Article

The Natural Complexity of Patent Eligibility

Introduction

Recently, patents on human genes, software, and business methods have stoked a heated public discussion on patent law. Much of that discussion has focused on the doctrine of patent eligibility, or patentable subject matter, a century-and-a-half old legal doctrine that limits the types of inventions that can be patented.1 The doctrine currently prohibits patents on “laws of nature, natural phenomena, and abstract ideas,” as well as “products of nature.”2 Courts and commentators have long viewed these phrases as legalistic terms of art. That is, terms that have, or should have, particular legal significance apart from a scientific or philosophical exegesis of the words themselves.3 But there is good reason to doubt this assumption. Since patent eligibility’s inception, the Supreme Court has never provided a concrete definition or a legal test for what makes a natural “law,” “phenomenon,” or “product.” Rather, it has tethered patent eligibility’s “natural” terms to a varied list of scientific tropes in an apparent attempt to extract a scientific or philosophical meaning from them.4

This disconnect between how courts and scholars view patent eligibility’s “natural” terms and how they analogize them to the real world has contributed to the doctrine’s lack of either consistency or clarity.5 Virtually no cases or legal scholarship have focused on what these terms mean in a scientific or philosophical context—that is, what science considers to be a “law of nature,” whether a phenomenon is “natural,” or when a product is “of nature.”6 And none have discussed whether these meanings have changed since patent eligibility’s inception over 150 years ago. This Article shows how one branch of scientific philosophy—natural complexity—both illuminates and challenges the doctrine of patent eligibility and can be harnessed to ultimately simplify it.

Originally concerned with the ills of overbroad patents, early American and British decisions on patent eligibility concerned the prohibition of patenting “principles” or “abstractions,” as opposed to their concrete applications.7 This test, despite its difficulties, was a decidedly legalistic one, and the few references to “laws of nature” were simple shorthands for “principles.”8 In 1948, however, the Supreme Court, in Funk Brothers Seed Co. v. Kalo Inoculant Co., separately proscribed patents on “laws of nature” or “natural phenomena.”9 And around the same time, courts also began to incorporate patent law’s long-standing ban on patenting “products of nature” into this reimagined doctrine of patent eligibility.10

Since then, the Supreme Court has struggled to give these “natural” terms any concrete, legal meaning.11 Unlike its jurisprudence in other areas of the law that similarly struggle with vague terms, the Court has devised no framework, no factors, and no legal definition to discern them.12 Rather, the Court’s opinions have continually relied on a list of putative examples of natural “laws,” “phenomena,” and “products,” such as electricity, the qualities of metals, or wild plants.13 In this way, patent eligibility’s “natural” terms have shifted from legal descriptions to philosophical or scientific concepts.

Unsurprisingly, recent technologies have tested courts’ abilities to provide coherency to this concept of “nature” in patent eligibility.14 The results, so far, have been less than satisfactory.15 Some of this difficulty comes from the scientific advances since patent eligibility’s inception 150 years ago. Spurred by revolutions in the sciences, the past century-and-a-half witnessed an explosive increase in the amount and diversity of information about the natural world.16 Beginning in the 1940s, this increase became the object of scientific and philosophical inquiry.17 Scientists began to take note of “the number and variety of [nature’s] constituent elements and of the elaborateness of their interrelational structure.”18 At the same time, philosophers began to describe the cognitive difficulties that this increase in information posed for reducing nature to simplistic descriptions.19 “More,” it turned out, was different.20 This view of information’s effect on science developed into a theory of “natural complexity.”21 In particular, scientific philosophers realized that natural complexity complicated efforts to describe nature with either constancy or causality, attenuated the force of certain conclusions derived from statistics, and caused “emergent properties” to appear that could not be construed as fundamental natural “laws” or “phenomena.”22 Simply put, natural complexity made using terms like “laws of nature,” “natural phenomena,” or “products of nature” harder to justify and more difficult to define.

The uncertainties that natural complexity imparts on patent eligibility’s “natural” terms therefore explain some of the problems with the current doctrine. First, patent eligibility struggles to equivalently exclude all claims encompassing a natural “law,” “phenomena,” or “product,” even though natural complexity demonstrates that such concepts occupy a varied spectrum of both scope and depth. Second, without the ability to precisely delineate which patent claim elements encompass natural “laws,” “phenomena,” or “products,” the Supreme Court has incorrectly marginalized the importance of claim language in assessing patent eligibility. And third, although patent law prides itself on being “technology neutral,” the uncertainties facing patent eligibility’s “natural” terms give their application an unwanted technology-specific effect.23

These difficulties suggest that patent eligibility’s “natural” terms should be abandoned. In their place, courts should rely on a descriptive legal framework to assess patent eligibility. Constructing such a framework proves difficult, however, because patent eligibility has itself become complex: the doctrine must now contend with more, and more varied, precedent, patents, and technologies than ever before.24 In the sciences, descriptive frameworks to naturally complex systems are often created through the twin strategies of “decomposition,” breaking down a system into cognitively simple subparts, and “localization,” the mapping of each of those subparts to the goals or purpose of the system.25 This occurs in the law as well, through the use of “multiprong” or “multifactor” analyses.26 For patent eligibility, a cognitively simple yet robust analysis could be developed by breaking down the component parts of a typical patent—the claims and the specification—and by mapping these components to the policy goals of patent eligibility. This, or a similar analysis, would bring much-needed clarity to patent eligibility despite the complexities of both science and the law.

This Article recounts the development of patent eligibility’s “natural” terms, explains how natural complexity complicates this terminology and patent eligibility, generally, and proposes a method to solve these problems. Part I traces the doctrine of patent eligibility from its inception as a rule against patenting “principles” to today’s prohibition on patenting “laws of nature,” “natural phenomena,” and “products of nature.” Part II discusses how natural complexity imparts cognitive difficulties in developing and defining patent eligibility’s “natural” terms. And Part III explains these difficulties’ roles in some of the problems present in today’s patent eligibility determinations. Part IV attempts to solve these difficulties: it posits that patent eligibility has itself become complex, and builds on the complexity literature to propose a solution; it describes how science employs the strategies of decomposition and localization to describe complex systems; and it uses this framework to develop a similar test for patent eligibility.

I.     The Law and Science of Patent Eligibility

The Constitution authorizes Congress “[t]o promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries,”27 i.e., to grant patents.28 Since 1790, Congress has exercised this authority by statute and “fixed the conditions upon which patents and copyrights shall be granted.”29 The subject matter eligible for patenting is now codified in § 101 of the patent statute: “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”30 This liberal definition of “Writings and Discoveries” has changed little in over 200 years,31 and “embodie[s the] philosophy that ‘ingenuity should receive a liberal encouragement.’”32

Yet liberality is not limitless. Section 101, as interpreted by the Supreme Court, has long excluded various forms of inventions from patent eligibility. Such efforts began humbly, as attempts to avoid the ills of patent applications on “principles” or “abstractions,” rather than inventions.33 The modern doctrine, however, has since grown wildly. Today, in addition to “abstract ideas,” the doctrine of patent eligibility also excludes “laws of nature,” “natural phenomena,” and “products of nature.”34 This has been a change in kind as well as degree. While the bar struggled to determine what precisely constituted a “principle” or an “abstraction,” its difficulties were legalistic ones.35 The difficulties inherent in defining “laws of nature,” “natural phenomena,” and “products of nature,” however, have had a decidedly scientific or philosophical feel. Indeed, rather than articulating any precise factors to determine what constitutes natural “laws,” “phenomena,” or “products,” the Court has tethered those terms to scientific rather than legal concepts.36 Understanding patent eligibility’s “natural” terms, therefore, requires a historical understanding of the doctrine as a fundamental shift from law to scientific philosophy.

A.     The Early Rule Against Patenting “Principles”

In 1790, Congress modeled the first patent statute in the U.S. after the British Statute of Monopolies.37 More expansive than the British Statute, which allowed only “manufactures” to be patented,38 the Patent Act of 1790 granted an inventor a monopoly for “any useful art, manufacture, engine, machine, or device.”39 Congress updated this language slightly in 1793 to include “any new and useful art, machine, manufacture or composition of matter,”40 and has left it virtually unchanged since.41

Early American courts heartily adopted the British maxim that patents “for a principle or function detached from machinery” were void.42 In Wyeth v. Stone, Justice Joseph Story—“one of the architects of American patent law”43—invalidated a patent for an automated method “to cut ice of a uniform size,” concluding that “[s]uch a claim [was] utterly unmaintainable in point of law,” because “[i]t is a claim for an art or principle in the abstract, and not for any particular method or machinery.”44 Denying eligibility to the asserted patent prevented monopolizing “a right to cut ice by all means or methods, or by all or any sort of apparatus, although he is not the inventor of any or all of such means, methods, or apparatus.”45 Justice Story similarly struck down a patent for a method “of communication of motion from the reed to the yarn beam” in a loom.46 That patent, too, was “utterly void, as being an attempt to maintain a patent for an abstract principle, or for all possible and probable modes whatsoever of such communication, although they may be invented by others, and substantially differ from the mode described by the plaintiff in his specification.”47 And in Smith v. Downing, one of the cases concerning the Morse telegraph, the court clarified that “some expressions may have been used by one or two judges, which look like a sanction to patenting a principle, yet they are used in the above sense, of a principle in operation, in the manner set out in the specification.”48

In 1852, in Le Roy v. Tatham, the Supreme Court accepted the analysis that a “principle,” alone, could not be patented.49 The Court assessed a process patent concerning the manufacture of metal pipes under continuous heat and pressure.50 The patent claimed the manufacturing process “in the manner set forth [in the patent], or in any other manner substantially the same.”51 Although the case did not discuss whether it was the subject of a patent, the Court nonetheless concurred that “a principle is not patentable.”52 But it also recognized that “[t]he word principle is used . . . with such a want of precision in its application, as to mislead,”53 and attempted to define the term as “a fundamental truth; an original cause; a motive.”54 “[T]hese,” the Court concluded, “cannot be patented, as no one can claim in either of them an exclusive right. Nor can an exclusive right exist to a new power, should one be discovered in addition to those already known.”55 Nonetheless, the Court agreed that:

[a] patent will be good, though the subject of the patent consists in the discovery of a great, general, and most comprehensive principle in science or law of nature, if that principle is by the specification applied to any special purpose, so as thereby to effectuate a practical result and benefit not previously attained.56

The Court reaffirmed the specific-application reasoning the following year in O’Reilly v. Morse, the seminal Morse telegraph case, striking down one of Morse’s claims for “the use of the motive power of the electric or galvanic current . . . however developed for marking or printing intelligible characters, signs, or letters, at any distances.”57 The claim did “not confine [itself] to the machinery or parts of machinery . . . [but] a monopoly in its use, however developed, for the purpose of printing at a distance.”58 Such a monopoly was too broad—it impeded, rather than promoted the constitutional directive concerning the “Progress of Science.”59 As such, the Court invalidated claim 8 of Morse’s patent because it prevented “some future inventor, in the onward march of science, [from] discover[ing] 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.”60

This connection between “principle” and claim scope seemed to also extend to compositions of matter, as well as machines and processes. In Parke–Davis & Co. v. H.K. Mulford Co., Judge Learned Hand famously upheld a patent directed to adrenaline.61 Although the chemical was no different from how it was found in the adrenal gland, the court concluded that the act of isolating and purifying the chemical from its natural surroundings was “a purification of the principle, [for] it became for every practical purpose a new thing commercially and therapeutically.”62 This made “[t]he purpose of the claims . . . quite clear . . . with a corresponding limitation of scope.”63

Rather than focus on issues of science or philosophy, scholars have since described these cases as concerning “overbreadth”—whether the patents attempted to claim more than they invented.64 And indeed, Supreme Court decisions soon after Le Roy and O’Reilly bear out this logic.65 Defining “principles” or “abstractions,” therefore, was a purely legal exercise tied to the scope of patents’ claims relative to their disclosure. Reduced to a simple syllogism, patent eligibility stood for little more than this: “Applying a basic scientific principle to the construction of a useful object is patentable; claiming every use of that principle isn’t.”66

B.     Funk Brothers Seed Co. v. Kalo Inoculant Co. and the Rise of Patent Eligibility’s “Natural” Terms

This uniform view against patenting “principles,” however, concealed two greater disputes. First, the advances in science in the early twentieth century quickly began to erode the assumption that scientific advances themselves—apart from physical machinery—should not be patent eligible. Yet scholars struggled to conceive the contours of a potentially new regime. One commentator noted that “practical difficulties. . . . [lay in the] primary importance that the scientific discovery which is to be rewarded be very carefully defined.”67 Another, referring to Einstein’s theory of relativity, recognized “[a] very serious difficulty . . . in defining what is a newly discovered ‘truth or fact,’ as distinguished from the use that can be made of it in the practical and industrial arts.”68 Second, courts and commentators began to tussle over the level and definition of “inventiveness” required for patent eligibility. Since 1851, the Supreme Court had required every invention to “be the product of ‘more ingenuity and skill . . . than were possessed by an ordinary mechanic acquainted with the business.’”69 The standard—amorphous and unworkable—was ardently condemned.70

Against this backdrop, agricultural researcher Varley Sherman Bond, in 1938, filed for a patent directed to “a bacterial culture useful for the inoculation of the seeds of leguminous plants.”71 Although the bacteria, Rhizobia, were well known and widely used in standard agricultural practice, the patentee had isolated and combined several strains of the bacteria that did not mutually inhibit one another.72 Because different crops responded to different strains of Rhizobium, the patentee had, in essence, developed a single Rhizobium inoculant that could be used for multiple crops.73 Rather than claiming a “one-size-fits-all” inoculant of specific Rhizobium strains, the patentee extended his claims to all inoculants “comprising a plurality of selected cultures . . . said cultures being substantially unaffected by each other.”74

In Funk Brothers, the Supreme Court invalidated the patent on the ground that Bond’s inoculant “fell short of invention within the meaning of the patent statutes.”75 In drawing that conclusion, however, the Court did not rely on its cases assessing the invention’s level of “ingenuity” or “skill.”76 Nor did it reject the patent for being directed to a “principle”—“the idea that there are compatible strains”—rather than an application of one.77 Rather, the Court invalidated the patent on the basis that Bond’s invention was “the work of nature” and that “patents cannot issue for the discovery of the phenomena of nature.”78

Unlike its predecessor cases, however, this appeal to “phenomena of nature” did not simply appear to be legal shorthand. Rather, it appeared to incorporate some of the scientific and naturalistic mysticism popular at the time.79 The Court described Rhizobium’s nitrogen-fixing properties as “some mysterious process,”80 “part of the storehouse of knowledge of all men. . . . free to all men and reserved exclusively to none.”81 These properties were “like the heat of the sun, electricity, or the qualities of metals,”82 and “serve[d] the ends nature originally provided and act[ed] quite independently of any effort of the patentee.”83 Similarly, the Court characterized Bond’s invention as “the handiwork of nature,”84 “nature’s secret,”85 and an “ancient secret[] of nature.”86 This language dramatically departed from the Court’s earlier remarks on allowing patents for a “great, general, and most comprehensive principle in science or law of nature” as long as the inventor concretely applied them.87

Both the dissent and the concurrence disputed the majority’s notion of patent eligibility as divorced from the traditional understanding of the rule against patenting overbroad principles. In dissent, Justices Burton and Jackson simply did “not agree that the patent issued for such products is invalid for want of a clear, concise description of how the combinations were made and used.”88 This concern with the patent’s description paralleled the Court’s reasoning in O’Reilly that overbroad claims prevented “some future inventor, in the onward march of science, [from] discover[ing] a mode of writing or printing at a distance . . . without using any part of the process or combination set forth in the plaintiff’s specification.”89 In concurrence, Justice Frankfurter agreed as to the invalidity of the patent because the claims were overbroad: “the phrase ‘the claims cover a composite culture’ might mean ‘a particular composite culture’ or ‘any composite culture’” including those “quite different from Bond’s composite culture.”90 But Justice Frankfurter disagreed with the majority’s “introduc[tion of] such terms as ‘the work of nature’ and the ‘laws of nature.’ For these are vague and malleable terms infected with too much ambiguity and equivocation.”91 In rejecting the scope and vagueness of the majority’s choice of language, Justice Frankfurter voiced a prescient concern: “Everything that happens may be deemed ‘the work of nature’ . . . .”92

C.     The Modern Doctrine of Patent Eligibility and Scientific Philosophy

Justice Frankfurter’s axiom was perhaps truer than he realized. Since Funk Brothers, every Supreme Court opinion to substantively address patent eligibility has adopted the case’s focus on “nature.”93 In Diamond v. Chakrabarty, the Court upheld a patent directed to a bacterium containing two synthetic pieces of circular DNA, or plasmids.94 The Court described the function of these plasmids as giving the bacteria a “property . . . possessed by no naturally occurring bacteria,”95 with “markedly different characteristics from any found in nature . . . and . . . . not nature’s handiwork.”96 This distinguished the invention from that in Funk Brothers because the claim encompassed not “a hitherto unknown natural phenomenon, but . . . a nonnaturally occurring manufacture or composition of matter.”97

In Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Court considered patents for a method of optimizing the dosage of thiopurine drugs in treating Crohn’s disease patients.98 The method simply directed a physician to “administer” the drug to a patient and then “determine” the level of a metabolite of that drug, where a level above or below certain values indicated a need to adjust the dosage accordingly.99 Like patents on “principles” before it, the patents’ claims do “not confine [themselves] to [any] machinery or parts of machinery,”100 but rather sought a monopoly on any “administration” of thiopurine followed by a “determination” of the quantity of their metabolites.101 Nonetheless, the Court invalidated the patents on the grounds that they “set forth laws of nature.”102 The relationship between thiopurine administration and its metabolites were “natural laws or natural phenomena,”103 “natural responses” that were a consequence of human biology,104 or “natural correlations” between two events.105 Prometheus’s claims, therefore, were unpatentable natural “laws,” “phenomena,” and “manifestations of nature,” even though the Court recognized that “all inventions at some level embody, use, reflect, rest upon, or apply laws of nature [or] natural phenomena.”106

More recently, in Association for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court considered several patents encompassing two types of DNA molecules: DNA excised directly from chromosomes, or “isolated genomic DNA,” and synthetic transcripts of only the coding portions of genes, or “cDNA.”107 The opinion framed the issue as whether each class of molecules was “naturally occurring” or a “product of nature.”108 In its assessment, the Court heavily focused on the biochemical differences between isolated genomic DNA and cDNA.109 But it framed the differences largely in “natural” terms: whether each patented molecule was “naturally occurring,” whether they were variants of “natural DNA,” and whether their sequences were “dictated by nature.”110 These differences counseled against the patent eligibility of isolated genomic DNA as resulting from activity that was “not an act of invention.”111

Even the Supreme Court’s jurisprudence regarding “abstract ideas”—the historical ancestor of “principles”—has recently been infected with such language. In Gottschalk v. Benson—a case concerning the patentability of a mathematical formula for processing binary code—the Supreme Court rejected the patent’s claims as falling afoul of the prohibition on patenting “phenomena of nature.”112 Similarly, in Parker v. Flook, the Court construed its previous decisions as “[r]easoning that an algorithm . . . is like a law of nature.”113 As such, the Court invalidated the patentee’s software process patent “not on the notion that natural phenomena are not processes, but rather on the more fundamental understanding that they are not . . . ‘discoveries’” for the Constitution’s purposes.114 And in Diamond v. Diehr, the Court upheld the patentees’ claims to a computerized process for automatically curing rubber as “not unpatentable simply because it contains a law of nature.”115 Despite this linguistic shift, the Court, in Bilski v. Kappos in 2010, boldly suggested that such language had been inherent in the patent eligibility statute for 150 years.116

These repeated invocations of natural “laws,” “phenomenon,” and “products” have never received any definition from the Supreme Court. The Court has made no attempt to impart on them any linguistic meaning, e.g., explications of the terms’ ordinary usage in speech, dictionary definitions, or historical accounts of their concepts.117 Nor has it attempted to provide them with any legal construction—normative judgments as to what natural “laws,” “phenomena,” or “products” should mean.118 It provides no framework, no formula, and no list of factors to assess their construction. Nor does it tie them to historical concerns about descriptive overbreadth in patenting “principles.”119 Rather, the Supreme Court has engaged in a fundamentally different type of analysis: analogies to a list of examples of what the Court thinks are obvious natural “laws,” “phenomena,” and “products.” Those include “mineral[s] discovered in the earth,” “new plant[s] found in the wild,” the equation E=mc2, gravity, electromagnetism, steam power, “the heat of the sun, electricity, [and] the qualities of metals,” among others.120 This is simply unlike other areas of the Court’s jurisprudence that confront vague terminology in legal rules or standards.121

Patent eligibility’s ever-growing list of excluded “sciency things” does little, if anything, to explain what exactly natural “laws,” “phenomena,” or “products” are. Declaring that one cannot patent “E=mc2,” for example, does not tell us why it is a “law” or a “phenomenon,” which one of the two it is, or whether it can be both at the same time. Nor does it begin to resolve the fundamental problem of distinguishing natural laws from man-made representations of them.122 Assuming that “gravity” must be excluded from patentable subject matter informs us little about which other scientific concepts must similarly be excluded. Prohibiting patents on electromagnetism, electricity, and steam power—even when such powers result solely from man-made activity—does little to elucidate what, legally, makes them unpatentable natural “phenomena.” And concluding that one cannot patent wild plants or extracted minerals as “products of nature” does nothing more than leave that controlling term hopelessly void of meaning.

This list of scientific concepts, therefore, likely serves one particular function for the Supreme Court: as a collection of concepts that the Court believes scientists would agree on as natural “laws,” “phenomena,” and “products.” This understanding seems to explain some of the Court’s language concerning its own difficulties in making patent eligibility determinations. In his dissent in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., Justice Stephen Breyer paused to “concede that the category of nonpatentable ‘[p]henomena of nature,’ like the categories of ‘mental processes’ and ‘abstract intellectual concepts,’ is not easy to define.”123 Similarly, in Mayo, the Court declined the patent holder’s invitation to discern among different types of natural “laws,” not because the issue may not have been illustrative, but because “[c]ourts and judges are not institutionally well suited to making the kinds of judgments needed to distinguish among different laws of nature.”124Mayo’s assertion may partially explain the Court’s choice of popularly known scientific developments, such as electricity and steam power, even whenother lesser-known examples from actually litigated cases, such as the Arrhenius equation in Diehr,125 remain available.

Patent eligibility’s “natural” terms are, therefore, the Supreme Court’s attempt to introduce a scientific or philosophical meaning into natural “laws,” “phenomena,” and “products.” It focuses on what the Court believes science or philosophy considers “laws of nature,” “natural phenomena,” and “products of nature.” And, like early twentieth-century debates on granting patents to pure scientific discoveries, it struggles with the difficulties of distinguishing scientific concepts.126 Contrary to the doctrine’s historical focus on patenting “principles,” patent eligibility’s “natural” terms are more scientific and philosophical than legal.

II.     Natural Complexity and Natural Laws, Phenomena, and Products

Given the Supreme Court’s approach to patent eligibility’s “natural” terms, science or philosophy would appear to be natural sources of discourse to help crystallize their meanings. After all, “What is a law of nature?” is a central question for the philosophy of science.127 Unfortunately, neither science nor philosophy has provided any clarity. Rather, the issues surrounding the terms’ meanings have long been—and are still—hotly debated.128 Regularity, universality, functionality, probabilism, necessitation, and contingency—all complicate a straightforward definition.129 At the same time, one avenue of scientific philosophy centers around these very difficulties: natural complexity.

Complexity, generally, is the measure of three facets of a system: (1) the number of elements, or components, present in the system; (2) the variety of those elements; and (3) the interrelationships between those elements.130 As those facets increase, a system becomes increasingly “complex.”131 A simple wristwatch, for example, may contain nothing more than a fixed gear and a tension spring, turning a single hand. But wristwatches often involve many more components—several gears and springs, and, often, multiple measures of time. Those components, in turn, often come in several varieties, sizes, and shapes. And all of the components are, in one way or another, interconnected—the absence of a single gear or spring can affect the performance of many other components, and sometimes fatally so.132 Such a watch is “complex,” in philosophical terms.133

The principle effect of complexity is cognitive.134 Complexity hinders our ability to reduce a system to its component parts, to understand a system’s causes and effects, and to describe or explain a system with either completeness or certainty.135 Difficulties in understanding how a complex wristwatch works may arise simply because of difficulties in determining which components are required, or how the components affect the watch’s movement, either individually or in combination.136 It may also be difficult to understand how a complex wristwatch works because we may lack the words to describe its components or those components’ interactions with one another.137 We may also simply lack the cognitive operators to understand the watch as a whole.138

So, too, with nature. Since 1850, almost every scientific discipline has seen the introduction, development, and adoption of radical theories and practices that have changed our understanding of the simplicity—or lack thereof—of the natural world. Scientists unearthed countless new objects and forces previously hidden from view: new sub-atomic particles and forces in physics; DNA and genes in biology; continental plates in earth science; and more.139 The number of specialties in almost every scientific discipline multiplied many times over.140 And through interdisciplinary research, science has uncovered a network of innumerable interrelationships in nature.141 These revolutions, in turn, fed an explosive increase in the amount of scientific research and information. Since 1850, the quantity and funding of scientific research has, accordingly, exponentially increased.142 The amount of scientific literature is now likely produced at one thousand times the rate it was then.143 And so many people now work as professional scientists that over eighty percent of all the scientists who have ever lived are living now.144

Beginning in the 1940s, scientists and philosophers proposed that this growth was itself extraordinary.145 In the words of Philip W. Anderson, the recipient of the 1977 Nobel Prize in physics, “More Is Different.”146 More scientific information uncovered a vast, varied, and interrelated web of information that could “not . . . be understood in terms of a simple extrapolation of the properties of a few particles.”147 Rather, this increase in scientific information made it appear that “[a]t each stage [of inquiry] entirely new laws, concepts, and generalizations [were] necessary” to theorize the whole.148 This all implied the radical notion that “[t]he ability to reduce everything to simple fundamental laws [did] not imply the ability to start from those laws and reconstruct the universe.”149

These observations gave rise to the study of “natural complexity,”150 or the cognitive difficulties with synthesizing how the Earth’s “many biological and physical components interact across all space and time scales.”151 Because “natural reality has an infinite descriptive depth,”152 natural complexity counsels us to “abandon the idea that our linguistic resources can—at least in the theoretical long run—fully characterize the descriptive nature of the real.”153 Thus, the ultimate problem with terms like natural “laws,” “phenomena,” and “products” is that such terms “are inevitably inadequate to explain by themselves the phenomena as we actually observe them.”154 Three features—constancy and causality, probabilism, and fundamentalism—demonstrate the terms’ inadequacy in describing naturally complex systems.

A.     Constancy and Causality

Natural “laws” or “phenomena” classically require two factors: (1) constancy, or, as termed by the philosopher David Hume, a “constant conjunction”; and (2) causality.155 If event A happens in conjunction with event B, this is only a “law” or a “phenomenon” if event A always occurs in conjunction with event B. If, for example, water always boils (event A) when it is heated to 100°C (event B), then we have satisfied Hume’s constancy requirement.156 Accidents happen, however. That is, sometimes events repeatedly, even always, occur in conjunction with one another that have no causal link between the two. One famous example is the statement, “Whenever I go to Paris, it rains.”157 Even taking this statement as true—and therefore, satisfying the Humean constancy requirement—does not make it a natural “law” because the speaker’s presence in Paris is surely not causing it to rain.158 Rather, the speaker is simply the victim of unerring bad luck and Paris the host of bad weather.

Separating repetitive accidents from repeatable causal events is the classical philosophical problem of induction.159 That is, how can we inductively generalize facts about the world given the epistemological uncertainty about any two events’ constancy and causality? In the classical school, at least, natural “laws” or “phenomena” are only those pairings of events that can be inductively determined to be both universally constant and universally causal.160 This view of natural laws and phenomena consequently implies that the terms occupy an immensely broad scope. For a natural relationship to be a “law” or a “phenomenon” it must “stipulate—quite ambitiously—how things are always and everywhere.”161

Natural complexity complicates this analysis. As a natural system becomes more complex, it becomes increasingly difficult to determine whether any observed natural relationships are either constant or causal.162 As the number, variety, and interconnectedness of elements in a system increases, determining which elements cause which events becomes a much harder task. Isolating and identifying not simply which elements are responsible for a particular natural phenomenon, but which interactions of those elements give rise to it greatly hinders our ability to distill what causes a particular phenomenon. This hindrance ultimately means that in naturally complex systems “there may often be no way of telling whether something proposed as a cause of some effect was in fact required for the occurrence of that effect.”163 Which cellular factors contribute to cancer, for example, is a famously complex question “that is already complex almost beyond measure.”164 As a result, even the best attempts by researchers to reduce cancer to several causal or constant “hallmarks” have generally failed.165 Natural “laws” or “phenomena” of cancer simply elide over research’s ability to “add[] further layers of complexity.”166

In other instances, constancy and causality may exist at one level of complexity, but vanish entirely at another. Newton’s law of universal gravitation, for example, describes the relationship between two objects’ mass and distance and the gravitational force between them.167 But it is both empirically and philosophically not universal.168 It does much to describe the primary attractive force between celestially sized objects, like planets, but in some naturally complex systems, such as those with a variety of smaller objects, the regularity of Newton’s law is called into question. Indeed, the “universal” law of gravity seemingly fails to apply on microscopic levels because other forces, like electricity and magnetism, completely dominate its effect.169

A number of scientific philosophers similarly dispute the existence of constancy and causality in biology.170 The complexity of biological diversity is, after all, simply the product of historical accident: “Rewind the tape of evolutionary history and play it again as many times as you will; it will never be the same twice.”171 Discerning causal or constant factors from this history—that is, identifying “laws” “phenomena,” or even “products” in biology—is simply impossible. On this point, John Beatty, a philosopher of biology, declared that “there are no laws of biology. For, whatever ‘laws’ are, they are supposed to be more than just contingently true.”172 At another level, some biological processes are so complex, that one can regard each instance of them as practically unique.173 This sentiment illustrates the problem of constancy and causality in natural “laws” and “phenomena” in general: that “[i]t is quite impossible to have for unique phenomena general laws like those that exist in classical mechanics.”174

B.     Probabilism

Where constancy and causality fail, “probabilism”—the use of probabilities or statistics as the basis for inductive reasoning—begins.175 As some natural systems become more complex, the “laws” that govern them, or the “phenomena” that explain them, must be increasingly couched in mathematical terms.176 The N-body problem in physics perhaps serves as the best example. The “law of gravity” provides an equation for the gravitational force of one body, N, on another, depending on its mass and the distance between them.177 The law is ideal when one body is fixed in space (an admittedly unrealistic situation) because each body will effect a gravitational pull on the other. As the number of bodies increases, however, the law begins to break down. Strange though it may seem, for a larger number of Ns, i.e., the system becomes more complex, and the universal law of gravity becomes more embedded in statistical probability than mathematical certainty.178

In other instances, the probabilistic conclusions of experiments in naturally complex systems are regarded as “laws” or “phenomena” themselves.179 Epidemiology—the study of “the health of a population . . . as a complex adaptive system”—must contend with a countless number, variety, and interdependency of factors: “history, culture, . . . socioeconomic structures,” environment, ecosystems, and others.180 And whatever conclusions can be drawn from such research are often bound in the language of statistics, e.g., confidence intervals, p-values, and Mantel–Haenszel odds ratios.181 Yet, such conclusions are often conceived of as embodying the causalities of a system, i.e., as “laws” or “phenomena” themselves, rather than mathematical observations.182 This leap, from mathematical observation to explanation of reality, suffers from what scientific philosopher Nancy Cartwright terms the “simulacrum account of explanation”:

I do not think these distributions are real. Statistical mechanics works in a massive number of highly differentiated and highly complex situations. In the vast majority of these it is incredible to think that there is a true probability distribution for that situation; and proofs that, for certain purposes, one distribution is as good as another, do not go any way to making it plausible that there is one at all. It is better, I think, to see these distributions as fictions . . . .183

Thus, terms like natural “laws” or “phenomena” in complex, probabilistic fields should have significantly less force: they are less “laws” or “phenomena” of nature than they are “laws” or “phenomena” of a statistical, “simulacrum account” of observations of nature.

Similarly, defining a “product” of nature is also often an exercise in probabilism, complicated by natural complexity. What scientists refer to as a “typical” human gene, for example, actually encompasses a wide variety of genetic sequences within the human population.184 Determining the archetypal sequence of that gene, the “consensus sequence,” is therefore very much a product of statistics, rather than the specific identification of a gene with the consensus sequence as it actually exists in nature.185 Characterizing a particular genetic sequence as a “natural product” is consequently a two-step act of probabilism: using statistical methodology to determine a consensus sequence, and then using statistical methodology to subsequently determine whether the studied genetic sequence is similar enough to the consensus sequence to be considered equivalent. Even this, however, does not necessarily resolve the issue of whether a particular genetic sequence is a natural “product” because there are “a massive number of highly differentiated and highly complex” methods to compute similarity.186 Recently, researchers’ efforts to determine how much of the human genome was covered by patents claiming “an isolated DNA having at least 15 nucleotides” of a particular sequence erupted into a fiery debate over methodology.187 This has all “led these biologists into a philosophical trap: confounding the model of reality (the consensus sequence) with reality.”188 Ultimately, if natural “laws,” “phenomena,” and “products” are “irreducibly probabilistic . . . . [They] may often be limited to distinguishing factors that influence the probability of the effect to be explained. . . . But that is the most to which we can legitimately aspire.”189

C.     Fundamentalism

As a general matter, natural “laws” and “phenomena” imply a sense of “fundamentalism”: that is, whether a law or a phenomena is wholly irreducible, and therefore, “fundamental,” or, rather, a construct of other irreducible laws.190 Under this framework, the photon theory of light—that light is composed of smaller subunits, termed “photons”—is a “fundamental law” or a “phenomenon” because it cannot be reduced any further. The heat radiating properties of light, however, are not fundamental “laws” or “phenomena” in this sense because they are reducible: they can be explained by photon theory.191 Light’s propensity to heat a target is actually photons’ propensity to heat a target. Under a fundamentalist interpretation, at least, natural “laws” and “phenomena” are only those observations that meet at “the point of convergence of all our arrows of explanation.”192

Natural complexity, however, upends this distinction because, often, “[t]he behavior of large and complex aggregates of elementary particles, it turns out, is not to be understood in terms of a simple extrapolation of the properties of a few particles.”193 Rather, “at each level of complexity entirely new properties appear” that cannot be explained by simply reducing that system to its component parts.194 Understanding the molecular structure of water, for example, does little to explain why each snowflake forms its own unique crystalline pattern.195 This principle of “emergence” has long been one of the defining features of complex systems.196

Emergence has several consequences for using the terms “laws,” “phenomena,” or “products” to describe naturally complex systems. First, emergence equalizes, across scientific fields, the existence of events arguably termed “laws” or “phenomena” because almost all scientific fields have irreducible, and therefore, fundamental properties. This counsels against a “hierarchy of sciences” where some sciences contain such “fundamental laws,” while others are mere applications of them; emergence “does not imply that science X is ‘just applied Y.’”197 Therefore, if the laws or phenomena that govern elementary particle physics are only “natural laws” or “phenomena” because their behavior reduces to smaller component parts, then emergence suggests that the “laws” governing the social sciences are equally so because we have difficulty reducing concepts like rational choice, dichotomous balloting, or television’s effect on violence.198

Second, emergent phenomena complicate distinguishing “natural products” from those that are the result of human intervention in naturally complex processes. The immune system, for example, produces antibodies, the workhorses of the immune system, in response to foreign macromolecules, or antigens.199 Whether a synthetic vaccine actually confers immunity on a particular patient therefore depends on whether the immune system produces antibodies to the vaccine antigens. But such antibodies are “emergent entities that are defined by their specific antibody partners and exist only in the context of the immune system” unique to the individual in which they are produced.200 This complicates the question of whether any particular antibody produced in response to human intervention—in this example, the administration of antigens—is a natural product rather than a byproduct of this synthetic utilization of emergent phenomena. Such antibodies exist only due to human activity, and yet are created independently from human control. The same could also be said of species altered by climate change or exotic particles from “atom-smasher” experiments.

Lastly, emergence suggests, in fact, that some “fundamental laws” or “phenomena” may not be fundamental after all—not because they are irreducible, but because they simply fail to govern emergent properties of their aggregates. That is, even “grant[ing] that a law is true—even a law of ‘basic’ physics or a law about the so-called ‘fundamental particles’—is far from admitting that it is universal—that it holds everywhere and governs in all domains.”201 Some “phase transitions” in physical chemistry—the dividing lines between phases of matter, like liquids or solids—demonstrate this aphorism because they are subject to emergent properties that appear to directly oppose the “fundamental laws” governing their components. For example, certain iron-based magnets, cooled below certain temperatures, display magnetic direction even though the “fundamental laws” governing magnetism concerning their individual atoms in isolation would dictate otherwise.202 This highlights the paradox of calling either of these properties fundamental “laws of nature.” For, “if one thinks that laws are among the fundamental facts we hope to discover about the universe, such dependency will seem a serious embarrassment.”203

III.     The Effects of Natural Complexity on Patent Eligibility

Natural complexity therefore confounds classical notions of natural “laws,” “phenomena,” and “products.” It places significant cognitive difficulties on determining whether “laws” or “phenomena” are either constant or causal, as is traditionally required. It further muddies clear definitions of natural “laws,” “phenomena,” or “products” by tying such terms to probabilistic determinants. And it repudiates patent eligibility’s natural terms’ adherence to principles of fundamentalism.

Because the Supreme Court’s historical reliance on such terms is tethered to a scientific understanding of them, the difficulties complexity imparts on patent eligibility’s “natural” terms account for several of the doctrine’s troubles. First, patent eligibility wrongly equates all claims directed to natural “laws,” “phenomena,” and “products,” even though natural complexity shows that such terms encompass a wide variety of concepts. Second, the difficulties in defining such terms have led the Supreme Court to marginalize patent claim language. And third, the vagueness of what constitutes natural “laws,” “phenomena,” and “products” has had an impermissible technology-specific effect for molecular biology.

A.     False Equivalency

The current doctrine of patent eligibility falsely equates all “laws of nature,” “natural phenomena,” and “products of nature,” irrespective of their individual content.204 Any patent claim that encompasses one of these identities is rendered ineligible.205 Thus, a court would treat a claim encompassing wide-ranging, almost universal natural “laws,” such as mass-energy equivalence, identically to highly irreproducible and narrow data from clinical trials.206 Over time, the Supreme Court has given several justifications for this equivalency: that treating all natural “laws,” “phenomena,” and “products” the same is cognitively simpler; that all such claims monopolize knowledge about the natural world—a normatively undesirable result; and that such patents, by way of stare decisis, are not “Discoveries” for the Constitution’s purposes. Given that natural complexity complicates precise definitions of natural “laws,” “phenomena,” and “products,” this calls for a critical re-examination of the Court’s justifications.

First, the Court has expressly declined to draw distinctions among different natural “laws” or “phenomena” because, among other reasons, “[c]ourts and judges are not institutionally well suited to making the kinds of judgments needed to distinguish among different laws of nature,”207 paralleling other areas of the Court’s scientifically cautious jurisprudence.208 According to the Court, this counsels in favor of “a bright-line prohibition against patenting laws of nature” because it “serves as a somewhat more easily administered proxy.”209 This is not atypical: other areas of patent law have long favored bright-line rules as proxies for cognitive simplicity.210 But in the patent eligibility context, such favor glosses over the predicate question of whether it is cognitively simple to discern natural “laws,” “phenomena,” or “products” in the first instance—something that natural complexity suggests is not. Indeed, the difficulties with some of the traditional issues associated with natural “laws” and “phenomena”—constancy, causality, probabilism, and fundamentalism—even independent of natural complexity cast doubt on the Court’s rationale that its refusal to distinguish among natural “laws” and “phenomena” is due to cognitive simplicity.211

Second, the Court has recently expressed its belief that allowing any patents encompassing natural “laws,” “phenomena,” or “products” “will inhibit future innovation premised upon them,”212 by “preempt[ing] the use of a natural law” in research.213 Thus, while “the underlying functional concern here is a relative one: how much future innovation is foreclosed relative to the contribution of the inventor,” a “narrow law of nature . . . can [still] inhibit future research.”214 But if natural “laws” or “phenomena” have little inherent content or are not “laws” or “phenomena” in the traditional sense (as natural complexity would suggest), research preemption should be of significantly less concern. The natural “laws” at issue in Mayo, for example, concerned blood concentrations of drug metabolites as derived from clinical study data.215 And the Court recognized that the “naturalness” of the gene sequences at issue in Myriad was a fiction: “[T]here is no ‘typical’ gene because nucleotide sequences vary between individuals, sometimes dramatically.”216 These putative “laws” suffer from the various complications natural complexity imposed: they were neither constant nor causal; they were based on probabilistic inference; and they were not “fundamental” in any sense of the word. In fact, the clinical data incorporated into the Mayo patents’ specifications suggested that the “law” claimed in those patents applied to less than half of patients.217 This would presumably leave researchers free to challenge the veracity of the “law” in a variety of contexts, or make practical use of it for those situations falling outside of the specifications’ clinical data, rather than meaningfully preempting research in any way. True concerns about preemption, therefore, counsel in favor of making individualized determinations about the exclusionary scope of natural “laws,” “phenomena,” and “products” rather than the Court’s current per se exclusionary rule.218

And third, the Court suggests that stare decisis compels it to forbid all claims concerning natural “laws,” “phenomena,” and “products” because its “cases have not distinguished among different laws of nature according to whether or not the principles they embody are sufficiently narrow.”219 But, in other areas, the Court has acknowledged that stare decisis carries less force if “facts have so changed, or come to be seen so differently, as to have robbed the old rule of significant application or justification.”220 The relatively recent scientific and philosophical recognition of natural complexity, and its effect on terms like natural “laws,” “phenomena,” and “products,” seem like precisely the sort of facts, seen so differently, as to rob older conceptions of patent eligibility’s “natural” terms of their reasonable application. When patent eligibility concerned itself with “principles” and “abstractions,” a uniform exclusionary rule may have had its justifications. But given natural complexity’s effect on these terms, the Court’s own jurisprudence on stare decisis favors abandoning its reliance on past uniformity.

B.     Marginalization of Claim Language

Because “all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, [or] natural phenomena,”221 the Supreme Court has repeatedly made clear that claims are not patent ineligible simply if they contain natural “laws” or “phenomena.”222 Rather, the doctrine of patent eligibility only excludes claims that encompass natural “laws” or “phenomena,” or “simply state the law of nature while adding the words ‘apply it.’”223 In drawing this distinction, a patent’s claim language—the precise verbiage used in a patent’s claims—has long been thought to be “of primary importance”224 because claim language does not simply describe the invention, but “define[s] and circumscribe[s]” the invention itself.225 Natural complexity, however, makes defining what a natural “law” or “phenomena” is in the first instance increasingly difficult. As a result, the Court has had trouble parsing claim language into separate “elements”226 to determine whether claims read on natural “laws” or “phenomena” themselves or whether they simply “use, reflect, rest upon, or apply” those “laws” or “phenomena.”227

In response to its troubles parsing claim language, the Court has marginalized, and in some cases, entirely discounted, the importance of claim language precision. It has, instead, adopted a variety of proxies to ascertain whether “the invention” reads on natural “laws,” “phenomena,” or “products”—even though there is no concept of “the invention” apart from the patent’s claims.228 Notably, as in Diehr, the Court resorted to reading the claims “as a whole.”229 Where the claims, “as a whole,” were directed to “a function which the patent laws were designed to protect,” the application is eligible.230 Where, “as a whole,” they are not, “a competent draftsman [could] evade the recognized limitations on the type of subject matter eligible for patent protection.”231

Similarly, in Mayo, the Court repeatedly referred to the “inventive concept” of the patent independent of the patent’s precise claim language.232 This allowed the Court to elide over the precise claim language at issue by turning patent eligibility into a quantitative rather than qualitative inquiry: “[D]o 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?”233 In the Court’s words, patent claims making use of “laws of nature” are not patent eligible “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.”234

In other instances, the Court has simply belittled the significance of claim language. In Flook, for example, the Court criticized the use of claim language in the eligibility determinations as “the draftsman’s art [that] would ill serve the principles underlying the prohibition against patents for ‘ideas’ or phenomena of nature.”235 “A competent draftsman could attach some form of post-solution activity to almost any mathematical formula,” the Court declared.236 The Court has since repeated this “draftsman” epithet in almost every one of its patent eligibility cases.237

The Court’s decision in Myriad may initially appear as an exception to its diminishment of claim language.238 In invalidating Myriad’s composition claims directed to molecules of DNA, the Court noted that “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.”239 But this brief allusion to claim language factored little in the Court’s decision separating isolated genomic DNA from cDNA. Indeed, the actual claim language for both classes of DNA was remarkably similar: both expressed themselves as limited to an “isolated DNA.”240 The Court’s effort in Myriad does less to parse claim language as the determinant of patent eligibility than it uses claim language as a cover to decide what is and is not “natural.”

Ultimately, this denigration of claim language has made claim drafting increasingly problematic.241 Without guidance as to what constitutes a natural “law,” “phenomena,” or “product,” patent practitioners have few ways to assess whether a claim element constitutes one.242 And even with such guidance, patent practitioners are left with “no definitive answer on what additional elements/steps would be sufficient to ensure that a natural phenomena would have a practical application that would be patentable.”243 Patent practitioners must therefore cope with a field where “esoteric terms of art are simply indispensable” but where “the inherent complexity of technology, the limitations of language, and the doctrinal standard for evaluating patents” provide little concrete measure as to how to assess such terms for eligibility.244 Now, “[t]he diversity and dizzying complexity of contemporary innovation, the broader reach of patentable subject matter, and the brisker pace of technological advancement render prescient claim drafting an ideal far more difficult to achieve today.”245

C.     Technology-Specific Effects

Patent law has long prided itself on being “technology-neutral”; it generally does not set different rules for inventions in different areas of technology.246 Relatively few legal doctrines turn on the class of technology sought to be patented, and even fewer statutory provisions distinguish among technologies.247 The Federal Circuit has noted that this “accords the same treatment to all forms of invention.”248 This principle of technological neutrality is further embodied in the watershed international agreement on patents, the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”).249 Article 27(1) of TRIPS requires signatories to confirm that “patents shall be available for any inventions, whether products or processes, in all fields of technology.”250 Ideally, the normative purpose of the rule is forward-looking: it ensures that patent eligibility can “adapt flexibly to new technologies,” without waiting for the laborious legislative process to unwind itself each time a pioneering technology seeks patent protection.251 In this sense, U.S. patent law is “a unified patent system that provides technology-neutral protection to all kinds of technologies.”252

Technologically-neutral language, however, can have technologically specific application.253 Although the difficulties natural complexity imparts on patent eligibility’s “natural” terms would appear to apply across multiple fields, the Court has, in practice, only applied them in the biotechnology context. Indeed, every Supreme Court decision to substantively address arguments that a patent claimed a “law of nature” or a “natural phenomena” (as opposed to an “abstract idea”) has concerned patents in the biotechnology space. Funk Brothers concerned the patenting of bacterial inoculants;254Chakrabarty, recombinant bacteria;255Mayo, medical diagnostic tests;256 and Myriad, human genes.257 Even Laboratory Corp.—a dissent from a dismissal of an improperly granted writ—concerned biotechnology.258 This biotechnology-specific effect has also been generally true of the Federal Circuit and its predecessor court, the U.S. Court of Customs and Patent Appeals.259 Exceptions have been rare.260

Meanwhile, patents in other technologies have avoided being labeled as “laws of nature,” “natural phenomena,” or “products of nature.” Questions concerning the patent eligibility of mathematical algorithms—even those describing aspects of the natural world—have been shunted to “abstract ideas.” Diehr, for example, turned on whether the industrial application of the Arrhenius equation—the influence of temperature on the rate of chemical reactions—was too abstract to be patented, rather than whether it encompassed, and wholly preempted, a “law of nature” or a “natural phenomenon.”261 Similarly, chemical-process patents have largely evaded scrutiny under patent eligibility’s “natural” terms since the Supreme Court’s 1966 decision in Brenner v. Manson, allowing such patents to go forward as long as the patentee could identify the chemical compound’s specific utility.262 This despite the fact that chemical process patents are largely directed to sequential series of chemical reactions—reactions that, like the technology in Mayo, simply take advantage of telling a reader to make use of natural regularities in step-wise fashion.263 Even nanotechnology, a field that largely takes advantage of rare but often naturally occurring materials’ inherent properties, has thus far escaped scrutiny as potentially ineligible subject matter.264

This difference in how patent eligibility is applied to biotechnology is not because these technologies do not raise the same concerns as those in the biological context. The dangers in patenting the Arrhenius equation, for example—that the patent’s claims will likely be too broad relative to their disclosure,265 that doing so would inhibit further research in the equation’s area of science,266 and that it would monopolize a “part of the storehouse of knowledge of all men,”267—parallel those raised in Funk Brothers, Mayo, and Myriad. Nor does this biotechnology-specific effect mean that nonbiological inventions are any less “natural” in principle. It is also surely not because nonbiological inventions are somehow less affected by natural complexity than their biological counterparts.268 Rather, it simply seems that courts have had more difficulty struggling with patent eligibility’s “vague and malleable terms infected with too much ambiguity and equivocation”269 in some scientific contexts rather than others.

IV.     Simplifying Patent Eligibility

A.     Patent Eligibility’s Complexity

Despite the problems natural complexity poses for using patent eligibility’s “natural” terms, the Supreme Court seems to be obstinate in using them. And recent opportunities for the Court to provide a legalistic framework to patent eligibility, such as Bilski, Mayo, and Myriad, have done little more than promote the doctrine’s “subjective and empty words.”270 Scholars’ proposals to provide workarounds to using the terms have gained, unfortunately, little traction.271 And Congress, even in its most recent overhaul of the patent statute—the most significant in sixty years—has abdicated responsibility.272 Any realistic solution to the riddle of patent eligibility’s “natural” terms must take these limits into account. Calls to reform patent eligibility by eliminating or circumventing the doctrine or calls asking for Congress or the Patent and Trademark Office (“PTO”) to step in have failed before; there is good reason to believe they will fail again.273 But, as this Article seeks to demonstrate, any attempt to provide more concrete definitions to patent eligibility’s “natural” terms is also bound to fail. “Natural laws,” “phenomena,” and “products” are, at this point, too bound up in confusing and contradictory Supreme Court precedent, and too infected with the vagaries of natural complexity, to be clearly resolved.

In this way, and like the science it attempts to assess, the doctrine of patent eligibility has itself “complexified.” Relative to its predecessor 150 years ago, patent eligibility must now concern itself with more elements: more technologies, more patents, more claims, and more precedent.274 These elements have also increased in variety: more diverse technologies, more types of patents, more classes of claims, and more administrative procedures to challenge them.275 And the number of interrelationships between these elements has similarly increased.276

This recognition that patent eligibility is, itself, complex provides an important foundation for reform. Indeed, this suggests that patent eligibility would tend to benefit from other successful approaches “involve[d in] the consideration of a most complexly organized whole.”277 Like traditional legal analyses, scientific approaches to natural complexity have long relied upon methods of “collection, description, classification, and the observation of concurrent and apparently correlated effects.”278 And, like the law, science has called upon several familiar legal tropes to accomplish its tasks: “weighing evidence; . . . deciding what is relevant and what is not; . . . [and] finding, interpreting, and facing facts.”279 Borrowing science’s strategies to accomplish its goals may therefore be useful strategies for patent eligibility.

B.     Decomposition and Localization as Strategies for Natural Complexity

In the sciences, the problem of describing complex interactions is often solved through the twin processes of “decomposition and localization.”280 Decomposition concerns breaking down a complex system into subparts—“the subdivision of the explanatory task so that the task becomes manageable and the system intelligible.”281 In physics, for example, this may concern decomposing a particular phenomenon into subatomic particles.282 Neurobiologists often decompose the brain into separate neural structures.283 And, in molecular biology, decomposition concerns breaking down physiology into cells, proteins, or genes.284 Decomposition is the strategy of “divide and conquer.”

Localization concerns identifying the function or functions of each subpart; “the identification of the different activities proposed in a task decomposition with the behavior or capacities of specific components.”285 That is, it attempts to “localize” one or more properties of the complex system to the behavior of one or more subparts. In neurobiology, for example, a portion of the left frontal cortex is responsible for producing speech, although not responsible for comprehending it.286 Localization is, essentially, mapping a function of a system to one of its components. Together, decomposition and localization allow one to develop a “mechanistic” explanation of a complex system.287

Harnessing decomposition and localization as strategies in simplifying complex problems first requires an understanding of where to begin. To that end, “[b]efore it is possible, or even relevant, to develop a fully mechanistic explanation of how a system performs some function . . . it is necessary to identify what functions are performed and what system performs these functions.”288 This can be termed “isolating the locus of control.”289 In some instances, “[f]inding the right system is often difficult.”290 But in others, “nature seems to divide naturally into systems.”291 As such, identifying the locus of control of any particular system is, often, a dynamic product of trial and error.292

The question, “How does a car move?” serves as a good example of decomposition and localization in practice. As an initial matter, one should recognize that the question is deceptively complex. The internal combustion engine is not famous for being simple.293 Aside from the complexity of the engine, moving from point A to point B is contingent on many variable, interdependent parts: the wheels, the engine, the drivetrain, the gasoline, and, of course, the driver. All must be present and all must act in concert for the car to move at all. Nonetheless, in asking how the car physically moves, we can begin by isolating the locus of control by separating the system into car and driver. Here, the system that is moving is the car itself, rather than the driver, alone. (The driver is surely responsible for starting and operating the car, but it is the car that moves the driver, not the other way around.) Once this is identified, we can decompose the car into various components—the engine, the drivetrain, and the wheels, for instance. We can then localize each component to a particular function of the system: the engine is powered by gasoline and powers the drivetrain, the drivetrain powers the wheels, and so on. And from there, we can generalize these functions to a mechanistic description of the car’s movement: it converts the chemical energy of the gasoline into mechanical energy that moves the wheels.294

To be sure, decomposition and localization as strategies for simplifying complex phenomena has its limits. The appearance of emergent properties of complex systems—the behavior of which does not appear to be controlled by any particular mechanism of the individual, underlying components—makes decomposition and localization particularly difficult.295 For truly emergent phenomena, where “the parts do not seem to be performing intelligible subtasks contributing to the overall task . . . decomposition and localization . . . fall short.”296 Similarly, where the functions of a system solely depend on the connections between elements, rather than any individual properties of its separate components, we should be counseled to “abandon[] decomposition and localization.”297 Nonetheless, decomposition and localization have historically solved a broad variety of complex scientific problems, including those in cellular respiration,298 fermentation,299 and biochemical genetics.300 Even if decomposition and localization fail in simplifying mechanistic explanations to complex phenomena, “they may serve as probative tools for facilitating discovery.”301

C.     A Mechanistic Description of Patent Eligibility

Decomposition and localization appear to be especially apt strategies for solving the patent eligibility puzzle. Rather than rely on “a largely meaningless ‘litany’ recited before ‘the Court . . . chooses up sides and decides the case,’”302 decomposition and localization provide an avenue to mechanistically describe which particular factors actually control the Court’s patent eligibility jurisprudence.303 This description should remand patent eligibility inquiries from high levels of abstraction—What is a “law of nature”?—to more concrete, narrower questions. These narrower questions, built into a “multiprong” or “multifactor” analysis, can provide a legalistic, descriptive test that harmonizes and explains the Court’s past precedent while moving away from the vagaries of natural “laws,” “phenomena,” and “products.” This analytical approach to patent eligibility should be cognitively easier than the current state of affairs.304

This strategy of replacing standards’ reliance on “subjective and empty words”305 with narrower questions of application has proved successful elsewhere in the law. For example, the Constitution’s requirement that federal courts hear only “cases or controversies”—the meanings of which have been debated since Ratification—is now assessed through a robust analytical framework.306 Similarly, the Constitution’s prohibition on “cruel and unusual” punishments incorporates familiar and well-worn common law standards.307 And personal jurisdiction’s call for “fair play and substantial justice”—truly subjective and empty terms, if there ever were ones—has since been parceled into several objective factors.308 Indeed, this approach of pruning increasingly gnarly jurisprudence into cleaner branches “is as time-honored in law as the striving for generality.”309 Patent eligibility—which continues to reference lists of philosophically pregnant conceits, such as whether gravity is, in fact, a “natural law”—is ripe for a similar trimming.310

Ideally, any such breakdown would avoid the hopelessly undefinable terms “laws of nature,” “natural phenomena,” and “products of nature,” and replace them with a standard that is both objective and clear. Constructed properly, such an analysis could also overcome the difficulties complexity generally imparts on the doctrine of patent eligibility by allowing for nuance among marginal eligibility cases, respecting claim language, and eliminating technological bias.311 Breaking down patent eligibility into cognitively simple—and concrete—subparts is also both politically and judicially viable: it requires neither the intervention of Congress nor a radical shift in jurisprudence, something for which the Supreme Court has expressed its distaste.312 And litigants are more likely to achieve better results from courts: it is more like what courts typically do.313 Faced with indefinite, complex terms, decomposition and localization appear to be coherent, feasible strategies to resolving patent eligibility’s “natural” terms.

1.     Identifying the Locus of Control and Decomposing Patents

The first step in decomposition and localization is identifying the “locus of control”—the aspect of the system that “carries out a transformation of inputs into outputs.”314 While identifying a system’s locus of control “is often difficult,”315 this is not the case for patent eligibility: the locus of control for patent eligibility is the patent document. It is the patent document itself—rather than extrinsic evidence, such as scientific norms, enforcement policies, or market effects—that ultimately controls whether a patent application falls within the bounds of patentable subject matter.316

A patent can typically be decomposed into only two components: its claims and its specification. Under 35 U.S.C. § 112(a), the patent must “contain a written description of the invention, and of the manner and process of making and using it”—its specification.317 The specification must also “conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor . . . regards as the invention.”318 A patent may also contain other elements—drawings,319 appendices,320 and even models of the invention321—but these are not always necessary, and they are often of minor importance when interpreting the patent document.322

The claims and the specification serve several functions. The claims “alert[ ] the public of the metes and bounds of an inventor’s discovery”323 or “the outer boundaries of the patent.”324 In this way, the claims “define the scope of protection afforded by the patent” that, like land grants, provide “descriptions of lands by metes and bounds in a deed which define the area conveyed but do not describe the land.”325 And, like any land grant, claims fence their domain from their neighbors’: they “differentiate [the invention] over the prior art.”326 The patent specification, on the other hand, “serves a teaching function, as a ‘quid pro quo’ in which the public is given ‘meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.’”327 The specification describes the land of the invention—it provides a general description of the invention as a whole, explains its contribution to the art, and lists examples of how to use the invention.328 And, until recently, a patent could be invalidated for failing to include, in the specification, the best mode of making or using the invention.329 In short: “Specifications teach. Claims claim.”330

2.     Localizing Patents’ Components to Patent Eligibility’s Goals

The second step in decomposition and localization is to map, or “localize,” the system’s components to particular outputs of the system—here, the ultimate patent eligibility determination.331 That is, how does each function of the claims and specification map to answer whether a particular claim is patent eligible? Viewing each of those functions through the lens of the Supreme Court’s patent eligibility jurisprudence provides some insight into a mechanistic description of patent eligibility apart from traditional assessments of its “natural” terms.

a.     Claim Scope

The central function of patent claims is “to define the scope of protection afforded by the patent.”332 To that end, a significant portion of the Supreme Court’s patent eligibility jurisprudence has focused on claims that appeared to be so broad as to potentially cover yet undeveloped technologies. In Benson, for example, the Court characterized the applicants’ claims as virtually unlimited in scope, “not limited to any particular art or technology, to any particular apparatus or machinery, or to any particular end use.”333 Rather, the claims “purported to cover any use of the claimed method in a general-purpose digital computer of any type.”334 This made the claims “so abstract and sweeping as to cover both known and unknown uses of the BCD to pure binary conversion.”335 In Flook, the Court noted that the applicant’s claims “cover[ed] any use of [the applicant’s] formula for updating the value of an alarm limit” in its field, which, although not expressly disclosed in the patent application, nonetheless “cover[ed] a broad range of potential uses of the method.”336 Allowing such claims to proceed, in the Court’s view, would make “the beachhead of [the patent] privilege . . . wider, and the area of public use narrower” than Congress had presumably directed.337 And in Bilski, the Court referred to the petitioners’ claims as merely “broad examples of how hedging can be used in commodities and energy markets,”338 and noted that “[i]f 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.”339

Scholars have written extensively about this concern over claim breadth in the Court’s assessment of “abstract ideas.” In one seminal article, Life After Bilski, Mark A. Lemley, Michael Risch, Ted Sichelman, and R. Polk Wagner argued that “the rule against patenting abstract ideas is best understood as an effort to prevent inventors from claiming their ideas too broadly.”340 In another article, Dan L. Burk and Mark A. Lemley similarly noted that “[t]he rule against patenting abstract ideas, while couched in terms of patentable subject matter, is really a judicial effort to restrict the permissible scope of patents.”341 Kevin Emerson Collins has explicated the nuances concerning abstract claim scope and abstract claim language scope.342 And Alan L. Durham has recognized that “[t]he scope of the claim, and its impact on the progress of the technological arts, is what ultimately condemns it” under § 101.343 Meanwhile, in the lead up to Mayo, Rebecca S. Eisenberg famously highlighted the diversity of these approaches.344

Claim scope’s strong effect on the Supreme Court’s “abstract ideas” jurisprudence suggests that it likely plays a similar role in the Court’s assessments of natural “laws,” “phenomena,” and “products.” Indeed, claim scope was at the core of the Court’s recent decisions in Mayo and Myriad. In Mayo, the Court read its prior case law concerning “abstract ideas” as “warn[ing] us against upholding patents that claim processes that too broadly preempt the use of a natural law.”345 And paralleling its language in Benson, the Court construed the claims at issue in Mayo as “set[ting] forth in highly general language . . . all processes that make use of the correlations after measuring metabolites.”346 Thus, although the Mayo Court struggled throughout its opinion to define a “natural law” in order to ground its decision,347 it simultaneously voiced a simpler concern over the contested claims’ breadth as it had done in its “abstract ideas” cases. And in Myriad, the Court again recognized that patent eligibility was concerned with claim scope—“imped[ing] the flow of information that might permit, indeed spur, invention”348—while simultaneously characterizing the claims as “concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.”349 Thus, although the Myriad Court rooted its decision in the “naturalness” of isolated genomic DNA as opposed to cDNA, it, too, expressed simpler, normative concerns about claim breadth.

Even prior to these cases, a number of scholars noted the potential for claim scope to bridge “abstract ideas” and “natural laws,” “phenomena,” and “products.” Tun-Jen Chiang, in particular, has argued that patent eligibility’s prohibition on applications directed to “abstract ideas” and “laws of nature” “are one and the same in purpose and effect and are simply limits on the scope of patents.”350 Similarly, Efthimios Parasidis struggled with uniformly combining the two doctrines, but did suggest a hybrid framework for the two, complete with a binary decision-tree.351 And, in Life After Bilski, Lemley, Risch, Sichelman, and Wagner likened “a claim to an abstract idea [to] a claim to a product of nature: not limited to real-world applications of human inventiveness, and thus ineligible for patenting.”352

At the same time, distinguishing merely broad patent claims from ones so broad they render themselves ineligible for patent protection remains a difficult task. And while precisely resolving the contours of that question remains outside the scope of this Article, the best proposal thus far—the one proposed by Lemley, Risch, Sichelman, and Wagner—has identified five factors important to that inquiry: the generative potential of the claimed invention; the nature of invention in the industry; the pace of innovation in the field; the number of disclosed embodiments relative to the breadth of the claims; and the difference between the claimed invention and the prior art.353 In the aftermath of Myriad, Sichelman has recently demonstrated the fruitfulness of applying these factors to the Court’s traditional “natural” terms cases.354 Sichelman argued that the result in Funk Brothers, for example, could be explained from Varley Sherman Bond’s invention’s generative and cumulative nature: Bond’s seed inoculant mixture gave rise to the potential of other, undisclosed noninhibitory inoculant mixtures for use in an industry—agriculture—famous for building innovation on old practices.355 Similarly, the claims in both Mayo and Myriad were predicated on few embodiments in the context of highly generative and rapidly developing technologies.356

Localizing claim scope to patent eligibility—and away from philosophically troublesome attempts to define what “natural” truly means—provides a substantially clearer and more workable understanding of the prohibition on patenting natural “laws,” “phenomena,” or “products.” And it would appear to solve the greater problems with natural complexity’s effect on cabining patentable subject matter. It would not be subject to the current false equivalency of patent eligibility—that is, that patent claims on all “natural laws,” regardless of their scope, are ineligible—because, unlike asking whether a patent claim is or is not a natural law, claim scope inquiries are inherently spectral: the breadth of a claim is an inherently multihued inquiry. A focus on claim scope would also refocus patent eligibility on claim language, and not on unarticulated notions of “the invention as a whole,” because such a focus would presumably pay close attention to specific claim language.357 And while such a focus may still cause the doctrine to suffer from technological specificity, a renewed concern with the patent document and the absence of the biologically loaded word, “Nature,” counsels that technological specificity is at least less likely to happen. Whether, in making patent eligibility determinations, courts assess claim scope through the factors identified by Lemley, Risch, Sichelman, and Wagner, or others, any mechanistic description of patent eligibility should rely in part on an analysis of the scope of the contested claims.

b.     The Claims’ and Specification’s Relationship to the Prior Art

Both the claims and the specification serve another function: demarcating the invention’s boundaries from the prior art.358 The specification in particular will often include a description of not only how to make and use the invention, but also why the invention is an important contribution in its field beyond that of previously existing innovations.359 While the invention’s relationship with the prior art has not been traditionally thought of as playing an important role in determining patent eligibility, the Court’s recent trio of cases—Bilski, Mayo, and Myriad—have increasingly noted patents’ relationships to prior art in their respective fields. In Bilski, the Court noted that the patent’s underlying principle—commodities hedging—was “long prevalent in our system of commerce and taught in any introductory finance class.”360 Far from radically reinventing finance, the procedure taught by the patent application was an older, “basic concept of . . . protecting against risk.”361 Furthermore, the Court noted that several elements of the contested claims concerning certain random analysis techniques were already “well-known” to practitioners.362 The claims and specification, therefore, did little, if anything, to distinguish the patent’s greater contribution to the field of commodities purchasing.

More recently, in Mayo, the Court repeatedly focused on the fact that the patent described “well-understood, routine, conventional activity previously engaged in by researchers in the field.”363 According to the Court, the patent’s direction to “determine” the particular level of a metabolite in a patient’s blood simply “tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists who work in the field.”364 The Court analogized this to the “[p]urely ‘conventional or obvious’ ‘[pre]-solution activity’” at issue in Flook.365 And the Court noted that “any additional steps consist[ed] of well-understood, routine, conventional activity already engaged in by the scientific community.”366 These statements, too, expressed the belief that the patent—aside from simply claiming a “law of nature”—added nothing to the greater medical diagnostics field at large.

And the Myriad Court remarked that the patented genes were extracted through “well known laboratory methods” and synthesized according to “processes similarly well known in the field of genetics.”367 The Court specifically noted that “Myriad’s patent descriptions highlight the problem with its claims” in that it “simply detail[ed] the ‘iterative process’ of [gene] discovery”—something well known in genetics.368 This counseled the Court to characterize “Myriad’s principal contribution [as] uncovering the precise location and genetic sequence,” rather than “creating” or “inventing” the sequences themselves.369

These recent statements about the claims’ and specification’s relationships to their inventions’ respective arts evince concern over granting method patents to inventions accomplished through an art’s core operational techniques—hedging in finance, dosing in medicine, or sequencing in genetics. In such instances, allowing method patents to essentially mimic these techniques—even if the particular patented use of the techniques otherwise met the remaining strictures of the patent statute—raises the specter of monopolizing the techniques themselves. Distilled to a truism, claims’ and specifications’ prior-art demarcating function concerns itself more with how an invention is accomplished than what an invention is.370 The more a patent relies on “well-understood, routine, conventional activity previously engaged in by researchers in the field,”371 the more likely the patent will fail for ineligibility.

To be sure, there are several problems with equating claim demarcation to an invention’s field’s core operation techniques: it greatly overlaps with other aspects of patentability, notably obviousness; it may discriminate against inventions made through trial and error rather than a “flash of genius,” in contravention of the patent statute; and it potentially places an increased fact-finding burden on the PTO.372 But, like tacking claim language toward scope rather than “abstractness,” this approach seems to avoid the shoals complexity threatens on interpreting natural “laws,” “phenomena,” and “products.” It would seem to also avoid the false equivalency trap because assessing a patent’s claims and specification relative to “well-understood” techniques in its field is not an all-or-nothing proposition. Such an assessment would also reorient patent eligibility to claim language rather than scientific philosophy. And far from promoting a technological bias, the inquiry would allow nuanced, field-by-field determinations into the invention’s place in its particular art. This, too, would be a marked improvement to amorphous definitions of natural “laws,” “phenomena,” and “products.”

c.     The Specification’s Teaching Function

Lastly, the specification also serves a teaching function, or as defined by the Federal Circuit, “a ‘quid pro quo’ in which the public is given ‘meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.’”373 The Federal Circuit’s diction, namely—“meaningful”—proves rather illuminating. While patent law’s other requirements concerning the specification—written description and enablement—involve whether the specification’s disclosure is sufficient enough to practice the invention,374 the specification’s function in patent eligibility is tied to whether the disclosure is meaningful enough for the invention to receive patent protection at all. Here, too, recent patent eligibility litigation proves instructive. In Mayo, in particular, the Supreme Court repeatedly described its concern with the contested patent application—and patent applications, in general—as what it presumed to “tell” others in the field. A fictional attempt by Albert Einstein to patent a process using “E=mc2” in nuclear acceleration failed, in the Court’s view, because it amounted to little more than “telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced”—a meaningless, even if enabling disclosure.375 A similar fictional attempt by Archimedes to patent an application of buoyancy with respect to shipbuilding also failed in the Court’s esteem because that “consist[ed] of simply telling boat builders to refer to that principle in order to determine whether an object will float.”376 Analogously, the patent application in Mayo failed, in part, because even though the specification more than sufficiently enabled physicians to control drug dosage according to the patent, it did little more than teach users of the invention to make use of a particular principle in otherwise “well-understood” techniques.377

Similarly, in Myriad, the Court repeatedly referenced the shortcomings of Myriad’s specifications—that they detailed Myriad’s method of discovering the genes but nothing more. These disclosures described only “fairly uniform” approaches to making use of the technology “insofar as any scientist engaged in the search for a gene would likely have utilized a similar approach.”378

These concerns with the quality of the specification’s disclosure—not just its sufficiency—focus on whether the specification actually fulfills its teaching function in a manner worthy of the societal quid pro quo for the patent grant—whether the disclosure is meaningful to its particular art. Although the Mayo and Myriad Courts did not ground their decisions in those terms, their dicta concerning the patents’ specifications highlight the difference between specifications that teach a meaningful new way of implementing the claimed invention and those that simply describe variants on “well-understood, routine, conventional activity.”379 In some ways, this provides an avenue to reinvigorate § 101’s statutory command that all patented inventions be both “new and useful.”380 A patent specification that teaches neither new nor useful concepts—even if it makes use of old concepts in a new, useful, and nonobvious way—may, in some cases, run afoul of patent eligibility. This potentially demonstrates another avenue for localizing disclosure’s teaching requirement to patent eligibility.

3.     Building a Mechanistic Description of Patent Eligibility

The scope of the claims, the claims’ and specification’s relationship to the prior art, and the “meaningfulness” of the specification’s disclosure all affect whether a patent application is, or is not, patent eligible. Taken together, these three functions describe a mechanistic view of patent eligibility. At these functions’ extremes, the inquiry is disjunctive. If a claim’s scope is wildly too broad, the claim will almost certainly be rendered ineligible under one of the traditional patent eligibility inquiries. If the invention, as set forth in the claims or described in the specification, operates perfectly coequal with “well-understood” operational methods in the invention’s field, then it, too, will likely be rendered ineligible. Or, if the specification’s disclosure is so meaningless that it fails to teach its practitioners anything “new or useful” about its field, its overlying patent application may fail as well.

At the same time, these factors are not always present at such extremes. There are, to be sure, close cases. And the precise metrics courts should use in analyzing these factors is well up to debate. Regarding overly broad claim scope, the factors proposed by Lemley, Risch, Sichelman, and Wagner do not appear to be an exhaustive list.381 Even those may require a further, nuanced explanation.382 Similarly, determining how much the underlying invention—as defined in the claims or described in the specification—overlaps with “well-understood” operational techniques in its field may require a detailed understanding of how to assess how an invention’s field performs research or business. And practically assessing “meaningfulness” of the specification’s contribution to the art will likely require further parsing by the courts.

But these factors at least provide concrete, legalistic explanations for the Supreme Court’s patent eligibility jurisprudence; mechanistic descriptions of how the actual components of the patent document determine patentable subject matter. Like modern understandings of complex phenomena in the sciences, decomposition and localization here provide insight into how the poorly articulated, confusing, and seemingly contradictory area of patentable subject matter can be explained by reference to patents themselves, rather than unrelated discourses into scientific philosophy. This is one of the principal strengths—not weaknesses—in decomposition and localization in legal analysis: it simultaneously roots legal decision-making in concrete identifiable legal factors while allowing courts the opportunity to engage in the underlying policy levers regarding technological innovation.383

Whether courts, or rather, another legal institution, should be engaging in such explicit policy determinations for patent eligibility—regarded by some as simply a threshold test or a “coarse filter” that should be easy to apply—is another, higher-order question.384 And given the modern development of patent law, whether patent eligibility does any useful work apart from its statutory cousins—novelty, nonobviousness, and enablement—is another, separate question.385 But there is little simplicity or ease in the doctrine as it currently exists, and the Supreme Court has recently and explicitly rejected arguments to abandon it.386 Few would argue that the Court’s repeated invocation of philosophically pregnant terms, like “law of nature,” rests on firm, principled, legal analysis. An honest acknowledgment of how these factors affect patent eligibility, if nothing else, frees legal decision makers from grappling with the complexity of natural “laws,” “phenomena,” or “products.”

Applying this mechanistic framework to Mayo and Myriad, the Court’s two recent patent eligibility cases, one can reach similar, normatively desirable outcomes without reference to natural “laws,” “phenomena,” or “products.” As recently detailed by Sichelman, the first function, claim breadth, likely weighs heavily against the validity of the claims at issue in Myriad but would appear to allow them in Mayo.387 In Myriad, the scope of the claim likely prohibited a great deal of follow-on innovation and encompassed a number of practical applications for the gene, only some of which were disclosed in the specification.388 In addition, the invention—a discrete application of information in a rapidly advancing field—was potentially the subject of significant improvement by future researchers.389 Indeed, since the Myriad patents on BRCA1 and BRCA2 were filed in 1998, genetic sequencing technologies have completely revolutionized.390 In Mayo, however, the claims were relatively narrow and likely did not hinder follow-on innovation.391 Rather, they appeared more like incremental improvements, with few applications, in an otherwise cumulatively developing field.392 Since the Prometheus Laboratories patents were filed in 1998, there has been little improvement in honing the appropriate dosage of thiopurine drugs to treat Crohn’s and inflammatory bowel disease.393

The second function—distinguishing the claims and specification from the prior art—would seem to counsel against the validity of both the Mayo and Myriad patents. Both were directed to core operational techniques in their respective fields—drug dosing in Mayo and sequencing in Myriad—that added only an informational component. That is, the operational techniques described in the Mayo patents, “administering” the drug, and “determining” its metabolite, were well known in the prior art. Indeed, the Mayo patents themselves described them as such.394 The only element distinguishing the contested claims was the particular dosage threshold itself. Similarly, the operational techniques of many of the claims in the Myriad patents were also well-known to researchers at the time.395 And again, the only element distinguishing the contested claims from the known operational techniques was the particular sequence itself. The proximity between the Mayo and Myriad patents and core operational techniques in their fields strongly counsels in favor of finding the contested claims invalid.

The last function—the meaningfulness of the specification—likely cuts the other way, however. Both cases’ patents provided not merely sufficient but meaningful information concerning their fields. As detailed in the Mayo patents, “it was unknown what concentrations of [thiopurine] metabolites correlated with optimized therapeutic efficacy or with toxicity.”396 The patents expressly and clearly provided such information: less than 230 picomoles of thiopurine metabolites per titer of blood indicated a need to increase the dosage; greater than 400 picomoles of thiopurine metabolites per titer of blood indicated a need to decrease the dosage.397 This information was both “new and useful” to practitioners in the field.398 Similarly, the specifications of the Myriad patents were quite meaningful with respect to detecting whether a particular patient possessed an increased risk for breast cancer. If a patient possessed the sequence variants disclosed in the patent specification, their risk for developing breast cancer increased by a calculable amount—also disclosed in the patents.399 If a patient did not, their risk was presumed to be the same as that found in the general population.400 This type of analysis, applied to breast cancer, was both “new and useful” for clinical purposes,401 and counsels against the Court’s invalidity determination.

This mechanistic-functional analysis of Mayo and Myriad demonstrates the principal benefit to the approach: it compels similar, normatively desirable results to those reflected in the Court’s opinions without relying on philosophical language. The Mayo patents, which prior to the Supreme Court’s decision were subject to a nuanced analysis by commentators,402 receive an equally nuanced portrait here. Their claims do not appear overly broad, nor do their specifications disclose meaningless improvements, but their contributions above and beyond core operational techniques for diagnostics border on zero. This clearly and strongly factored into the Court’s opinion in Mayo with its repeated reference to “well-understood, routine, conventional activity previously engaged in by researchers in the field”403—stronger, perhaps, than concerns regarding the breadth of the patents’ claims or the meaningfulness of the specifications’ contributions. The Myriad patents, however, received almost universal censure from commentators and scientists alike.404 Accordingly, the mechanistic analysis presented here condemns those patents under both the claim-breadth and prior-art demarcating functions. In this way, patent eligibility can replace attempts to define natural “laws,” “phenomena,” and “products” with the sort of legal analysis courts are typically tasked to do. Without it, it would seem, patent eligibility may remain needlessly complex.

Conclusion

Patent law’s traditional concern over patents on “principles” or “abstractions” has been replaced with incantations against “laws of nature,” “natural phenomena,” and “products of nature.” These words, however, are meaningless as both legal terms of art and as scientific concepts. Since their adoption, the Supreme Court has provided no framework or set of factors to assess whether a patent’s claims come within those terms’ ambit. And worse yet, a branch of scientific philosophy, known as natural complexity, stresses the cognitive difficulties imposed on crafting general rules about a multi-elemental, multi-variable, interconnected concept of Nature. The Court’s continued reliance on this legally and scientifically meaningless terminology explains some of the difficulties the doctrine of patent eligibility suffers from today, including falsely equating all natural concepts as unpatentable “laws” or “phenomena,” marginalizing claim language, and effecting an anti-biotechnology bias.

Today, after years of doctrinal accretion, patent eligibility has itself become complex. Consequently, distilling patent eligibility into a simple formula—without doing significant, and politically untenable harm to the Supreme Court’s patent jurisprudence—remains challenging. Complexity theorists, however, have recognized twin strategies to developing “mechanistic” descriptions of complex phenomena: “decomposition,” breaking a system down into cognitively simple subparts, and “localization,” mapping the functions of those subparts to the system as a whole. While this may appear inapplicable to the law, many other complex areas of jurisprudence use this methodology by breaking down high-order, generalized questions into separate “factors” or “prongs” that map to the law’s substantive purposes. Patent eligibility could be similarly simplified by decomposing the inquiry into assessing how the functions of each component part of the patent document—the claims and the specification—localize to patent eligibility’s policy goals. In particular, courts should consider the scope of the patent’s claims, the claims’ and the specification’s relationship to the prior art, and whether the specification provides a meaningful—not merely sufficient—disclosure of a “new and useful” technology. This analysis has several advantages to the current state of affairs: it frees patent eligibility from its focus on scientifically meaningless terms; it is likely to be politically palatable to both the Supreme Court and Congress; and it does not readily suffer from some of the difficulties patent eligibility currently poses on patent law, generally. Such a test, regardless as to how it is ultimately crafted, is unlikely to be without its own uncertainties. But without decomposition and localization, patent eligibility will likely remain needlessly complex.

  1. [1]. See, e.g., Ed Black, Op-Ed., Patent Reform Will Remove the Breaks from Innovation, San Jose Mercury News (Mar. 15, 2009, 8:00 PM), http://perma.cc/YF9S-BLQK (“The only real solution is to raise the basic standard of what is a patentable invention.”); Editorial, Congress, Not Courts, Must Fix Flaws in Gene-Patent System, Boston.com (Nov. 21, 2010), http://perma.cc/
    Q826-Q7QK (“Perhaps the best policy would be to simply do away with [gene] patents.”); Editorial, Patently Ridiculous, N.Y. Times (Mar. 22, 2006), http://perma.cc/GA9R-NTLZ (“The definition of what is patentable has slowly evolved to include business practices and broad ideas.”); Editorial, Reining in Patents, L.A. Times (Mar. 30, 2010), http://perma.cc/PH9V-EKSQ (“Underlying many of these disputes is a fundamental question about what patents should cover.”).

  2. [2]. Diamond v. Diehr, 450 U.S. 175, 185 (1981) (“Excluded from such patent protection are laws of nature, natural phenomena, and abstract ideas.”); Diamond v. Chakrabarty, 447 U.S. 303, 313 (1980) (“Congress thus recognized that the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions.”).

  3. [3]. See, e.g., Dan L. Burk & Mark A. Lemley, Inherency, 47 Wm. & Mary L. Rev. 371 (2005) (viewing patentable subject matter as a function of “inherency”); Tun-Jen Chiang, The Rules and Standards of Patentable Subject Matter, 2010 Wis. L. Rev. 1353 (dividing patent eligibility into easier “rules” and more difficult “standards”); Dennis Crouch & Robert P. Merges, Operating Efficiently Post-Bilski by Ordering Patent Doctrine Decision-Making, 25 Berkeley Tech. L.J. 1673 (2010) (attempting to simplify patent eligibility through decision ordering); Rebecca S. 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, 50–64 (2012) (describing patent eligibility through three normative functions); John M. Golden, Patentable Subject Matter and Institutional Choice, 89 Tex. L. Rev. 1041, 1079 (2011) (“[T]he real concern seems to be that the so-called laws of nature cited by the Supreme Court are ‘abstract ideas’—generalized descriptions untethered to any particular, practical ends.”); Eileen M. Kane, Patent Ineligibility: Maintaining a Scientific Public Domain, 80 St. John’s L. Rev. 519, 551 (2006) (“It appears that ‘law of nature’ in patent law can be called a term of art . . . .”); Mark A. Lemley et al., Life After Bilski, 63 Stan. L. Rev. 1315, 1332–35 (2011) (tying patent eligibility to claim scope); Michael Risch, Everything Is Patentable, 75 Tenn. L. Rev. 591 (2008) (arguing that the other requirements for patentability, such as enablement, nonobviousness, and novelty, in total, satisfy the doctrine of patent eligibility); Katherine J. Strandburg, Much Ado About Preemption, 50 Hous. L. Rev. 563, 569–86 (2012) (describing and criticizing patent eligibility as a test of “preemption”).

  4. [4]. See, e.g., Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012) (giving, as examples of “laws of nature” or “natural phenomena,” “a new mineral discovered in the earth or a new plant found in the wild,” the equation E=mc, and “the law of gravity” (quoting Chakrabarty, 447 U.S. at 309) (internal quotation marks omitted)); Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124, 126–27 (2006) (Breyer, J., dissenting) (listing electromagnetism, steam, “the heat of the sun, electricity, [and] the qualities of metals” (quoting Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) (citing O’Reilly v. Morse, 56 U.S. (15 How.) 62, 116 (1853)))).

  5. [5]. See MySpace, Inc. v. GraphOn Corp., 672 F.3d 1250, 1260 (Fed. Cir. 2012) (declaring patentable subject matter a “swamp of verbiage” and a “murky morass”); Chiang, supra note 3, at 1354–55 (“[T]he doctrines on patentable subject matter are difficult to apply.”); Risch, supra note 3, at 591 (characterizing patent eligibility as the “confused and inconsistent jurisprudence of patentable subject matter”); Strandburg, supra note 3, at 566–67 (“The precise reasons for [patentable subject matter] exclusions have been left murky, however, frustrating their implementation and often leading to incoherence in courts’ reasoning about whether claims are too abstract or too ‘natural’ to be patentable.”).

  6. [6]. But see, e.g., Golden, supra note 3, at 1079 (proposing that the doctrine only concern itself with prohibiting “abstract ideas” as a way of circumventing philosophical concerns (internal quotation marks omitted)); Kane, supra note 3, at 551 (writing that, despite philosophical debates over terms like “laws of nature,” “[i]t appears that ‘law of nature’ in patent law can be called a term of art”).

  7. [7]. See infra Part I.A.

  8. [8]. See Tilghman v. Proctor, 102 U.S. 707, 726–27 (1880) (quoting O’Reilly v. Morse in support of sustaining a patent directed to a process of treating fats and oils); O’Reilly, 56 U.S. (15 How.) at 119 (“And it makes no difference, in this respect, whether the effect is produced by chemical agency or combination; or by the application of discoveries or principles in natural philosophy known or unknown before his invention; or by machinery acting altogether upon mechanical principles. In either case he must describe the manner and process as above mentioned, and the end it accomplishes.”); Le Roy v. Tatham, 55 U.S. (14 How.) 156, 175 (1852) (“A patent will be good, though the subject of the patent consists in the discovery of a great, general, and most comprehensive principle in science or law of nature, if that principle is by the specification applied to any special purpose, so as thereby to effectuate a practical result and benefit not previously attained.” (quoting Househill Coal & Iron Co. v. Nielson, (1843) 8 Eng. Rep. 616 (H.L.); 1 Web. P.C. 673, 683)).

  9. [9]. Funk Bros., 333 U.S. at 130 (“[P]atents cannot issue for the discovery of the phenomena of nature.... [T]he heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none. He who discovers a hitherto unknown phenomenon of nature has no claim to a monopoly of it which the law recognizes.” (citation omitted)); see also Ted Sichelman, Funk Forward, in Intellectual Property at the Edge: The Contested Contours of IP (Rochelle Dreyfuss et al. eds., forthcoming 2014), available at http://papers.
    ssrn.com/sol3/papers.cfm?abstract_id=2035027 (discussing the effect of Funk Brothers on patent eligibility’s “natural” terms).

  10. [10]. See Parke–Davis & Co. v. H.K. Mulford Co., 189 F. 95 (C.C.S.D.N.Y. 1911) (allowing, as patent eligible, an “isolated” and “purified” form of adrenaline), aff’d in part, rev’d in part, 196 F. 496 (2d Cir. 1912); Christopher Beauchamp, Patenting Nature: A Problem of History, 16 Stan. Tech. L. Rev. 257, 300–06 (2013) (tracing the historical incorporation of the “products of nature” doctrine into the doctrine of patent eligibility).

  11. [11]. See Chiang, supra note 3, at 1389 (“The label ‘laws of nature’ is, like the label ‘abstract idea,’ infinitely malleable and thus conclusory.”); Sichelman, supra note 9, at 2 (“[T]horny and problematic legal issues in today’s case law are reflected by the Funk Brothers decision itself. Indeed, I argue that the misguided reasoning of the Funk Brothers majority opinion—which declared the bacteria mixture ineligible for patenting—continues to plague patentable subject matter jurisprudence.”).

  12. [12]. See, e.g., Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S. 167, 180–81 (2000) (providing an analytical framework for assessing the existence of a “case or controversy” under the Constitution); Farmer v. Brennan, 511 U.S. 825, 839–40 (1994) (defining “deliberate indifference,” for purposes of “cruel and unusual” punishment under the Eighth Amendment, as “subjective recklessness ... a familiar and workable standard” in criminal law); Asahi Metal Indus. Co. v. Superior Court, 480 U.S. 102, 113 (1987) (articulating personal jurisdiction’s requirement of “fair play and substantial justice” as encompassing several factors, including “the burden on the defendant, the interests of the forum State, and the plaintiff’s interest in obtaining relief”).

  13. [13]. See supra note 4.

  14. [14]. See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2111 (2013) (assessing gene patents); Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1294 (2012) (assessing the patent eligibility of medical diagnostics).

  15. [15]. See Robert R. Sachs, Punishing Prometheus: The Supreme Court’s Blunders in Mayo v. Prometheus, Patently-O (Mar. 26, 2012, 8:10 AM), http://perma.cc/3LHW-QVJ3 (“Like so many pseudo-sciences in which every phenomenon can be rationalized and in which there is no test that can show the theory to be incorrect, under Prometheus seemingly anything can be ‘explained’ as being unpatentable subject matter.”).

  16. [16]. See Nicholas Rescher, Complexity: A Philosophical Overview 75–77 (1998) (describing the growth of scientific research, information, spending, and facilities).

  17. [17]. See generally Warren Weaver, Science and Complexity, 36 Am. Scientist 536, 538 (1948) (discussing the implications for the scientific study of systems “in which the number of variables is very large, and one in which each of the many variables has a behavior which is individually erratic, or perhaps totally unknown”).

  18. [18]. See Rescher, supra note 16, at 1.

  19. [19]. See id. at 87 (“[T]he increasing resource requirement for digging into ever deeper layers of complexity is such that successive triumphs in our cognitive struggles with nature are only to be gained at an increasingly greater price. The world’s inherent complexity renders the task of its cognitive penetration increasingly demanding and difficult. The process at issue with the growth of scientific knowledge in our complex world is one of drastically diminishing returns.”).

  20. [20]. P.W. Anderson, More Is Different, 177 Science 393 (1972).

  21. [21]. See Rescher, supra note 16, at 25–54 (discussing natural complexity).

  22. [22]. See infra Part II.

  23. [23]. See infra Part III.

  24. [24]. See generally John R. Allison & Mark A. Lemley, The Growing Complexity of the United States Patent System, 82 B.U. L. Rev. 77 (2002) (examining the recent increase in the complexity of the patent system).

  25. [25]. See generally William Bechtel & Robert C. Richardson, Discovering Complexity: Decomposition and Localization as Strategies in Scientific Research xxviii–xxxvii (MIT Press ed. 2010) (2000) (describing decomposition and localization in scientific practice).

  26. [26]. See, e.g., Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S. 167, 180–81 (2000) (providing a multiprong analysis for standing); Asahi Metal Indus. Co. v. Superior Court, 480 U.S. 102, 113 (1987) (articulating a set of factors to assess personal jurisdiction); Lemley et al., supra note 3, at 1341 (proposing five factors to identify “abstract ideas” in patent eligibility); Sichelman, supra note 9, at 15–17 (applying a similar set of factors to rectify Mayo and Myriad); see also William A. Fletcher, The Structure of Standing, 98 Yale L.J. 221, 290–91 (1988) (“The solution [to the generality problem in standing is] to break down what might appear to be a single, general question into discrete and particular questions. In seeking to determine whether a particular plaintiff has standing, we should ask, as a question of law on the merits, whether the plaintiff has the right to enforce the particular legal duty in question. Standing, if seen in this fashion, is a question of substantive law, and the answers to standing questions will vary as the substantive law varies.”).

  27. [27]. U.S. Const. art. I, § 8, cl. 8.

  28. [28]. See Sears, Roebuck & Co. v. Stiffel Co., 376 U.S. 225, 228–29 (1964) (“Pursuant to this constitutional authority, Congress in 1790 enacted the first federal patent and copyright law, and ever since that time has fixed the conditions upon which patents and copyrights shall be granted.” (citations omitted)).

  29. [29]. Id.

  30. [30]. 35 U.S.C. § 101 (2006).

  31. [31]. Compare Patent Act of 1790, ch. 7, §1, 1 Stat. 109, 109–12 (repealed 1793) (allowing patents for “any useful art, manufacture, engine, machine, or device, or any improvement therein”), with Patent Act of 1793, ch. 11, §1, 1 Stat. 318, 318–23 (repealed 1836) (allowing patents for “any new and useful art, machine, manufacture or composition of matter”), and Patent Act of 1836, ch. 357, §6, 5 Stat. 117 (repealed 1952) (same), and Patent Act of 1952, ch. 950, §101, 66 Stat. 792 (changing “art” to “process” to read “any new and useful process, machine, manufacture, or composition of matter”), and 35 U.S.C. § 101 (same).

  32. [32]. Diamond v. Chakrabarty, 447 U.S. 303, 308 (1980) (quoting 5 Writings of Thomas Jefferson 75–76 (Washington ed. 1871)).

  33. [33]. See O’Reilly v. Morse, 56 U.S. (15 How.) 62, 116 (1853) (“[T]he discovery of a principle in natural philosophy or physical science, is not patentable.”); Le Roy v. Tatham, 55 U.S. (14 How.) 156, 175 (1852) (“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.”).

  34. [34]. Diamond v. Diehr, 450 U.S. 175, 185 (1981) (“Excluded from such patent protection are laws of nature, natural phenomena, and abstract ideas.”); Chakrabarty, 447 U.S. at 313 (“Congress thus recognized that the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions.”).

  35. [35]. See George Ticknor Curtis, A Treatise on the Law of Patents for Useful Inventions: As Enacted and Administered in the United States of America, at xxviii–xxix (The Lawbook Exch., Ltd., 4th ed. 2005) (1873) (“When it has been laid down that a ‘principle,’—meaning by this use of the term a law of nature, or a general property of matter, or rule of abstract science,—cannot be the subject of a patent, the doctrine, rightly understood, asserts only that a law, property, or rule cannot, in the abstract, be appropriated by any man...unless the variation of means, apparatus, method, form, or arrangement of matter introduces some new law, or creates some new characteristic, which produces or constitutes a substantially different result.”); S.H.H., Patenting a Principle, 16 Am. L. Reg. 129, 129–30 (1868) (“The opinions of professional men are far from being settled, apparently, upon all the questions involved in patenting a principle.... Several things have contributed to this discordance of sentiment. One of the most prominent is a misapprehension of the effect and bearing of some of the cases on the subject.”).

  36. [36]. See Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012) (“[T]he 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=mc; nor could Newton have patented the law of gravity.” (quoting Chakrabarty, 447 U.S. at 309) (internal quotation marks omitted)); Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124, 126–27 (2006) (Breyer, J., dissenting) (“Neither can one patent ‘a novel and useful mathematical formula,’ the motive power of electromagnetism or steam, ‘the heat of the sun, electricity, or the qualities of metals.’” (citations omitted)); Diehr, 450 U.S. at 185 (quoting Chakrabarty, 447 U.S. at 309).

  37. [37]. John F. Duffy, Inventing Invention: A Case Study of Legal Innovation, 86 Tex. L. Rev. 1, 34–36 (2007).

  38. [38]. Statute of Monopolies, 1623, 21 Jac., c. 3, § 6 (Eng.) (allowing patents for only the “working or makinge of any manner of new Manufactures within this Realme, to the true and first Inventor and Inventors of such Manufactures”).

  39. [39]. Patent Act of 1790, ch. 7, §1, 1 Stat. 109, 110 (repealed 1793).

  40. [40]. Patent Act of 1793, ch. 11, §1, 1 Stat. 318, 319 (repealed 1836).

  41. [41]. See supra note 31.

  42. [42]. Blanchard v. Sprague, 3 F. Cas. 648, 650 (C.C.D. Mass. 1839) (No. 1518).

  43. [43]. Frank D. Prager, The Influence of Mr. Justice Story on American Patent Law, 5 Am. J. Legal Hist. 254, 254 (1961).

  44. [44]. Wyeth v. Stone, 30 F. Cas. 723, 727 (C.C.D. Mass. 1840) (No. 18,107).

  45. [45]. Id.

  46. [46]. Stone v. Sprague, 23 F. Cas. 161, 162 (C.C.D.R.I. 1840) (No. 13,487).

  47. [47]. Id.

  48. [48]. Smith v. Downing, 22 F. Cas. 511, 514 (C.C.D. Mass. 1850) (No. 13,036).

  49. [49]. Le Roy v. Tatham, 55 U.S. (14 How.) 156, 175 (1852).

  50. [50]. Id. at 172–73.

  51. [51]. Id. at 172 (internal quotation marks omitted).

  52. [52]. Id. at 175.

  53. [53]. Id. at 174.

  54. [54]. Id. at 175.

  55. [55]. Id.

  56. [56]. Id. (quoting Househill Coal & Iron Co. v. Nielson, (1843) 8 Eng. Rep. 616 (H.L.); 1Web. P.C. 673, 683) (internal quotation marks omitted).

  57. [57]. O’Reilly v. Morse, 56 U.S. (15 How.) 62, 112 (1853).

  58. [58]. Id. at 113.

  59. [59]. See U.S. Const. art. I, § 8, cl. 8 (describing Congress’s power “[t]o promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries”).

  60. [60]. O’Reilly, 56 U.S. (15 How.) at 113.

  61. [61]. Parke–Davis & Co. v. H.K. Mulford Co., 189 F. 95, 104 (C.C.S.D.N.Y 1911), aff’d in part, rev’d in part, 196 F. 496 (2d Cir. 1912).

  62. [62]. Id. at 103.

  63. [63]. Id. at 109.

  64. [64]. See Lemley et al., supra note 3, at 1333–35.

  65. [65]. E.g., Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245, 257 (1928) (prohibiting a patentee from “claiming a patent on the result or function of a machine [to] extend his patent to devices or mechanisms not described in the patent”); Minerals Separation, Ltd. v. Butte & Superior Mining Co., 250 U.S. 336, 349 (1919) (noting that “the scope of [the patentees’] right is limited to the means they have devised and described as constituting the process”); Westinghouse v. Boyden Power Brake Co., 170 U.S. 537, 581 (1898) (“[W]hether you call Westinghouse’s discovery ... a process, or a mode of operation .. . if he was the first to disclose it and to describe a mechanical means to give practical effect to the invention, he must be regarded as a pioneer inventor, and as entitled to protection . . . .”); Winans v. Denmead, 56 U.S. (15 How.) 330, 341–42 (1853) (patenting “principles” monopolized “any thing which is matter of common right, [rather than] what [inventors] themselves have created”).

  66. [66]. Lemley et al., supra note 3, at 1334–35.

  67. [67]. Hector M. Holmes, Book Review, 45 Harv. L. Rev. 1431, 1433 (1932) (reviewing C.J. Hamson, Patent Rights for Scientific Discoveries (1930)).

  68. [68]. J. Lewis Stackpole, Book Review, 41 Yale L.J. 941, 941 (1932) (reviewing Hamson, supra note 67).

  69. [69]. See Duffy, supra note 37, at 39 (alteration in original) (quoting Hotchkiss v. Greenwood, 52 U.S. 248, 267 (1850)).

  70. [70]. Id. at 42–43 (discussing several prominent judges’ criticisms of the requirement).

  71. [71]. U.S. Patent No. 2,200,532 col. 1 ll. 2–4 (filed Aug. 24, 1938).

  72. [72]. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 129–30 (1948).

  73. [73]. Id. at 130.

  74. [74]. ’532 Patent col. 13 ll. 22–27.

  75. [75]. Funk Bros., 333 U.S. at 131–32.

  76. [76]. See id. at 127–32; see also Duffy, supra note 37, at 39 (discussing Hotchkiss v. Greenwood’s requirement that inventions encompass “more ingenuity and skill ... than were possessed by an ordinary mechanic acquainted with the business” (alteration in original) (quoting Hotchkiss v. Greenwood, 52 U.S. 248, 267 (1850)) (internal quotation marks omitted)).

  77. [77]. Funk Bros., 333 U.S. at 133 (Frankfurter, J., concurring).

  78. [78]. Id. at 130 (majority opinion).

  79. [79]. See, e.g., Vannevar Bush, As We May Think, Atlantic (July 1, 1945), http://perma.cc/
    G7AL-R33Q (“Thus science may implement the ways in which man produces, stores, and consults the record of the race. It might be striking to outline the instrumentalities of the future more spectacularly, rather than to stick closely to the methods and elements now known and undergoing rapid development, as has been done here. Technical difficulties of all sorts have been ignored, certainly, but also ignored are means as yet unknown which may come any day to accelerate technical progress as violently as did the advent of the thermionic tube.”).

  80. [80]. Funk Bros., 333 U.S. at 128.

  81. [81]. Id. at 130.

  82. [82]. Id.

  83. [83]. Id. at 131.

  84. [84]. Id.

  85. [85]. Id. at 132.

  86. [86]. Id.

  87. [87]. Le Roy v. Tatham, 55 U.S. (14 How.) 156, 175 (1852).

  88. [88]. Funk Bros., 333 U.S. at 136 (Burton, J., dissenting).

  89. [89]. O’Reilly v. Morse, 56 U.S. (15 How.) 62, 113 (1853).

  90. [90]. Funk Bros., 333 U.S. at 134 (Frankfurter, J., concurring).

  91. [91]. Id. at 134–35.

  92. [92]. Id. at 135 (emphasis added).

  93. [93]. See supra notes 84–86 and accompanying text.

  94. [94]. Diamond v. Chakrabarty, 447 U.S. 303, 305 (1980).

  95. [95]. Id.

  96. [96]. Id. at 310.

  97. [97]. Id. at 309.

  98. [98]. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1294–95 (2012).

  99. [99]. Id. at 1295.

  100. [100]. O’Reilly v. Morse, 56 U.S. (15 How.) 62, 113 (1853).

  101. [101]. See Mayo, 132 S. Ct. at 1297–98 (“First, the ‘administering’ step simply refers to the relevant audience, namely doctors who treat patients with certain diseases with thiopurine drugs.... 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.... 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.... 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.”).

  102. [102]. Id. at 1296.

  103. [103]. Id.

  104. [104]. Id. at 1305.

  105. [105]. Id. at 1296.

  106. [106]. Id. at 1293.

  107. [107]. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2111 (2013).

  108. [108]. Id.

  109. [109]. Id. at 2114–15.

  110. [110]. Id. at 2119.

  111. [111]. Id. at 2117.

  112. [112]. Gottschalk v. Benson, 409 U.S. 63, 67–68 (1972) (“As we stated in [Funk Brothers], He who discovers a hitherto unknown phenomenon of nature has no claim to a monopoly of it which the law recognizes.... We dealt there with a ‘product’ claim, while the present case deals with a ‘process’ claim. But we think the same principle applies.” (citation omitted) (quoting Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948)) (internal quotation marks omitted)).

  113. [113]. Parker v. Flook, 437 U.S. 584, 589 (1978).

  114. [114]. Id. at 593.

  115. [115]. Diamond v. Diehr, 450 U.S. 175, 187 (1981) (quoting Flook, 437 U.S. at 590).

  116. [116]. Bilski v. Kappos, 130 S. Ct. 3218, 3225 (2010).

  117. [117]. Cf. Tun-Jen Chiang & Lawrence B. Solum, The Interpretation-Construction Distinction in Patent Law, 123 Yale L.J. 530, 543–48 (2013) (describing the facets of “interpretation” in claim construction).

  118. [118]. Cf. id. at 549–52.

  119. [119]. See supra notes 64–66 and accompanying text.

  120. [120]. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012); Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124, 126–27 (2006) (Breyer, J., dissenting).

  121. [121]. See cases cited supra note 12.

  122. [122]. Kevin Emerson Collins has written extensively on how patentable subject matter’s prohibitions on “laws of nature, natural phenomena, and abstract ideas” are prohibitions on man-made representations of “laws of nature, natural phenomena, and abstract ideas,” however defined. E.g., Kevin Emerson Collins, Bilski and the Ambiguity of “An Unpatentable Abstract Idea, 15 Lewis & Clark L. Rev. 37, 46 (2011) [hereinafter Collins, Bilski and the Ambiguity] (analogizing patents on abstract ideas to representations of mental phenomena as patents on drugs are to patents on chemical formulas); Kevin Emerson Collins, Prometheus Laboratories, Mental Steps, and Printed Matter, 50 Hous. L. Rev. 391, 395–97 (2012) (describing how restrictions on patenting abstract ideas are actually prohibited on representations of abstract ideas in the context of the printed matter doctrine); Kevin Emerson Collins, Propertizing Thought, 60 SMU L. Rev. 317, 329 (2007) (describing patents on abstract ideas as “mental representations of knowledge”).


    This issue has also, of course, occupied a central place in the philosophy of science.
  123. [123]. Lab. Corp., 548 U.S. at 134 (Breyer, J., dissenting) (quoting Parker v. Flook, 437 U.S. 584, 589 (1978)).

  124. [124]. Mayo, 132 S. Ct. at 1303.

  125. [125]. Diamond v. Diehr, 450 U.S. 175, 177–81 (1981). The Arrhenius equation generally describes the effect of temperature on chemical reaction rates. See Keith J. Laidler, The Development of the Arrhenius Equation, 61 J. Chemical Educ. 494, 494 (1984).

  126. [126]. See Sichelman, supra note 9, at 10 (“[S]eparating the ‘natural’ from the ‘synthetic’ is not so simple a task.”); supra notes 67–68 and accompanying text.

  127. [127]. See, e.g., philosophy sources cited supra note 122.

  128. [128]. See, e.g., philosophy sources cited supra note 122. See generally The Oxford Companion to Philosophy 506–07 (Ted Honderich ed., 2d ed. 2005) (discussing various philosophical approaches to defining a “law of nature”).

  129. [129]. See generally Armstrong, supra note 122.

  130. [130]. Rescher, supra note 16, at 1 (defining one form of complexity as “the number and variety of an item’s constituent elements and of the elaborateness of their interrelational structure”).

  131. [131]. See id. at 8–16 (giving examples of increasingly complex systems).

  132. [132]. This, however, is not always the case in complex systems. One branch of complexity theory, complex adaptive systems, or CAS, describes how certain complex systems can adapt to changes in their configuration despite their interconnected nature. See generally John H. Holland, Complex Adaptive Systems, Daedalus, Winter 1992, at 17. J.B. Ruhl has written numerous articles on how various areas of the law similarly adapt despite their complexity. E.g., J.B. Ruhl, Complexity Theory as a Paradigm for the Dynamical Law-and-Society System: A Wake-Up Call for Legal Reductionism and the Modern Administrative State, 45 Duke L.J. 849 (1996); J.B. Ruhl, Law’s Complexity: A Primer, 24 Ga. St. U. L. Rev. 885 (2008); J.B. Ruhl & Harold J. Ruhl, Jr., The Arrow of the Law in Modern Administrative States: Using Complexity Theory to Reveal the Diminishing Returns and Increasing Risks the Burgeoning of Law Poses to Society, 30 U.C. Davis L. Rev. 405 (1997); J.B. Ruhl, The Fitness of Law: Using Complexity Theory to Describe the Evolution of Law and Society and Its Practical Meaning for Democracy, 49 Vand. L. Rev. 1407 (1996).

  133. [133]. See Herbert A. Simon, The Sciences of the Artificial 188–90 (3d ed. 1996).

  134. [134]. See Rescher, supra note 16, at 16 (“All in all, then, the best overall index we have of a system’s complexity is the extent to which resources (of time, energy, ingenuity) must be expanded on its cognitive domestication.”).

  135. [135]. See id. at 16–21 (describing the cognitive difficulties with complex systems).

  136. [136]. See Simon, supra note 133, at 188–90 (recounting the watchmaker parable).

  137. [137]. See Rescher, supra note 16, at 14 (discussing cognitive difficulties in ontological complexity).

  138. [138]. See id.

  139. [139]. See 15 Charles Darwin, On the Origin of Species (Paul H. Barrett & R.B. Freeman eds., Pickering & Chatto Ltd. 1988) (1859) (discussing evolution and natural selection); 2 Michael B. Green et al., Superstring Theory (1987); Werner Heisenberg, The Physical Principles of the Quantum Theory (Carl Eckhart & Frank C. Hoyt trans., 1930); A.A. Penzias & R. W. Wilson, A Measurement of Excess Antenna Temperature at 4080 Mc/s, 142 Astrophysical J. 419 (1965); F.J. Vine & D.H. Matthews, Magnetic Anomalies over Oceanic Ridges, 199 Nature 947 (1963) (demonstrating the existence of magnetic striations over the seafloor, proof of seafloor “spreading” and “continental drift”); J.D. Watson & F.H.C. Crick, Molecular Structure of Nucleic Acids: A Structure for Deoxyribose Nucleic Acid, 171 Nature 737 (1953) (discussing the discovery of the structure of DNA); Count K.A.H. Mörner, Rector, Royal Caroline Inst., Presentation Speech: Award Ceremony Speech (Dec. 10, 1905), available at http://perma.cc/BZY3-AU6X (awarding Robert Koch the 1905 Nobel Prize in medicine for his “discover[y of] the causes of individual diseases,” i.e., microbes); see also Thomas S. Kuhn, The Structure of Scientific Revolutions 111 (3d ed. 1996) (“[A]fter a revolution scientists are responding to a different world.”).

  140. [140]. Rescher, supra note 16, at 75–77 (recounting the growth and increase in the number of subdivisions in the sciences).

  141. [141]. Id. at 45 (describing how scientific interdisciplinarity “broaden[s] one’s notion of a natural phenomenon to include not just the processes themselves . .. but also the relationships among them”).

  142. [142]. See id. at 75–77 (discussing the growth of scientific research).

  143. [143]. See id. at 76 (computing the rate of production of scientific literature to increase ten-fold every fifty years).

  144. [144]. Id.

  145. [145]. See, e.g., Weaver, supra note 17, at 540 (“These problems—and a wide range of similar problems in the biological, medical, psychological, economic, and political sciences—are just too complicated to yield to the old nineteenth-century techniques which were so dramatically successful on two-, three-, or four-variable problems of simplicity. These new problems, moreover, cannot be handled with the statistical techniques so effective in describing average behavior in problems of disorganized complexity.”).

  146. [146]. Anderson, supra note 20, at 393.

  147. [147]. Id.

  148. [148]. Id.

  149. [149]. Id.

  150. [150]. Rescher, supra note 16, at 50–52 (summarizing the procession of natural complexity).

  151. [151]. Nicholas W. Watkins & Mervyn P. Freeman, Natural Complexity, 320 Science 323, 323 (2008) (describing natural complexity from a geoscience perspective).

  152. [152]. Rescher, supra note 16, at 28.

  153. [153]. Id. at 33. Interestingly, several other scholars have written about the limits of language in other areas of patent law. See, e.g., Andrew Chin, The Ontological Function of the Patent Document, 74 U. Pitt. L. Rev. 293, 299–305 (2012) (describing the limits of language in defining what constitutes enablement); supra note 122 (citing works by Kevin Emerson Collins discussing what constitutes an “abstract idea”).

  154. [154]. Rescher, supra note 16, at 31.

  155. [155]. The Oxford Companion to Philosophy, supra note 128, at 506 (emphasis omitted). The twinning of constancy and causality in natural “laws” or “phenomena” is an almost infinitely rich topic in the philosophy of science. See generally G.E.M. Anscombe, Professor of Philosophy, Univ. of Cambridge, Inaugural Lecture Before the University of Cambridge (May 6, 1971), in Causality and Determination (1971) (describing the state of the field). The purpose of this Subpart, however, is to simply describe the prevailing, classical view of constancy and causality.

  156. [156]. The Oxford Companion to Philosophy, supra note 128, at 506.

  157. [157]. Id. (internal quotation marks omitted).

  158. [158]. See id.

  159. [159]. For a brief account of the traditional problem of induction, see Mario Bunge, Causality and Modern Science 251–55 (Transaction Publishers 4th ed. 2009) (1959).

  160. [160]. But see Nancy Cartwright, The Dappled World: A Study of the Boundaries of Science 148–49 (1999) (criticizing this view).

  161. [161]. Rescher, supra note 16, at 65.

  162. [162]. See Anderson, supra note 20, at 393 (“The constructionist hypothesis breaks down when confronted with the twin difficulties of scale and complexity. The behavior of large and complex aggregates of elementary particles, it turns out, is not to be understood in terms of a simple extrapolation of the properties of a few particles.”); see also Cartwright, supra note 160, at 25–26 (discussing how complexity makes problematic “treating a real situation [by] . . . piec[ing] together a model from these fixed components”); John Dupré, The Disorder of Things: Metaphysical Foundations of the Disunity of Science 103 (1993) (“I suspect that the complex interdependencies of entities at many different levels of structural complexity characteristic of biology is sufficient to show the implausibility of the reductionistic project.”).

  163. [163]. Dupré, supra note 162, at 184.

  164. [164]. Douglas Hanahan & Robert A. Weinberg, The Hallmarks of Cancer, 100 Cell 57, 57 (2000); see also Cartwright, supra note 160, at 17–18 (discussing this in the philosophy of science context).

  165. [165]. In their famous paper in 2000, notable cancer researchers Douglas Hanahan and Robert A. Weinberg proposed reducing cancer to six cellular “hallmarks” that appeared to be present in almost all cancers. Hanahan & Weinberg, supra note 164, at 57. But this attempt to impose constancy on a complex natural system eventually gave way; ironically, Hanahan and Weinberg’s “hallmark” principle has itself “complexified.” Since its publication, the authors have added two more hallmarks, while other scientists have noted that many of the hallmarks apply to noncancerous tumors, as well. Douglas Hanahan & Robert A. Weinberg, Hallmarks of Cancer: The Next Generation, 144 Cell 646 (2011) (adding additional hallmarks); see also Sébastien L. Floor et al., Hallmarks of Cancer: Of All Cancer Cells, All the Time?, 18 Trends Molecular Med. 509, 514 (2012) (discussing how “the complexity of in vivo human cancer... explains why it is so difficult to treat cancer”); Yuri Lazebnik, What Are the Hallmarks of Cancer?, 10 Nature Reviews Cancer 232, 232 (2010) (questioning whether “the proposed hallmarks of cancer [are] indeed such” given “the puzzling complexity of numerous and interrelated properties of cancers”).

  166. [166]. Hanahan & Weinberg, supra note 164, at 57.

  167. [167]. Larry D. Kirkpatrick & Gregory E. Francis, Physics: A World View 79 (6th ed. 2007).

  168. [168]. See Cartwright, supra note 122, at 56–57 (discussing gravity); Dupré, supra note 162, at 185 (“[D]eterminism claims that there are exceptionless universal laws of nature. Notoriously, the truth of such laws cannot be empirically established.”).

  169. [169]. Cartwright, supra note 122, at 57–59. Some physicists have responded to this philosophical criticism of gravity by arguing that simply because other forces drown out gravity’s effect at the quantum level does not make it less of a “law.” See, e.g., Steven Weinberg, Dreams of a Final Theory 91–95 (1993) (discussing gravity as a history of “anomalies” but a law nonetheless). But this argument fails to address the classical requirement that “laws” as “laws,” as opposed to just statistical regularities or coincidences, must be universal. See infra Part II.B (discussing this counterargument with respect to probabilism).

  170. [170]. See, e.g., John Beatty, The Evolutionary Contingency Thesis, in Concepts, Theories, and Rationality in the Biological Sciences 45, 46–47 (Gereon Wolters et al. eds., 1995); J.J.C. Smart, Philosophy and Scientific Realism 59–61 (1963).

  171. [171]. Paul S. Agutter & Denys N. Wheatley, About Life: Concepts in Modern Biology 128 (2007) (paraphrasing Stephen Jay Gould).

  172. [172]. Beatty, supra note 170, at 46.

  173. [173]. See Ernst Mayr, Cause and Effect in Biology, 134 Science 1501, 1505 (1961) (discussing the “uniqueness” of biology).

  174. [174]. Id.

  175. [175]. See Dupré, supra note 162, at 194 (discussing probabilism as “residual deterministic [i.e., causal and constant] thinking”).

  176. [176]. See id. at 184 (“[O]ur most successful scientific theories describe a probabilistic rather than a deterministic world.”). See generally 2 The Probabilistic Revolution: Ideas in the Sciences (Lorenz Krüger et al. eds., 1990) (discussing the increase in probabilism in psychology, sociology, economics, physiology, evolutionary biology, and physics).

  177. [177]. See supra note 167 and accompanying text.

  178. [178]. See generally Patrick Suppes, Probabilistic Metaphysics 125–30 (1984) (discussing the history and implications of the N-body problem).

  179. [179]. But see Cartwright, supra note 122, at 154 (describing and rejecting this approach); Cartwright, supra note 160, at 111–12 (same).

  180. [180]. Neil Pearce & Franco Merletti, Complexity, Simplicity, and Epidemiology, 35 Int’l J. Epidemiology 515, 516–17 (2006).

  181. [181]. Sandro Galea et al., Causal Thinking and Complex System Approaches in Epidemiology, 39 Int’l J. Epidemiology 97, 101 (2010) (“Epidemiological methods, frequently married with biostatistical techniques and approaches, continue to dwell, almost entirely, on the analysis of data that are collected through epidemiological studies and the application of various statistical techniques to document association present in the data collected.”).

  182. [182]. See id. at 100–01 (“Although epidemiological methods are predicated on population-based methods that should, in a perfect world, be used only for group-level inference, epidemiologists are nonetheless accustomed to thinking of our methods as providing insight into individual health and disease formation. The epidemiological concern with individual health and disease poses a substantial challenge to methods, such as complex systems dynamic models....”).

  183. [183]. Cartwright, supra note 122, at 154.

  184. [184]. See Michele Cargill et al., Characterization of Single-Nucleotide Polymorphisms in Coding Regions of Human Genes, 22 Nature Genetics 231, 232–33 (1999) (measuring the diversity of polymorphisms in 106 human genes).

  185. [185]. Thomas D. Schneider, Consensus Sequence Zen, 1 Applied Bioinformatics 111, 111, 113 (2002).

  186. [186]. See Cartwright, supra note 122, at 154.

  187. [187]. Compare Jeffrey Rosenfeld & Christopher E. Mason, Pervasive Sequence Patents Cover the Entire Human Genome, 5 Genome Med. 27 (2013) (claiming that randomized, 15 nucleotide DNA sequences cover approximately 41% of all human genes), and Christopher Mason, Dr. Chris Mason Responds to Blog Posts on Genome Medicine Article—Updated, Patent Docs (Apr. 10, 2013, 11:59 PM), http://perma.cc/7KEH-P64Y (same), with Donald Zuhn, Genome Medicine Article Calls for Limits on Patenting of Existing Nucleotide Sequences, Patent Docs (Apr. 2, 2013, 11:59 PM), http://perma.cc/5SSM-VG8U (criticizing the study’s methodology and application to patent law), and Donald Zuhn, Revisiting Genome Medicine Article on “Pervasive Sequence Patents” that “Cover the Entire Human Genome, Patent Docs (Apr. 8, 2013, 11:59 PM), http://perma.cc/
    H87W-TYPK (same), and Kevin E. Noonan, A Response to Dr. Mason’s “Rebuttal” to Criticisms of His Genomics Medicine Article, Patent Docs (Apr. 11, 2013, 11:59 PM), http://perma.cc/K2UV-U7TT (same), and Donald Zuhn, A Primer on Claim Construction—Comments on Dr. Mason’s Response, Patent Docs (Apr. 11, 2013, 11:55 PM), http://perma.cc/4MQT-EJ23 (same).

  188. [188]. See Schneider, supra note 185, at 118.

  189. [189]. Dupré, supra note 162, at 184.

  190. [190]. See Weinberg, supra note 169, at 144–49 (discussing fundamentalism and explanatory power).

  191. [191]. See id. at 20 (“We have an overwhelming sense that the photon theory of light is more fundamental than any statement about heat radiation and is therefore the explanation of the properties of heat radiation. And in the same way, although Newton derived his famous laws of motion in part from the earlier laws of Kepler that describe the motion of planets in the solar system, we say that Newton’s laws explain Kepler’s, not the other way around.”).

  192. [192]. Id. at 43; accord Philip W. Anderson, Physics: The Opening to Complexity, 92 Proc. Nat’l Acad. Sci. U.S. 6653, 6653 (1995) (“[I]gnorance about these laws persists only on the extreme scales of the very small, the very cosmic, or the very weak and subtle.”).

  193. [193]. Anderson, supra note 20, at 393.

  194. [194]. Id.

  195. [195]. Bruce C. Gibb, Reaching Out to Complexity, 1 Nature Chemistry 252, 252 (2009) (describing snowflake formation through complexity and emergence).

  196. [196]. R.B. Laughlin & David Pines, The Theory of Everything, 97 Proc. Nat’l Acad. Sci. U.S. 28, 30 (2000) (discussing emergence).

  197. [197]. Anderson, supra note 20, at 393.

  198. [198]. William A. Gorton, The Philosophy of Social Science, Internet Encyclopedia Phil., http://perma.cc/5BC7-C6J4 (last visited Jan. 16, 2014).

  199. [199]. See Holland, supra note 132, at 18–19.

  200. [200]. Marc H.V. Van Regenmortel, Reductionism and Complexity in Molecular Biology, 5 EMBO Rep. 1016, 1019 (2004).

  201. [201]. Cartwright, supra note 160, at 24.

  202. [202]. Paul Humphreys, Emergence, Not Supervenience, 64 Phil. Sci. S337, S344 (1997) (describing the spontaneous symmetry breaking of ferromagnets below Curie temperatures as an example of emergent phenomena).

  203. [203]. Dupré, supra note 162, at 206.

  204. [204]. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1303 (2012) (“[O]ur cases have not distinguished among different laws of nature according to whether or not the principles they embody are sufficiently narrow.”).

  205. [205]. Bilski v. Kappos, 130 S. Ct. 3218, 3225 (2010) (“The Court’s precedents provide three specific exceptions to § 101’s broad patent-eligibility principles: ‘laws of nature, physical phenomena, and abstract ideas.’” (quoting Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980))).

  206. [206]. Mayo, 132 S. Ct. at 1297 (comparing Einstein’s famous equation, E=mc, to the conclusions derived from the clinical trial data at issue in the patent claims and holding the claim invalid); see also John P.A. Ioannidis, Contradicted and Initially Stronger Effects in Highly Cited Clinical Research, 294 JAMA 218, 218 (2005) (discussing the difficulties in reproducing and drawing definitive conclusions from most clinical trials).

  207. [207]. Mayo, 132 S. Ct. at 1303.

  208. [208]. See, e.g., Gen. Elec. Co. v. Joiner, 522 U.S. 136, 148 (1997) (Breyer, J., concurring) (“[J]udges are not scientists and do not have the scientific training that can facilitate the making of [scientific] decisions.... [W]hen law and science intersect, those duties often must be exercised with special care.”).

  209. [209]. Mayo, 132 S. Ct. at 1303.

  210. [210]. See, e.g., Peter Lee, Patent Law and the Two Cultures, 120 Yale L.J. 2, 34–35 (2010) (discussing the use of a bright-line rule in the context of prosecution history estoppel).

  211. [211]. See Sichelman, supra note 9, at 10 (“This tension is exacerbated by current judicial and Patent Office practice, which—in order to keep the administrative costs of gatekeeping low—tend to draw bright lines to demarcate areas of patentable subject matter from non-patentable subject matter. These practices remove the flexibility that a more policy-driven approach requires, and introduces more than a modicum of arbitrariness in many cases. Of course, these concerns raise the specter of the old rules-standards debate—which are often difficult to answer without concerted empirical analysis—but in a legal field with rapid change, rigid rules often seem out of place.”).

  212. [212]. Mayo, 132 S. Ct. at 1301.

  213. [213]. Id. at 1294.

  214. [214]. Id. at 1303; accord Bilski v. Kappos, 130 S. Ct. 3218, 3231 (2010) (rejecting a “patent [on] risk hedging [because it] would pre-empt use of this approach in all fields, and would effectively grant a monopoly over an abstract idea”); Parker v. Flook, 437 U.S. 584, 589 (1978) (quoting Gottschalk v. Benson, 409 U.S. 63, 71–72 (1972)); Benson, 409 U.S. at 72 (concluding that the patent “would wholly pre-empt the mathematical formula and in practical effect would be a patent on the algorithm itself”).

  215. [215]. Mayo, 132 S. Ct. at 1295.

  216. [216]. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2112 n.1 (2013).

  217. [217]. See U.S. Patent No. 6,355,623 B2 col. 17 ll. 10–22 (filed Apr. 8, 1999) (tabulating the claimed dosage ranges only for patients that initially responded to drug therapy and had a drug metabolism that fell within specified ranges—45 out of 107 subjects).

  218. [218]. See Strandburg, supra note 3, at 587–91 (criticizing per se exclusion in patentable subject matter’s preemption rationale).

  219. [219]. Mayo, 132 S. Ct. at 1303; accord Bilski, 130 S. Ct. at 3225 (“[T]hese exceptions have defined the reach of the statute as a matter of statutory stare decisis going back 150 years.... [as] ‘part of the storehouse of knowledge of all men... free to all men and reserved exclusively to none.’” (second ellipses in original) (quoting Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948))).

  220. [220]. Planned Parenthood of Se. Pa. v. Casey, 505 U.S. 833, 855 (1992) (citing Burnet v. Coronado Oil & Gas Co., 285 U.S. 393, 412 (1932) (Brandeis, J., dissenting)); accord Am. Trucking Ass’ns, Inc. v. Scheiner, 483 U.S. 266, 302 (1987) (O’Connor, J., dissenting) (“Significantly changed circumstances can make an older rule, defensible when formulated, inappropriate....”).

  221. [221]. Mayo, 132 S. Ct. at 1293.

  222. [222]. Id. (“[A] process is not unpatentable simply because it contains a law of nature or a mathematical algorithm.” (quoting Diamond v. Diehr, 450 U.S. 175, 187 (1981)) (internal quotation marks omitted)).

  223. [223]. Id. at 1294 (citing Gottschalk v. Benson, 409 U.S. 63, 71–72 (1972)).

  224. [224]. Merrill v. Yeomans, 94 U.S. 568, 570 (1876); see also Mayo, 132 S. Ct. at 1294 (“Our conclusion rests upon an examination of the particular claims before us in light of the Court’s precedents.”).

  225. [225]. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1347 (Fed. Cir. 2010) (“Claims define the subject matter that, after examination, has been found to meet the statutory requirements for a patent.Their principal function, therefore, is to provide notice of the boundaries of the right to exclude and to define limits;it is not to describe the invention, although their original language contributes to the description and in certain cases satisfies it. Claims define and circumscribe, the written description discloses and teaches.” (citation omitted)). But see Oskar Liivak, Rescuing the Invention from the Cult of the Claim, 42 Seton Hall L. Rev. 1, 7–8 (2012) (rejecting this view on historical grounds as a “cult”).

  226. [226]. See Perkin–Elmer Corp. v. Westinghouse Elec. Corp., 822 F.2d 1528, 1533 n.9 (Fed. Cir. 1987) (“Because claims are composed of a number of limitations, the limitations have on occasion been referred to as ‘claim elements’ or ‘elements of the claim’....”).

  227. [227]. Mayo, 132 S. Ct. at 1293; see also id. at 1294 (“[A] process that focuses upon the use of a natural law [must] 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.” (quoting Parker v. Flook, 437 U.S. 584, 594 (1978))); Bilski v. Kappos, 130 S. Ct. 3218, 3230 (2010) (“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.’” (alterations in original) (quoting Diehr, 450 U.S. at 188)); Flook, 437 U.S. at 590 n.12 (“[T]he Court [has] upheld a patent on an improvement on a papermaking machine that made use of the law of gravity to enhance the flow of the product. The patentee, of course, did not claim to have discovered the force of gravity, but that force was an element in his novel conception.”).

  228. [228]. See Aro Mfg. Co. v. Convertible Top Replacement Co., 365 U.S. 336, 344–45 (1961) (“[It is a] basic fallacy ... [to] require[ ] the ascribing to one element of the patented combination the status of patented invention in itself. ... [T]his Court has made it clear ... that there is no legally recognizable or protected ‘essential’ element, ‘gist’ or ‘heart’ of the invention . . . .”); Retractable Techs., Inc. v. Becton, Dickinson & Co., 659 F.3d 1369, 1372 (Fed. Cir. 2011) (Moore, J., dissenting) (“The error in Retractable is the majority’s attempt to rewrite the claims to better conform to what it discerns is the ‘invention’ of the patent instead of construing the language of the claim.”); Computer Docking Station Corp. v. Dell, Inc., 519 F.3d 1366, 1373 (Fed. Cir. 2008) (“The words of the claims define the scope of the patented invention.” (emphasis added) (citing Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996))); Vas–Cath Inc. v. Mahurkar, 935 F.2d 1555, 1565 (Fed. Cir. 1991) (“We find the district court’s concern with ‘what the invention is’ misplaced.... ‘The invention’ is defined by the claims on appeal.”).

  229. [229]. See Diehr, 450 U.S. at 187 (“[I]f the computer use incorporated in the process patent significantly lessens the possibility of ‘overcuring’ or ‘undercuring,’ the process as a whole does not thereby become unpatentable subject matter.” (emphasis added)); id. at 188 (“In determining the eligibility of respondents’ claimed process for patent protection under § 101, their claims must be considered as a whole.” (emphasis added)); id. at 192 (“On the other hand, when a claim containing a mathematical formula implements or applies that formula in a structure or process which, when considered as a whole, is performing a function which the patent laws were designed to protect ... then the claim satisfies the requirements of § 101.” (emphasis added)); id. at 193 n.15 (“The fact that one or more of the steps in respondents’ process may not, in isolation, be novel or independently eligible for patent protection is irrelevant to the question of whether the claims as a whole recite subject matter eligible for patent protection under § 101.” (first emphasis added)).

  230. [230]. Id. at 192.

  231. [231]. Id.

  232. [232]. Mayo, 132 S. Ct. at 1294 (“[A] process that focuses upon the use of a natural law [must] 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.” (emphasis added) (quoting Flook, 437 U.S. at 594)); id. at 1299 (“[P]utting the formula to the side [in Flook] there was no ‘inventive concept’ in the claimed application of the formula.” (emphasis added) (quoting Flook, 437 U.S. at 594)).

  233. [233]. Id. at 1297.

  234. [234]. Id.

  235. [235]. Flook, 437 U.S. at 593.

  236. [236]. Id. at 590.

  237. [237]. E.g., Mayo, 132 S. Ct. at 1294 (“[C]ases 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].’” (alteration in original) (quoting Flook, 437 U.S. at 593)); Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124, 137 (2006) (Breyer, J., dissenting) (“[Diehr] warn[s] against ‘allow[ing] a competent draftsman to evade the recognized limitations on the type of subject matter eligible for patent protection.’” (third alteration in original) (quoting Diamond v. Diehr, 450 U.S. 175, 192 (1981))).

  238. [238]. See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2118 (2013).

  239. [239]. Id.

  240. [240]. See id. at 2113.

  241. [241]. See Rebecca S. Eisenberg, Re-Examining the Role of Patents in Appropriating the Value of DNA Sequences, 49 Emory L.J. 783, 785 (2000) (“The standard patent lawyer’s response to the ‘products of nature’ limitation is to treat it as a technical, claim-drafting problem.”).

  242. [242]. See 1 Donald S. Chisum, Chisum on Patents § 1.03[2][f][ix] (2013) (“The three determinations for implementing [Mayo] are as follows. First, one determines whether a claim is drawn to a law of nature, natural phenomena, or abstract idea.... The first weak point is the Court’s failure to define what constitutes a ‘law of nature.’ The absence of a definition is reflected in the Court’s rather summary determination that the claims at issue did involve such a ‘law of nature.’”).

  243. [243]. 2 John Gladstone Mills III et al., Patent Law Fundamentals § 7:4.50 (2d ed. 2013).

  244. [244]. Lee, supra note 210, at 19–20.

  245. [245]. John R. Thomas, Claim Re-Construction: The Doctrine of Equivalents in the Post-Markman Era, 9 Lewis & Clark L. Rev. 153, 166 (2005).

  246. [246]. But see Dan L. Burk & Mark A. Lemley, Policy Levers in Patent Law, 89 Va. L. Rev. 1575, 1675–95 (2003) (arguing that, normatively, courts should use “policy levers” to adopt technological specificity in some fields of art).

  247. [247]. See Dan L. Burk & Mark A. Lemley, Is Patent Law Technology-Specific?, 17 Berkeley Tech. L.J. 1155, 1156 (2002) (“Patent law has a general set of legal rules to govern the validity and infringement of patents in a wide variety of technologies. With very few exceptions, the statute does not distinguish between different technologies in setting and applying legal standards.”).

  248. [248]. Eolas Techs. Inc. v. Microsoft Corp., 399 F.3d 1325, 1339 (Fed. Cir. 2005).

  249. [249]. Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299; see also Uruguay Round Agreements Act, Pub. L. No. 103-465, 108 Stat. 4809 (1994).

  250. [250]. Agreement on Trade-Related Aspects of Intellectual Property Rights, supra note 249, art. 27(1), at 331.

  251. [251]. Burk & Lemley, supra note 247, at 1156; id. at 1158 (“Congress cannot enact a new form of intellectual property statute each time a new technology arises.”).

  252. [252]. Id. at 1156.

  253. [253]. See generally id. (documenting how courts apply the nonobviousness standard differently between biotechnology and software patents).

  254. [254]. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 129 (1948).

  255. [255]. Diamond v. Chakrabarty, 447 U.S. 303, 305 (1980).

  256. [256]. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1291 (2012).

  257. [257]. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2111 (2013).

  258. [258]. Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124, 125 (2006) (Breyer, J. dissenting) (concerning medical diagnostic tests).

  259. [259]. E.g., PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App’x 65, 66 (Fed. Cir. 2012) (screening for Down’s syndrome); Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1059 (Fed. Cir. 2011) (immunization schedule for chronic immune-mediated disorders); Pioneer Hi-Bred Int’l, Inc. v. J.E.M. Ag Supply, Inc., 200 F.3d 1374, 1375 (Fed. Cir. 2000) (seeds for hybrid corn), aff’d, 534 U.S. 124 (2001); Application of Bergy, 596 F.2d 952, 969 (C.C.P.A. 1979) (bacteria), vacated in part sub nom. Diamond v. Chakrabarty, 444 U.S. 1028 (1980); Application of Kirk, 376 F.2d 936, 939 (C.C.P.A. 1967) (hormones); see also Animal Legal Defense Fund v. Quigg, 932 F.2d 920, 922–23 (Fed. Cir. 1991) (addressing whether PTO’s “interpretative rule” that “nonnaturally occurring non-human multicellular living organisms, including animals, to be patentable subject matter” under §101, fell under the Administrative Procedure Act).

  260. [260]. There appears to have been only three cases where the Federal Circuit or its predecessor court has described a property of a patented invention as a “law of nature” or “natural phenomena” outside of the biotechnology context. EMI Grp. N. Am., Inc. v. Cypress Semiconductor Corp., 268 F.3d 1342, 1351 (Fed. Cir. 2001) (describing a “vapor-induced fuse explosion mechanism” as an inherent “law of nature”); In re Bonczyk, 10 F. App’x 908, 911 (Fed. Cir. 2001) (calling “energy” a “natural phenomenon”); In re Arnold, 185 F.2d 686, 691 (C.C.P.A. 1950) (characterizing the ideal frequency used in electrostatic fusion as a “phenomenon of nature”).

  261. [261]. Diamond v. Diehr, 450 U.S. 175, 188 (1981); see Laidler, supra note 125, at 494 (describing the Arrhenius equation).

  262. [262]. Brenner v. Manson, 383 U.S. 519, 534–36 (1966).

  263. [263]. Cf. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1298 (2012) (“For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.”).

  264. [264]. See Mark A. Lemley, Patenting Nanotechnology, 58 Stan. L. Rev. 601, 613–14 (2005) (describing nanotechnology patents and stating that there is “no question about patentable subject matter”); see also U.S. Patent No. 6,689,674 B2 (filed May 7, 2002) (claiming a method for fabricating nanotubes by using a nanoparticle catalyst to assemble itself on a matrix).

  265. [265]. Cf. Lemley et al., supra note 3, at 1317 (equating patent law’s prohibition on “abstract ideas” to a concern with preventing overbroad claims).

  266. [266]. Cf. Mayo, 132 S. Ct. at 1294 (“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.”).

  267. [267]. Cf. Bilski v. Kappos, 130 S. Ct. 3218, 3225 (2010) (quoting Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948)) (internal quotation marks omitted).

  268. [268]. But see Burk & Lemley, supra note 246, at 1676 (“Biotechnology products arise out of living systems and are typically intended to interact with other human or nonhuman living systems. Such interactions, whether physiological or ecological, are enormously complex and the systems involved are poorly characterized.”).

  269. [269]. Funk Bros., 333 U.S. at 135 (Frankfurter, J., concurring).

  270. [270]. CLS Bank Int’l v. Alice Corp. Pty., 717 F.3d 1269, 1335 (Fed. Cir. 2013) (Rader, C.J., additional reflections) (“I enjoy good writing and a good mystery, but I doubt that innovation is promoted when subjective and empty words like ‘contribution’ or ‘inventiveness’ are offered up by the courts to determine investment, resource allocation, and business decisions.”), cert. granted, 82 U.S.L.W. 3131 (Dec. 6, 2013) (No. 13–298).

  271. [271]. See, e.g., Chiang, supra note 3 (not cited by any cases); Crouch & Merges, supra note 3 (cited by CLS Bank, although not followed); Eisenberg, supra note 3 (cited by Mayo, although not followed); Golden, supra note 3 (not cited by any cases); Kane, supra note 3 (not cited by any cases); Risch, supra note 3 (explicitly rejected by Mayo); Strandburg, supra note 3 (not cited by any cases). But see Lemley et al., supra note 3 (cited by Mayo, 132 S. Ct. at 1301–02, for the proposition that the doctrine of patent eligibility concerns whether the invention “forecloses more future invention than the underlying discovery could reasonably justify”).

  272. [272]. See Leahy–Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (failing to amend §101).

  273. [273]. See, e.g., Diamond v. Chakrabarty, 447 U.S. 303, 317 (1980) (“The choice [on patentable subject matter] we are urged to make is a matter of high policy for resolution within the legislative process after the kind of investigation, examination, and study that legislative bodies can provide and courts cannot.... Whatever their validity, the contentions now pressed on us should be addressed to the political branches of the Government, the Congress and the Executive, and not to the courts.”); Crouch & Merges, supra note 3, at 1683–91 (asking courts to address patent eligibility last in an effort to avoid difficult eligibility determinations); Golden, supra note 3, at 1041 (“[T]he enterprise of regulating patentable subject matter should be primarily entrusted to the USPTO, rather than, as it is now, to the courts.”); Risch, supra note 3, at 598–609 (advocating for the elimination of patent eligibility by using other areas of the patent statute).


    To be clear: this is not to say that these proposals were not good, or that they would not have worked had they been implemented. This is only to say that these proposals have little chance of actually being adopted.
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  275. [275]. See sources cited supra note 274.

  276. [276]. See Allison & Lemley, supra note 24, at 104–25 (describing, empirically, the interrelationships among these characteristics).

  277. [277]. Weaver, supra note 17, at 536.

  278. [278]. Id. at 536–37.

  279. [279]. Id. at 542.

  280. [280]. See generally Bechtel & Richardson, supra note 25 (describing decomposition and localization in scientific practice).

  281. [281]. Id. at 23.

  282. [282]. William Bechtel, Reducing Psychology While Maintaining Its Autonomy via Mechanistic Explanations, in The Matter of the Mind: Philosophical Essays on Psychology, Neuroscience, and Reduction 172, 178 (Maurice Schouten & Huib Looren de Jong eds., 2007) (describing decomposition in physics).

  283. [283]. Tadeusz Zawidzki & William Bechtel, Gall’s Legacy Revisited: Decomposition and Localization in Cognitive Neuroscience, in The Mind as a Scientific Object: Between Brain and Culture 293, 293 (Christina E. Erneling & David Martel Johnson eds., 2005).

  284. [284]. Fred C. Boogerd et al., Mechanistic Explanations and Models in Molecular Systems Biology, 18 Found. Sci. 725 (2013).

  285. [285]. Bechtel & Richardson, supra note 25, at 24.

  286. [286]. See Zawidzki & Bechtel, supra note 283, at 298–99 (discussing localization in the context of Broca’s and Wernicke’s areas).

  287. [287]. Bechtel & Richardson, supra note 25, at 17–23.

  288. [288]. Id. at 35.

  289. [289]. Id. (emphasis omitted).

  290. [290]. Id. at 39.

  291. [291]. Id.

  292. [292]. See id. at 40 (“In most domains of inquiry, such recognition evolves with time and research as scientists develop conceptual frameworks to determine a particular way of decomposing nature into systems.”).

  293. [293]. See 2 Charles Fayette Taylor, The Internal-Combustion Engine in Theory and Practice: Combustion, Fuels, Materials, Design 423 (rev. ed. 1985) (“The subject of detail design of a machine so complex as an engine would require much more space than is available here and could easily fill several volumes if covered in a thorough manner.”).

  294. [294]. See Bechtel & Richardson, supra note 25, at 39 (giving a car as an example of decomposition and localization).

  295. [295]. Id. at 202–03.

  296. [296]. Id. at 203.

  297. [297]. Id. at 222–23.

  298. [298]. Id. at 72–88.

  299. [299]. Id. at 153–68.

  300. [300]. Id. at 173–92.

  301. [301]. Id. at 243.

  302. [302]. Cf. Fletcher, supra note 26, at 221 (alteration in original) (discussing a similar problem regarding standing); see also id. at 290 (“The solution ...is . . . to break down what might appear to be a single, general question into discrete and particular questions.”).

  303. [303]. Cf. Bechtel & Richardson, supra note 25, at 17–23 (identifying the goal of decomposition and localization as providing mechanistic explanations of complex systems).

  304. [304]. See id. at 23 (describing decomposition as “the subdivision of the explanatory task so that the task becomes manageable and the system intelligible”); Fletcher, supra note 26, at 290 (“As Justice Iredell wrote in 1793 in his great dissent in Chisholm v. Georgia: ‘I have often found a great deal of confusion to arise from taking too large a view at once....’ The solution for Iredell was (as it is here) to break down what might appear to be a single, general question into discrete and particular questions.” (alteration in original) (footnotes omitted)).

  305. [305]. Cf. CLS Bank Int’l v. Alice Corp. Pty., 717 F.3d 1269, 1335 (Fed. Cir. 2013) (Rader, J., additional reflections) (criticizing patent eligibility’s continued reliance on such terms).

  306. [306]. See Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S. 167, 180–81 (2000) (providing an analytical framework for assessing the existence of a “case or controversy” under the Constitution).

  307. [307]. Farmer v. Brennan, 511 U.S. 825, 839–40 (1994) (incorporating the criminal law concept of “deliberate indifference” into defining “cruel and unusual” punishment).

  308. [308]. Asahi Metal Indus. Co. v. Superior Court, 480 U.S. 102, 113 (1987) (analyzing “fair play and substantial justice” as including “the burden on the defendant, the interests of the forum State, and the plaintiff’s interest in obtaining relief”).

  309. [309]. Fletcher, supra note 26, at 290.

  310. [310]. See Cartwright, supra note 122, at 56–59 (discussing gravity); Dupré, supra note 162, at 185–87 (same).

  311. [311]. See supra Part III.

  312. [312]. See Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1303 (2012) (refusing to jettison § 101 in favor of other statutory requirements because “[t]he approach is ... not consistent with prior law. The relevant cases rest their holdings upon section 101, not later sections”).

  313. [313]. See id. (describing how courts and judges are poorly suited to address questions of scientific philosophy); Fletcher, supra note 26, at 290 (discussing how courts do well at breaking down general issues of legal theory into discrete questions).

  314. [314]. Bechtel & Richardson, supra note 25, at 35.

  315. [315]. Id. at 39.

  316. [316]. This may appear to be a tautology—what controls patent eligibility depends, after all, on how we define it—but courts and commentators do appear to take it as a descriptive truth in principle, if not practice. See Ass’n for Molecular Pathology v. USPTO, 689 F.3d 1303, 1324 (Fed. Cir. 2012) (“[I]t is important to state what this appeal is not about. It is not about whether individuals... are entitled to a second opinion. Nor is it about whether the [patentee] ... has acted improperly in its licensing or enforcement policies with respect to the patents. The question is also not whether is it desirable for one company to hold a patent or license covering a test that may save people’s lives, or for other companies to be excluded from the market encompassed by such a patent—that is the basic right provided by a patent, i.e., to exclude others from practicing the patented subject matter.”), aff’d in part, rev’d in part sub nom. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013); Jeanne C. Fromer, Patent Disclosure, 94 Iowa L. Rev. 539, 554 (2009) (“[T]he patent document is typically the primary situs of information about patented inventions.”). At the same time, Mark Janis and Timothy Holbrook have written about the practical difficulties in such clean distinctions between patent law’s definitions and their objects. Mark D. Janis & Timothy R. Holbrook, Patent Law’s Audience, 97 Minn. L. Rev. 72, 111–16 (2012). Nonetheless, Janis and Holbrook are “unsure whether conjuring up a different heuristic is likely to advance the law here.” Id. at 111.

  317. [317]. 35 U.S.C. § 112(a) (2006 & Supp. V 2011).

  318. [318]. Id. § 112(b).

  319. [319]. Id. § 113 (2006).

  320. [320]. See, e.g., U.S. Patent No. 8,349,334 B2 col. 93–388 (filed June 30, 2011).

  321. [321]. 35 U.S.C. § 114.

  322. [322]. See Phillips v. AWH Corp., 415 F.3d 1303, 1314–17 (Fed. Cir. 2005) (en banc) (discussing the central importance of the claims and the specification in interpreting a patent).

  323. [323]. In re Rosuvastatin Calcium Patent Litig., 703 F.3d 511, 536 (Fed. Cir. 2012). But see Janis & Holbrook, supra note 316, at 112­–16 (discussing the contradictory jurisprudence in this area).

  324. [324]. Mark A. Lemley, Point of Novelty, 105 Nw. U. L. Rev. 1253, 1272 (2011).

  325. [325]. In re Vamco Mach. & Tool, Inc., 752 F.2d 1564, 1577 n.5 (Fed. Cir. 1985).

  326. [326]. John Burke, The Prior Art by Admission Doctrine: Judicially Created Private Prior Art, 13 Fed. Cir. B.J. 607, 624 (2004).

  327. [327]. Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 922 (Fed. Cir. 2004) (quoting Enzo Biochem, Inc. v. Gen–Probe Inc., 323 F.3d 956, 970 (Fed. Cir. 2002)); see Fromer, supra note 316, at 594­–99 (calling for a reinvigorated disclosure requirement); Sean B. Seymore, The Teaching Function of Patents, 85 Notre Dame L. Rev. 621, 669 (2010) (calling for simpler patent disclosure to better fulfill the teaching function). But see Timothy R. Holbrook, Possession in Patent Law, 59 SMU L. Rev. 123, 131–46 (2006) (arguing that structural limitations in patent law minimize the teaching function).

  328. [328]. See Donald S. Chisum, Weeds and Seeds in the Supreme Court’s Business Method Patents Decision: New Directions for Regulating Patent Scope, 15 Lewis & Clark L. Rev. 11, 18 (2011).

  329. [329]. See generally Lee Petherbridge & Jason Rantanen, The Pseudo-Elimination of Best Mode: Worst Possible Choice?, 59 UCLA L. Rev. Discourse 170 (2012) (discussing the legal status of the best mode requirement).

  330. [330]. SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 n.14 (Fed. Cir. 1985).

  331. [331]. Cf. Bechtel & Richardson, supra note 25, at 35.

  332. [332]. In re Vamco Mach. & Tool, Inc., 752 F.2d 1564, 1577 n.5 (Fed. Cir. 1985).

  333. [333]. Gottschalk v. Benson, 409 U.S. 63, 64 (1972) (emphasis added).

  334. [334]. Id. (emphasis added).

  335. [335]. Id. at 68.

  336. [336]. Parker v. Flook, 437 U.S. 584, 586 (1978) (emphasis added).

  337. [337]. Id. at 596 (quoting Deepsouth Packing Co. v. Laitram Corp., 406 U.S. 518, 531 (1972)).

  338. [338]. Bilski v. Kappos, 130 S. Ct. 3218, 3231 (2010).

  339. [339]. Id. at 3229.

  340. [340]. Lemley et al., supra note 3, at 1317.

  341. [341]. Burk & Lemley, supra note 246, at 1642.

  342. [342]. Collins, Bilski and the Ambiguity, supra note 122, at 51 (“Critically—and this point is often overlooked—abstraction in the language used to delineate the scope of a claim can be independent of abstraction in the individual embodiments of an invention that are described by the claim language.”).

  343. [343]. Alan L. Durham, The Paradox of “Abstract Ideas, 2011 Utah L. Rev. 797, 814.

  344. [344]. Eisenberg, supra note 3, at 56–61.

  345. [345]. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1294 (2012) (emphasis added).

  346. [346]. Id. at 1302 (emphasis added). Compare id., with Parker v. Flook, 437 U.S. 584, 586 (1978) (noting that the “patent claims cover any use of [the applicant’s] formula for updating the value of an alarm limit” (emphasis added)).

  347. [347]. E.g., Mayo, 132 S. Ct. at 1297–98 (comparing physical “principles” to “laws of nature”); id. at 1298–99 (mathematical equations); id. at 1302 (statistical relationships).

  348. [348]. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116 (2013) (alteration in original) (quoting Mayo, 132 S. Ct. at 1305).

  349. [349]. Id. at 2118 (first emphasis added).

  350. [350]. Chiang, supra note 3, at 1381 n.148.

  351. [351]. Efthimios Parasidis, A Uniform Framework for Patent Eligibility, 85 Tul. L. Rev. 323, 406–08 (2010).

  352. [352]. Lemley et al., supra note 3, at 1329.

  353. [353]. Id. at 1341.

  354. [354]. Sichelman, supra note 9, at 15.

  355. [355]. Id. at 15–16.

  356. [356]. Id. at 15–17.

  357. [357]. But see Collins, Bilski and the Ambiguity, supra note 122, at 51 (arguing that the two inquiries can be separated).

  358. [358]. See Burke, supra note 326, at 624; Chisum, supra note 328, at 18. But see Diamond v. Diehr, 450 U.S. 175, 188–91 (1981) (rejecting novelty as a consideration in § 101 determinations).

  359. [359]. Chisum, supra note 328, at 18.

  360. [360]. Bilski v. Kappos, 130 S. Ct. 3218, 3231 (2010) (quoting In re Bilski, 545 F.3d 943, 1013 (Fed. Cir. 2008) (Rader, J., dissenting)) (internal quotation marks omitted).

  361. [361]. Id.

  362. [362]. Id.

  363. [363]. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1294 (2012).

  364. [364]. Id. at 1298.

  365. [365]. Id. (second alteration in original) (quoting Parker v. Flook, 437 U.S. 584, 590 (1978)).

  366. [366]. Id.

  367. [367]. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2112 (2013).

  368. [368]. Id. at 2117–18.

  369. [369]. Id. at 2116.

  370. [370]. Jacob S. Sherkow, And How: Mayo v. Prometheus and the Method of Invention, 122 Yale L.J. Online 351, 352 (2013) (“Rather than focusing on what the invention is, [this function] focuses on how the invention is accomplished.”).

  371. [371]. Mayo, 132 S. Ct. at 1294.

  372. [372]. Sherkow, supra note 370, at 354–57.

  373. [373]. Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 922 (Fed. Cir. 2004) (quoting Enzo Biochem, Inc. v. Gen–Probe Inc., 323 F.3d 956, 970 (Fed. Cir. 2002)).

  374. [374]. See 35 U.S.C. § 112(a) (2006 & Supp. V 2011) (requiring that the specification be written “in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains... to make and use the same”).

  375. [375]. Mayo, 132 S. Ct. at 1297.

  376. [376]. Id.

  377. [377]. See id. (“[T]he ‘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).”).

  378. [378]. Ass’n for Molecular Pathology v. Myriad Genetics Inc., 133 S. Ct. 2107, 2119–20 (2013) (quoting Ass’n for Molecular Pathology v. USPTO, 702 F. Supp. 2d 181, 203 (S.D.N.Y. 2010)).

  379. [379]. See Mayo, 132 S. Ct. at 1298.

  380. [380]. 35 U.S.C. § 101 (2006).

  381. [381]. Lemley et al., supra note 3, at 1341 (“In sum, we believe at least five factors are critical to a proper scope-based determination for patentable subject matter eligibility under § 101.... No one factor should dominate; we advocate a contextual, common-law approach. Courts and scholars are likely to develop other factors as our approach is applied over time.”).

  382. [382]. See Peter Lee, The Evolution of Intellectual Infrastructure, 83 Wash. L. Rev. 39, 89 (2008) (analogizing the differences in these approaches as tradeoffs between “analytical rigor” and “valuable flexibility”); Sichelman, supra note 9, at 15–17 (describing some difficulties in applying these factors to the technologies at issue in Mayo and Myriad).

  383. [383]. See Burk & Lemley, supra note 246, at 1642–58 (describing patentable subject matter through “policy levers” rather than legal formalism); Lemley et al., supra note 3, at 1327 (“Lack of rigidity is not inherently bad; we suggest a flexible, factors-based test ourselves. But because gatekeeping rules attempt to draw conceptual lines around classes of technology with unclear boundaries—instead of using the policy-based factors that should drive patentable subject matter determinations—the result is a set of tests that overexclude and underexclude in a costly and haphazard way.”).

  384. [384]. Compare, e.g., Anna B. Laakmann, An Explicit Policy Lever for Patent Scope, 19 Mich. Telecomm. & Tech. L. Rev. 43, 60–61 (2012) (arguing that courts should engage in explicit policy determinations for patent eligibility), and Lemley et al., supra note 3, at 1327 (same), and Arti K. Rai, Engaging Facts and Policy: A Multi-Institutional Approach to Patent System Reform, 103 Colum. L. Rev. 1035, 1040–41 (2003) (arguing that both courts and the PTO should), with Mary Mitchell & Dana A. Remus, Interstitial Exclusivities After Association for Molecular Pathology, 109 Mich. L. Rev. First Impressions 34, 39 (2010) (arguing that only Congress should), and Melissa F. Wasserman, The Changing Guard of Patent Law: Chevron Deference for the PTO, 54 Wm. & Mary L. Rev. 1959, 2008–12 (2013) (arguing that the PTO, rather than the Federal Circuit, should).

  385. [385]. Risch, supra note 3, at 591–92 (advocating for the elimination of patent eligibility by using other areas of the patent statute).

  386. [386]. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1304 (2012) (rejecting the government’s arguments to abandon patent eligibility in light of patent law’s evolution).

  387. [387]. Sichelman, supra note 9, at 15–17.

  388. [388]. Id.

  389. [389]. Id. at 15–16.

  390. [390]. See Michael L. Metzker, Sequencing Technologies—The Next Generation, 11 Nature Reviews Genetics 31, 31 (2010).

  391. [391]. Sichelman, supra note 9, at 15.

  392. [392]. Id. at 15–16.

  393. [393]. See L. Chouchana et al., Review Article: The Benefits of Pharmacogenetics for Improving Thiopurine Therapy in Inflammatory Bowel Disease, 35 Alimentary Pharmacology & Therapeutics 15, 21 (2012) (listing, in a review of recent literature concerning thiopurine dosage, remarkably similar range dosage thresholds to those in Prometheus’s patents).


    Interestingly, however, a good deal of follow-on innovation concerning thiopurine treatment has recently come about using molecular diagnostics—the same technology at issue in the
  394. [394]. See, e.g., U.S. Patent No. 6,355,623 B2 col. 8, ll. 37–43 (filed Apr. 8, 1999) (“Previous studies suggested that measurement of 6-MP metabolite levels can be used to predict clinical efficacy and tolerance to azathioprine or 6-MP. However, it was unknown what concentrations of 6-MP metabolites correlated with optimized therapeutic efficacy or with toxicity.” (citations omitted)).

  395. [395]. See, e.g., U.S. Patent No. 5,693,473 col. 30, ll. 41–46 (filed June 7, 1995) (“Preferred embodiments relating to methods for detecting BRCA1 or its mutations include enzyme linked immunosorbent assays (ELISA), radioimmunoassays (RIA), immunoradiometric assays (IRMA) and immunoenzymatic assays (IEMA), including sandwich assays using monoclonal and/or polyclonal antibodies.”).

  396. [396]. ’623 B2 Patent col. 8, ll. 40–42.

  397. [397]. Id. at col. 20, ll. 10–25.

  398. [398]. See C. Cuffari et al., Quantitation of 6-Thioguanine in Peripheral Blood Leukocyte DNA in Crohn’s Disease Patients on Maintenance 6-Mercaptopurine Therapy, 74 Canadian J. Physiology & Pharmacology 580, 582 (1996) (discussing the development of “an assay to measure 6TG levels in leukocyte DNA”).

  399. [399]. ’473 Patent passim.

  400. [400]. Id. passim.

  401. [401]. See Elizabeth B. Claus et al., Genetic Analysis of Breast Cancer in the Cancer and Steroid Hormone Study, 48 Am. J. Hum. Genetics 232, 232 (1991) (remarking that, at the time, this was the largest data set collected to study genetic risk profiles for breast cancer).

  402. [402]. See Lemley et al., supra note 3, at 1344 (“[T]he claim was to very specific measurements of a particular drug. Like Metabolite, Prometheus involves an application of the natural principles discovered by the patentee. It is not generative, nor will it unduly bar future inventors. If, however, this claim were expanded to cover all drugs without any specific measurements, then it would be an abstract idea.”).

  403. [403]. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1294 (2012).

  404. [404]. See, e.g., Lori B. Andrews & Jordan Paradise, Gene Patents: The Need for Bioethics Scrutiny and Legal Change, 5 Yale J. Health Pol’y L. & Ethics 403, 404 (2005) (criticizing Myriad’s patents on public health grounds); Aaron S. Kesselheim et al., Gene Patenting—The Supreme Court Finally Speaks, 369 New Eng. J. Med. 869 (2013) (same for research preemption purposes).

*

Fellow, Center for Law and the Biosciences, Stanford Law School.



For their comments, and for reading earlier drafts of this paper, thanks to Will Baude, Nathan Chapman, Beth Colgan, Becky Eisenberg, Shubha Ghosh, Hank Greely, Sara Gabriella Hoffman, Tim Holbrook, Matt Lamkin, Peter Lee, Mark Lemley, Lisa Larrimore Ouellette, Menesh Patel, J.J. Prescott, Zach Price, Sarah Rajec, Jacob Rooksby, Amanda Shanor, Ted Sichelman, and Andrew K. Woods. Thanks as well to the participants at WIPIP 2013 and PatCon 3 for their helpful comments. And a final thanks to Amanda and Lilah for keeping things simple.