The distinction between the made and the grown structures the conceptual architecture of the modern patent system. The doctrinal concept of invention as it has evolved since the early nineteenth century is thoroughly infused with the logic of making or manufacturing. Indeed, nowhere in legal doctrine is that logic more systematically developed than in the figure of the invention. The essential characteristics of patentable ingenuity express an implicit theory of making: Ingenuity is original—or originating—in the sense that it entirely controls the form, structure, and articulation of the artifacts in which it is embodied; ingenuity can be reduced to textual form without losing any of its genetic potency (see Biagioli 2006); ingenuity forms a design whose exemplars can be reproduced in multiple copies by means of a process of industrial manufacture. From the early twentieth century onwards, this figure of invention was confronted with biological inventions, which could not be described, explained, or reproduced in the same manner as machines or mechanically reproduced artifacts. In a number cases, judges drew on the distinction between discovery and invention, or between products of nature and manufactures, in an attempt to draw the distinction between the made and the grown. These unsystematic attempts were finally, and somewhat abruptly, brought to an end by the decision of the U.S. Supreme Court in Diamond v. Chakrabarty (1980), which cleared the way for the routine patenting of biotechnological inventions by holding that invention could encompass the grown as well as the made. In Chakrabarty, the essential doctrinal question was whether a genetically engineered microorganism could qualify as a manufacture in the sense of the U.S. patent statute. The answer—that “anything under the sun that is novel and made by man is patentable”—affirmed the novelty of an invention, rather than its mode of origination or reproduction, as the essential qualification for patentability. A new organism was every bit as novel as a new machine.

In U.S. patent law, this maneuver effectively closed off fundamental doctrinal questions about the patentability of biological and biotechnological inventions. Indeed, the broader effect of the decision in Chakrabarty was “to normalize genetic engineering by providing forms and methods of discourse that made the applications of the technique seem amenable to control” (Jasanoff 1995, p. 140). In Europe, by contrast, legal form did not have these effects of normalization or domestication. Given a quite different configuration of political interest and institutional structures, legal form became the medium or expression of competing normative interpretations of biotechnology. Political campaigns against the patenting of genetic inventions were able to exploit provisions in the European Patent Convention that allow parties other than claimants to inventorship to oppose the granting of a patent on the grounds of morality or ordre public. This form of opposition procedure allowed political parties and nongovernmental organizations to turn the texture of patent law doctrine into a matter of sustained political interest. And the extensive debate surrounding the European Biotechnology Directive of 1998 meant that the texture of doctrine became even more thoroughly permeable to legislative debate, national plebiscites, and expert evaluation (see, generally, European Union 1998). Unsurprisingly, legal-theoretical scholarship is sensitive to these variations in the mode of acculturation of biotechnologies, so that different political and institutional landscapes are reflected in styles of commentary.

Scholarship in the United States has tended to approach the decision in Chakrabarty from the perspective of a critique of economic power (see, generally, Thackeray 1998). Patent doctrine, as interpreted and developed by judges, is theorized as a more or less responsive instrument of the economic interest. The refusal of the Supreme Court in Chakrabarty to the deploy the distinction between discovery and invention as a limit on patentability is seen as the outcome of strategies that had been pursued by the life science industries since well before the era of biotechnological invention (see Kevles 1998). This form of economic critique is not exclusive to the United States (see, notably, Dutfield 2003, Drahos & Braithwaite 2002), but the mode of politicization of biotechnologies in Europe has given rise to a style of scholarship that is rare in the United States. Because the European Patent Convention treats morality as an effective criterion of patentability, certain strands of scholarship in Europe address the tension between discovery and invention not as an index to economic power but as a symptom of controversy as to the meaning of morality in the age of biotechnology. In one approach, the question is referred to practical reasoning: What normative content should be ascribed to the notion of morality as it is deployed in the context of patent law (see, for example, Beyleveld & Brownsword 2004)? Other perspectives are more self-consciously interventionist. For example, in France legal theory has become a resource for political opposition to what are seen as the socially corrosive effects of biotechnology (see Fabre-Magnan & Moullier 2004, Supiot 2007). Although these interventionist arguments often resemble political critique more than theoretical analysis, they are interesting because they shift attention to the form of patent law rather than its instrumental uses.

The argument emerges from the doctrinal distinction between discovery and invention. One of the more persistent arguments against the moral validity of biotechnology patents is that they illegitimately treat natural products as man-made artifacts, thereby undoing the prestige of the grown and sanctioning the appropriation of resources that should remain common or uncommodified. When the invention in question is a human gene sequence, the emphasis of the argument shifts to human dignity: To grant a private monopoly over a component of the human body is to subvert the peculiar form of dignity that post-Enlightenment philosophy attributed to human beings as ends in themselves (see Beyleveld & Brownsword 1998, Edelman 1999). The theoretical import of these objections becomes clearer if they are rephrased in more abstract terms; in effect, the argument is that law should not be treated as an instrument of instrumentalization. This last phrase is not an empty tautology. Rather than ask the first-order question of what ends patent law should serve—which biotechnological techniques or artifacts should be patented and which should not?—these critiques ask a second-order question: Is law really just a means to an end? They argue that to treat law as a mere means, as an instrument for the execution of any manner of end, and more precisely as a mute medium for the deployment of biotechnological projects, would be to denature legal form. Supiot (2007) argues that law, and more precisely the legal form of the person, is both the condition and the expression of a particular kind of rational or normative architecture. This is an effect of historical momentum rather than natural law. As a repository of sedimented traditions, legal form has acquired the anthropological function of conditioning and delimiting individual existences; legal institutions inscribe each individual into a logic of kinship, sexual division, and chronology in such a way as to deny fantasies of individual self-creation or self-sovereignty. These are precisely the institutional coordinates that biotechnology threatens to dissolve.

In a sense, it is already too late for this mode of critique; the valorization of legal tradition is now necessarily “a political act of self-referential moral action” (Habermas 2003, p. 26), and a tradition that is self-consciously deployed rather than silently effective is no longer a tradition. But Supiot's argument exposes a question that is usually overlooked in analyses of biotechnological invention; it reveals (in polemical terms) the terms of a more general corrosion of legal form. Precisely because it is the purest doctrinal discourse of instrumentality, patent law expresses the double bind described in the introduction to this review. On one hand, patent law is programmed to construe technological interventions in instrumentalist terms, which makes it seem the ideal servant of biotechnology. On the other hand, because it construes technology in instrumental terms (inventive ideas imprint or inscribe useful human designs in matter), patent law is vulnerable to the deconstruction of instrumentalist logic by biological process. Again, there is at once too much instrumentality and too little. This might be conceived as a point at which patent law itself becomes especially interesting as a technology that reproduces the made (invention) and the grown (nature) (Strathern 2001). But returning to the theme of legal form, patent law still works with a theory of instrumentality that is premised on the distinction between the grown and the made. Political critique responds to the dissolution of those terms by reviving them as tradition, whereas theoretical critique exposes the inability of patent law to fabricate coherent patent rights in relation to emergent biological process. Both modes of critique reveal a crisis of legal form; what would be required is not just cognitive adjustment on the part of patent doctrine, but rather a reinvention of the tradition of patent law in such a way as to enfranchise it from its commitment to the notion that there are two kinds of kind in the world: the grown and the made.

Two widely publicized Canadian cases illustrate the point. In Harvard v. Commissioner of Patents (2002) before the Canadian Supreme Court, the question was almost exactly that addressed by the U.S. Supreme Court in Chakrabarty: Was a genetically engineered organism—in this case a mouse—a manufacture or a composition of matter? Unlike its counterpart in the United States, the Canadian court started with the distinction between the made and the grown and held that because representatives of the patented variety of mouse were both made and grown the new variety could not count as an invention. Although the inventor had invented and manufactured the gene construct that was inserted into each mouse embryo, the ultimate products (adult mice bearing the trait conferred by the construct) were grown through natural metabolic and ontogenetic processes. The mouse as a whole could not be a manufacture because its material form was not entirely structured or programmed by the patented idea. Only two years later, deciding the celebrated case of Monsanto v. Schmeiser (2004), a majority in the Canadian Supreme Court held that to reproduce knowingly a plant containing a patented gene construct was to infringe the patent. Although the patent encompassed only the gene construct rather than the whole plant, by reproducing plants containing the gene construct the defendant had made unauthorized use of the patented invention: “[I]f an infringing use were alleged in building a structure with patented Lego blocks, it would be no bar to a finding of infringement that only the blocks were patented and not the entire structure” (Monsanto v. Schmeiser 2004, at paragraph 42).

What the Harvard and Schmeiser decisions leave unresolved is how or where to draw the line between the grown and the made. Unlike the Chakrabarty decision, the two Canadian decisions open the question of whether an organism can be a manufacture or composition of matter into the broader question of the normative principles that (should) inform the structure of patent law and that might condition its instrumental uses. Both decisions deal with inventions that are hybrid in the sense that they belong simultaneously to two distinct orders of being, or to two kinds of kind. The distinction between these two orders of being is made according to their respective genetic principles, biological heredity in one case and inventive design in the other. Only the latter accords with the instrumentalist logic of patent law, which expects that inventive ideas should be entirely reducible to writing. In both Harvard and Schmeiser, the court reduced a difference to a relation of proportionality, or of parts to a whole. The analogy between a gene construct and a block of Lego not only collapses the difference between the grown and the made, but it does so by the distinction between tangible and intangible things, or between form and matter. The proper object of intellectual property is the idea or design that informs and structures each exemplar or embodiment of an invention, and it is at the level of design that the tension arises. Again, the problem here is that patent law's commitment to the distinction between the grown and the made prevents it from exploring other modes of existence.

The expansion of transnational intellectual property regimes has recently become a central focus of theoretical and historical scholarship (see Drahos & Braithwaite 2002, Maskus & Reichman 2005, Sell 2003). There is a sense in which the emergence and functioning of many of these regimes are attributable to the global expansion of the biotechnology industry. According to the most succinct definition, transnational law is “law that is neither supranational nor international, but which is made by the parties themselves” (Delmas-Marty 2003, p. 27). These parties—global corporations, nongovernmental organizations, agencies of international organizations, academic institutions, novel forms of tribunal or arbitration panel—are collectively fabricating a form of intellectual property law that is quite different from the international regimes of the late nineteenth and early twentieth centuries. Whereas the great intellectual property conventions of the nineteenth and twentieth centuries were conceived by formally equal state actors with shared paradigms of scientific and technical knowledge, broadly similar understandings of creativity, and common political justifications of intellectual property, transnational intellectual property is not produced by the replication of homogenous doctrine. Transnational discourses of intellectual property are addressed to new and expanded constituencies, they negotiate diverse conceptions of authorship or creativity, and they articulate novel configurations of law, politics, economics, and science (see Coombe 2003). Global intellectual property is now diffracted into a multiplicity of interpenetrating regimes, each of which links intellectual property into the discourses of economics, development, human rights, culture, and biomedicine, respectively (see Helfer 2004).

Biotechnology has played a significant role in creating these discursive networks. In two particular areas, the discourse of molecular information has drawn diverse actors and perspectives into a common horizon so as to complicate homogenous doctrine. In one case, that of global health within the framework of the TRIPS (Trade Related Aspects of Intellectual Property Rights) agreement (see Abbott 2005), the economic or industrial understanding of biotechnology enters into a tension with the therapeutic promise of biotechnology. From an economic perspective, biotechnology is an industry like any other, and biotechnological innovation falls squarely within the remit of the so-called patent bargain. There are variations on the theme of the patent bargain (see Mazzoleni & Nelson 1998), with the most essential justification that patent rights work prospectively as incentives to encourage innovation and retrospectively as rewards for increasing the fund of public knowledge. Against this, the biomedical interpretation of biotechnology emphasizes its potential for tackling global health issues and suggests that pharmaceuticals should be available as a human right rather than as a public contractual benefit. Indeed, one might say that the controversy surrounding the interpretation of the Doha Declaration (Médecins sans Frontières 2004) is not so much a dispute between interested actors as a conflict between two discursive rationalities: economics and human rights (see Fischer-Lescano & Teubner 2004). Whereas, in the case of global health, intellectual property doctrine is challenged by a political or moral interpretation of technological potential, in the case of bioprospecting heterogeneous interests are brought together by the industrial program of natural products research.

Natural products research is premised on the observation that many of the most familiar and successful pharmaceutical agents have been based on compounds found in nature. In the latter part of the twentieth century, pharmaceutical corporations began to undertake various kinds of bioprospecting activity in an attempt to exploit these natural genetic variations. Since then, commercial and academic participants have taken differing views on the viability of screening natural compounds for pharmaceutical activity, and many biotechnology corporations now favor rational drug design rather than bioprospecting as an approach to drug discovery. Those corporations that engage in bioprospecting are ultimately interested in molecules with interesting therapeutic or industrial properties, but access to these molecules is often mediated by local ethnobotanical knowledge: The most interesting pharmaceutical candidates are often plants that are recognized in traditional medicine (see Jaszi & Woodmansee 2003). Ever since 1992, when the parties to the Convention on Biological Diversity affirmed that genetic resources were not the common heritage of humankind but rather the resources of sovereign states, access to plants and the knowledge associated with them have involved extensive legal and political negotiation. Pharmaceutical corporations now enter into complex bioprospecting contracts that include not only agencies representing the authors or providers of the resource, but also a broad set of intermediaries such as academic institutions, governmental agencies, and corporate subsidiaries. The form of these contracts reflects the purpose of the convention as “an instrument to promote the equitable exchange of access to genetic resources and associated knowledge for finance, technology and participation in research” (Convention on Biological Diversity 1996, paragraph 1.1).

Bioprospecting has become the focus of some of the most innovative scholarship in the field of intellectual property. The question of how property rights are indexed to the fluid character of molecular information and cultural authorships is addressed by a number of anthropological studies. Hayden (2003a,b) starts from the premise that bioprospecting contracts draw on too many idioms of entitlement: “In what idiom—territoriality, nationalism, cosmopolitanism, authorship—will biological collections be attached to social relations, interests, and claims?” (Hayden 2003a, p. 368). As a result, given that there are inevitably too many grounds for claiming or justifying ownership of genetic resources, the attribution of property rights becomes a transparently constructive operation: “[P]rospecting agreements do not merely direct the traffic in resources but rather help generate their constituent subjects and objects” (Hayden 2003b, p. 127). In related studies, Brush (1999) surveys the complex relations between cosmopolitan plants and the diverse groups that were historically responsible for their cultivation and conservation, whereas Greene (2004) explores how indigenous peoples resolve themselves into political agents so as to stake prospective ownership claims to genetic resources. Coombe (2003) addresses the nature of the global process in which novel intellectual property concepts and institutions emerge from bioprospecting practices. The analysis focuses partly on the paradigm of solidarity that is fostered by the idiom of bioprospecting, which “asks ‘us’ to embrace impoverished others as subjects on whom ‘we’ are or might at some future point be dependent [for genetic resources]” (Coombe 2003, p. 280) and partly on the expansion of the conception of authorship beyond the narrowly economic interpretation of Western intellectual property law and into discourses of human rights and cultural distinction.

Against the background of these discussions of biotechnology and intellectual property forms, the specter of Terminator technology emerges as a strangely conservative figure. The technology itself is highly innovative, but political and normative responses have turned it into an expression of familiar modes of appropriation and familiar logics of property. Terminator technologies first emerged in 1998 in a U.S. patent that claimed an array of gene sequences that, when activated, would express a toxic protein, preventing further development of the cells that composed the seed tissues of the maturing plant. The invention was designed to prevent proprietary plants from developing seeds that could be saved by farmers and used to reproduce the genetic property of agricultural biotechnology corporations. By programming the maturing plant to act as a kind of proprietary automaton, Terminator technologies sought to turn living organisms into enclosures of genetic information. But this technology is an instance of fiction science in that it exemplifies “the way in which innovative designs take account of prospective interests in, uses of, and resistances to alternative material arrangements” (Jordan & Lynch 1998, p. 776). Ever since the first Terminator patent was granted, various studies have made the point that it was an ongoing research program rather than a finished product. And since 1998 this research program has been characterized in different terms, some of which have been reflected back into the form of the technology. For example, in response to complaints about unnatural effects of Terminator technologies on the reproductive cycles of plants, the biotechnology laboratories proposed a version in which proprietary traits would become optional extras; plant seeds engineered to carry a premium trait would be reproducible naturally, access to the proprietary trait being conditional on payment of a fee or royalty for the appropriate chemical-inducing agent. In yet another guise, Terminator technology evolved from an intellectual property mechanism into an instrument of environmental protection; Terminator sequences could be used to excise transgenes from plant tissues to prevent their accidental dispersal through genetic drift (Keenan & Stemmer 2002).

Legal commentaries have addressed Terminator technologies as a means of restoring a logic of ownership that is eroded by the global expansion of agrobiotechnology. For example, Swanson & Goeschl (2005) suggest that the evolution of Terminator technologies can be seen as a rational response to the problems of enforcing intellectual property rights in certain jurisdictions; biological property is just an alternative means of realizing institutional property. Another line of argument emphasizes the sense in which Terminator technologies reinforce corporate power by turning biotechnologies into “strange life sciences that conspire against the marvelous property of living things to reproduce themselves and multiply in farmers’ fields so that capital can reproduce and multiply in investors’ bank accounts” (Berlan & Lewontin 1998). The maneuver of folding biological property back into familiar logics of appropriation can also be seen in doctrinal legal discussions of the nature of plants as objects of property. In broad terms, the ability to turn plant genomes into programmable text—which is exactly what Terminator technology seems to do—is taken to represent a profound transformation in the legal existence of plants; plants now become “genetic datasets” (Janis & Smith 2006), or embodiments of digitally archived information. The notion that recombinant DNA technology now resembles digital information processing is specifically applied to Terminator technologies, which are seen as examples of “the instantiation of a proprietary rule in genetic code” (Burk 2002, p. 114). Ultimately, the more dramatically researchers can reduce the complexity of biological organisms, the better they can turn these organisms into instrumentalizable media and simultaneously reduce the difficulties (and the interest) of the encounter between biotechnologies and patent law.

Biotechnologies have not only generated new challenges for legal governance; they have also elicited new idioms and referents for governance and regulation. The challenges arise principally from the commercialization of genetically modified organisms (GMOs), the introduction of various modes of genetic testing and identification, and the emergence of a global market in genetic information. Regimes of legal governance seek to adapt the languages of regulation, liability, compensation, and insurance to the specific potentialities (risks and opportunities) of transactions in biotechnology. As a result, these new governmental norms are structurally coupled to the evolving character of biotechnological knowledge and to the complexities of molecular information. This mode of coupling is multiple and reflexive. For example, in debates concerning the risks of biotechnology, scientific practices and representations are mobilized as resources for political argument, and this politicization of the technical is amplified by the role of politics in framing research agendas and securing budgets (for a case study, see Lassen et al. 2002). But the translation of biotechnological knowledge into governmental policy is creative in other ways; it generates new artifacts of governance, either in the sense that genetic information becomes the object of governmental interventions or in the sense that molecules themselves become agents or media of normative regulation. The most innovative scholarship in this area explores these interpenetrations of governmental schemes and biotechnological knowledge. The broader approach treats biotechnological knowledge as a novel variation on the familiar themes of biopower (Rose 2006) and governmentality [for the original specifications of the theory, see Foucault (1978), and for commentary, see Rose (1999), Rose et al. (2006)]. At another order of scale, scholars undertake more specific investigations into the molecularization of normative form (Gottweis 1998, Lezaun 2006).

Biopower (see, generally, Foucault 1978) has long been a familiar theme in legal-theoretical scholarship, and it has recently been revivified by the critical studies of Agamben (1998) and Hardt & Negri (2000). One of the key insights of Foucault's presentation of biopower was the proposition that “the action of norms replaces the juridical system of law as the code and language of power” (Ewald 1990, p. 159). Norms were articulated by the set of practices, policies, and pastoral exhortations that shaped the expression of individual sexuality and that articulated a governmental interest in fertility. These normative (self-) descriptions might or might not have been channeled through legal rules and institutions; the point was that they were productive rather than repressive. They were directed to the enhancement of life and to increasing the productivity and value of individualized and collective biological existence. Recent studies have described the emergence of governmental strategies designed to enhance the molecular potentiality of the body rather than rates of fertility; life is “imagined, investigated, explained, and intervened upon at a molecular level—in terms of the molecular structure of bodily components, the molecular processes of life functions, and the molecular properties of pharmaceutical products” (Novas & Rose 2000, p. 487). The proposition is not that molecular information has replaced or eclipsed other resources for (self-) identification, nor do scholars suggest that no sources and techniques of biological citizenship exist (Rose & Novas 2003) that are not directly derived from the molecular gaze. Nevertheless, some do argue that biotechnology informs an entirely new theme of governance that colonizes legal form just as effectively as earlier modes of biopower.

As in the classical model of biopower, which distinguished the life of the population from that of the individual, there are two interlinked dimensions to the molecular gaze (Rose 2006). In one register, molecular potentiality is a concern of governmental institutions, which seek to maximize the value of the genetic variations represented in their populations and to modulate the economic and social costs of disease. For example, genome mapping has generated the figure of the single nucleotide polymorphism (SNP), which has been absorbed into governmental discourses as an index to variations within populations: “[T]he science itself, and the recognition of the variability of the human genome at the level of the single nucleotide, immediately open up a new way of conceptualizing population differences—in terms of geography and ancestry—at the molecular level” (Rabinow & Rose 2006, p. 207). Molecular cartographies have various governmental uses. One such use is premised on genetic testing in areas such as employment, education, parenting, criminal law, and insurance (Rose 2006, chapter 4). In another kind of strategy, molecular cartographies are the basis for the exploitation of an emerging form of biological capital; governments, often in alliance with private corporations, have turned genetic information into a marketable resource for consumption in commercial biomedicine (Waldby & Mitchell 2006). Extending this governmental logic, categories of race are appropriated and reshaped in patent specifications as ways of extending the period of time for which certain pharmaceutical inventions remain under patent (Kahn 2006). In these various ways, “a modified biopolitical rationality in relation to health is taking shape, in which knowledge, power and subjectivity are entering into new configurations, some visible, some potential” (Rabinow & Rose 2006, p. 213).

In another register, molecular potentiality is the medium in which individuals sculpt their own selves in the light of information about their susceptibilities to disease or their reproductive potential. Information gathered from genetic testing becomes a resource for the constitution of somatic individuality (Novas & Rose 2000); in an alternative formulation, discourses and information drawn from biotechnological knowledge are said to extend and reinforce existing projects of bio-individuation (Memmi 2003). Already, the first participants in assisted reproduction were moral pioneers (Rapp 2000) in the sense that they experimented with new normative idioms, and this mode of bio-individuation is increasingly linked to governmental expertise by a relation of reciprocal constitution: In the context of medical care, the individual becomes “skilled, prudent and active, an ally of the doctor, a proto-professional” (Novas & Rose 2000, p. 489). Indeed, developing the Foucauldian model of biopower, Memmi (2003) argues that the biopolitical regulation of life is increasingly delegated to the individual, in forms that are “encouraged, guaranteed, and supported by the state itself” (p. 292). Biopower is individualized and incarnated in an operation of bioreflexivity.

Biopolitical strategies now include private corporate research programs in genetic diagnostics, targeted therapy, and pharmacogenomics; indeed, one might say that this mode of research is one of the essential characterizing features of contemporary biopower. More precisely, it reveals a particular variation on the theme of governance as risk management. As with the classical forms of biopower studied by Foucault, research programs in genetic medicine have interdependent cognitive and normative effects. Biomedicine is an epistemic project in the sense that it construes the world according to a particular set of diagrams, categories, and traces, but this epistemic horizon also conditions the (self-) formation of subjects across an increasingly broad range of social discourses. One effect of the rise of biomedicine has been the parallel expansion of the domain of the therapeutic. Sunder Rajan (2006) argues that aspects of human existence are increasingly characterized as conditions or illnesses that are susceptible to diagnosis and treatment by molecularized therapies, with the effect that individuals increasingly become the site of calculations as to research risks and market risks: “genomic information that configures individual subjectivities as those of patients-in-waiting by foretelling future possible illnesses also very much configures their subjectivities as consumers-in-waiting for drug development companies looking to increase their market” (Sunder Rajan 2006, pp. 143–44).

Two points are essential here. The first is that bioreflexivity is premised on a calculus of risk rather than a tension between the normal and the pathological, the effect being “a reconfiguration of subject categories away from normality and pathology toward variability and risk, thereby placing every individual within a probability calculus as a potential target for therapeutic intervention” (Sunder Rajan 2006, p. 167). The second is that this risk calculus simultaneously mobilizes and defers the risks inherent in biotechnologies. Precisely because it tries to instrumentalize complex and emergent biological processes, biomedical research is necessarily a speculative activity, but the core strategy of biomedicine is to make this mode of speculation economically productive by drawing investors and consumers into parallel modes of orientation to the future, both of which treat research risk as capital. Investors are invited to gamble on the stock market prospects of profitable research programs, while consumers are invited to incorporate the promise of effective diagnosis and personalized therapy into their own modes of bio-individuation. These two modes of speculation link up at the point where individuals as patients-in-waiting also constitute themselves as consumers-in-waiting; on one hand, these potential consumers form the market that guarantees (in the mode of futurity) investors’ stakes, while on the other hand increased investments extend and refine the range of diagnostic and therapeutic options with which individuals have to reckon in their capacity as patients-in-waiting. The outcome—the standing imperative for a wide range of actors “constantly to calculate their futures precisely because of the difficulty of calculating them” (Sunder Rajan 2006, p. 177)—is a specific variation on the predicament of individuality as it is described in Foucault's discussions of biopower.

This scholarship reveals one facet of bioreflexivity as a normatively productive operation that constitutes and holds together diverse forms of biopolitical entities. Other forms of scholarship reveal another, equally significant, mode of bioreflexivity, in which uncertainty is not capitalized as a resource but accentuated and dramatized as a political predicament. This mode of reflexivity is nicely brought out in studies of the so-called precautionary principle (Godard 1997, Noiville 2003, Sunstein 2005). The essential premise of the precautionary principle is that technologies that have the potential to cause massive and irreversible harm should be subject to regulation even in the absence of clear evidence of the likelihood of harm, with the burden of proof placed on proponents of the technology. Given the importance of technological innovation to economic development, the precautionary principle effectively becomes the basis for a very specific mode of balancing technological evolution against potential social harm. The global reach of the precautionary principle was negotiated in the debate surrounding the adoption by the World Trade Organization of the Cartagena Protocol on Biosafety (2000), which addressed the marketing of GMOs. The final text was a compromise between the precautionary principle and the science-based approach favored by the United States; it gave some recognition to the notion of precaution by recognizing that nations were not obliged to justify trade restrictions on the importation of GMOs on the basis of specific scientific evidence (which was the approach pressed by the United States as a principal global exporter of GMOs), but the precautionary principle was not named as such in the text of the Protocol, nor were its normative premises developed to any extent. So the precautionary principle represents only one approach to the problem of governing the risks of biotechnology, and it has been widely criticized as a conceptually incoherent formula that is at best a cause of economic paralysis and at worst a generator of increased social risk (Sunstein 2005). Nevertheless, the principle serves as an interesting case study in the mobilization of bioreflexivity in the construction of normative form.

Ewald (2002) situates the precautionary principle in a genealogical diagram of different governmental and legal strategies for managing risks and accidents: legal liability, social solidarity, and precaution. This diagram traces the transformation within governmental or regulatory logic of a set of terms that are each essential to the theme of instrumentality: causation, prediction, and compensation. The classic liberal-legal regime of liability was based on the principle of prudence in the sense of moral self-mastery and self-restraint. It was left to each (legal) person to apprehend and engage with causal processes according to their own volition, and a failure of prudence automatically entailed the attribution of liability: “[I]t is I who was unable to take a particular element into account; it is I who did not understand the laws of nature or was unable to use them. In any case, and always without exception, it is my fault” (Ewald 2002, p. 275). The obverse of liability was the legal right to damages; in cases in which there was loss without liability, the legal regime made no provision for pure victims. Regimes of solidarity corrected this failing by shifting from a principle of prudence to a principle of insurance. Just as regimes of biopower apprehended death as a permanent social fact rather than an individualized event (Foucault 1997, p. 217), so in regimes of solidarity responsibility “is no longer the attribute of a subject, but rather a consequence of a social fact” (Ewald 2002, p. 280). Obligations to make compensation did fall on individual subjects, but only in terms of a social-contractual calculus of fairness and ability to pay. Although social facts and laws exceed the cognitive capacities of individuals, there is a sense in which the logic of insurance-based solidarity assumes that contingencies can be assessed and accounted for from some superior vantage point. In other words, the regime of solidarity does not entirely give up on causal analysis. By contrast, the regime of precaution entirely abandons any pretension to master social contingencies.

In one sense, this inability to master social contingencies arises because the stance of precaution corrodes the available grounds of predictive knowledge and risk assessment. It thoroughly relativizes scientific knowledge by deconstructing the social and cognitive architecture of scientific paradigms. First, it extends the time frame for catastrophe into a future that extends well beyond the usual span of plausibility of scientific theories, thereby undermining knowledge by confronting it with its future obsolescence. Second, it turns scientific disciplines into incoherent and internally contested bodies of knowledge by giving particular weight to fringe positions that are usually externalized by the process of scientific paradigm formation. Moreover, by emphasizing the catastrophic and irreversible nature of potential harm, the idiom of precaution disqualifies the use of insurance as an effective means of compensation. Ultimately, the regime of precaution is predicated on suspicion rather than risk analysis. Decisions have to be made, but they are made “not in a context of certainty, nor even of available knowledge, but of doubt, suspicion, premonition, foreboding, challenge, mistrust, fear, and anxiety” (Ewald 2002, p. 294). Ewald presents the precautionary principle as one of many instruments of “reflexive modernization” (Ewald 2002, p. 295) and more precisely as a response to a situation in which scientific knowledge—rather like society itself—encounters its own limits. Arguably, this understates the persistence of reflexivity. One might say that the reason the paradigm of solidarity and insurance falls away is that the representation of the social as whole aggregate becomes untenable; the basic condition for the emergence of the precautionary principle is the disaggregation of society into a number of differentiated discourses, each of which evaluates risks to society as a whole in terms of its own cognitive schemata and normative objectives (see, generally, Luhmann 1989). To the extent that there are systematized forms of probability calculus or actuarial reckoning, the meaning of these analyses is reconstructed in accordance with the specific logic of each discursive rationality.

In what sense does the precautionary principle link this general predicament of risk, reflexivity, and social differentiation to the contingencies of biotechnology in such a way as to constitute a specific mode of bioreflexive governance? One might begin with the proposition that the principle of precaution is premised on a particular characterization of risk. The political theme of “sanitary vigilance [vigilance sanitaire]” (Memmi 2003, p. 282) represents risk as a physical or corporeal phenomenon: Risks are apprehended not as indices of potential economic loss but as traces of a prospective danger to the integrity of the human body or of the environmental networks in which bodies are (still) immersed. The body is again mobilized as a biopolitical device. And regulatory attention to GMOs is motivated by concerns about just this sort of corporeal risk: To what extent might transgenes be incorporated into wild species by means of genetic drift, and what might be the ecological impact of genetic drift? To what extent does the intensive use of antibiotic agents in plant modification put consumers’ health at risk? To what extent might metabolites formed from transgenic organisms be passed up the food chain, and with what toxicological risks? From this perspective, the precautionary principle as it has evolved in European politics articulates a particular kind of biopolitical strategy. In the theme of sanitary vigilance as it is deployed by a new constituency of political actors (Memmi 2003, p. 283), the body-at-risk materializes and warrants the kind of suspicion that sustains the precautionary principle. The body-at-risk becomes an emblem of political commitment and a motive for the “doubt, suspicion, premonition, foreboding, challenge, mistrust, fear, and anxiety” (Ewald 2002, p. 294) that make the precautionary principle so corrosive of scientific knowledge.

This mode of bioreflexivity is the obverse of bioreflexivity as it is mobilized in the making of commercial biomedicine. Commercial programs in genetic diagnostics and pharmacogenomics exploit one variation on the theme of corporeal risk; speculative research programs are sustained by replicating bodily risk into the two complementary figures of the patient-in-waiting and the consumer-in-waiting (Sunder Rajan 2006, chapter 4). Both figures are produced from within the medium of corporeal risk. The political program of health vigilance recruits corporeal risks in an entirely opposite way; it does not share the assumption that risks can be addressed and mobilized within reflexive processes of individuation; instead, it constantly accentuates and dramatizes risk in order to promote a particular political program. Corporeal risk becomes a kind of surplus value of social differentiation, which is drawn upon by political critique as resource for argumentation. The reach of this political critique is such that it even draws Ewald's own genealogical theory of the precautionary principle into responding to the politics of sanitary vigilance (see Ewald 2004a,b). With reference to the organizing rubric of this review—how do biotechnologies engage legal form?—the significance of the precautionary principle is that it reveals a species of normative form that is structured—or continually restructured—by tensions between the diverse social rationalities that compose biotechnologies: politics, economics, science.

The shift from the grown to the made might be represented as a shift from selection to instruction, or as the outcome of a process in which, through “molecular biological writing,” human beings have “gained access to the texture—and hence the calculation, instruction, and legislation—of the human individual's organic existence—that is, to a script that until now it has been the privilege of evolution to write, rewrite and alter” (Rheinberger 1995, p. 252). This understanding of instruction is usually interpreted in terms of engineering competence or as a cipher for the ability of biotechnologies to manipulate or instrumentalize biological components by reducing them to a set of permutable or combinable elements. This notion of life as text or mechanism—the two variations are conjoined in the implicit metaphor of genetic code as moveable type (Pottage 2006a)—is represented in debates over human cloning, in which the mastery of genetic script is seen as a condition for the success of reproductive or therapeutic cloning. The technology itself may be somewhat more complex than that (see Franklin 2007), but the general representation of clones as genetic copies trades on the logic of instruction. The questions that biotechnological instruction poses for law and legal theory are understood to be essentially questions of regulation: Should the parents of a child with an otherwise untreatable genetic condition be allowed to design their next child as a kind of resource to ensure treatment for the first? To what extent should therapeutic cloning be encouraged as an effective means of realizing biomedical objectives? These approaches construe law in instrumental terms, as a means of articulating and imposing the norms that define the human, but what might be more interesting is a focus on the effects that the fantasy of instruction has had on the structure of legal concepts and institutions rather than on the uses of instruction as a mode of creating new objects of legal attention.

Consistent with the theme of this review, the question is what effect technologies of molecular writing have had on the making of legal institutions. In what sense does apprehension of biological facts at a dramatically enhanced order of resolution disturb the architecture of legal institutions? More precisely, what effects has the use of DNA fingerprinting had in the institutions of family law and criminal law? How do biotechnologies (re)constitute the referential relation between legal categories and biological facts? Classically, legal institutions deal in evidence of biological states or events rather than biology itself. The difference between the two registers is nicely expressed by Austin (1962, p. 115): One has “evidence for the statement that some animal is a pig [when] the beast itself is not actually on view, but I can see plenty of pig-like marks on the ground outside its retreat, [but] if the animal then emerges and stands there plainly in view, there is no longer any question of collecting evidence; its coming into view doesn't provide me with more evidence that it's a pig, I can now just see that it is, the question is settled.” Evidence points beyond itself to the object it represents, but there is always an essential distance or discrepancy between object and representation. The ultimate fact is incorporated in the evidential trace, but only and always in the mode of deferral or anticipation. And because the state of biological knowledge did not allow this moment of deferral to be collapsed completely, there was considerable room for maneuver in constructing institutional schemes—principally forms of genealogical relationship—that performed certain kinds of contingent legal operation in the name of biology.

The effect of biotechnology on this mode of evidential knowledge is illustrated in studies of how courts have addressed the possibility of being certain about biological relationships. Since the 1980s, DNA testing has been able to be used to establish or verify paternity with certainty. Dolgin (2000) tracks the shift from a form of paternity that was premised on the logic of presumptions to a form of paternity that takes into account the scientific certainty of DNA testing. In most jurisdictions, a child born within a marriage is presumed to be the child of the husband, with the burden on the husband to adduce persuasive evidence that he is not the father, or, more precisely, to prove that he had no opportunity or capacity to be the father by virtue of nonaccess, impotence, or sterility. In one sense, the structure of the presumption was an attempt to second-guess the biological facts. In another sense, it was a fiction sustained on the basis of evidence rather than knowledge of the facts themselves. And the difference between evidence and the facts themselves was crucial to the institutional logic of family law. The institution of paternity was ostensibly predicated on biological facts; it was an autonomous construct within which certain institutional effects were triggered by biological events, but the institution itself was not a direct translation of biology into law. It followed that the presumption of paternity was not simply an evidentiary technique; it was also a device that structured disputes in such a way as to regulate the effect of corrosive information on family relations that were already established and that stabilized broader legal and social expectations as to the proper location and transmission of responsibility, authority, and property.

The availability of accurate DNA fingerprinting has complicated the functioning of this institution by shifting the register of institutional knowledge from evidence to the thing itself. Dolgin (2000) explores the effects of this shift by reference to jurisprudence concerning the admissibility of DNA evidence. In one case (discussed in Dolgin 2000, pp. 530–32), a court in the United States refused to admit DNA evidence proving that a man was not the father of a child born while he was married to his former wife. The court reasoned that the presumption of paternity continued to apply because the paternal relationship had been formed well before the DNA test was made, and that this relationship continued to characterize both the father and the child. The presumption was deployed as fiction sustained in plain contradiction to the facts. The reason is obvious: The appellate court was concerned not only to address the particular case before it but also to establish a precedent that would regulate the admissibility of DNA evidence in future cases. According to the court's conception of healthy family relationships, fathers should be dissuaded from asserting scientific certainties against a family member whose relation to them was established by other means. DNA evidence was construed as a means of verifying relationships that were established by social and affective expectations rather than scientific truth.

Strathern's analyses of the cultural power of biological information (see Strathern 1999, chapter 4) offer a theoretical approach to this mode of judicial verification. Biological information is often effective as constitutive information: “[K]inspersons who find things out about their ancestry acquire identity by that very discovery. Parentage implies relatedness; facts about birth imply parentage. Euro-Americans cannot ignore these connections” (Strathern 1999, p. 68). Given the immediacy with which constitutive information takes effect, the real question for doubting fathers or adoptive children in search of their real parents is the second-order question of whether or not to seek access to constitutive information. And as the issue of paternity testing makes clear, the question is not only or necessarily theirs to decide. Courts and other regulatory agencies have assumed the role of regulating the risks of constitutive information in the interests of the different individuals who might be vulnerable to its effects. In the case of the institution of paternity, this regulatory relation is what constitutes the institution. The maneuver is not one in which a logic of evidence or presumptive certainty is exchanged for a logic of scientific certainty, but one in which the institution holds together both orders of knowledge.

Again, Strathern's observations are instructive here: “Knowledge that comes from [DNA] testing gives a modern way (genetic identification) of being certain about a traditional category of parentage (biological fatherhood); but it is also a traditional way (establishing biological connection) of defining a thoroughly modern kind of parentage (scientifically certain fatherhood)” (Strathern 1996, p. 48). The regulatory approach to biological information shifts between the two forms of knowledge, sustaining the traditional form of the institution at the same time that it incorporates modern certainties. Obviously, an institution such as paternity is not made through adjudication alone, but we have “more tradition and more modernity at the same time” (Strathern 1996, p. 45). This notion of a recombinant relation between tradition and modernity has some interesting implications for the thesis that biotechnologies are dissolving the distinction between the grown and the made by thoroughly instrumentalizing society. As the title of one of Strathern's reflections on Euro-American kinship—After Nature (Strathern 1992)—suggests, biotechnologies are after nature both in the sense that they undo and supplant natural ways of making kinship relations and in the sense that the relations they fabricate are modeled after nature, as factitious ways of remaking nature where nature fails, or as techniques for enhancing natural ways of being. So even if biotechnologies instrumentalize the world, they may do so by remaking the grown in alternative ways.

The other, and perhaps more contentious, use of DNA fingerprinting is as evidence in criminal trials. A number of issues arise from the incorporation of DNA evidence into trial procedure: the relation between legal judgment and scientific expertise (Jasanoff 1998); the socio-technological bases for the emergence and perfecting of the procedure (Jordan & Lynch 1998, Lynch 2003); and the expansion of DNA databases as resources for crime detection. One might say that, as with paternity testing, the effect of DNA evidence has been to transform the basis of institutional references to biological fact. Again, although evidence in criminal trials pointed beyond itself to the event itself, the reality was that the facts were iterated and produced by various modes of institutional inscription and narration, so that the facts themselves were literally (re)materialized in the trial process (Scheffer 2004). To the extent that the essential logic of identification in criminal trials was a logic of discernible uniqueness, according to which “two indistinguishable marks must have been produced by a single object” (Saks & Koehler 2005, p. 892), then the arrival of DNA fingerprinting promised to collapse evidence of uniqueness into proof of uniqueness. Indeed, DNA evidence was initially presented as a more perfect analogue of fingerprint evidence. Just as the evaluation of a fingerprint was based on quantifying the number of matches between a print from the scene and an archived print, so were the bands of DNA drawn from two samples compared according to the number of points at which they matched: In both cases, prints and bands were “visually identified as elements in a holistic comparison” (Lynch 2003, p. 95).

However, there is a significant difference between the institutional acculturation of DNA evidence in the contexts of paternity disputes and criminal trials. Whereas paternity disputes incorporate DNA evidence by means of discursive techniques that take effect only once the evidence has been delivered and the question of admissibility arises, criminal procedure has been much more active in constituting the scientific practice of DNA testing. At the outset, DNA evidence seemed unreliable and inherently contestable; doubts were raised about the rigor of the sciences involved, the integrity of sample collection procedures (Lander & Budowle 1994), the foundation of calculations as to the probability of matches, and the presentation of evidence in the courtroom (Jasanoff 1998). Since then, with the evolution of the so-called multiplex short tandem repeat (STR) system, which evaluates matches not on the basis of a comparison of two traces but on a comparison of multiple DNA traces drawn from a number of different chromosomal sites, DNA evidence has become the gold standard (Lynch 2003) in forensic evidence: “Trust is invested in a combination of automated systems, impressive numbers, graphic outputs, and bureaucratic procedures” (Lynch 2003, p. 96). The process by which DNA evidence became trustworthy reveals how legal and scientific practices joined in the production of a specific form of referential relation. Returning to the observation that “innovative designs take account of prospective interests in, uses of, and resistances to alternative material arrangements” (Jordan & Lynch 1998, p. 776), one might say that the scientific form of the DNA fingerprint is just such a material arrangement; it is a form that incorporates the outcome of debates about the nature of forensic DNA evidence. Doubts and criticisms made by lawyers were factored into the organization and design of procedures for collecting, archiving, and presenting DNA evidence, with the result that the test itself became a kind of coconstituted artifact of law and science.

In this case, the referential relation is not simply a relation between a word and a thing; the relation is traced and maintained by a chain of reference that conditions, articulates, and materializes a particular way of seeing the world. As a process, reference is itself a particular kind of technological artifact. A variation on this theme of legal-scientific reference technologies is found in Lezaun's (2006) account of the emergence in the European Union of the regulatory category of the transformation event. Regulatory agencies in the United States treat GMOs as substantially equivalent to natural organisms, so that GMOs become the objects of regulatory intervention only in cases in which there is specific evidence that a given organism poses a hazard, whereas legislation in the European Union starts from the premise that there is a fundamental difference in kind between natural and artificial biological organisms. The theory is that GMOs should be rigorously distinguished from natural organisms at all stages of production and marketing, partly to allow regulatory authorities to intervene to remove any hazardous products from the market, and partly to allow consumers to make an informed choice as to whether or not to consume the products of biotechnology. But what is a GMO? Before 2003, GMOs were characterized by the detection of the most obvious traces of genetic intervention. The modification of plant cells usually involves the insertion of highly recognizable and effectively standardized regulatory gene sequences, which control the expression of the core transgenic trait, and it is relatively easy to distinguish natural organisms from artificial organisms by testing for one or other of these standard regulatory sequences. But although this mode of testing sufficed to distinguish artificial organisms from natural organisms, it could not distinguish between artificial organisms. In 2003, the European regulations shifted to a new mode of testing based on the detection of transformation events.

The object is to identify GMOs by reference to the unique molecular pattern that is produced at “the junction areas, the two regions where the transgenic DNA is ‘welded’ to the genome of the host organism” (Lezaun 2006, p. 511). Laboratories are required to record the creation and marketing of new transformation events rather than new organisms. And because transgenic modification is a highly random operation, in which transgenic DNA is inserted into the host genome at unpredictable points, the point of welding will be unique to each act of transformation, even when the act manipulates copies of a single gene construct and exemplars of the same plant variety. A transformation event is potentially specific to each individual product of genetic modification. In broad terms, the regulatory objective was “to constitute a new bio-legal entity and make it real in the world of biological organisms and food production” (Lezaun 2006, p. 521). What is emphasized in Lezaun's analysis is the regulatory reach of this new artifact, the purpose of which is to channel the processes of manufacturing and marketing GMOs into clearly identifiable spatial domains; the new technology has “the capacity to fix things in specific places, to draw visible limits in organisms and along the networks through which they move” (Lezaun 2006, p. 521).

This mode of fabricating reference is interesting for two related reasons. First, the index of the transformation event identifies organisms without reference to any of the taxonomies or categories that were traditionally used to actualize biological form. Organisms are not apprehended as genealogically produced entities, but are identified by reference to a temporal and spatial order that is entirely generated by the regulatory institution itself. Not only does the institution fabricate its own referents; in so doing it enfranchises the regulatory scheme from the distinction between natural and artificial organisms and from the distinction between the grown and the made. The transformation event is, quite literally, a new kind of kind. Second, the axis of reference is internal to the regulatory institution. Lezaun describes the production of a material artifact, a form of referent that is made to answer to a particular regulatory concept, but the materiality of the referent is just a moment in a process of self-observation. In constructing a means of tracing the movement of GMOs, the discourse of regulation divides a conceptual form into a category and its referent, and this materialized referent becomes a way of observing, testing, and enhancing the knowledge that is invested in the category. The form of transformation event is sufficiently generalized to function not only as a technique for governing or disciplining the production of GMOs, but also as a cognitive form that is ideally suited to the accumulation of information that can be fed back into the assumptions and expectations that structure regulatory action. The transformation event would be an ultracontemporary variation on the theme of the biopolitical norm as an instrument that actualizes the world to which it refers (see, generally, Canguilhem 1991).