Reconstructing the public domain in the wake of Bayh-Dole Alain Pottage I How has the Bayh-Dole Act changed the character or orientation of university-based research?1 From one perspective, the answer is relatively simple. The implementation of the Act has dissolved a traditional culture of basic science: ‘For a century or more, the white-hot core of American innovation has been basic science. And the foundation of basic science has been the fluid exchange of ideas at the nation's research universities. It has always been a surprisingly simple equation: Let scientists do their thing and share their work – and industry picks up the spoils. Academics win awards, companies make products, Americans benefit from an everrising standard of living. That equation still holds, with the conspicuous exception of medical research. In this one area, something alarming has been happening over the past 25 years: Universities have evolved from public trusts into something closer to venture capital firms. What used to be a scientific community of free and open debate now often seems like a litigious scrum of data-hoarding and suspicion’.2 This complaint about the end of basic (biomedical) science shades into a somewhat different argument about the effects of privatization on the culture of ‘university research norms’. Starting from the premise that the Bayh-Dole Act has created the conditions for a productive balance between privatization and the public domain,3 this line of argument proposes that we should now reflect on how to adjust the terms and implementation of the legislation so as to conserve the culture of university research norms, but only to the extent that the latter actually work to enhance the There are some empirical resources for that question, but studies of the xx are just resources; much depends on the in reation tt evidence. 2 Law of unintended consequences; the 3 ‘[R]esearch universities have developed informal policies that attempt to preserve certain elements of traditional research norms while incorporating some of the developmentpromoting aspects of property rights. Specifically, university policies privatize discoveries that are likely to have specific commercial uses while leaving in the public domain other discoveries that may have a variety of future research uses, may be necessary for the development of many different commercial products, or may be difficult to utilize effectively without access to other discoveries’ (Arti K Rai,‘Regulating scientific research’ (1999) 94 Northwestern University Law Review, xx-152, at p 144). 1 public domain. The difference between these two perspectives is quite interesting. The argument from basic science adopts the theory of the differentiation of basic science and applied research that informed the representation of the 19th century German research university, which emerged as a reaction to the technocratic form of the polytechnic or the technical university.4 Plainly, there was a utilitarian justification for the cultivation of science for science’s sake, and one of the proofs of that justification may have been the quality of the patents in chemical inventions that were compulsorily acquired from German corporations by the Allies under the terms of the Treaty of Versailles. The utilitarian justification is, if anything, even plainer in the constitution of basic science in the United States. Before the Second World War, there was no such thing as basic science in the sense of university-based, publicly-funded, research: ‘Until Hiroshima, the average American’s conception of the “scientist at work” was either the self-taught Thomas Edison or a white-coated industrial research chemist – not an academic at all’.5 In Vannevar Bush’s vision of things, the economically disinterested science of the research university was something that could be made useful, but this broader utility was supposed to be a spin-off from the non-utilitarian ethos of science itself. By contrast, the argument that we should conserve university research norms to the extent that they are ‘efficient’ in enhancing the public domain has already given up on this ideal of science for science’s sake. First, it effectively reduces the practice of a science to a set of norms. Second, it reduces the broad assemblage of norms described by Merton to a headline orientation toward the public rather than private. Third, it construes this preference as a more or less efficient (and tunable) instrument for translating science into technology. The effect is to turn the once differentiated (if only ideally) sphere of basic science into an ‘upstream’ resource of downstream production. The Which had themslevs been In established France and Germany), in the wake of the French revolution, the old corporate or guild form of the university as a universitas magistrorum et scholarium. 5 Steve Fuller, ‘The road not taken. Revisiting the original new deal’ in Philip Mirowski & Esther-Mirjam Sent, Science Bought and Sold. Essays in the Economics of Science (Chicago: University of Chicago Press, 2002) 444-462, at p 444. 4 theme of innovation dissolves cultural and institutional specificities into a single, economically calculable, process. As one would expect, this understanding of science is expressed even more affirmatively in the argument in favor of the Bayh-Dole project; quite simply, the effective transfer of title to inventions to universities has benefited the public by giving institutions and their researchers the necessary incentives to license concepts6 that would otherwise have remained unexploited.7 This premise is restated by Birch Bayh (and two other significant actors in the story of the Bayh-Dole Act) in a commentary on the Federal Circuit decision in Stanford v Roche: ‘While royalties resulting from successful commercialization are reinvested in campus research, paying associated technology transfer costs, and in rewarding inventors, those are not the primary goals of Bayh-Dole. Bringing new products into the marketplace where they benefit the public through providing enhanced health, safety, and the realization of better living standards – as well as the promotion of economic growth – is the real objective’.8 Again, the understanding is that science matters as a public good only to the extent that it functions as an upstream input into innovation. Take the argument that ‘[t]he Bayh-Dole Act unleashed the previously untapped potential of university inventions, allowing them to be turned from disclosures in scientific papers into products benefiting the taxpaying public’.9 What if scientific papers were actually the medium of a knowledge culture that was valuable as such, and also, perhaps, as a resource for a differentiated culture of technology? Three decades of STS scholarship, and a much more long-standing line of economic argument, have problematized this distinction, but it may be that the story Bayh-Dole should prompt us to return to the question of what ‘basic science’ actually is. Most university inventions as proof of concept stage; see Jerry G Thursby & Marie C Thursby, ‘The disclosure and licensing of university inventions’, NBER Working Paper No W9734. 7 The same point is made in the amicus brief filed in the name of Birch Bayh for Stanford v Roche: ‘Although the federal patent policies preceding the Bayh-Dole Act led to the creation of thousands of patentable inventions, the vast majority of those inventions remained on government shelves, unlicensed, undeveloped, and unable to benefit the public. Of more than 28,000 patents owned by the federal government, only four percent were licensed for development’ (ref). 8 Birch Bayh, Joseph P Allen & Howard W. Bremer, ‘Universities, inventors, and the BayhDole Act’ (2009) 3:24 Life Sciences Law & Industry 1-5, at p 3. 9 Bayh, Allen & Bremer, ‘Universities, inventors, and the Bayh-Dole Act’, at p 1. 6 If we take the biography of the Bayh-Dole Act as a case study in the construction of the public domain, then what do we mean by the public domain? More precisely, in what sense does the ‘public domain’ overlap with ‘basic science’, and in what sense does the public domain supposed to be ‘open’. My suggestion is that the sense of the public domain that informs the broad legal debate about the effects of Bayh-Dale depends on a deep archetype of nature as the paradigm of a public resource. The same archetype informs intuitions about the distinction between discovery and invention, or abstraction and concreteness, that is so central to the debate surrounding the Bilski and Myriad Genetics cases. For reasons that we know very well, the figure of ‘nature’ is even more problematic now than it was in the late 18th or early 19th century. One might see the emergence of open source synthetic biology perhaps as a reaction to the effects of the Bayh-Dole Act, and hence as an exercise in reconstructing the public domain, but synthetic biology has gone yet further in dissolving the figure of nature and the old sense of the public domain. II First, we should notice the sense in which more skeptical takes on Bayh-Dole presuppose the role of the university, either as a corral of ‘basic science’ or as an institutional platform for ‘traditional research norms’. Both modes of skepticism take the university to be one of two figures of the public, the first being the res publica of the university itself – the community, institution, or normative ethos – and the second the public domain as the fund or constituency on behalf of which the university is supposed to produce and culture ‘basic science’, or to exercise its ‘traditional research norms’. The argument puts two ‘publics’ in play; crudely, the proposition is that it is by cultivating the ‘public’ in the narrower sense of the university that we best serve the ‘public’ in the broader sense of the public domain. This diffraction of the public into different avatars or instantiations, or between means and ends, or principal and agent, goes to the question of what we mean by openness or ‘publicity’ in science. ‘Openness’ is not an abstract quality, but an effect of how particular sub-publics generate and practice ‘science’ in the interests of the broader public. So, for example, if we say that ‘[i]n order for basic research truly to be in the public domain, it must be performed by entities that refrain from claiming any significant property rights in such research’,10 then the crucial question is how science is actually held in the institution of the university. Even if we take it that there is more to Mertonian norms than ‘vocabularies of justification’,11 then is the university really just a platform for these norms? Can the agency of the university be explained in terms of a specific normative orientation? The institution has a specific historical trajectory and sociological density, and the story of Bayh-Dole could be seen as just an interesting episode in that trajectory. Indeed, the question of the constitution of the res publica of the university is crucial to deciphering the effects of the Bayh-Dole Act. Historically, the practice of waiving Federal title to inventions by means of IPAs (Institutional Patent Agreements) may have been much more influential than many commentators allow. Elizabeth Popp Berman has suggested that the passage of the Bayh-Dole Act and its subsequent implementation within the university was prepared and facilitated first by a ‘skilled actor’ working in the NIH in the 1960s and 1970s, and then by the rapid institutionalization of university patent offices or technology transfer offices in the same period.12 Within the space of xxx decades, the creative use of IPAs had fostered Rai, ‘Regulating scientific research’, at p 144. Ref Michael Mulkay 12 See Elizabeth Popp Berman, ‘Why did universities start patenting? Institution-building and the road to the Bayh-Dole Act’ (2008) 38:6 Social Studies of Science 835-871. The argument starts from the empirical observation that university patenting ‘increased almost as rapidly in the 12 years leading up to Bayh-Dole (by about 250%) as it did in the 12 years following the Act (by about 300%)’ (at p 836). Berman suggests that the origins lie in the practice adopted by the Department of Health, Education and Welfare, the parent of the NIH, which in the 1950s began waiving title to inventions in cases where the grantee could show that it had the necessary administrative competence to develop the invention. Initially the device of Institutional Patent Agreement, which was introduced in the 1950s, was used less restrictedly, albeit on a case-by-case basis, and when, in the 1960s the approach hadened, and IPAS were routinely denied, the NIH’s patent counsel, Norman Latker, began to advocate the use of streamlined IPAs as a way of transferring technology to the market. A minor scandal over the non-development of (proto-)inventions generated within the NIH’s medicinal chemistry program in the late 1960s facilitated Latker;’s strategy, and, even though relatively few IPAs were issued, the form of the instrument functioned as a kind of ‘proto-institution’, that is, ‘a new practice, rule, or technology that is narrowly diffused and only weakly entrenched, but that has the potential to become widely institutionalized’ (at p 846). The issuing of IPAs fostered the evolution of the function of the university patent administrator. When the first conference of university patent officers was held at Case 10 11 the creation of a broad administrative platform of technology transfer expertise: ‘As patent administration became a job description, and particularly as actual patenting or technology transfer offices were formed, individuals and groups were created who had interests in perpetuating the practice as well’.13 It is not surprising that one of the most upbeat retrospective appraisals of ‘Bayh-Dole at 30’ was offered in 2010 by the Association of University Technology Managers, which created a dedicated website for the anniversary: www.b-d30.com. Keeping in mind the question of the constitution of the university, there are two crucial points here. First, even if we think about the university as a platform for ‘research norms’, then we need to bear it in mind that the norms of administrators may not be entirely congruent with those of scientists.14 Looking ahead to the example of synthetic biology, we can find an illustration of the potential tensions between technology transfer practices and the preferences of university researchers. Kenneth Oye and Rachel Wellhausen refer to the case of Adam Arkin, named as the co-inventor of a patent relating to ‘a system and method for simulating operation of biochemical systems’, who says that he was pressured by Stanford to apply for what he characterized as ‘an example of an outrageously broad IPR claim’.15 Second, and Western Reserve University in 1974, it had 118 participants. When in 1978 the newlyappointed Secretary for the HEW reversed policy and decided to review all applications for IPAs, leaving some 30 inventions in limbo, it was a patent administrator who brought this situation to the attention of Senator Birch Bayh. And, in an interview given in 2005, Bayh identified this factor as a crucial impetus for the movement toward legislation: ‘Discoveries were lying there, gathering dust. So the taxpayers weren't being protected. We'd spent $30 billion in research for ideas that weren't helping anybody’ (cited in Clifton Leaf, ‘The law of unintended consequences’ Fortune, 19 September, 2005). On the history of university patenting, see also Grischa Metlay, ‘Reconsidering renormalization: stability and change in 20th-century views on university patents’ (2006) 36:4 Social Studies of Science, 565-597. Cf Rebecca Henderson, Adam B Jaffe & Manuel Trajtenberg, ‘Universities as a source of commercial technology: a detailed analysis of university patenting, 1965-1988’ (1998) 80:1 Review of Economics and Statistics 119-127. 13 Berman, ‘Why did universities start patenting?’, at p 853. 14 See generally (2010) 81:3 Journal of Higher Education 243-249 (Special issue on ‘Norms in Academia’). See also David H Guston, ‘Stabilizing the Boundary between US Politics and Science: The Rôle of the Office of Technology Transfer as a Boundary Organization’ (1999) 29:1 Social Studies of Science 87-111. 15 The authors observe that ‘as the parts, methods, and design principles that constitute synthetic biology take on significant commercial value, conflict between technology licensing offices wishing to privatize intellectual property and researchers seeking to the strengthen the intellectual commons will only increase’Kenneth A Oye & Rachel Wellhausen, ‘The intellectual commons and property in synthetic biology’ in Markus Schmidt et al (eds), more to the point, the agency of the university cannot be construed as an effect of legislative or normative cultures. Two or three decades of STS and ANT scholarship have revealed the sense in which norms – textual, verbal, or tacit normative propositions – are the elements of broader networks or assemblages, and the articulation of the assemblage shapes its constituent elements. As Stanley Fish once observed, texts are not self-implementing; they come to life only in a skein of social dispositions, practices, technologies; the same is obviously true of tacit normative expectations. So talk of norms is meaningless unless we give some account of their social or material felicity conditions.16 How are norms (formal or informal) wired, mediated, communicated, and translated into practice? More precisely, how has the textual material of the Bayh-Dole Act been integrated into the multiple form of the university?17 How is a public made? III The question of the university raises broader question of what we mean by openness or ‘publicity’. One approach to these questions is offered by Chris Kelty’s study of free software culture, which centers on the characterization of the geek community as a ‘recursive public’: Recursive publics are publics concerned with the ability to build, control, modify, and maintain the infrastructure that allows them to come into being in the first place and which, in turn, constitutes their everyday practical commitments and the identities of the participants as creative and autonomous individuals.18 Synthetic Biology. The Technoscience and its Societal Consequences (Dordrecht: Springer, 2009) 121-140, at pp 137-138. 16 The short cut isto look at statsical data or the xx to say ththey are ore or less efficcious, bu this is the xx 17 On the university as multiplicity, see Dirk Baecker, ‘A systems primer on universities’ (2011), at: http://www.dirkbaecker.com/Universities.pdf 18 Chris Kelty, Two Bits. The Cultural Significance of Free Software (Durham NC: Duke University Press, 2008), at p 7. This formulation is amplified further on in the book: ‘Why recursive? I call such publics recursive for two reasons: first, in order to signal that this kind A recursive public is the made by the strategic activity of materializing its own conditions of existence. In the case of free software culture this means that participants selectively pattern the medium of the Internet so as to generate the technical, material, and discursive codes that enable their communications about ‘code’. So the Internet is not already a public domain; it is the medium or environment out of which a recursive public creates itself. In a sense, a recursive public simply is this ongoing process of self-creation. Bearing in mind the broad theme of Bayh-Dole, Kelty’s notion of ‘recursive publics’ brings out some essential points about terms such as ‘open’, ‘public’, or ‘basic’. First, a public is not an entirely spiritual thing; it has be embodied, materialized or wired into a medium of existence. The recursive public of the free software movement might be a normative community, but this ‘ethical’ existence is maintained by an ongoing reconstruction of the socio-technical medium of the Internet. As information theorists observe, the content of a medium is always another medium. What is the medium of existence of the classical public domain? Is it the research university as a contemporary version of the universitas magistrorum et scholarium? Is it the medium of text and its associated apparatus of publication, archiving, and distribution. Whatever the answer, the public domain cannot simply be knowledge or information; it has to include the socio-historical felicity conditions and material media that are presupposed by the communication of information. Second, to the extent that the public domain is identified with a specific normative ethos, then these norms – whether formal or informal, macro or micro – also have to be wired, materialized, and communicated, by some means. This has implications for of public includes the activities of making, maintaining, and modifying software and networks, as well as the more conventional discourse that is thereby enabled; and second, in order to suggest the recursive “depth” of the public, the series of technical and legal layers— from applications to protocols to the physical infrastructures of waves and wires—that are the subject of this making, maintaining, and modifying. The first of these characteristics is evident in the fact that geeks use technology as a kind of argument, for a specific kind of order: they argue about technology, but they also argue through it. They express ideas, but they also express infrastructures through which ideas can be expressed (and circulated) in new ways’( at p 29)) an analysis of the ability of legislation to ‘engineer’ or ‘re-engineer’ a public domain. Norms do not function instrumentally; they have felicity conditions whose contingencies have been amply characterized in the sociology of law.19 Third, putting the first and second points together, a public exists within an assemblage or network in the classical STS sense. And Kelty’s notion of the recursive public specifies how a public exists within a network. The process that constitutes a recursive public is a process of internal differentiation in which a particular public detaches itself from the medium in which it remains immanent.20 One might say that a recursive public is one of the ways in which a network becomes present to itself. Fourth, one of the most crucial implications of this process of differentiation or detachment is that publics are always – structurally, operationally – closed. The differentiation of the public from within a medium necessarily creates a distinction between what is inside and what is outside, and a recursive public ongoingly creates that distinction by reconstructing the medium that defines what qualifies as appropriate (or perhaps just recognizable) communication. One can join a recursive public, but only if one plays by its discursive and non-discursive ‘rules’. For the recursive public of the free software movement openness really means inclusiveness, but the movement of inclusion is always centripetal. The ‘source’ of open source is vivified through closure, selectivity, and reduction. The same is true of all processes of knowledge formation. In terms of Bayh-Dole, and broader debates about the constitution of the public domain, the point might be that instead of beginning with normative ideals of openness we should pay more attention to the modalities of closure that condition openness. See especially Niklas Luhmann, Law as a Social System (Oxford: Oxford University Press, 2007). 20 Having revealed the sociality of networks, ANT is now taking on the task of characterizing this mode of differentiation; for a statement of this intent see Bruno Latour, ‘Note brève sur l’écologie du droit saisie comme énonciation’, in Frédéric Audren & Laurent de Sutter (eds), Cosmopolitiques 8. Pratiques cosmopolitiques du droit, 34-40. 19 Fifth, if media do not of themselves constitute publics – the Internet is the just the medium from out of which the public of the free software movement fashions itself, and print was just a medium from which diverse modern publics emerged – then the broader point is that publics are multiple. There is no such thing as a singular public domain, only a medium or set of media that are folded into a public sphere by different modes of recursive politics. All of this means that in reflecting on the extent or openness of the public domain, we should pay closer attention, first, to the material and socio-technical conditions of existence of publics, and second, to the way that these conditions are folded or ‘closed’ into publics. IV In a chapter of his popular economic history, David Landes traces ‘the invention of invention’ back to the mediaeval period, and to a specifically European culture of labor, time, science, and, above all, enterprise: ‘Enterprise was free in Europe. Innovation worked and paid, and rulers and vested interests were limited in their ability to prevent or discourage innovation’.21 The truth, however, is that invention in the sense of patent law emerged only in the late 18th century, precisely because ‘vested interests’ had until then worked to keep ‘ideas’ embedded in matrices of patronage, territory and corporate interest.22 Indeed, one might say that invention in the modern sense only really got going when ‘novelty’ became a routine and effective criterion of bureaucratic practice (rather than an ad hoc adjudicative determination), and when invention became an industry of the kind that is associated with Thomas Edison; when, that is to say, the course of innovation was construed as a succession of technical solutions to technical problems, when David S Landes, The Wealth and Poverty of Nations. Why Some Are So Rich And Some So Poor (New York: Norton & Co, 1999), at p 59. 22 See Alain Pottage & Brad Sherman, Figures of Invention. A History of Modern Patent Law (Oxford: Oxford University Press, 2010), chapter 2, and Mario Biagioli, ‘Patent republic. Representing inventions, constructing rights and authors’ (2006) 73 Social Research 11291172. 21 inventors were primed to recognize ‘solutions’ when they happened,23 and when the process of invention itself became as industrialized or serialized as any of its products. This industrial sense of invention was affirmed by the legal criterion of novelty as the concept that relayed invention to invention: ‘While the patents-asprivileges regime was primarily concerned with the novelty of an invention in a certain place, early US patent law started to conceive of novelty in terms of the difference between a patent and another that preceded it’.24 Given that inventions necessarily mobilized nature (in the shape of diverse forces and materials) how did the chain of novelty replicate itself without extracting anything from nature? First, this question was new to the late 18th century. The concern to define the public domain was a direct reflex of the concern to define the newly-forged right of the inventor. Before then, what could the public have been if not the interest represented by a patron or sovereign?25 How could ‘basic science’ be disembedded from networks of patronage and local or tacit knowledge any more easily than ‘invention’? If a patent was a species of private right, and if the justification of that right was contractual – the inventor had to give something to the public that it did not already have – then the question of what the public already had became pertinent. So too did the question of how applications of natural forces or materials could add to nature without taking from it. How did the relaying of innovation to innovation pass through nature without diminishing it? Crucially, the modern sense of the public domain in patent law is a legacy of the way that this question was answered. Commenting on Daguerre’s discovery of the photochemical effects of silver iodide because mercury happened to be in same cabinet as a preparation of iodized silver, Friedrich Kittler observes that ‘if an accidental effect like the one that occurred in Daguerre’s cupboard had taken place 200 years earlier, …the whole matter would have fallen flat again simply because no one would have captured, stored, recorded, and exploited it as a natural technology. …Daguerre thus represent[s] the beginning of an epoch where the duration, the reproducibility, and practically even the success of inventions – and in the end that means historically contingent effects – are guaranteed (Friedrich Kittler, Optical Media (Cambridge: Polity Press, 2010), at p 130). Kittler observes (also at p 130) that ‘I hope it is clear how much chemistry must have historically already taken place in order that iodized silver and quicksilver could be accidentally placed in the same cupboard’. 24 Biagioli, ‘Patent republic’, at p 1142. 25 Notwithstanding references to the public interest. 23 The core of the modern sense of the public domain was worked out in the arcane 19 th century theory of the ‘principle’ of a machine. To recapitulate a history that is more fully set out elsewhere,26 the patent act of 1793 had characterized the subject matter of machine patents as the ‘principle’ of a machine, and, in interpreting these provisions courts in the US drew on English cases, notably that of Boulton & Watt v Bull, to say that in effect a principle was a kind of ‘neither/nor’. The principle of a machine was defined as a kind of double negative: neither the principle of nature or science that was applied by the machine, nor the material form or configuration of the machine. Or, in other terms, the principle of a machine could be identified by distinguishing between two senses of the term ‘principle’: ‘the principle so embodied and applied and the principle of such embodiment and application, are essentially distinct; the former being a truth of exact science, or a law of natural science, or a rule of practice; the latter a practice founded upon such truth, law, or rule’.27 What was a ‘principle of embodiment’ as distinct from an embodied principle of nature? One answer was proposed by George Ticknor Curtis in his mid-century treatise. Curtis explained that human intervention in nature took effect by reorganizing matter, by ‘placing its particles in new relations’.28 But if that were all that invention involved, then the invention itself would be a material embodiment rather than the ‘principle’ of a material embodiment. The patentable ‘principle’ of a machine patent consisted in the agency or operation of the material machine rather than its material form or configuration: ‘the form or arrangement of matter is but the means to accomplish a result of a character which remains the same, through a certain range of variations of those means’.29 Yet, given that the functioning of any of these classical machines necessarily employed natural forces or principles, how could one say that a machine patent did not enclose natural forces or properties that were already in the public domain? Curtis’s argument was that the operation of the See Pottage & Sherman, Figures of Invention, esp chapter 4. Wintermute v Redington 30 F. Cas. 367 (C.C.N.D. Ohio 1856). 28 ‘Over the existence of matter itself [man] has no control. He can neither create nor destroy a single matter of it; he can only change its form, by placing its particles in new relations, which may cause it to appear as a solid, a fuel, a gas’ (Curtis, A Treatise on the Law of Patents for Useful Inventions (Boston: Little & Brown, 1849) at p xxv). 29 Curtis at p 17 26 27 machine elicited a certain effect from nature; a new machine ‘call[ed] into effect some latent law, or force, or property’.30 So the ‘principle’ of a machine – the ‘thing’ protected by a patent and specified in an infringement action – was the action of the machine in eliciting a specific inflection of physical or mechanical forces. With the question of public domains in mind, there are two important points about this sense of the invention as the operation of eliciting an effect from nature. First, in the language of classical patent doctrine, a machine patent related to the mode of operation of a machine, or, more precisely, ‘a new mode of operation, by means of which a new result is obtained’.31 A machine patent related to the machine as a means in itself, as the functioning of a machine rather than its ultimate end or function. The difficult – but crucial – exercise here was to imagine the functioning of a machine not just as the articulation of its moving parts but more importantly as the way in which the machine provoked a specific effect from nature. The patent did not enclose natural forces or properties as such but only the means by which those forces or properties were cajoled into producing a particular effect. And, again, the means in question was not the material configuration of the machine but the ‘idea of means’32 that it expressed. In that sense machines embodied ideas, but ideas qualified as inventive by virtue of their capacity to instruct machines to elicit effects. The upshot of this theory was, first, that the public domain or ‘storehouse’ of nature remained undiminished. Other inventors were free to design machines that elicited different effects from the same forces or properties, or even machines that elicited the same effect by way of a different idea of means. Second, the process of invention was indebted to but not entirely immersed in nature. Different technologies for eliciting effects from nature could succeed each other, differentiated and relayed by the criterion of novelty, so that innovation remained a differentiated and in some sense self-producing process. Curtis, 1849, xxvi. Winans v Denmead 56 U.S. 330, 341 (1854). 32 See generally Robinson 1890. 30 31 This sense of the public domain has already been rendered problematic, if not entirely unworkable, by the emergence of biotechnological and software inventions. In the case of software inventions the old distinction between the ‘idea of means’ and the effect elicited from nature disappears. Concepts formed in relation to the medium of energy do not necessarily work in relation to the medium of information. And it is now a trite observation that biotechnologies invent the distinction between nature and culture rather than taking it as their premise.33 But synthetic biology goes further in reinventing invention. Prospectively, one might say the effect of technological and commercial evolution of gene synthesis technologies will be to generate a medium that entirely uncouples the notion of the public domain from any representation of nature, or from any distinction between basic science and technology. V The progress of synthetic biology is likely to be shaped by the economics of gene synthesis. Prospective accounts of synthetic biology – is it possible to write about synthetic biology in any register other than that of futurity? – look forward to the invention of DNA printers that will able to ‘print out’ designed sequences on demand.34 There are some good economic reasons for suggesting that such devices are unlikely to be central to the practice of synthetic biology, but the point of the image is that the automated technologies that are involved in assembling, correcting and proofreading DNA are becoming increasingly refined, reliable, and cheap (relatively speaking):35 ‘It seems plausible that …commercial gene synthesis could Ref Strather. For a current example of ‘bioprinting’, see Wired: http://www.wired.com/rawfile/2010/07/gallery-bio-printing/ 35 Incidentally, this process of evolution has implications for the collection of standardized DNA parts that is often taken as the headline feature of synthetic biology as open source science. In the early days of the Biobricks initiative the DNA parts were stored as wet DNA, and these material molecules were carefully packaged up as sets and distributed to participants in the annual iGEM competition. As Biobrick parts increase in number and as DNA synthesis becomes more affordable, the parts could be stored as sequence information in electronic databases rather than ‘wet’ parts in registries, and gene synthesis could be outsourced to commercial operators. 33 34 reach the same level of convenience as for synthetic oligos: a cost and time on a par with overnight shipping. When this condition is met, much of the work currently done to manipulate DNA in research labs will be outsourced. Instead of cloning into vectors stored in those labs, custom or standard vectors could simply be resynthesized on demand’.36 The argument is that the availability of cheap synthetic DNA has become an economic and technological factor in its own right: [T]he increasing availability of gene sequencing creates more and larger electronic gene databases. This drives demand for protein-expression systems, directed evolution and metabolic engineering, which creates demand for synthetic biology technologies and tools.37 New opportunities might be phrased as challenges – ‘a paradoxical gap exists between our ability to synthesize and our ability to design valuable novel constructs’38 – but the basic point is that the technical evolution of oligo synthesis is turning DNA into the kind of medium that is ‘designable’ in a way that collapses the division between nature and invention that was essential to the old theory of the public domain.39 One might say that biotechnology had already achieved the same effect, but synthetic biology promises to turn life into a truly digital medium. The enterprise of synthetic biology is usually presented as a hierarchy of operations of different orders of scale. In ascending order of abstraction, first, the engineering and characterization of parts (promoters or open reading frames), second, the assembly of parts into genes, third, the relaying of genes to make pathways or Peter A Carr & George M Church, ‘Genome engineering’ (2009) 27:12 Nature Biotechnology 1151-1162, at p 1156. This may not be the whole story. The current costs of single-gene custom synthesis are still prohibitive for many university laboratories, even before taking into account the fact that much of the action in synthetic biology will lie in combinatorial swapping, and hence increased costs of synthesis. 37 Mike May, ‘Engineering a new business’ (2009) 27: 12 Nature Biotechnology 1112-1120, at p 1113, referencing the research of John Bergin. 38 Peter A Carr & George M Church, ‘Genome engineering’ (2009) 27:12 Nature Biotechnology 1151-1162, at p 1151. 39 And, incidentally, this quality of ‘writeability’ or ‘designability’ has been characterized as an effect of the Bayh-Dole Act.(see Richard Hogrefe. ‘A short history of oligonuckeotide synthesis’, available at: http://www.trilinkbiotech.com/tech/oligo_history.pdf) 36 devices, and, finally the design and assembly of parts into genomic ‘software’. From the perspective of the molecular biologist, the challenges posed by these operations have to do with physical assembly and operational contextualization. For those who do not already presume the future development of DNA synthesis, ‘the limit of what synthetic biology can achieve is becoming determined by our ability to physically assemble DNA’.40 So, for example many Biobricks parts are not usable because they contain scar sequences that complicate the process of assembly. Turning to contextualization, the point is, first, that synthetic genomes have to be booted, and, second, that the operation of synthetic genes or genomes will be conditioned by contexts that remain opaque.41 But for those who have taken up the prospective theory of synthetic biology, the limitations of physical assembly are likely soon to be overcome.42 Indeed, from this perspective assembled DNA is already of less interest than the things that one can do with it: ‘Although the assembly of large DNA circuits is presently a technological challenge, and is therefore valuable, the relative value of that assembled DNA is quite small. Of much greater value are the molecules or behaviors specified by those sequences: networks that enable computation or fabrication, enzymes that facilitate processing plants into fuels or fine chemicals, proteins and other molecules that serve as therapeutics and antibiotics’.43 Ultimately, then, the presentation of synthetic biology abstracts from the materialities of assembly and operation to the technique of design. The practice of synthetic biology is scheduled to become an exercise in computeraided design: ‘Once natural enzymatic and regulatory modules are adapted, refined and measured, they can be combined – at the drawing console – with a high degree Tom Ellis, Tom Adie, & Geoff S Baldwin, ‘DNA assembly for synthetic biology: from parts to pathways and beyond’ (2011) 3 Integrative Biology 109-118, at p 110. 41 ‘[F]or biological systems especially, the background environment is still very incompletely understood when contrasted with other disciplines, such as electronics design. Though a given genome sequence may be known, the functions of many predicted proteins typically remain unknown and the relationships between known functions completely unmapped’ (Carr & Church, ‘Genome engineering’, at p 1159). 42 ‘’The long-term expectation in this area is that increasingly available DNA synthesis will make some of the current assembly restrictions unnecessary, and that new or modified standards will develop to take advantage of those resources’ (Carr & Church, ‘Genome engineering’, at p 1154). 43 Robert Carlson, ‘The changing economics of DNA synthesis’ (2009) 27:12 Nature Biotechnology 1091-1094,at p 1093. 40 of abstraction (ideally with intuitive graphics) while increasingly sophisticated computational methods handle “lower level” steps’.44 The prototypes for this kind of software platform already exist, in the guise of programs such as Gene Designer and Clotho, which set out precisely the kind of ‘drawing console’ that we look forward to. As Adrian Mackenzie points out, the ambition is to concentrate into a software interface an entire repertoire of technologies, each of which might once have addressed ‘nature’ in the mode of experimentation or provocation, but which now collectively serve as instruments for ‘shap[ing] things across multiple scales and locations’.45 In such an interfaces, biological techniques and materials are rendered entirely; the operations transacted in these ‘development environments’ consist of ‘browsing lists of components, cutting and pasting, dragging and dropping components on screen, applying various commands to selected components, and then ordering the DNA construct via a commercial web service’.46 So, ‘[in] the compressed space of the software interface, the history of molecular biology as a series of technical accomplishments is re-rendered as an expanding tree of menu options’.47 Of course there are some continuities with established programs of biological science. Synthetic biology will involve doing what molecular biologists have been doing for decades, that is, experimenting with combinatorial swappings.48 One of the Peter A Carr & George M Church, ‘Genome engineering’ (2009) 27:12 Nature Biotechnology 1151-1162, at p 1154. 45 Adrian Mackenzie, ‘Design in synthetic biology’ (2010) 5:2 Biosocieties 180-198, at p 183. 46 Mackenzie, ‘Design in synthetic biology’, at p 188. 47 Mackenzie, ‘Design in synthetic biology’, at p 189. 48 Hence the representation of synthetic biology as a mode of ‘accelerated evolution’, or as a continuation of with the ‘ancient manipulation and testing of billion-base-pair DNA systems [that] is evident in the diversity of dog breeds and agricultural species relative to their wild ancestors’ (Carr & Church, ‘Genome engineering’ at p 1151). Biotechnology had already suspended, the process of evolution, and synthetic biology, or more precisely the medium of synthetic DNA, takes things further. Some fifteen years ago, Hans-Joerg Rheinberger observed that molecular biology had acquired the capacity to ‘invent’ biological reality: ‘What is new about molecular biological writing is that we have now 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. What Darwin called ‘methodical’ or ‘artificial selection’ has barely scratched the surface of this script in the last 10,000 years. For, in a sense, artificial selection itself was still nothing more than a specific human mode of natural evolution. This has now gone; and with its disappearance, natural evolution has come to an end. Molecular biology will come to invent biological reality’ (Hans-Joerg Rheinberger, ‘Beyond nature and culture: 44 virtues of the decreasing cost of gene synthesis is that it might eventually allow synthetic biology designers to design and assemble constructs (within the framework of the drawing console) combinatorially. Designers would be able to order tens or hundreds of variants on the same construct, each of which might have (say) a different substitution of a promoter or ORF at the same location. The resulting constructs could then be compared for performance in making biofuels or pharmaceuticals. Perhaps, too, some artifacts of synthetic biology are more like science of an older kind; for example, one might say of the ‘manipulation of genomes by constructing, deleting, and to some extent reorganizing components’, that this is not yet ‘design’.49 But the basic program of synthetic biology (prospectively construed) is already suggested by one of the first exercises in construction, namely, the operation of ‘refactoring’ that is described in Drew Endy’s first practical papers on synthetic biology.50 In the case of software, the technique of refactoring involves editing or rewriting code so as to alter its structure but not its performance. In synthetic biology it involves translating or transcribing biological materials into a new medium: ‘Without substantially altering any biological function, refactoring readies a specific biological substance for wider participation in processes of design, modification, standardization and experimentation’.51 The technique of refactoring pointed the way toward what is scheduled to happen when gene synthesis really takes off; the agency of biological materials will be reconstructed in the medium of synthetic DNA, which will in turn be amenable to combinatorial design of an intensity and effect that is quite novel. The effect of transcription or reconstruction A note on medicine in the age of molecular biology’, (1995) 8:1 Science in Context, 249-263, at p 252). Synthetic biology now invents a reality that is no longer, or not necessarily, biological. 49 ‘These tend to be proof-of-principle reports pushing the limits of scale – often asking, How much can this cell tolerate? – but not of design’ (Carr & Church, ‘Genome engineering’, at p 1153). 50 Leon Chan, Sriram Kosuri & Drew Endy, ‘Refactoring bacteriophage T7’ (2005) 1:1 Molecular Systems Biology: ‘A system that is partially understood can continue to be studied in hope of exact characterization. Or, if enough is known about the system, a surrogate can be specified to study, replace, or extend the original. Here, we decided to redesign the genome of a natural biological system, bacteriophage T7, in order to specify an engineered biological system that is easier to study and manipulate’. 51 Adrian Mackenzie, ‘Design in synthetic biology’ (2010) 5:2 Biosocieties 180-198, at p 190. is to grant DNA a new potentiality; not the potentiality that it had in vivo,52 nor even the potentiality that was actualized by the opportunistic interventions of recombinant DNA technologies, but the potentiality that emerges from the digitized medium of synthetic DNA and the sociality that infuses that medium.53 Katherine Hayles54 resists the argument that the computer is ‘the ultimate solvent that is dissolving all other media into itself’,55 and argues instead that code is involved in relations of ‘intermediation’ with analogue media, notably texts, bodies, and consciousnesses. The point is that the world is not entirely digital, it consists in the difference between the digital and analogue, and is animated by the ‘complex feedback loops [that] connect humans and machines, old technologies and new, language and code, analogue processes and digital fragmentations’.56 But, if we start from the perspective of Kelty’s notion of the ‘recursive publics’, then these relations of ‘intermediation’ are simply the medium from which a recursive public produces itself. What kind of recursive public will synthetic biology – whether open source or commercial – fashion for itself? VI The emergence of synthetic biology has raised questions that are similar to those posed by the Bayh-Dole Act in relation to biomedical research. For example, a comparison of the views of scientists engaged in synthetic biology suggests that there is no shared understanding as to where to draw the line between what should be private and what should be common. Although there is ‘widely shared agreement Though of course the very fact of observation changes what exists only in vivo. One should be careful here; for example, the practice of bioinformatics involved a similar ‘medial effect’ (see Adrian Mackenzie, ‘Bringing sequences to life: how bioinformatics corporealizes sequence data’ (2003) 22 New Genetics and Society, 315-332). What is new about synthetic biology is the totality of the medium. 54 N Katherine Hayles, My Mother Was a Computer. Digital Subjects and Literary Texts. (Chicago: University of Chicago Press, 2005), at p 31. 55 Cf, Friedrich Kittler, Gramophone, Film, Typewriter (Stanford: Stanford University Press, 1999), at pp 1-2: ‘Inside computers everything becomes a number: quantity without image, sound, or voice. …With numbers, everything goes. Modulation, transformation, synchronization; delay, storage, transposition; scrambling, scanning, mapping – a total media link on a digital base will erase the very concept of medium’ (Kittler 1999: 1-2). 56 Hayles, My Mother Was a Computer, at p 31. 52 53 on the need for common ownership of infrastructure, including registries of parts for basic research and education, standards for performance and interoperability, and design and testing methods’, there is also divergence as to whether the design tools needed to turn these infrastructural elements into synthetic biology applications should or should not be proprietary.57 From one perspective the progress of techniques of design and assembly, and the future of synthetic biology as an information science, might depend on an effective ‘commons’,58 but as synthetic DNA becomes a relatively low-grade commodity, this is precisely the area in which economic value is likely to be concentrated. But perhaps the real point of introducing the case of synthetic biology into the debate is to take it as the endpoint of a process in which Bayh-Dole is implicated. That endpoint is nicely formulated by Adrian Mackenzie in his analysis of synthetic biology as a novel design practice: ‘biological work’ becomes ‘a process that is no longer primarily concerned with experiment and knowledge production, but with the organization of work, production and innovation’.59 In a sense this endpoint is already prefigured in both skeptical and affirmative accounts of Bayh-Dole. For example, the analysis of the effects of the Act in terms of a flow of upstream and downstream research already imagines science less as a practice of ‘experiment and knowledge production’ than as a mode of ‘work, production and innovation’. Scientific knowledge is noticeable or relevant only to the extent that it has the potentiality to act as an upstream resource in a flow that is conceptually mapped backwards, from products to potential, and that is mapped in terms of an instrumental logic of efficient innovation. Whereas the old theory (or mythology) of basic science and its technological applications imagined separate spheres (or publics, perhaps) with traversable boundaries, even the skeptical economic analysis See Oye & Wellhausen, ‘The intellectual commons and property in synthetic biology’, at p 137-138 58 ‘[T]he vision is to decouple the characterization of pathway components by specialists from the end user’s ability to search and build pathways from these data. The data generated by end users building and testing pathways could then be incorporated, extended and searched by other users, allowing the pathway data set to grow’ (Travis S Bayer, ‘Transforming biosynthesis into an information science’ (2010) 6 Nature Chemical Biology 859-861, at p 859). 59 Mackenzie, ‘Design in synthetic biology’, at p 189. 57 of the effects of Bayh-Dole has implicitly given up on the notion of science as a public in its own right. The evolution of synthetic biology might or might not prove that premise to be mistaken.