that, inter alia, permitted grants of exclusive rights to the "working or making of any manner of new Manufacture." § 6.

Pursuant to that provision, patents issued for the "mode, method, or way of manufacturing," F. Campin, Law of Patents for Inventions 11 (1869) (emphasis deleted), and English courts construed the phrase "working or making of any manner of new manufactures" to encompass manufacturing processes, see, e.g., Boulton v. Bull, 2 H. Bl. 463, 471, 492, 126 Eng. Rep. 651, 655, 666 (C.P. 1795) (holding that the term "manufacture" "applied not only to things made, but to the practice of making, to principles carried into practice in a new manner, to new results of principles carried into practice"). Thus, English courts upheld James Watt's famous patent on a method for reducing the consumption of fuel in steam engines,[8] as well as a variety of patents issued for methods of synthesizing substances or building mechanical devices.[9]

Although it is difficult to derive a precise understanding of what sorts of methods were patentable under English law, there is no basis in the text of the Statute of Monopolies, nor in pre-1790 English precedent, to infer that business methods could qualify.[10] There was some debate throughout the relevant time period about what processes could be patented. But it does not appear that anyone seriously believed that one could patent "a method for organizing human activity." 545 F.3d, at 970 (Dyk, J., concurring).[11]

There were a small number of patents issued between 1623 and 1790 relating to banking or lotteries and one for a method [3241] of life insurance,[12] but these did not constitute the "prevail[ing]" "principles and practice" in England on which our patent law was based, Pennock v. Dialogue, 2 Pet. 1, 18, 7 L.Ed. 327 (1829). Such patents were exceedingly rare, and some of them probably were viewed not as inventions or discoveries but rather as special state privileges[13] that until the mid-1800's were recorded alongside inventions in the patent records, see MacLeod 1-2 (explaining that various types of patents were listed together). It appears that the only English patent of the time that can fairly be described as a business method patent was one issued in 1778 on a "Plan for assurances on lives of persons from 10 to 80 years of Age." Woodcroft 324.[14] And "[t]here is no indication" that this patent "was ever enforced or its validity tested," 545 F.3d, at 974 (Dyk, J., concurring); the patent may thus have represented little more than the whim—or error—of a single patent clerk.[15]

In any event, these patents (or patent) were probably not known to the Framers of early patent law. In an era before computerized databases, organized case law, and treatises,[16] the American drafters probably would have known about particular patents only if they were well publicized or subject to reported litigation. So far as I am aware, no published cases pertained to patents on business methods.

Also noteworthy is what was not patented under the English system. During the 17th and 18th centuries, Great Britain saw innovations in business organization,[17] business models,[18] management techniques,[19] [3242] and novel solutions to the challenges of operating global firms in which subordinate managers could be reached only by a long sea voyage.[20] Few if any of these methods of conducting business were patented.[21]

Early American Patent Law

At the Constitutional Convention, the Founders decided to give Congress a patent power so that it might "promote the Progress of ... useful Arts." Art. I, § 8, cl. 8. There is little known history of that Clause.[22] We do know that the Clause passed without objection or debate.[23] This is striking because other proposed powers, such as a power to grant charters of incorporation, generated discussion about the fear that they might breed "monopolies."[24] Indeed, at the ratification conventions, some States recommended amendments that would have prohibited Congress from granting "`exclusive advantages of commerce.'"[25] If the original understanding of the Patent Clause included the authority to patent methods of doing business, it might not have passed so quietly.

In 1790, Congress passed the first Patent Act, an "Act to promote the progress of useful Arts" that authorized patents for persons who had "invented or discovered any useful art, manufacture, engine, machine, or device, or any improvement therein not before known or used," if "the invention or discovery [was] sufficiently useful and important." 1 Stat. 109-110. Three years later, Congress passed the Patent Act of 1793 and slightly modified the language to cover "any new and useful [3243] art, machine, manufacture or composition of matter, or any new and useful improvement on any art, machine, manufacture or composition of matter." 1 Stat. 319.

The object of the constitutional patent power and the statutory authorization for process patents in the early patent Acts was the term "useful art." It is not evident from the face of the statutes or the Constitution whether the objects of the patent system were "arts" that are also useful, or rather a more specific category, the class of arts known as "useful arts." Cf. Graham, 383 U.S., at 12, 86 S.Ct. 684 (describing the "`new and useful' tests which have always existed in the statutory scheme" and apply to all categories of subject matter). However, we have generally assumed that "useful art," at least as it is used in the Patent Act, is itself a term of art. See Burden, 15 How., at 267-268, 14 L.Ed. 683.

The word "art" and the phrase "useful arts" are subject to many meanings. There is room on the margins to debate exactly what qualifies as either. There is room, moreover, to debate at what level of generality we should understand these broad and historical terms, given that "[a] rule that unanticipated inventions are without protection would conflict with the core concept of the patent law," Chakrabarty, 447 U.S., at 316, 100 S.Ct. 2204. It appears, however, that regardless of how one construes the term "useful arts," business methods are not included.

Noah Webster's first American dictionary[26] defined the term "art" as the "disposition or modification of things by human skill, to answer the purpose intended," and differentiated between "useful or mechanic" arts, on the one hand, and "liberal or polite" arts, on the other. 1 An American Dictionary of the English Language (1828) (facsimile edition) (emphasis added). Although other dictionaries defined the word "art" more broadly,[27] Webster's definition likely conveyed a message similar to the meaning of the word "manufactures" in the earlier English statute. And we know that the term "useful arts" was used in the founding era to refer to manufacturing and similar applied trades.[28] See Coulter, [3244] The Field of the Statutory Useful Arts, 34 J. Pat. Off. Soc. 487, 493-500 (1952); see also Thomas, The Patenting of the Liberal Professions, 40 Boston College L.Rev. 1139, 1164 (1999) ("[The Framers of the Constitution] undoubtedly contemplated the industrial, mechanical and manual arts of the late eighteenth Century, in contrast to the seven `liberal arts' and the four `fine arts' of classical learning"). Indeed, just days before the Constitutional Convention, one delegate listed examples of American progress in "manufactures and the useful arts," all of which involved the creation or transformation of physical substances. See T. Coxe, An Address to an Assembly of the Friends of American Manufactures 17-18 (1787) (listing, inter alia, meal, ships, liquors, potash, gunpowder, paper, starch, articles of iron, stone work, carriages, and harnesses). Numerous scholars have suggested that the term "useful arts" was widely understood to encompass the fields that we would now describe as relating to technology or "technological arts."[29]

Thus, fields such as business and finance were not generally considered part of the "useful arts" in the founding Era. See, e.g., The Federalist No. 8, p. 69 (C. Rossiter ed. 1961) (A.Hamilton) (distinguishing between "the arts of industry, and the science of finance"); 30 The Writings of George Washington 1745-1799, p. 186 (J. Fitzpatrick ed.1939) (writing in a letter that "our commerce has been considerably curtailed," but "the useful arts have been almost imperceptible pushed to a considerable degree of perfection"). Indeed, the same delegate to the Constitutional Convention who gave an address in which he listed triumphs in the useful arts distinguished between those arts and the conduct of business. He explained that investors were now attracted to the "manufactures and the useful arts," much as they had long invested in "commerce, navigation, stocks, banks, and insurance companies." T. Coxe, A Statement of the Arts and Manufactures of the United States of [3245] America for the Year 1810, (1814), in 2 American State Papers, Finance 666, 688 (1832).

Some scholars have remarked, as did Thomas Jefferson, that early patent statutes neither included nor reflected any serious debate about the precise scope of patentable subject matter. See, e.g., Graham, 383 U.S., at 9-10, 86 S.Ct. 684 (discussing Thomas Jefferson's observations). It has been suggested, however, that "[p]erhaps this was in part a function of an understanding—shared widely among legislators, courts, patent office officials, and inventors—about what patents were meant to protect. Everyone knew that manufactures and machines were at the core of the patent system." Merges, Property Rights for Business Concepts and Patent System Reform, 14 Berkeley Tech. L.J. 577, 585 (1999) (hereinafter Merges). Thus, although certain processes, such as those related to the technology of the time, might have been considered patentable, it is possible that "[a]gainst this background, it would have been seen as absurd for an entrepreneur to file a patent" on methods of conducting business. Ibid.

Development of American Patent Law

During the first years of the patent system, no patents were issued on methods of doing business.[30] Indeed, for some time, there were serious doubts as to "the patentability of processes per se," as distinct from the physical end product or the tools used to perform a process. Id., at 581-582.[31]

Thomas Jefferson was the "`first administrator of our patent system'" and "the author of the 1793 Patent Act." Graham, 383 U.S., at 7, 86 S.Ct. 684. We have said that his "conclusions as to conditions of patentability ... are worthy of note." Ibid. at 7, 86 S.Ct. 684. During his time administering the system, Jefferson "saw clearly the difficulty" of deciding what should be patentable.[32] Id., at 9, 86 S.Ct. 684. He drafted the 1793 Act, id., at 7, 86 S.Ct. 684, and, years later, explained that in that Act "`the whole was turned over to the judiciary, to be matured into a system, under which every one might know when his actions were safe and lawful,'" id., at 10, 86 S.Ct. 684 (quoting Letter to Isaac McPherson, in VI Writings of Thomas Jefferson 181-182 (H. Washington ed. 1861)). As the Court has explained, "Congress agreed with Jefferson ... that the courts should develop additional conditions for patentability." Graham, 383 U.S., at 10, 86 S.Ct. 684. Thus "[a]lthough the Patent Act was amended, revised or codified some 50 times between 1790 and 1950, Congress steered clear" of adding statutory requirements of patentability. Ibid. For nearly 160 years, Congress retained the term "useful arts," see, e.g., Act of July 4, 1836, ch. 357, 5 Stat. 117, leaving "wide latitude for judicial construction ... to keep pace with industrial development," Berman, Method Claims, 17 J. Pat. Off. Soc. 713, 714 (1935) (hereinafter Berman).

Although courts occasionally struggled with defining what was a patentable "art" [3246] during those 160 years, they consistently rejected patents on methods of doing business. The rationales for those decisions sometimes varied. But there was an overarching theme, at least in dicta: Business methods are not patentable arts. See, e.g., United States Credit Sys. Co. v. American Credit Indem. Co., 53 F. 818, 819 (CCSDNY 1893) ("method of insuring against loss by bad debts" could not be patented "as an art"); Hotel Security Checking Co. v. Lorraine Co., 160 F. 467, 469 (C.A.2 1908) ("A system of transacting business disconnected from the means for carrying out the system is not, within the most liberal interpretation of the term, an art"); Guthrie v. Curlett, 10 F.2d 725, 726 (C.A.2 1926) (method of abbreviating rail tariff schedules, "if it be novel, is not the kind of art protected by the patent acts"); In re Patton, 29 C.C.P.A. 982, 127 F.2d 324, 327-328 (CCPA 1942) (holding that novel "`interstate and national fire-fighting system'" was not patentable because, inter alia, "a system of transacting business, apart from the means for carrying out such system is not" an art within the meaning of the patent law, "nor is an abstract idea or theory, regardless of its importance or ... ingenuity"); Loew's Drive-in Theatres, Inc. v. Park-in Theatres, Inc., 174 F.2d 547, 552 (C.A.1 1949) ("[A] system for the transaction of business, such, for example, as the cafeteria system for transacting the restaurant business... however novel, useful, or commercially successful is not patentable apart from the means for making the system practically useful, or carrying it out"); Joseph E. Seagram & Sons, Inc. v. Marzall, 180 F.2d 26, 28 (C.A.D.C.1950) (method of focus-group testing for beverages is not patentable subject matter); see also In re Howard, 55 C.C.P.A. 1121, 394 F.2d 869, 872 (CCPA 1968) (Kirkpatrick, J., concurring) (explaining that a "method of doing business" cannot be patented). Between 1790 and 1952, this Court never addressed the patentability of business methods. But we consistently focused the inquiry on whether an "art" was connected to a machine or physical transformation,[33] an inquiry that would have excluded methods of doing business.

By the early 20th century, it was widely understood that a series of steps for conducting business could not be patented. A leading treatise, for example, listed "`systems' of business" as an "unpatentable subjec[t]." 1 A. Deller, Walker on Patents § 18, p. 62 (1937).[34] Citing many of the cases listed above, the treatise concluded that a "method of transacting business" is not an "`art.'" Id., § 22, at 69; see also L. Amdur, Patent Law and Practice § 39, p. 53 (1935) (listing "Methods of doing business" as an "Unpatentable [A]r[t]"); Berman 718 ("[C]ases have been fairly unanimous in denying patentability to such methods"); Tew, Method of Doing Business, 16 J. Pat. Off. Soc. 607 (1934) ("It is probably settled by long practice and many precedents that `methods of doing business,' as these words are generally understood, are unpatentable"). Indeed, "[u]ntil recently" it was still "considered well established that [business] methods were non-statutory." 1 R. Moy, Walker on Patents § 5:28, p. 5-104 (4th ed.2009).[35]

[3247]

 

Modern American Patent Law

By the mid-1900's, many courts were construing the term "art" by using words such as "method, process, system, or like terms." Berman 713; see Expanded Metal Co. v. Bradford, 214 U.S. 366, 382, 29 S.Ct. 652, 53 L.Ed. 1034 (1909) ("The word `process' has been brought into the decisions because it is supposedly an equivalent form of expression or included in the statutory designation of a new and useful art").[36] Thus in 1952, when Congress updated the patent laws as part of its ongoing project to revise the United States Code, it changed the operative language in § 101, replacing the term "art" with "process" and adding a definition of "process" as a "process, art or method," § 100(b).

That change was made for clarity and did not alter the scope of a patentable "process." See Diehr, 450 U.S., at 184, 101 S.Ct. 1048. The new terminology was added only in recognition of the fact that courts had been interpreting the category "art" by using the terms "process or method"; Congress thus wanted to avoid "the necessity of explanation that the word `art' as used in this place means `process or method.'" S.Rep. No.1979, 82d Cong., 2d Sess., 5 (1952) (hereinafter S. Rep.1979); accord, H.R.Rep. No.1923, 82d Cong., 2d Sess., 6 (1952) (hereinafter H.R. Rep.1923); see also id., at 17 (explaining that "the word `art'" in § 101 "has been interpreted by the courts as being practically synonymous with process or method," and that the switch to the word "[p]rocess" was intended only for clarity).[37]

It appears that when Congress changed the language in § 101 to incorporate the prevailing judicial terminology, it merely codified the prevailing judicial interpretation of that category of subject matter. See Diehr, 450 U.S., at 184, 101 S.Ct. 1048; see also Barber v. Gonzales, 347 U.S. 637, 641, 74 S.Ct. 822, 98 L.Ed. 1009 (1954) ("While it is true that statutory language should be interpreted whenever possible according to common usage, some terms acquire a special technical meaning by a process of judicial construction"). Both the Senate and House Committee Reports explained that the word "process" was used in § 101 "to clarify the present law as to the patentability of certain types of processes or methods as to which some insubstantial doubts have been expressed." S. Rep.1979, at 5; accord, H. Rep.1923, at 6. And both noted that those terms were used to convey the prevailing meaning of the term "art," "as interpreted" by courts, S. Rep.1979, at 17; accord, H. Rep.1923, at 17. Indeed, one of the main drafters of the Act explained that the definition of the term "process" in § 100(b) reflects "how the courts have construed the term `art.'" Tr. of address by Judge Giles S. Rich to [3248] the New York Patent Law Association 7-8 (Nov. 6, 1952).

As discussed above, by this time, courts had consistently construed the term "art" to exclude methods of doing business. The 1952 Act likely captured that same meaning.[38] Cf. Graham, 383 U.S., at 16-17, 86 S.Ct. 684 (reasoning that because a provision of the 1952 Act "paraphrases language which has often been used in decisions of the courts" and was "added to the statute for uniformity and definiteness, "that provision should be treated as "a codification of judicial precedents").[39] Indeed, Judge Rich, the main drafter of the 1952 Act, later explained that "the invention of a more effective organization of the materials in, and the techniques of teaching a course in physics, chemistry, or Russian is not a patentable invention because it is outside of the enumerated categories of `process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.'" Principles of Patentability, 28 Geo. Wash. L.Rev. 393, 394 (1960). "Also outside that group," he added, was a process for doing business: "the greatest inventio[n] of our times, the diaper service." Ibid.[40]

"Anything Under the Sun"

Despite strong evidence that Congress has consistently authorized patents for a limited class of subject matter and that the 1952 Act did not alter the nature of the then-existing limits, petitioners and their amici emphasize a single phrase in the Act's legislative history, which suggests that the statutory subject matter "`include[s] anything under the sun that is made by man.'" Brief for Petitioners 19 (quoting Chakrabarty, 447 U.S., at 309, 100 S.Ct. 2204, in turn quoting S. Rep.1979, at 5). Similarly, the Court relies on language from our opinion in Chakrabarty that was based in part on this piece of legislative history. See ante, at 3224, 3226.

This reliance is misplaced. We have never understood that piece of legislative history to mean that any series of steps is a patentable process. Indeed, if that were so, then our many opinions analyzing what [3249] is a patentable process were simply wastes of pages in the U.S. Reports. And to accept that errant piece of legislative history as widening the scope of the patent law would contradict other evidence in the congressional record, as well as our presumption that the 1952 Act merely codified the meaning of "process" and did not expand it, see Diehr, 450 U.S., at 184, 101 S.Ct. 1048.

Taken in context, it is apparent that the quoted language has a far less expansive meaning. The full sentence in the Committee Reports reads: "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 [this] title are fulfilled." S.Rep.1979, at 5; H.R. Rep. 1923, at 6. Viewed as a whole, it seems clear that this language does not purport to explain that "anything under the sun" is patentable. Indeed, the language may be understood to state the exact opposite: that "[a] person may have `invented' ... anything under the sun," but that thing "is not necessarily patentable under section 101." Thus, even in the Chakrabarty opinion, which relied on this quote, we cautioned that the 1952 Reports did not "suggest that § 101 has no limits or that it embraces every discovery." 447 U.S., at 309, 100 S.Ct. 2204.

Moreover, even if the language in the Committee Reports was meant to flesh out the meaning of any portion of § 101, it did not purport to define the term "process." The language refers only to "manufacture[s]" and "machine[s]," tangible objects "made by man." It does not reference the "process" category of subject matter (nor could a process be comfortably described as something "made by man"). The language may also be understood merely as defining the term "invents" in § 101. As Judge Dyk explained in his opinion below, the phrase "made by man" "is reminiscent" of a 1790's description of the limits of English patent law, that an "invention must be `made by man'" and cannot be "`a philosophical principle only, neither organized or capable of being organized' from a patentable manufacture." 545 F.3d, at 976 (quoting Hornblower v. Boulton, 8 T.R. 95, 98 (K. & B. 1799)).

The 1952 Act, in short, cannot be understood as expanding the scope of patentable subject matter by suggesting that any series of steps may be patented as a "process" under § 101. If anything, the Act appears to have codified the conclusion that subject matter which was understood not to be patentable in 1952 was to remain unpatentable.

Our recent case law reinforces my view that a series of steps for conducting business is not a "process" under § 101. Since Congress passed the 1952 Act, we have never ruled on whether that Act authorizes patents on business methods. But we have cast significant doubt on that proposition by giving substantial weight to the machine-or-transformation test, as general methods of doing business do not pass that test. And more recently, Members of this Court have noted that patents on business methods are of "suspect validity." eBay Inc. v. MercExchange, L.L. C., 547 U.S. 388, 397, 126 S.Ct. 1837, 164 L.Ed.2d 641 (2006) (KENNEDY, J., concurring).

* * *

Since at least the days of Assyrian merchants, people have devised better and better ways to conduct business. Yet it appears that neither the Patent Clause, nor early patent law, nor the current § 101 contemplated or was publicly understood to mean that such innovations are patentable. Although it may be difficult to define with precision what is a patentable "process" [3250] under § 101, the historical clues converge on one conclusion: A business method is not a "process." And to the extent that there is ambiguity, we should be mindful of our judicial role. "[W]e must proceed cautiously when we are asked to extend patent rights" into an area that the Patent Act likely was not "enacted to protect," Flook, 437 U.S., at 596, 593, 98 S.Ct. 2522, lest we create a legal regime that Congress never would have endorsed, and that can be repaired only by disturbing settled property rights.

V

Despite the strong historical evidence that a method of doing business does not constitute a "process" under § 101, petitioners nonetheless argue—and the Court suggests in dicta, ante, at 3228-3229— that a subsequent law, the First Inventor Defense Act of 1999, "must be read together" with § 101 to make business methods patentable. Brief for Petitioners 29. This argument utilizes a flawed method of statutory interpretation and ignores the motivation for the 1999 Act.

In 1999, following a Federal Circuit decision that intimated business methods could be patented, see State Street, 149 F.3d 1368, Congress moved quickly to limit the potential fallout. Congress passed the 1999 Act, codified at 35 U.S.C. § 273, which provides a limited defense to claims of patent infringement, see § 273(b), regarding certain "method[s] of doing or conducting business," § 273(a)(3).

It is apparent, both from the content and history of the Act, that Congress did not in any way ratify State Street (or, as petitioners contend, the broadest possible reading of State Street). The Act merely limited one potential effect of that decision: that businesses might suddenly find themselves liable for innocently using methods they assumed could not be patented. The Act did not purport to amend the limitations in § 101 on eligible subject matter. Indeed, Congress placed the statute in Part III of Title 35, which addresses "Patents and Protection of Patent Rights," rather than in Part II, which contains § 101 and addresses "Patentability of Inventions and Grant of Patents." Particularly because petitioners' reading of the 1999 Act would expand § 101 to cover a category of processes that have not "historically been eligible" for patents, Diehr, 450 U.S., at 184, 101 S.Ct. 1048, we should be loathe to conclude that Congress effectively amended § 101 without saying so clearly. We generally presume that Congress "does not, one might say, hide elephants in mouseholes." Whitman v. American Trucking Assns., Inc., 531 U.S. 457, 468, 121 S.Ct. 903, 149 L.Ed.2d 1 (2001).

The Act therefore is, at best, merely evidence of 1999 legislative views on the meaning of the earlier, 1952 Act. "[T]he views of a subsequent Congress," however, "form a hazardous basis for inferring the intent of an earlier one." United States v. Price, 361 U.S. 304, 313, 80 S.Ct. 326, 4 L.Ed.2d 334 (1960). When a later statute is offered as "an expression of how the ... Congress interpreted a statute passed by another Congress ... a half century before," "such interpretation has very little, if any, significance." Rainwater v. United States, 356 U.S. 590, 593, 78 S.Ct. 946, 2 L.Ed.2d 996 (1958).

Furthermore, even assuming that Congress' views at the turn of the 21st century could potentially serve as a valid basis for interpreting a statute passed in the mid-20th century, the First Inventor Defense Act does not aid petitioners because it does not show that the later Congress itself understood § 101 to cover business methods. If anything, it shows that a few judges on the Federal Circuit understood [3251] § 101 in that manner and that Congress understood what those judges had done. The Act appears to reflect surprise and perhaps even dismay that business methods might be patented. Thus, in the months following State Street, congressional authorities lamented that "business methods and processes ... until recently were thought not to be patentable," H.R.Rep. No. 106-464, p. 121 (1999); accord, H.R.Rep. No. 106-287, pt. 1, p. 31 (1999).[41] The fact that Congress decided it was appropriate to create a new defense to claims that business method patents were being infringed merely demonstrates recognition that such claims could create a significant new problem for the business community.

The Court nonetheless states that the 1999 Act "acknowledges that there may be business method patents," thereby "clarify[ing]" its "understanding" of § 101. Ante, at 3228. More specifically, the Court worries that if we were to interpret the 1952 Act to exclude business methods, our interpretation "would render § 273 meaningless." Ibid. I agree that "[a] statute should be construed so that effect is given to all its provisions." Corley v. United States, 556 U.S. ___, ___, 129 S.Ct. 1558, 1566, 173 L.Ed.2d 443 (2009) (internal quotation marks omitted). But it is a different matter altogether when the Court construes one statute, the 1952 Act, to give effect to a different statute, the 1999 Act. The canon on which the Court relies is predicated upon the idea that "[a] statute is passed as a whole." 2A N. Singer & J. Singer, Statutes and Statutory Construction § 46:5, p. 189 (7th ed.2007). But the two statutes in question were not passed as a whole.

Put another way, we ordinarily assume, quite sensibly, that Congress would not in one statute include two provisions that are at odds with each other. But as this case shows, that sensible reasoning can break down when applied to different statutes.[42] The 1999 Act was passed to limit the impact of the Federal Circuit's then-recent statements on the 1952 Act. Although repudiating that judicial dictum (as we should) might effectively render the 1999 Act a nullity going forward, such a holding would not mean that it was a nullity when Congress enacted it. Section 273 may have been a technically unnecessary response to confusion about patentable subject matter, but it appeared necessary in 1999 in light of what was being discussed [3252] in legal circles at the time.[43] Consider the logical implications of the Court's approach to this question: If, tomorrow, Congress were to conclude that patents on business methods are so important that the special infringement defense in § 273 ought to be abolished, and thus repealed that provision, this could paradoxically strengthen the case against such patents because there would no longer be a § 273 that "acknowledges ... business method patents," ante, at 3228. That is not a sound method of statutory interpretation.

In light of its history and purpose, I think it obvious that the 1999 Congress would never have enacted § 273 if it had foreseen that this Court would rely on the provision as a basis for concluding that business methods are patentable. Section 273 is a red herring; we should be focusing our attention on § 101 itself.

VI

The constitutionally mandated purpose and function of the patent laws bolster the conclusion that methods of doing business are not "processes" under § 101.

The Constitution allows Congress to issue patents "[t]o promote the Progress of... useful Arts," Art. I, § 8, cl. 8. This clause "is both a grant of power and a limitation." Graham, 383 U.S., at 5, 86 S.Ct. 684. It "reflects a balance between the need to encourage innovation and the avoidance of monopolies which stifle competition without any concomitant advance in the `Progress of Science and useful Arts.'" Bonito Boats, 489 U.S., at 146, 109 S.Ct. 971. "This is the standard expressed in the Constitution and it may not be ignored. And it is in this light that patent validity `requires reference to [the] standard written into the Constitution.'" Graham, 383 U.S., at 6, 86 S.Ct. 684 (quoting Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 154, 71 S.Ct. 127, 95 L.Ed. 162 (1950) (Douglas, J., concurring) (emphasis deleted)); see also Grant v. Raymond, 6 Pet. 218, 241-242, 8 L.Ed. 376 (1832) (explaining that patent "laws which are passed to give effect to this [constitutional] purpose ought, we think, to be construed in the spirit in which they have been made").[44]

Thus, although it is for Congress to "implement the stated purpose of the Framers by selecting the policy which in its judgment best effectuates the constitutional aim," Graham, 383 U.S., at 6, 86 S.Ct. 684, we interpret ambiguous patent laws as a set of rules that "wee[d] out those inventions which would not be disclosed or devised but for the inducement of a patent," id., at 11, 86 S.Ct. 684, and that "embod[y]" the "careful balance between the need to promote innovation and the recognition that imitation and refinement through imitation are both necessary to invention itself and the very lifeblood of a competitive economy," Bonito Boats, 489 [3253] U.S., at 146, 109 S.Ct. 971. And absent a discernible signal from Congress, we proceed cautiously when dealing with patents that press on the limits of the "`standard written into the constitution,'" Graham, 383 U.S., at 6, 86 S.Ct. 684, for at the "fringes of congressional power," "more is required of legislatures than a vague delegation to be filled in later," Barenblatt v. United States, 360 U.S. 109, 139-140, 79 S.Ct. 1081, 3 L.Ed.2d 1115 (1959) (Black, J., dissenting); see also Greene v. McElroy, 360 U.S. 474, 507, 79 S.Ct. 1400, 3 L.Ed.2d 1377 (1959) ("[D]ecisions of great constitutional import and effect" "requir[e] careful and purposeful consideration by those responsible for enacting and implementing our laws"). We should not casually risk exceeding the constitutional limitation on Congress' behalf.

The Court has kept this "constitutional standard" in mind when deciding what is patentable subject matter under § 101. For example, we have held that no one can patent "laws of nature, natural phenomena, and abstract ideas." Diehr, 450 U.S., at 185, 101 S.Ct. 1048. These "are the basic tools of scientific and technological work," Benson, 409 U.S., at 67, 93 S.Ct. 253, and therefore, if patented, would stifle the very progress that Congress is authorized to promote, see, e.g., O'Reilly, 15 How., at 113, 14 L.Ed. 601 (explaining that Morse's patent on electromagnetism for writing would preempt a wide swath of technological developments).

Without any legislative guidance to the contrary, there is a real concern that patents on business methods would press on the limits of the "standard expressed in the Constitution," Graham, 383 U.S., at 6, 86 S.Ct. 684, more likely stifling progress than "promot[ing]" it. U.S. Const., Art. I, § 8, cl. 8. I recognize that not all methods of doing business are the same, and that therefore the constitutional "balance," Bonito Boats, 489 U.S., at 146, 109 S.Ct. 971, may vary within this category. Nevertheless, I think that this balance generally supports the historic understanding of the term "process" as excluding business methods. And a categorical analysis fits with the purpose, as Thomas Jefferson explained, of ensuring that "`every one might know when his actions were safe and lawful,'" Graham, 383 U.S., at 10, 86 S.Ct. 684; see also Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 730-731, 122 S.Ct. 1831, 152 L.Ed.2d 944 (2002) ("The monopoly is a property right; and like any property right, its boundaries should be clear. This clarity is essential to promote progress"); Diehr, 450 U.S., at 219, 101 S.Ct. 1048 (STEVENS, J., dissenting) (it is necessary to have "rules that enable a conscientious patent lawyer to determine with a fair degree of accuracy" what is patentable).

On one side of the balance is whether a patent monopoly is necessary to "motivate the innovation," Pfaff v. Wells Electronics, Inc., 525 U.S. 55, 63, 119 S.Ct. 304, 142 L.Ed.2d 261 (1998). Although there is certainly disagreement about the need for patents, scholars generally agree that when innovation is expensive, risky, and easily copied, inventors are less likely to undertake the guaranteed costs of innovation in order to obtain the mere possibility of an invention that others can copy.[45] Both common sense and recent economic scholarship suggest that these dynamics of cost, risk, and reward vary by the type of thing being patented.[46] And the functional [3254] case that patents promote progress generally is stronger for subject matter that has "historically been eligible to receive the protection of our patent laws," Diehr, 450 U.S., at 184, 101 S.Ct. 1048, than for methods of doing business.

Many have expressed serious doubts about whether patents are necessary to encourage business innovation.[47] Despite the fact that we have long assumed business methods could not be patented, it has been remarked that "the chief business of the American people, is business."[48] Federal Express developed an overnight delivery service and a variety of specific methods (including shipping through a central hub and online package tracking) without a patent. Although counterfactuals are a dubious form of analysis, I find it hard to believe that many of our entrepreneurs forwent business innovation because they could not claim a patent on their new methods.

"[C]ompanies have ample incentives to develop business methods even without patent protection, because the competitive marketplace rewards companies that use more efficient business methods." Burk & Lemley 1618.[49] Innovators often capture advantages from new business methods notwithstanding the risk of others copying their innovation. Some business methods occur in secret and therefore can be protected with trade secrecy.[50] And for those methods that occur in public, firms that innovate often capture long-term benefits from doing so, thanks to various first mover advantages, including lockins, branding, and networking effects.[51] Business innovation, moreover, generally does not entail the same kinds of risk as does more traditional, technological innovation. It generally does not require the same "enormous costs in terms of time, research, and development," Bicron, 416 U.S., at 480, 94 S.Ct. 1879, and thus does not require the same kind of "compensation to [innovators] for their labor, toil, and expense," Seymour v. Osborne, 11 Wall. 516, 533-544, 20 L.Ed. 33 (1871).[52]

Nor, in many cases, would patents on business methods promote progress by encouraging "public disclosure." Pfaff, 525 U.S., at 63, 119 S.Ct. 304; see also Brenner v. Manson, 383 U.S. 519, 533, 86 S.Ct. 1033, 16 L.Ed.2d 69 (1966) ("[O]ne of the purposes of the patent system is to encourage dissemination of information concerning discoveries and inventions"). Many business methods are practiced in public, and therefore a patent does not necessarily [3255] encourage the dissemination of anything not already known. And for the methods practiced in private, the benefits of disclosure may be small: Many such methods are distributive, not productive—that is, they do not generate any efficiency but only provide a means for competitors to one-up each other in a battle for pieces of the pie. And as the Court has explained, "it is hard to see how the public would be benefited by disclosure" of certain business tools, since the nondisclosure of these tools "encourages businesses to initiate new and individualized plans of operation," which "in turn, leads to a greater variety of business methods." Bicron, 416 U.S., at 483, 94 S.Ct. 1879.

In any event, even if patents on business methods were useful for encouraging innovation and disclosure, it would still be questionable whether they would, on balance, facilitate or impede the progress of American business. For even when patents encourage innovation and disclosure, "too much patent protection can impede rather than `promote the Progress of ... useful Arts.'" Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., 548 U.S. 124, 126-127, 126 S.Ct. 2921, 165 L.Ed.2d 399 (2006) (BREYER, J., dissenting from dismissal of certiorari). Patents "can discourage research by impeding the free exchange of information," for example, by forcing people to "avoid the use of potentially patented ideas, by leading them to conduct costly and time-consuming searches of existing or pending patents, by requiring complex licensing arrangements, and by raising the costs of using the patented" methods. Id., at 127, 126 S.Ct. 2921. Although "[e]very patent is the grant of a privilege of exacting tolls from the public," Great Atlantic, 340 U.S., at 154, 71 S.Ct. 127 (Douglas, J., concurring), the tolls of patents on business methods may be especially high.

The primary concern is that patents on business methods may prohibit a wide swath of legitimate competition and innovation. As one scholar explains, "it is useful to conceptualize knowledge as a pyramid: the big ideas are on top; specific applications are at the bottom." Dreyfuss 275. The higher up a patent is on the pyramid, the greater the social cost and the greater the hindrance to further innovation.[53] Thus, this Court stated in Benson that "[p]henomena of nature ..., mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work," 409 U.S., at 67, 93 S.Ct. 253; see also, Joseph E. Seagram & Sons, Inc., 180 F.2d, at 28 ("To give appellant a monopoly, through the issuance of a patent, upon so great an area ... would in our view impose without warrant of law a serious restraint upon the advance of science and industry"). Business methods are similarly often closer to "big ideas," as they are the basic tools of commercial work. They are also, in many cases, the basic tools of further business innovation: Innovation in business methods is often a sequential and complementary process in which imitation may be a "spur to innovation" and patents may "become an impediment." Bessen & Maskin, Sequential Innovation, Patents, and Imitation, 40 RAND J. Econ. 611, 613 (2009).[54] "Think [3256] how the airline industry might now be structured if the first company to offer frequent flyer miles had enjoyed the sole right to award them." Dreyfuss 264. "[I]mitation and refinement through imitation are both necessary to invention itself and the very lifeblood of a competitive economy." Bonito Boats, 489 U.S., at 146, 109 S.Ct. 971.

If business methods could be patented, then many business decisions, no matter how small, could be potential patent violations. Businesses would either live in constant fear of litigation or would need to undertake the costs of searching through patents that describe methods of doing business, attempting to decide whether their innovation is one that remains in the public domain. See Long, Information Costs in Patent and Copyright, 90 Va. L.Rev. 465, 487-488 (2004) (hereinafter Long). But as we have long explained, patents should not "embaras[s] the honest pursuit of business with fears and apprehensions of concealed liens and unknown liabilities to lawsuits and vexatious accountings for profits made in good faith." Atlantic Works v. Brady, 107 U.S. 192, 200, 2 S.Ct. 225, 27 L.Ed. 438 (1883).[55]

These effects are magnified by the "potential vagueness" of business method patents, eBay Inc., 547 U.S., at 397, 126 S.Ct. 1837 (KENNEDY, J., concurring). When it comes to patents, "clarity is essential to promote progress." Festo Corp., 535 U.S., at 730-731, 122 S.Ct. 1831. Yet patents on methods of conducting business generally are composed largely or entirely of intangible steps. Compared to "the kinds of goods ... around which patent rules historically developed," it thus tends to be more costly and time consuming to search through, and to negotiate licenses for, patents on business methods. See Long 539, 470.[56]

The breadth of business methods, their omnipresence in our society, and their potential vagueness also invite a particularly pernicious use of patents that we have long criticized. As early as the 19th century, we explained that the patent laws are not intended to "creat[e] a class of speculative schemers who make it their business to watch the advancing wave of improvement, and gather its foam in the form of patented monopolies, which enable them to lay a heavy tax upon the industry of the country, without contributing anything to the real advancement of the arts." Atlantic Works, 107 U.S., at 200, 2 S.Ct. 225. Yet business method patents may have begun to do exactly that. See eBay Inc., 547 U.S., at 396-397, 126 S.Ct. 1837 (opinion of KENNEDY, J.).

These many costs of business method patents not only may stifle innovation, but [3257] they are also likely to "stifle competition," Bonito Boats, 489 U.S., at 146, 109 S.Ct. 971. Even if a business method patent is ultimately held invalid, patent holders may be able to use it to threaten litigation and to bully competitors, especially those that cannot bear the costs of a drawn out, fact-intensive patent litigation.[57] That can take a particular toll on small and upstart businesses.[58] Of course, patents always serve as a barrier to competition for the type of subject matter that is patented. But patents on business methods are patents on business itself. Therefore, unlike virtually every other category of patents, they are by their very nature likely to depress the dynamism of the marketplace.[59]

* * *

The constitutional standard for patentability is difficult to apply with any precision, and Congress has significant discretion to "implement the stated purpose of the Framers by selecting the policy which in its judgment best effectuates the constitutional aim," Graham, 383 U.S., at 6, 86 S.Ct. 684. But Congress has not, either explicitly or implicitly, determined that patents on methods of doing business would effectuate this aim. And as I understand their practical consequences, it is hard to see how they would.

VII

The Constitution grants to Congress an important power to promote innovation. In its exercise of that power, Congress has established an intricate system of intellectual property. The scope of patentable subject matter under that system is broad. But it is not endless. In the absence of any clear guidance from Congress, we have only limited textual, historical, and functional clues on which to rely. Those clues all point toward the same conclusion: that petitioners' claim is not a "process" within the meaning of § 101 because methods of doing business are not, in themselves, covered by the statute. In my view, acknowledging as much would be a far more sensible and restrained way to resolve this case. Accordingly, while I concur in the judgment, I strongly disagree with the Court's disposition of this case.

Justice BREYER, with whom Justice SCALIA joins as to Part II, concurring in the judgment.

I

I agree with Justice STEVENS that a "general method of engaging in business transactions" is not a patentable "process" within the meaning of 35 U.S.C. § 101. Ante, at 3232 (STEVENS, J., concurring in judgment). This Court has never before held that so-called "business methods" are patentable, and, in my view, the text, history, and purposes of the Patent Act make clear that they are not. Ante, at [3258] 3236-3257. I would therefore decide this case on that ground, and I join Justice STEVENS' opinion in full.

I write separately, however, in order to highlight the substantial agreement among many Members of the Court on many of the fundamental issues of patent law raised by this case. In light of the need for clarity and settled law in this highly technical area, I think it appropriate to do so.

II

In addition to the Court's unanimous agreement that the claims at issue here are unpatentable abstract ideas, it is my view that the following four points are consistent with both the opinion of the Court and Justice STEVENS' opinion concurring in the judgment:

First, although the text of § 101 is broad, it is not without limit. See ante, at 3224-3225 (opinion of the Court); ante, at 3236 (STEVENS, J., concurring in judgment). "[T]he underlying policy of the patent system [is] that `the things which are worth to the public the embarrassment of an exclusive patent,' ... must outweigh the restrictive effect of the limited patent monopoly." Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 10-11, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966) (quoting Letter from Thomas Jefferson to Isaac McPherson (Aug. 13, 1813), in 6 Writings of Thomas Jefferson 181 (H. Washington ed.)). The Court has thus been careful in interpreting the Patent Act to "determine not only what is protected, but also what is free for all to use." Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 151, 109 S.Ct. 971, 103 L.Ed.2d 118 (1989). In particular, the Court has long held that "[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable" under § 101, since allowing individuals to patent these fundamental principles would "wholly pre-empt" the public's access to the "basic tools of scientific and technological work." Gottschalk v. Benson, 409 U.S. 63, 67, 72, 93 S.Ct. 253, 34 L.Ed.2d 273 (1972); see also, e.g., Diamond v. Diehr, 450 U.S. 175, 185, 101 S.Ct. 1048, 67 L.Ed.2d 155 (1981); Diamond v. Chakrabarty, 447 U.S. 303, 309, 100 S.Ct. 2204, 65 L.Ed.2d 144 (1980).

Second, in a series of cases that extend back over a century, the Court has stated 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." Diehr, supra, at 184, 101 S.Ct. 1048 (emphasis added; internal quotation marks omitted); see also, e.g., Benson, supra, at 70, 93 S.Ct. 253; Parker v. Flook, 437 U.S. 584, 588, n. 9, 98 S.Ct. 2522, 57 L.Ed.2d 451 (1978); Cochrane v. Deener, 94 U.S. 780, 788, 24 L.Ed. 139 (1877). Application of this test, the so-called "machine-ortransformation test," has thus repeatedly helped the Court to determine what is "a patentable `process.'" Flook, supra, at 589, 98 S.Ct. 2522.

Third, while the machine-or-transformation test has always been a "useful and important clue," it has never been the "sole test" for determining patentability. Ante, at 3227; see also ante, at 3231-3232 (STEVENS, J., concurring in judgment); Benson, supra, at 71, 93 S.Ct. 253 (rejecting the argument that "no process patent could ever qualify" for protection under § 101 "if it did not meet the [machine-or-transformation] requirements"). Rather, the Court has emphasized that a process claim meets the requirements of § 101 when, "considered as a whole," it "is performing a function which the patent laws were designed to protect (e.g., transforming or reducing an article to a different state or thing)." Diehr, supra, at 192, 101 [3259] S.Ct. 1048. The machine-or-transformation test is thus an important example of how a court can determine patentability under § 101, but the Federal Circuit erred in this case by treating it as the exclusive test.

Fourth, although the machine-or-transformation test is not the only test for patentability, this by no means indicates that anything which produces a "`useful, concrete, and tangible result,'" State Street Bank & Trust Co. v. Signature Financial Group, Inc., 149 F.3d 1368, 1373 (C.A.Fed.1998), is patentable. "[T]his Court has never made such a statement and, if taken literally, the statement would cover instances where this Court has held the contrary." Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., 548 U.S. 124, 136, 126 S.Ct. 2921, 165 L.Ed.2d 399 (2006) (BREYER, J., dissenting from dismissal of certiorari as improvidently granted); see also, e.g., O'Reilly v. Morse, 15 How. 62, 117, 14 L.Ed. 601 (1854); Flook, supra, at 590, 98 S.Ct. 2522. Indeed, the introduction of the "useful, concrete, and tangible result" approach to patentability, associated with the Federal Circuit's State Street decision, preceded the granting of patents that "ranged from the somewhat ridiculous to the truly absurd." In re Bilski, 545 F.3d 943, 1004 (C.A.Fed.2008) (Mayer, J., dissenting) (citing patents on, inter alia, a "method of training janitors to dust and vacuum using video displays," a "system for toilet reservations," and a "method of using color-coded bracelets to designate dating status in order to limit `the embarrassment of rejection'"); see also Brief for Respondent 40-41, and n. 20 (listing dubious patents). To the extent that the Federal Circuit's decision in this case rejected that approach, nothing in today's decision should be taken as disapproving of that determination. See ante, at 3231; ante, at 3232, n. 1 (STEVENS, J., concurring in judgment).

In sum, it is my view that, in reemphasizing that the "machine-or-transformation" test is not necessarily the sole test of patentability, the Court intends neither to de-emphasize the test's usefulness nor to suggest that many patentable processes lie beyond its reach.

III

With these observations, I concur in the Court's judgment.

[*] Justice SCALIA does not join Parts II-B-2 and II-C-2.

[1] Even if the machine-or-transformation test may not define the scope of a patentable process, it would be a grave mistake to assume that anything with a "`useful, concrete and tangible result,'" State Street Bank & Trust v. Signature Financial Group, Inc., 149 F.3d 1368, 1373 (C.A.Fed.1998), may be patented.

[2] For example, a rule that broadly-phrased claims cannot constitute patentable processes could call into question our approval of Alexander Graham Bell's famous fifth claim on "`[t]he method of, and apparatus for, transmitting vocal or other sounds telegraphically, as herein described, by causing electrical undulations, similar in form to the vibrations of the air accompanying the said vocal or other sounds, substantially as set forth,'" The Telephone Cases, 126 U.S. 1, 531, 8 S.Ct. 778, 31 L.Ed. 863 (1888).

[3] The Court quotes our decision in Diamond v. Chakrabarty, 447 U.S. 303, 100 S.Ct. 2204, 65 L.Ed.2d 144 (1980), for the proposition that, "`[i]n choosing such expansive terms. . . modified by the comprehensive "any," Congress plainly contemplated that the patent laws would be given wide scope.'" Ante, at 3225. But the Court fails to mention which terms we were discussing in Chakrabarty: the terms "manufacture" and "composition of matter." See 447 U.S., at 308, 100 S.Ct. 2204 ("In choosing such expansive terms as `manufacture' and `composition of matter,' modified by the comprehensive `any,' Congress plainly contemplated that the patent laws would be given wide scope"). As discussed herein, Congress' choice of the term "process" reflected a background understanding of what sorts of series of steps could be patented, and likely reflected an intentional design to codify that settled, judicial understanding. This may not have been the case with the terms at issue in Chakrabarty.

[4] For example, if this Court were to interpret the Sherman Act according to the Act's plain text, it could prohibit "the entire body of private contract," National Soc. of Professional Engineers v. United States, 435 U.S. 679, 688, 98 S.Ct. 1355, 55 L.Ed.2d 637 (1978).

[5] The Court attempts to avoid such absurd results by stating that these "[c]oncerns" "can be met by making sure that the claim meets the requirements of § 101." Ante, at 3226. Because the only limitation on the plain meaning of "process" that the Court acknowledges explicitly is the bar on abstract ideas, laws of nature, and the like, it is presumably this limitation that is left to stand between all conceivable human activity and patent monopolies. But many processes that would make for absurd patents are not abstract ideas. Nor can the requirements of novelty, nonobviousness, and particular description pick up the slack. Cf. ante, at 3229-3230 (plurality opinion). A great deal of human activity was at some time novel and nonobvious.

[6] Curiously, the Court concedes that "these exceptions are not required by the statutory text," but urges that "they are consistent with the notion that a patentable process must be `new and useful.'" Ante, at 3225 (emphasis added). I do not see how these exceptions find a textual home in the term "new and useful." The exceptions may be consistent with those words, but they are sometimes inconsistent with the "ordinary, contemporary, common meaning," ante, at 3226, 3228 (internal quotation marks omitted), of the words "process" and "method."

[7] See Pennock v. Dialogue, 2 Pet. 1, 18, 7 L.Ed. 327 (1829) ("[M]any of the provisions of our patent act are derived from the principles and practice, which have prevailed in the construction of that of England"); Proceedings in Congress During the Years 1789 and 1790 Relating to the First Patent and Copyright Laws, 22 J. Pat. Off. Soc. 352, 363 (1940) (explaining that the 1790 Patent Act was "framed according to the Course of Practice in the English Patent Office"); see also Walterscheid, The Early Evolution of the United States Patent Law: Antecedents, 76 J. Pat. & Trademark Off. Soc. 697, 698 (1994) (describing the role of the English backdrop).

[8] See Hornblower v. Boulton, 8 T.R. 95 (K. B. 1799).

[9] See, e.g., Roebuck and Garbett v. William Stirling & Son (H.L.1774), reprinted in 1 T. Webster, Reports and Notes of Cases on Letters Patent for Inventions 45 (1844) ("method of making acid spirit by burning sulphur and saltpetre, and collecting the condensed fumes"); id., at 77 ("`method of producing a yellow colour for painting in oil or water, making white lead, and separating the mineral alkali from common salt, all to be performed in one single process'"); see also C. MacLeod, Inventing the Industrial Revolution: The English Patent System, 1660-1800, pp. 84-93, 100-104, 109-110, 152-155 (1988) (listing patents) (hereinafter MacLeod).

[10] Some English cases made reference to the permissibility of patents over new "trades." But so far as I can tell, the term "trade" referred not to the methods of conducting business but rather to methods of making and using physical items or to the object of the trade. See, e.g., Clothworkers of Ipswich Case, 78 Eng. Rep. 147, 148 (K. B. 1603) ("[I]f a man hath brought in a new invention and a new trade within the kingdom . . . [the King] may grant by charter unto him").

[11] See also Pollack, The Multiple Unconstitutionality of Business Method Patents: Common Sense, Congressional Consideration, and Constitutional History, 28 Rutgers Computer & Tech. L.J. 61, 94-96 (2002) (hereinafter Pollack) (describing English practice).

[12] See id., at 95; B. Woodcroft, Alphabetical Index of Patentees of Inventions, from March 2, 1617 (14 James I) to October 1, 1852 (16 Victoriae) 383, 410 (2d ed.1969) (hereinafter Woodcroft).

[13] See, e.g., C. Ewen, Lotteries and Sweepstakes 70-71 (1932) (describing the "letters patent" to form a colony in Virginia and to operate lotteries to fund that colony).

[14] See also Renn, John Knox's Plan for Insuring Lives: A Patent of Invention in 1778, 101 J. Inst. Actuaries 285, 286 (1974) (hereinafter Renn) (describing the patent).

[15] "The English patent system" at that time "was one of simple registration. Extensive scrutiny was not expected of the law officers administering it." MacLeod 41. Thus, as one scholar suggested of the patent on life insurance, "perhaps the Law Officer was in a very good humour that day, or perhaps he had forgotten the wording of the statute; most likely he was concerned only with the promised `very considerable Consumption of [Revenue] Stamps' which [the patent holder] declared, would `contribute to the increase of the Public Revenues.'" Renn 285.

[16] See Markman v. Westview Instruments, Inc., 517 U.S. 370, 381, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996) ("[T]he state of patent law in the common-law courts before 1800 led one historian to observe that `the reported cases are destitute of any decision of importance'" (quoting Hulme, On the Consideration of the Patent Grant, Past and Present, 13 L.Q. Rev. 313, 318 (1897))); MacLeod 1, 61-62 (explaining the dearth of clear case law); see also Boulton v. Bull, 2 H. Bl. 463, 491, 126 Eng. Rep. 651, 665 (C.P. 1795) (Eyre, C.J.) ("Patent rights are no where that I can find accurately discussed in our books").

[17] See, e.g., A. DuBois, The English Business Company After the Bubble Act, 1720-1800, pp. 38-40, 435-438 (1938); Harris, The Bubble Act: Its Passage and its Effects on Business Organization, 54 J. Econ. Hist. 610, 624-625 (1994).

[18] See Pollack 97-100. For example, those who held patents on oil lamps developed firms that contracted to provide street lighting. See M. Falkus, Lighting in the Dark Ages of English Economic History: Town Streets before the Industrial Revolutions, in Trade, Government, and Economy in Pre-Industrial England 249, 255-257, 259-260 (D. Coleman & A. John eds.1976).

[19] See, e.g., G. Hammersley, The State and the English Iron Industry in the Sixteenth and Seventeenth Centuries, in id., at 166, 173, 175-178 (describing the advent of management techniques for efficiently running a major ironworks).

[20] See, e.g., Carlos & Nicholas, Agency Problems in Early Chartered Companies: The Case of the Hudson's Bay Company, 50 J. Econ. Hist. 853, 853-875 (1990).

[21] Nor, so far as I can tell, were business method patents common in the United States in the brief period between independence and the creation of our Constitution—despite the fact that it was a time of great business innovation, including new processes for engaging in risky trade and transport, one of which has been called "the quintessential business innovation of the 1780s." T. Doerflinger, A Vigorous Spirit of Enterprise: Merchants and Economic Development in Revolutionary Philadelphia 291 (1986) (describing new methods of conducting and financing trade with China).

[22] See Seidel, The Constitution and a Standard of Patentability, 48 J. Pat. Off. Soc. 5, 10 (1966) (hereinafter Seidel); Walterscheid, To Promote the Progress of Science and Useful Arts: The Background and Origin of the Intellectual Property Clause of the United States Constitution, 2 J. Intell. Prop. L. 1, 26 (1994) (hereinafter Walterscheid, Background and Origin); Walterscheid, To Promote the Progress 59, and n. 12; Prager, A History of Intellectual Property From 1545 to 1787, 26 J. Pat. Off. Soc. 711, 746 (1944).

[23] Walterscheid, Background and Origin 26; 2 Records of the Federal Convention of 1787, pp. 509-510 (M. Farrand ed. 1966).

[24] J. Madison, Notes of Debates in the Federal Convention of 1787, pp. 638-639 (Ohio Univ. Press ed.1966).

[25] See Walterscheid, Background and Origin 38, n. 124, 55-56 (collecting sources); see also The Objections of Hon. George Mason, One of the Delegates from Virginia, in the Late Continental Convention, to the Proposed Federal Constitution, Assigned as His Reasons For Not Signing the Same, 2 American Museum or Repository of Ancient and Modern Fugitive Pieces, etc. 534, 536 (1787) (reprint 1965); Ratification of the New Constitution by the Convention of the State of New York, 4 id., at 153, 156 (1789); Remarks on the Amendments to the Federal Constitution Proposed by The Conventions of Massachusetts, New Hampshire, New York, Virginia, South and North Carolina, with the Minorities of Pennsylvania and Maryland by the Rev. Nicholas Collin, D. D., 6 id., at 303, 303.

[26] Some scholars suggest that Webster's "close proximity to the Constitutional Convention coupled with his familiarity with the delegates makes it likely that he played some indirect role in the development" of the Constitution's Intellectual Property Clause—a Clause that established not only the power to create patents but also copyrights, a subject in which Webster had great interest. Donner, Copyright Clause of the U.S. Constitution: Why Did the Framers Include It With Unanimous Approval? 36 Am. J. Legal. Hist. 361, 372 (1992). But there is no direct evidence of this fact. See Walterscheid, Background and Origin 40-41.

[27] See, e.g., 1 S. Johnson, Dictionary of the English Language (1773) (reprint 1978) (listing as definitions of an "art": "[t]he power of doing something not taught by nature and instinct," "[a] science; as, the liberal arts," "[a] trade," "[a]rtfulness; skill; dexterity," "[c]unning," and "[s]peculation"). One might question the breadth of these definitions. This same dictionary offered as an example of "doing something not taught by nature and instinct," the art of "dance"; and as an example of a "trade," the art of "making sugar." Ibid.

[28] For examples of this usage, see Book of Trades or Library of Useful Arts (1807) (describing in a three-volume work 68 trades, each of which is the means of creating a product, such as feather worker or cork cutter); 1 J. Bigelow, The Useful Arts Considered in Connexion with the Applications of Science (1840) (surveying a history of what we would today call mechanics, technology, and engineering). See also D. Defoe, A General History of Discoveries and Improvements, in Useful Arts (1727); T. Coxe, An Address to an Assembly of the Friends of American Manufactures 17-18 (1787); G. Logan, A Letter to the Citizens of Pennsylvania, on the Necessity of Promoting Agriculture, Manufactures, and the Useful Arts 12-13 (2d ed. 1800); W. Kenrick, An Address to the Artists and Manufacturers of Great Britain 21-38 (1774); cf. Corning v. Burden, 15 How. 252, 267, 14 L.Ed. 683 (1854) (listing the "arts of tanning, dyeing, making water-proof cloth, vulcanizing India rubber, [and] smelting ores").

[29] See, e.g., 1 D. Chisum, Patents G1-23 (2010); Lutz, Patents and Science: A Clarification of the Patent Clause of the U.S. Constitution, 18 Geo. Wash. L.Rev. 50, 54 (1949-1950); Samuelson, Benson Revisited: The Case Against Patent Protection for Algorithms and Other Computer-Related Inventions, 39 Emory L.J. 1025, 1033, n. 24 (1990); Seidel 10, 13; see also Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 154, 71 S.Ct. 127, 95 L.Ed. 162 (1950) (Douglas, J., concurring) (explaining that in the Framers' view, an "invention, to justify a patent, had to serve the ends of science—to push back the frontiers of chemistry, physics, and the like; to make a distinctive contribution to scientific knowledge"); In re Waldbaum, 59 C.C.P.A. 940, 457 F.2d 997, 1003 (CCPA 1972) (Rich, J., concurring) ("`The phrase "technological arts," as we have used it, is synonymous with the phrase "useful arts" as it appears in Article I, Section 8 of the Constitution'"); Paulik v. Rizkalla, 760 F.2d 1270, 1276 (C.A.Fed. 1985) (explaining that "useful arts" is "the process today called technological innovation"); Thomas, The Post-Industrial Patent System, 10 Fordham Intell. Prop. Media & Ent. L.J. 3, 32-55 (1999) (cataloguing early understandings of technological arts). This view may be supported, for example, by an 1814 grant to Harvard University to create a "Professorship on the Application of Science to the Useful Arts," something that today might be akin to applied science or engineering. See M. James, Engineering an Environment for Change: Bigelow, Peirce, and Early Nineteenth-Century Practical Education at Harvard, in Science at Harvard University: Historical Perspectives 59 (C. Elliott & M. Rossiter eds.1992).

[30] See Walterscheid, To Promote the Progress 173-178; Pollack 107-108.

[31] These doubts ended by the time of Cochrane v. Deener, 94 U.S. 780, 24 L.Ed. 139 (1877), in which we held that "a process may be patentable irrespective of the particular form of the instrumentalities used," and therefore one may patent "an act, or series of acts, performed upon the subject matter to be transformed and reduced to a different state or thing." Id., at 788.

[32] A skeptic of patents, Jefferson described this as "drawing a line between things which are worth to the public the embarrassment of a patent, and those which are not." 13 Writings of Thomas Jefferson 335 (Memorial ed.1904).

[33] See, e.g., Expanded Metal Co. v. Bradford, 214 U.S. 366, 383, 385-386, 29 S.Ct. 652, 53 L.Ed. 1034 (1909); The Telephone Cases, 126 U.S., at 533-537, 8 S.Ct. 778; Cochrane, 94 U.S., at 787-788; Burden, 15 How., at 267-268, 14 L.Ed. 683.

[34] See also 1 A. Deller, Walker on Patents § 26, p. 152 (2d ed. 1964) (A "`system' or method of transacting business is not [a process], nor does it come within any other designation of patentable subject matter").

[35] Although a few patents issued before 1952 that related to methods of doing business, see United States Patent and Trademark Office, Automated Financial or Management Data Processing Methods, online at http://www.uspto.gov/web/menu/busmethp/index.html (all Internet materials as visited June 26, 2010, and available in Clerk of Court's case file), these patents were rare, often issued through self-registration rather than any formalized patent examination, generally were not upheld by courts, and arguably are distinguishable from pure patents on business methods insofar as they often involved the manufacture of new objects. See In re Bilski, 545 F.3d 943, 974, and n. 18 (C.A.Fed.2008) (case below) (Dyk, J., concurring); Pollack 74-75; Walterscheid, To Promote the Progress 243.

[36] For examples of such usage, see The Telephone Cases, 126 U.S., at 533, and Burden, 15 How., at 267, 14 L.Ed. 683.

[37] See also 98 Cong. Rec. A415 (1952) (remarks of Rep. Bryson) (describing, after the fact, the 1952 Patent Act, and explaining that "[t]he word `art' was changed to `process' in order to clarify its meaning. No change in substance was intended").

[38] The 1952 Act also retained the language "invents or discovers," which by that time had taken on a connotation that would tend to exclude business methods. See B. Evans & C. Evans, A Dictionary of Contemporary Usage 137 (1957) (explaining that "discover; invent" means "to make or create something new, especially, in modern usage, something ingeniously devised to perform mechanical operations").

[39] As explained in Part II, supra, the Court engages in a Jekyll-and-Hyde form of interpretation with respect to the word "process" in § 101. It rejects the interpretation I proffer because the words "process" and "method" do not, on their face, distinguish between different series of acts. Ante, at 3228. But it also rejects many sorts of processes without a textual basis for doing so. See ante, at 3224-3225, 3226, 3229-3231. And while the Courts rests a great deal of weight on Parker v. Flook, 437 U.S. 584, 98 S.Ct. 2522, 57 L.Ed.2d 451 (1978), for its analysis of abstract ideas, the Court minimizes Flook's rejection of "a purely literal reading of § 101," as well as Flook's reliance on the historical backdrop of § 101 and our understanding of what "the statute was enacted to protect," id., at 588-590, 593, 98 S.Ct. 2522; see also Diamond v. Diehr, 450 U.S. 175, 192, 101 S.Ct. 1048, 67 L.Ed.2d 155 (1981) (explaining that a "claim satisfies the requirements of § 101" when it "is performing a function which the patent laws were designed to protect").

[40] Forty years later, Judge Rich authored the State Street opinion that some have understood to make business methods patentable. But State Street dealt with whether a piece of software could be patented and addressed only claims directed at machines, not processes. His opinion may therefore be better understood merely as holding that an otherwise patentable process is not unpatentable simply because it is directed toward the conduct of doing business—an issue the Court has no occasion to address today. See State Street, 149 F.3d, at 1375.

[41] See also 145 Cong. Rec. 30985 (1999) (remarks of Sen. Schumer) (explaining that "[i]n State Street, the Court did away with the so-called `business methods' exception to statutory patentable subject matter," and "[t]he first inventor defense will provide ... important, needed protections in the face of the uncertainty presented by ... the State Street case"); id., at 31007 (remarks of Sen. DeWine) ("Virtually no one in the industry believed that these methods or processes were patentable"); id., at 19281 (remarks of Rep. Manzullo) ("Before the State Street Bank and Trust case ... it was universally thought that methods of doing or conducting business were not patentable items").

[42] The Court opines that "[t]his principle, of course, applies to interpreting any two provisions in the U.S.Code, even when Congress enacted the provisions at different times." Ante, at 3229 (emphasis added). The only support the Court offers for this proposition is a 1937 opinion for three Justices, in Hague v. Committee for Industrial Organization, 307 U.S. 496, 528-530, 59 S.Ct. 954, 83 L.Ed. 1423 (1939) (opinion of Stone, J.). But that opinion is inapposite. Although Justice Stone stated that two provisions "must be read together," id., at 530, 59 S.Ct. 954, he did so to explain that an ambiguity in a later-in-time statute must be understood in light of the earlier-in-time framework against which the ambiguous statute was passed, id., at 528-530, 59 S.Ct. 954, particularly because the later statute explicitly stated that it "shall not be construed to apply" to the provision created by an earlier Act, id., at 528, 59 S.Ct. 954.

[43] I am not trying to "overcome" an "established rule of statutory interpretation" with "judicial speculation as to the subjective intent of various legislators," ante, at 3229, but, rather, I am explaining why the Court has illogically expanded the canon upon which it relies beyond that canon's logical underpinnings.

[44] See also Quanta Computer, Inc. v. LG Electronics, Inc., 553 U.S. 617, 626, 128 S.Ct. 2109, 170 L.Ed.2d 996 (2008) ("`[T]he primary purpose of our patent laws is not the creation of private fortunes for the owners of patents but is "to promote the progress of science and useful arts"'" (quoting Motion Picture Patents Co. v. Universal Film Mfg. Co., 243 U.S. 502, 511, 37 S.Ct. 416, 61 L.Ed. 871 (1917))); Pfaff v. Wells Electronics, Inc., 525 U.S. 55, 63, 119 S.Ct. 304, 142 L.Ed.2d 261 (1998) ("[T]he patent system represents a carefully crafted bargain that encourages both the creation and the public disclosure of new and useful advances in technology").

[45] See generally W. Landes & R. Posner, The Economic Structure of Intellectual Property Law 13-15 (2003).

[46] See, e.g., Burk & Lemley, Policy Levers in Patent Law, 89 Va. L.Rev. 1575, 1577-1589 (2003) (hereinafter Burk & Lemley).

[47] See, e.g., Burk & Lemley 1618; Carrier, Unraveling the Patent-Antitrust Paradox, 150 U. Pa. L.Rev. 761, 826 (2002) (hereinafter Carrier); Dreyfuss, Are Business Methods Patents Bad for Business? 16 Santa Clara Computer & High Tech. L.J. 263, 274-277 (2000) (hereinafter Dreyfuss); Posner, The Law and Economics of Intellectual Property, 131 Daedalus 5 (Spring 2002).

[48] C. Coolidge, The Press Under a Free Government, in Foundations of the Republic: Speeches and Addresses 187 (1926).

[49] See also Pollack 75-76 ("Since business methods are `useful' when they directly earn revenue, they are inherently unlikely to be underproduced").

[50] See R. Levin et al., Appropriating the Returns from Industrial Research and Development, in 3 Brookings Papers on Econ. Activity 794-795 (1987).

[51] See Burk & Lemley 1618; Dreyfuss 275; see generally Carrier 821-823. Concededly, there may some methods of doing business that do not confer sufficient first-mover advantages. See Abramowicz & Duffy, Intellectual Property for Market Experimentation, 83 N.Y.U. & ensp; L.Rev. 337, 340-342 (2008).

[52] See Burk & Lemley 1618; Carrier 826; Olson, Taking the Utilitarian Basis for Patent Law Seriously: The Case For Restricting Patentable Subject Matter, 82 Temp. L.Rev. 181, 231 (2009).

[53] See Dreyfuss 276; Merges & Nelson, On the Complex Economics of Patent Scope, 90 Colum. L.Rev. 839, 873-878 (1990).

[54] See also Raskind, The State Street Bank Decision, The Bad Business of Unlimited Patent Protection for Methods of Doing Business, 10 Fordham Intell. Prop. Media & Ent. L.J. 61, 102 (1999) ("Interactive emulation more than innovation is the driving force of business method changes").

[55] There is substantial academic debate, moreover, about whether the normal process of screening patents for novelty and obviousness can function effectively for business methods. The argument goes that because business methods are both vague and not confined to any one industry, there is not a well-confined body of prior art to consult, and therefore many "bad" patents are likely to issue, a problem that would need to be sorted out in later litigation. See, e.g., Dreyfuss 268-270; Eisenberg, Analyze This: A Law and Economics Agenda for the Patent System, 53 Vand. L.Rev.2081, 2090 (2000); Merges 589-590.

[56] See also J. Bessen & M. Meurer, Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovators at Risk 46-72 (2008) (hereinafter Bessen & Meurer); P. Menell & S. Scotchmer, Intellectual Property Law, in 2 Handbook of Law and Economics 1500-1501, 1506 (M. Polinsky & S. Shavell eds.2007). Concededly, alterations in the remedy structure, such as the First Inventor Defense Act of 1999, § 4301 et seq., 113 Stat. 1536, codified at 35 U.S.C. § 273, mitigate these costs.

[57] See generally Farrell & Shapiro, How Strong Are Weak Patents? 98 Amer. Econ. Rev. 1347 (2008); Meurer, Controlling Opportunistic and Anti-Competitive Intellectual Property Litigation, 44 Boston College L.Rev. 509 (2003); Moore, Populism and Patents, 82 N.Y. U. L.Rev. 69, 90-91 (2007).

[58] See Bessen & Meurer 176; Lessig, The Death of Cyberspace, 57 Wash. & Lee L.Rev. 337, 346-347 (2000).

[59] Congress and the courts have worked long and hard to create and administer antitrust laws that ensure businesses cannot prevent each other from competing vigorously. If methods of conducting business were themselves patentable, then virtually any novel, nonobvious business method could be granted a federally protected monopoly. The tension this might create with our antitrust regime provides yet another reason for skepticism that Congress would have wanted the patent laws to extend to business methods.

2.2 Ass'n for Molecular Pathology v. Myriad 2.2 Ass'n for Molecular Pathology v. Myriad

133 S.Ct. 2107 (2013)

ASSOCIATION FOR MOLECULAR PATHOLOGY et al., Petitioners
v.
MYRIAD GENETICS, INC., et al.

No. 12-398.

Supreme Court of United States.

Argued April 15, 2013.
Decided June 13, 2013.

[2110] Christopher A. Hansen, Glenwood, MD, for Petitioners.

Donald B. Verrilli, Jr., Solicitor General, for the United States as amicus curiae, by special leave of the court, supporting neither party.

Gregory A. Castanias, Washington, DC, for Respondents.

Daniel B. Ravicher, Sabrina Y. Hassan, Public Patent Foundation (PUBPAT), Benjamin N. Cardozo, School of Law, New York, NY, Christopher A. Hansen, Counsel of Record, Sandra S. Park, Lenora M. Lapidus, Steven R. Shapiro, New York, NY, for Petitioners.

Justice THOMAS delivered the opinion of the Court.

Respondent Myriad Genetics, Inc. (Myriad), discovered the precise location and [2111] sequence of two human genes, mutations of which can substantially increase the risks of breast and ovarian cancer. Myriad obtained a number of patents based upon its discovery. This case involves claims from three of them and requires us to resolve whether a naturally occurring segment of deoxyribonucleic acid (DNA) is patent eligible under 35 U.S.C. § 101 by virtue of its isolation from the rest of the human genome. We also address the patent eligibility of synthetically created DNA known as complementary DNA (cDNA), which contains the same protein-coding information found in a segment of natural DNA but omits portions within the DNA segment that do not code for proteins. For the reasons that follow, we hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring. We, therefore, affirm in part and reverse in part the decision of the United States Court of Appeals for the Federal Circuit.

I

A

Genes form the basis for hereditary traits in living organisms. See generally Association for Molecular Pathology v. United States Patent and Trademark Office, 702 F.Supp.2d 181, 192-211 (S.D.N.Y. 2010). The human genome consists of approximately 22,000 genes packed into 23 pairs of chromosomes. Each gene is encoded as DNA, which takes the shape of the familiar "double helix" that Doctors James Watson and Francis Crick first described in 1953. Each "cross-bar" in the DNA helix consists of two chemically joined nucleotides. The possible nucleotides are adenine (A), thymine (T), cytosine (C), and guanine (G), each of which binds naturally with another nucleotide: A pairs with T; C pairs with G. The nucleotide cross-bars are chemically connected to a sugar-phosphate backbone that forms the outside framework of the DNA helix. Sequences of DNA nucleotides contain the information necessary to create strings of amino acids, which in turn are used in the body to build proteins. Only some DNA nucleotides, however, code for amino acids; these nucleotides are known as "exons." Nucleotides that do not code for amino acids, in contrast, are known as "introns."

Creation of proteins from DNA involves two principal steps, known as transcription and translation. In transcription, the bonds between DNA nucleotides separate, and the DNA helix unwinds into two single strands. A single strand is used as a template to create a complementary ribonucleic acid (RNA) strand. The nucleotides on the DNA strand pair naturally with their counterparts, with the exception that RNA uses the nucleotide base uracil (U) instead of thymine (T). Transcription results in a single strand RNA molecule, known as pre-RNA, whose nucleotides form an inverse image of the DNA strand from which it was created. Pre-RNA still contains nucleotides corresponding to both the exons and introns in the DNA molecule. The pre-RNA is then naturally "spliced" by the physical removal of the introns. The resulting product is a strand of RNA that contains nucleotides corresponding only to the exons from the original DNA strand. The exons-only strand is known as messenger RNA (mRNA), which creates amino acids through translation. In translation, cellular structures known as ribosomes read each set of three nucleotides, known as codons, in the mRNA. Each codon either tells the ribosomes which of the 20 possible amino acids to synthesize or provides a stop signal that ends amino acid production.

[2112] DNA's informational sequences and the processes that create mRNA, amino acids, and proteins occur naturally within cells. Scientists can, however, extract DNA from cells using well known laboratory methods. These methods allow scientists to isolate specific segments of DNA — for instance, a particular gene or part of a gene — which can then be further studied, manipulated, or used. It is also possible to create DNA synthetically through processes similarly well known in the field of genetics. One such method begins with an mRNA molecule and uses the natural bonding properties of nucleotides to create a new, synthetic DNA molecule. The result is the inverse of the mRNA's inverse image of the original DNA, with one important distinction: Because the natural creation of mRNA involves splicing that removes introns, the synthetic DNA created from mRNA also contains only the exon sequences. This synthetic DNA created in the laboratory from mRNA is known as complementary DNA (cDNA).

Changes in the genetic sequence are called mutations. Mutations can be as small as the alteration of a single nucleotide — a change affecting only one letter in the genetic code. Such small-scale changes can produce an entirely different amino acid or can end protein production altogether. Large changes, involving the deletion, rearrangement, or duplication of hundreds or even millions of nucleotides, can result in the elimination, misplacement, or duplication of entire genes. Some mutations are harmless, but others can cause disease or increase the risk of disease. As a result, the study of genetics can lead to valuable medical breakthroughs.

B

This case involves patents filed by Myriad after it made one such medical breakthrough. Myriad discovered the precise location and sequence of what are now known as the BRCA1 and BRCA2 genes. Mutations in these genes can dramatically increase an individual's risk of developing breast and ovarian cancer. The average American woman has a 12- to 13-percent risk of developing breast cancer, but for women with certain genetic mutations, the risk can range between 50 and 80 percent for breast cancer and between 20 and 50 percent for ovarian cancer. Before Myriad's discovery of the BRCA1 and BRCA2 genes, scientists knew that heredity played a role in establishing a woman's risk of developing breast and ovarian cancer, but they did not know which genes were associated with those cancers.

Myriad identified the exact location of the BRCA1 and BRCA2 genes on chromosomes 17 and 13. Chromosome 17 has approximately 80 million nucleotides, and chromosome 13 has approximately 114 million. Association for Molecular Pathology v. United States Patent and Trademark Office, 689 F.3d 1303, 1328 (C.A.Fed.2012). Within those chromosomes, the BRCA1 and BRCA2 genes are each about 80,000 nucleotides long. If just exons are counted, the BRCA1 gene is only about 5,500 nucleotides long; for the BRCA2 gene, that number is about 10,200. Ibid. Knowledge of the location of the BRCA1 and BRCA2 genes allowed Myriad to determine their typical nucleotide sequence.[1] That information, in turn, enabled Myriad to develop medical tests that are useful for detecting mutations in a patient's BRCA1 and BRCA2 genes and thereby assessing [2113] whether the patient has an increased risk of cancer.

Once it found the location and sequence of the BRCA1 and BRCA2 genes, Myriad sought and obtained a number of patents. Nine composition claims from three of those patents are at issue in this case.[2] See id., at 1309, and n. 1 (noting composition claims). Claims 1, 2, 5, and 6 from the '282 patent are representative. The first claim asserts a patent on "[a]n isolated DNA coding for a BRCA1 polypeptide," which has "the amino acid sequence set forth in SEQ ID NO:2." App. 822. SEQ ID NO:2 sets forth a list of 1,863 amino acids that the typical BRCA1 gene encodes. See id., at 785-790. Put differently, claim 1 asserts a patent claim on the DNA code that tells a cell to produce the string of BRCA1 amino acids listed in SEQ ID NO:2.

Claim 2 of the '282 patent operates similarly. It claims "[t]he isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1." Id., at 822. Like SEQ ID NO:2, SEQ ID NO:1 sets forth a long list of data, in this instance the sequence of cDNA that codes for the BRCA1 amino acids listed in claim 1. Importantly, SEQ ID NO:1 lists only the cDNA exons in the BRCA1 gene, rather than a full DNA sequence containing both exons and introns. See id., at 779 (stating that SEQ ID NO:1's "MOLECULE TYPE:" is "cDNA"). As a result, the Federal Circuit recognized that claim 2 asserts a patent on the cDNA nucleotide sequence listed in SEQ ID NO:1, which codes for the typical BRCA1 gene. 689 F.3d, at 1326, n. 9; id., at 1337 (Moore, J., concurring in part); id., at 1356 (Bryson, J., concurring in part and dissenting in part).

Claim 5 of the '282 patent claims a subset of the data in claim 1. In particular, it claims "[a]n isolated DNA having at least 15 nucleotides of the DNA of claim 1." App. 822. The practical effect of claim 5 is to assert a patent on any series of 15 nucleotides that exist in the typical BRCA1 gene. Because the BRCA1 gene is thousands of nucleotides long, even BRCA1 genes with substantial mutations are likely to contain at least one segment of 15 nucleotides that correspond to the typical BRCA1 gene. Similarly, claim 6 of the '282 patent claims "[a]n isolated DNA having at least 15 nucleotides of the DNA of claim 2." Ibid. This claim operates similarly to claim 5, except that it references the cDNA-based claim 2. The remaining claims at issue are similar, though several list common mutations rather than typical BRCA1 and BRCA2 sequences. See ibid. (claim 7 of the '282 patent); id., at 930 (claim 1 of the '473 patent); id., at 1028 (claims 1, 6, and 7 of the '492 patent).

C

Myriad's patents would, if valid, give it the exclusive right to isolate an individual's BRCA1 and BRCA2 genes (or any strand of 15 or more nucleotides within the genes) by breaking the covalent bonds that connect the DNA to the rest of the individual's genome. The patents would also give Myriad the exclusive right to synthetically create BRCA cDNA. In Myriad's view, manipulating BRCA DNA in either of these fashions triggers its "right to exclude others from making" its patented composition of matter under the Patent Act. 35 U.S.C. § 154(a)(1); see also § 271(a) ("[W]hoever without authority [2114] makes ... any patented invention ... infringes the patent").

But isolation is necessary to conduct genetic testing, and Myriad was not the only entity to offer BRCA testing after it discovered the genes. The University of Pennsylvania's Genetic Diagnostic Laboratory (GDL) and others provided genetic testing services to women. Petitioner Dr. Harry Ostrer, then a researcher at New York University School of Medicine, routinely sent his patients' DNA samples to GDL for testing. After learning of GDL's testing and Ostrer's activities, Myriad sent letters to them asserting that the genetic testing infringed Myriad's patents. App. 94-95 (Ostrer letter). In response, GDL agreed to stop testing and informed Ostrer that it would no longer accept patient samples. Myriad also filed patent infringement suits against other entities that performed BRCA testing, resulting in settlements in which the defendants agreed to cease all allegedly infringing activity. 689 F.3d, at 1315. Myriad, thus, solidified its position as the only entity providing BRCA testing.

Some years later, petitioner Ostrer, along with medical patients, advocacy groups, and other doctors, filed this lawsuit seeking a declaration that Myriad's patents are invalid under 35 U.S.C. § 101. 702 F.Supp.2d, at 186. Citing this Court's decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118, 127 S.Ct. 764, 166 L.Ed.2d 604 (2007), the District Court denied Myriad's motion to dismiss for lack of standing. Association for Molecular Pathology v. United States Patent and Trademark Office, 669 F.Supp.2d 365, 385-392 (S.D.N.Y.2009). The District Court then granted summary judgment to petitioners on the composition claims at issue in this case based on its conclusion that Myriad's claims, including claims related to cDNA, were invalid because they covered products of nature. 702 F.Supp.2d, at 220-237. The Federal Circuit reversed, Association for Molecular Pathology v. United States Patent and Trademark Office, 653 F.3d 1329 (2011), and this Court granted the petition for certiorari, vacated the judgment, and remanded the case in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___, 132 S.Ct. 1289, 182 L.Ed.2d 321 (2012). See Association for Molecular Pathology v. Myriad Genetics, Inc., 566 U.S. ___, 133 S.Ct. 694, 184 L.Ed.2d 496 (2012).

On remand, the Federal Circuit affirmed the District Court in part and reversed in part, with each member of the panel writing separately. All three judges agreed that only petitioner Ostrer had standing. They reasoned that Myriad's actions against him and his stated ability and willingness to begin BRCA1 and BRCA2 testing if Myriad's patents were invalidated were sufficient for Article III standing. 689 F.3d, at 1323; id., at 1337 (opinion of Moore, J.); id., at 1348 (opinion of Bryson, J.).

With respect to the merits, the court held that both isolated DNA and cDNA were patent eligible under § 101. The central dispute among the panel members was whether the act of isolating DNA — separating a specific gene or sequence of nucleotides from the rest of the chromosome — is an inventive act that entitles the individual who first isolates it to a patent. Each of the judges on the panel had a different view on that question. Judges Lourie and Moore agreed that Myriad's claims were patent eligible under § 101 but disagreed on the rationale. Judge Lourie relied on the fact that the entire DNA molecule is held together by chemical bonds and that the covalent bonds at both ends of the segment must be severed in order to isolate segments of DNA. This [2115] process technically creates new molecules with unique chemical compositions. See id., at 1328 ("Isolated DNA ... is a free-standing portion of a larger, natural DNA molecule. Isolated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule"). Judge Lourie found this chemical alteration to be dispositive, because isolating a particular strand of DNA creates a nonnaturally occurring molecule, even though the chemical alteration does not change the informationtransmitting quality of the DNA. See id., at 1330 ("The claimed isolated DNA molecules are distinct from their natural existence as portions of larger entities, and their informational content is irrelevant to that fact. We recognize that biologists may think of molecules in terms of their uses, but genes are in fact materials having a chemical nature"). Accordingly, he rejected petitioners' argument that isolated DNA was ineligible for patent protection as a product of nature.

Judge Moore concurred in part but did not rely exclusively on Judge Lourie's conclusion that chemically breaking covalent bonds was sufficient to render isolated DNA patent eligible. Id., at 1341 ("To the extent the majority rests its conclusion on the chemical differences between [naturally occurring] and isolated DNA (breaking the covalent bonds), I cannot agree that this is sufficient to hold that the claims to human genes are directed to patentable subject matter"). Instead, Judge Moore also relied on the United States Patent and Trademark Office's (PTO) practice of granting such patents and on the reliance interests of patent holders. Id., at 1343. However, she acknowledged that her vote might have come out differently if she "were deciding this case on a blank canvas." Ibid.

Finally, Judge Bryson concurred in part and dissented in part, concluding that isolated DNA is not patent eligible. As an initial matter, he emphasized that the breaking of chemical bonds was not dispositive: "[T]here is no magic to a chemical bond that requires us to recognize a new product when a chemical bond is created or broken." Id., at 1351. Instead, he relied on the fact that "[t]he nucleotide sequences of the claimed molecules are the same as the nucleotide sequences found in naturally occurring human genes." Id., at 1355. Judge Bryson then concluded that genetic "structural similarity dwarfs the significance of the structural differences between isolated DNA and naturally occurring DNA, especially where the structural differences are merely ancillary to the breaking of covalent bonds, a process that is itself not inventive." Ibid. Moreover, Judge Bryson gave no weight to the PTO's position on patentability because of the Federal Circuit's position that "the PTO lacks substantive rulemaking authority as to issues such as patentability." Id., at 1357.

Although the judges expressed different views concerning the patentability of isolated DNA, all three agreed that patent claims relating to cDNA met the patent eligibility requirements of § 101. Id., at 1326, and n. 9 (recognizing that some patent claims are limited to cDNA and that such claims are patent eligible under § 101); id., at 1337 (Moore, J., concurring in part); id., at 1356 (Bryson, J., concurring in part and dissenting in part) ("cDNA cannot be isolated from nature, but instead must be created in the laboratory... because the introns that are found in the native gene are removed from the cDNA segment").[3] We granted certiorari. [2116] 568 U.S. ___, 133 S.Ct. 694, 184 L.Ed.2d 496 (2012).

II

A

Section 101 of the Patent Act provides:

"Whoever invents or discovers any new and useful ... 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.

We have "long held that this provision contains an important implicit exception[:] Laws of nature, natural phenomena, and abstract ideas are not patentable." Mayo, 566 U.S., at ___, 132 S.Ct., at 1293 (internal quotation marks and brackets omitted). Rather, "`they are the basic tools of scientific and technological work'" that lie beyond the domain of patent protection. Id., at ___, 132 S.Ct., at 1293. As the Court has explained, without this exception, there would be considerable danger that the grant of patents would "tie up" the use of such tools and thereby "inhibit future innovation premised upon them." Id., at ___, 132 S.Ct., at 1301. This would be at odds with the very point of patents, which exist to promote creation. Diamond v. Chakrabarty, 447 U.S. 303, 309, 100 S.Ct. 2204, 65 L.Ed.2d 144 (1980) (Products of nature are not created, and "`manifestations... of nature [are] free to all men and reserved exclusively to none'").

The rule against patents on naturally occurring things is not without limits, however, for "all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas," and "too broad an interpretation of this exclusionary principle could eviscerate patent law." 566 U.S., at ___, 132 S.Ct., at 1293. As we have recognized before, patent protection strikes a delicate balance between creating "incentives that lead to creation, invention, and discovery" and "imped[ing] the flow of information that might permit, indeed spur, invention." Id., at ___, 132 S.Ct., at 1305. We must apply this well-established standard to determine whether Myriad's patents claim any "new and useful ... composition of matter," § 101, or instead claim naturally occurring phenomena.

B

It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA. Instead, Myriad's principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13. The question is whether this renders the genes patentable.

Myriad recognizes that our decision in Chakrabarty is central to this inquiry. Brief for Respondents 14, 23-27. In Chakrabarty, scientists added four plasmids to a bacterium, which enabled it to break down various components of crude oil. 447 U.S., at 305, and n. 1, 100 S.Ct. 2204. The Court held that the modified bacterium was patentable. It explained [2117] that the patent claim was "not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter — a product of human ingenuity `having a distinctive name, character [and] use.'" Id., at 309-310, 100 S.Ct. 2204 (quoting Hartranft v. Wiegmann, 121 U.S. 609, 615, 7 S.Ct. 1240, 30 L.Ed. 1012 (1887); alteration in original). The Chakrabarty bacterium was new "with markedly different characteristics from any found in nature," 447 U.S., at 310, 100 S.Ct. 2204, due to the additional plasmids and resultant "capacity for degrading oil." Id., at 305, n. 1, 100 S.Ct. 2204. In this case, by contrast, Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.

Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry. In Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 68 S.Ct. 440, 92 L.Ed. 588 (1948), this Court considered a composition patent that claimed a mixture of naturally occurring strains of bacteria that helped leguminous plants take nitrogen from the air and fix it in the soil. Id., at 128-129, 68 S.Ct. 440. The ability of the bacteria to fix nitrogen was well known, and farmers commonly "inoculated" their crops with them to improve soil nitrogen levels. But farmers could not use the same inoculant for all crops, both because plants use different bacteria and because certain bacteria inhibit each other. Id., at 129-130, 68 S.Ct. 440. Upon learning that several nitrogen-fixing bacteria did not inhibit each other, however, the patent applicant combined them into a single inoculant and obtained a patent. Id., at 130, 68 S.Ct. 440. The Court held that the composition was not patent eligible because the patent holder did not alter the bacteria in any way. Id., at 132, 68 S.Ct. 440 ("There is no way in which we could call [the bacteria mixture a product of invention] unless we borrowed invention from the discovery of the natural principle itself"). His patent claim thus fell squarely within the law of nature exception. So do Myriad's. Myriad found the location of the BRCA1 and BRCA2 genes, but that discovery, by itself, does not render the BRCA genes "new ... composition[s] of matter," § 101, that are patent eligible.

Indeed, Myriad's patent descriptions highlight the problem with its claims. For example, a section of the '282 patent's Detailed Description of the Invention indicates that Myriad found the location of a gene associated with increased risk of breast cancer and identified mutations of that gene that increase the risk. See App. 748-749.[4] In subsequent language Myriad explains that the location of the gene was unknown until Myriad found it among the approximately eight million nucleotide pairs contained in a subpart of chromosome [2118] 17. See Ibid.[5] The '473 and '492 patents contain similar language as well. See id., at 854, 947. Many of Myriad's patent descriptions simply detail the "iterative process" of discovery by which Myriad narrowed the possible locations for the gene sequences that it sought.[6] See, e.g., id., at 750. Myriad seeks to import these extensive research efforts into the § 101 patent-eligibility inquiry. Brief for Respondents 8-10, 34. But extensive effort alone is insufficient to satisfy the demands of § 101.

Nor are Myriad's claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule. Myriad's claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes. If the patents depended upon the creation of a unique molecule, then a would-be infringer could arguably avoid at least Myriad's patent claims on entire genes (such as claims 1 and 2 of the '282 patent) by isolating a DNA sequence that included both the BRCA1 or BRCA2 gene and one additional nucleotide pair. Such a molecule would not be chemically identical to the molecule "invented" by Myriad. But Myriad obviously would resist that outcome because its claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.

Finally, Myriad argues that the PTO's past practice of awarding gene patents is entitled to deference, citing J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc., 534 U.S. 124, 122 S.Ct. 593, 151 L.Ed.2d 508 (2001). See Brief for Respondents 35-39, 49-50. We disagree. J.E.M. held that new plant breeds were eligible for utility patents under § 101 notwithstanding separate statutes providing special protections for plants, see 7 U.S.C. § 2321 et seq. (Plant Variety Protection Act); 35 U.S.C. §§ 161-164 (Plant Patent Act of 1930). After analyzing the text and structure of the relevant statutes, the Court mentioned that the Board of Patent Appeals and Interferences had determined that new plant breeds were patent eligible under § 101 and that Congress had recognized and endorsed that position in a subsequent Patent Act amendment. 534 U.S., at 144-145, 122 S.Ct. 593 (citing In re Hibberd, 227 U.S.P.Q. 443 (1985) and 35 U.S.C. § 119(f)). In this case, however, Congress has not endorsed the views of the PTO in subsequent legislation. While Myriad relies on Judge Moore's view that Congress endorsed the PTO's position in a single sentence in the Consolidated Appropriations Act of 2004, see Brief for Respondents 31, n. 8; 689 F.3d, at 1346, that Act does not even mention genes, much [2119] less isolated DNA. § 634, 118 Stat. 101 ("None of the funds appropriated or otherwise made available under this Act may be used to issue patents on claims directed to or encompassing a human organism").

Further undercutting the PTO's practice, the United States argued in the Federal Circuit and in this Court that isolated DNA was not patent eligible under § 101, Brief for United States as Amicus Curiae 20-33, and that the PTO's practice was not "a sufficient reason to hold that isolated DNA is patent-eligible." Id., at 26. See also id., at 28-29. These concessions weigh against deferring to the PTO's determination.[7]

C

cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. As already explained, creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring.[8] Petitioners concede that cDNA differs from natural DNA in that "the non-coding regions have been removed." Brief for Petitioners 49. They nevertheless argue that cDNA is not patent eligible because "[t]he nucleotide sequence of cDNA is dictated by nature, not by the lab technician." Id., at 51. That may be so, but the lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a "product of nature" and is patent eligible under § 101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.[9]

III

It is important to note what is not implicated by this decision. First, there are no method claims before this Court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. But the processes used by Myriad to isolate DNA were well understood by geneticists at the time of Myriad's patents "were well understood, widely used, and fairly uniform insofar [2120] as any scientist engaged in the search for a gene would likely have utilized a similar approach," 702 F.Supp.2d, at 202-203, and are not at issue in this case.

Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. Judge Bryson aptly noted that, "[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications of that knowledge. Many of its unchallenged claims are limited to such applications." 689 F.3d, at 1349.

Nor do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Scientific alteration of the genetic code presents a different inquiry, and we express no opinion about the application of § 101 to such endeavors. We merely hold that genes and the information they encode are not patent eligible under § 101 simply because they have been isolated from the surrounding genetic material.

* * *

For the foregoing reasons, the judgment of the Federal Circuit is affirmed in part and reversed in part.

It is so ordered.

Justice SCALIA, concurring in part and concurring in the judgment.

I join the judgment of the Court, and all of its opinion except Part I-A and some portions of the rest of the opinion going into fine details of molecular biology. I am unable to affirm those details on my own knowledge or even my own belief. It suffices for me to affirm, having studied the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA (cDNA) is a synthetic creation not normally present in nature.

[1] Technically, there is no "typical" gene because nucleotide sequences vary between individuals, sometimes dramatically. Geneticists refer to the most common variations of genes as "wild types."

[2] At issue are claims 1, 2, 5, 6, and 7 of U.S. Patent 5,747,282 (the '282 patent), claim 1 of U.S. Patent 5,693,473 (the '473 patent), and claims 1, 6, and 7 of U.S. Patent 5,837,492 (the '492 patent).

[3] Myriad continues to challenge Dr. Ostrer's Declaratory Judgment Act standing in this Court. Brief for Respondents 17-22. But we find that, under the Court's decision in MedImmune, Inc. v. Genentech, Inc., Dr. Ostrer has alleged sufficient facts "under all the circumstances, [to] show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment." 549 U.S. 118, 127, 127 S.Ct. 764, 166 L.Ed.2d 604 (2007) (internal quotation marks omitted).

[4] The full relevant text of the Detailed Description of the Patent is as follows:

"It is a discovery of the present invention that the BRCA1 locus which predisposes individuals to breast cancer and ovarian cancer, is a gene encoding a BRCA1 protein, which has been found to have no significant homology with known protein or DNA sequences.... It is a discovery of the present invention that mutations in the BRCA1 locus in the germline are indicative of a predisposition to breast cancer and ovarian cancer. Finally, it is a discovery of the present invention that somatic mutations in the BRCA1 locus are also associated with breast cancer, ovarian cancer and other cancers, which represents an indicator of these cancers or of the prognosis of these cancers. The mutational events of the BRCA1 locus can involve deletions, insertions and point mutations." App. 749.

Notwithstanding Myriad's repeated use of the phrase "present invention," it is clear from the text of the patent that the various discoveries are the "invention."

[5] "Starting from a region on the long arm of human chromosome 17 of the human genome, 17q, which has a size estimated at about 8 million base pairs, a region which contains a genetic locus, BRCA1, which causes susceptibility to cancer, including breast and ovarian cancer, has been identified." Ibid.

[6] Myriad first identified groups of relatives with a history of breast cancer (some of whom also had developed ovarian cancer); because these individuals were related, scientists knew that it was more likely that their diseases were the result of genetic predisposition rather than other factors. Myriad compared sections of their chromosomes, looking for shared genetic abnormalities not found in the general population. It was that process which eventually enabled Myriad to determine where in the genetic sequence the BRCA1 and BRCA2 genes reside. See, e.g., id., at 749, 763-775.

[7] Myriad also argues that we should uphold its patents so as not to disturb the reliance interests of patent holders like itself. Brief for Respondents 38-39. Concerns about reliance interests arising from PTO determinations, insofar as they are relevant, are better directed to Congress. See Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___, ___, 132 S.Ct. 1289, 1304-05, 182 L.Ed.2d 321 (2012).

[8] Some viruses rely on an enzyme called reverse transcriptase to reproduce by copying RNA into cDNA. In rare instances, a side effect of a viral infection of a cell can be the random incorporation of fragments of the resulting cDNA, known as a pseudogene, into the genome. Such pseudogenes serve no purpose; they are not expressed in protein creation because they lack genetic sequences to direct protein expression. See J. Watson et al., Molecular Biology of the Gene 142, 144, fig. 7-5 (6th ed. 2008). Perhaps not surprisingly, given pseudogenes' apparently random origins, petitioners "have failed to demonstrate that the pseudogene consists of the same sequence as the BRCA1 cDNA." Association for Molecular Pathology v. United States Patent and Trademark Office, 689 F.3d 1303, 1356, n. 5 (C.A.Fed.2012). The possibility that an unusual and rare phenomenon might randomly create a molecule similar to one created synthetically through human ingenuity does not render a composition of matter nonpatentable.

[9] We express no opinion whether cDNA satisfies the other statutory requirements of patentability. See, e.g., 35 U.S.C. §§ 102, 103, and 112; Brief for United States as Amicus Curiae 19, n. 5.

2.3 Mayo Collaborative Services. v. Prometheus Labs, Inc. 2.3 Mayo Collaborative Services. v. Prometheus Labs, Inc.

132 S.Ct. 1289 (2012)

MAYO COLLABORATIVE SERVICES, dba Mayo Medical Laboratories, et al., Petitioners
v.
PROMETHEUS LABORATORIES, INC.

No. 10-1150.

Supreme Court of the United States.

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

[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, Jeffrey W. Sarles, Mayer Brown LLP, Chicago, IL, Eugene 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 Ballenger, Maximilian A. Grant, Matthew J. Moore, Gabriel K. Bell, Latham & Watkins LLP, Washington, DC, for Respondent.

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. ___, ___, 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 [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 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 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 practice 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 ___, 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 [1295] diseases, such as Crohn's disease and ulcerative colitis. When a patient ingests a thiopurine compound, his body metabolizes the drug, causing metabolites to form in his bloodstream. Because the way in which people metabolize thiopurine compounds varies, the same dose of a thiopurine drug affects different people differently, and it has been difficult for doctors to determine whether for a particular patient a given dose is too high, risking harmful side effects, or too low, and so likely ineffective.

At the time the discoveries embodied in the patents were made, scientists already understood that the levels in a patient's blood of certain metabolites, including, in particular, 6-thioguanine and its nucleotides (6-TG) and 6-methyl-mercaptopurine (6-MMP), were correlated with the likelihood that a particular dosage of a thiopurine drug could cause harm or prove ineffective. See U.S. Patent No. 6,355,623, col.8, ll.37-40, 2 App. 10. ("Previous studies suggested that measurement of 6-MP metabolite levels can be used to predict clinical efficacy and tolerance to azathioprine or 6-MP" (citing Cuffari, Théorêt, Latour, & Seidman, 6-Mercaptopurine Metabolism in Crohn's Disease: Correlation with Efficacy and Toxicity, 39 Gut 401 (1996))). But those in the field did not know the precise correlations between metabolite levels and likely harm or ineffectiveness. The patent claims at issue here set forth processes embodying researchers' findings that identified these correlations with some precision.

More specifically, the patents—U.S. Patent No. 6,355,623 (623 patent) and U.S. Patent No. 6,680,302 (302 patent)—embody findings that concentrations in a patient's blood of 6-TG or of 6-MMP metabolite beyond a certain level (400 and 7000 picomoles per 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 picomoles 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.10-20, 2 App. 16.

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

B

Respondent, Prometheus Laboratories, Inc. (Prometheus), is the sole and exclusive licensee of the 623 and 302 patents. It sells diagnostic tests that embody the processes the patents describe. For some time petitioners, Mayo Clinic Rochester and Mayo Collaborative Services (collectively Mayo), bought and used those tests. [1296] 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 5700 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. 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. ___, 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 ___ - ___, 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 [1297] 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 ___, 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 [1298] 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 ___, 130 S.Ct., at 3230 ("[T]he prohibition against patenting abstract ideas `cannot be circumvented by'... adding `insignificant post-solution activity'" (quoting Diehr, supra, 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 Diehr, supra, 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 [1299] 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 process variables, the use of alarm limits to trigger alarms, the notion that alarm limit values must be recomputed and readjusted, and the use of computers for `automatic monitoring-alarming'" were all "well known," to the point where, putting the formula to the side, there was no "inventive concept" in the claimed application of the formula. Id., at 594, 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 [1300] 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 ___ - ___, 130 S.Ct., at 3223-3224. The Court held that the described "concept of hedging" was "an unpatentable abstract idea." Id., at ___, 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 [1301] 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 ___, ___, 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. 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 ___, 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 [1302] 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 ___, 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.

[1303] 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 "law of nature" exclusion. Bilski, supra, at ___, 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 section 101, not later sections. Bilski, 561 U.S. ___, 130 S.Ct. 3218, 177 L.Ed.2d 792; 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, [1304] 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, ___ (forthcoming, 2012) (manuscript, at 85-86, online at http://www.patentlyo.com/files/eisenberg.wisdomordeadhand.patentlyo.pdf (as visited Mar. 16, 2012, and available in Clerk of Court's case file)); 2 D. Chisum, Patents § 5.03[3] (2005).

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

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

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

Other medical experts, however, argue strongly against a legal rule that would make the present claims patent eligible, invoking policy considerations that point in the opposite direction. The American Medical Association, the American College of Medical Genetics, the American Hospital Association, the American Society of [1305] 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.