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The Mutability of Biotechnology Patents: From Unwieldy Products of Nature to Independent ‘Object/s’ Michael S. Carolan Theory Culture Society 2010; 27; 110 DOI: 10.1177/0263276409350360 The online version of this article can be found at: http://tcs.sagepub.com/cgi/content/abstract/27/1/110

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110-129 TCS350360 Carolan_Article 156 x 234mm 04/02/2010 11:32 Page 110

The Mutability of Biotechnology Patents From Unwieldy Products of Nature to Independent ‘Object/s’

Michael S. Carolan

Abstract This article details how patent law works to create discrete, immutable biological ‘objects’. This socio-legal maneuver is necessary to distinguish these artifacts from the unwieldy (and thus unpatentable) realm of the natural world. The creation of ‘objects’ also serves the interests of capital, where a stable, unchanging, immutable object goes hand in hand with commodification. Yet this stabilization is incomplete. Pointing to a variety of different examples, this article illustrates how biotech patents do not speak to specific, immutable things. Biotech patents, rather, are better understood as ontologically fluid (though, as discussed, this fluidity can only occur within limits), which is to say their identity cannot be ‘fixed’ – or, at least, not without undermining the very existence of today’s biotechnology regime. The article concludes by speaking briefly about how this mutability is perpetuating certain inequalities, particularly between holders of various property forms. Key words GMO ■ immutable mobile Monsanto

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intellectual property

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Bruno Latour

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law

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hen a patent is issued one is given property rights over a particular invention – over a particular ‘thing’. A look at any patent application would quickly lead to this conclusion. The disclosure requirement of patent law requires that one be able to specify their

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Theory, Culture & Society 2010 (SAGE, Los Angeles, London, New Delhi, and Singapore), Vol. 27(1): 110–129 DOI: 10.1177/0263276409350360



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invention. This is based upon the old aphorism that a property right is worth nothing if you cannot enforce it, and you cannot enforce what you cannot specify. So: patents presuppose the stability of the object. Yet, as science and technology studies scholars have taught us, this is a big assumption. In light of recent scholarship (e.g. Berg and Mol, 1998; Law, 2002; Lee and Brown, 1994), we can no longer start from the supposition that ontological questions are of no concern to social scientists. Others have delved into the mutability of, say, heart disease (Mol, 2002), liver disease (Law and Singleton, 2005) and a water pump (De Laet and Mol, 2000). What about biotechnology patents? In creating enforceable property claims, one would not be chided for thinking that patents are attached to objects of sufficient immutability. If patents do not refer to specific ‘things’, how can the courts determine cases of infringement? At a rudimentary level, infringement presupposes the ability to say ‘this is mine’. This article sets out to reveal the mutability of biological patents. It is my claim that this lack of stability signifies something other than judicial oversight. We cannot, in other words, expect the courts to hold fixed the identity of biological patents; to create stability in these otherwise unwieldy objects – or, at least, we cannot expect this and still patent biological artifacts. As argued: biotechnology patents require a degree of flexibility in the ‘thing’ they are said to protect because biotechnologies are by their very nature ontologically mutable. Not unlike earlier patented forms (what are sometimes called ‘classic’ forms of intellectual property [e.g. mouse traps, light bulbs, etc.]) (see e.g. De Laet and Mol, 2000), the stability of biotech patents is produced. Yet, unlike conventional patented forms, the ‘thing’ produced with regard to biotech patents retains a significant degree of flexibility to it, which is why, at least in part, there has been so much activity in the courts in recent years over just what constitutes patent infringement. The article begins by speaking to how patent law works to stabilize biological inventions; how it works, in other words, to create the illusion of an immutable, ontologically independent object. This socio-legal maneuver is necessary if these objects are to be distinguished from the unwieldy (and thus unpatentable) realm of the natural world. I then speak to how biotechnological artifacts – particularly those of the self-reproducing sort – continue to thwart this object-ivity process. Pointing to a variety of different examples, I show how biological patents do not speak to a specific ‘thing’. Illustrating this, I argue that such ontological flexibility is essential for the existence of the current socio-legal biotechnological regime. Yet this flexibility also leads to legal rulings that create highly asymmetrical property and power relations between farmers and global capital. The article concludes by discussing some of these asymmetrical relations. In particular, attention is given to how biotechnology – precisely because of the ontological fluidity granted by the courts to these object/s – cuts into more conventional property forms.



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Towards an Ontologically Independent Biotechnological ‘Object’ The US Patent Act of 1790 states explicitly the requirement of ‘disclosure’: ‘[A patent would be voided if written specifications] did not contain the whole of the truth concerning its invention or discovery’ (US Patent Act of 1790, Sec. 6). The disclosure requirement specifies a thorough explanation of the invention in question, whereby anyone ‘skilled in the art’, upon reading the patent application, could replicate and operate the artifact in question. The detail required of patent applications today is a far cry from those under earlier patent regimes. For example, when Galileo was granted a patent in 1594 for a water pump his description of the invention involved only one sentence: ‘[the pump will] raise water and irrigate land, [and] with the work of a single horse it will keep twenty water spouts connected to it going at the same time’ (as quoted in Biagioli, 2006: 1132). Conversely, as Biagioli (2006: 1140) explains: . . . [a]nyone who looks at a modern patent is likely to be struck by its remarkably contrived language and stylized drawings – genres that are now codified in the Manual of Patent Examination Procedure (MPEP) – the multi-volume reference text issued by the U.S. Patent and Trademark Office and followed by both patent examiners and attorneys. Just the rules for patent drawings – down to the kind of ink to be used – fill several pages.

There are multiple reasons for this shift towards heightened specificity within patent applications. Some scholars point to how the disclosure requirement acts as an important counterbalance to the 20-year monopoly conferred when a patent is issued (Eisenberg, 2002). In doing this, disclosure serves as part of an exchange between the inventor and the public: the former receives protections for her invention; the latter is given access to the idea. As indicated earlier, specificity also makes possible the policing of patents. Without a detailed map of your property the law cannot protect you from trespassers. The elaborate documentation found in today’s patent applications is said to be necessary to accurately spell out just what is and is not ‘the invention’, which in turn allows for the monitoring (and enforcement) of those boundaries (Cambrosio and Keating, 1995). Less acknowledged, however, is the ontological function served by the disclosure requirement. To reduce something to written form presupposes that there is something to specify. Such reductionism is necessary under conditions of capitalism, where a stable, unchanging, immutable object goes hand in hand with commodification (Bakker, 2007; McAfee, 2003). Without specificity, an artifact has little economic value. Without specificity there is no ‘it’. And without an ‘it’ there is no-thing to exchange, sell and/or protect from misuse. The work that goes into making ‘things’ has been described in many ways – from the art of separation (Walzer, 1984), to purification (Latour, Downloaded from http://tcs.sagepub.com at COLORADO STATE UNIV LIBRARIES on March 5, 2010



1993), economic and methodological reductionism (McAfee, 2003), and cutting the network (Strathern, 1996). The disclosure requirement – in reducing ‘the’ invention to a stable written form – is one mechanism by which inventions are ‘cut’ from their socio-material milieu. Yet, with biological patents, more work is needed. Unlike so-called classic intellectual property, which at least has the appearance of a non-problematic ‘it-ness’ (e.g. a mouse trap), self reproducing inventions, which, for instance, require inputs, produce outputs and (in some cases at least) sexually reproduce (e.g. genetically modified [GM] maize), do not lend themselves as easily to the ontological requirements of capitalism. Among such artifacts, ‘it-ness’ only comes after still further acts of purification. Yet, even then this ‘it-ness remains tenuous. Patentable subject matter is statutorily defined. And for a long time, certain artifacts – deemed ‘products of nature’ – could not be patented. These natural artifacts were deemed not sufficiently novel (novelty is a key requirement of patent law). Yet novelty is but an analytic state created by way of ‘cuts’ that separate the claimed invention from nature. When something is deemed part of nature it becomes an effect of complex forces – ecological, thermodynamic, evolutionary, etc. – and not the product of any one person (the doctrine of the original inventor, which dates back to the 1836 US Patent Act, states that patents can only be granted to ‘the original and first inventor’) (Carolan, 2008). A number of years would pass before patent law looked upon such objects as patentable subject matter. How this (ontological) interdependence slowly turned into (ontological) independence is a story that deserves some attention. Creating Biological ‘Things’ In Ex parte Latimer, the Commissioner of Patents rejected a claim on a fiber made out of Southern Pine. This fiber had been: ‘eliminated in full lengths from the silicious, resinous, and pulpy part of the pine needles [of Southern Pine] and subdivided into long, pliant filaments adapted to be spun and woven’ (1889 Comm’r Dec., pp. 123–4). Rejecting the patent, the Commissioner emphasized the naturalness of the fiber. In doing this, he likened Latimer’s invention to ‘wheat which has been cut by a reaper or by some new method of reaping’ as well as to a middle ear bone that had been removed ‘in its natural condition’ (1889 Comm’r Dec., pp. 126–7). The Commissioner argued that Latimer’s discovery of this ‘natural product’ (1889 Comm’r Dec., p. 127) did not entitle him to patent protections ‘any more than to find a new gem or jewel in the earth would entitle the discoverer to patent all gems which should be subsequently found’ (1889 Comm’r Dec., p. 127). The Commissioner also raised concerns over what might happen if the patent were granted, noting that other ‘patents might be obtained upon the trees of the forest and the plants of the earth’ (1889 Comm’r Dec., pp. 125–6). Thus, while ‘the alleged invention is unquestionably very valuable’ and of ‘immense value to the people of the country [. . .] the invention resides, I am compelled to say, exclusively in the process and Downloaded from http://tcs.sagepub.com at COLORADO STATE UNIV LIBRARIES on March 5, 2010


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not at all in the product’ (1889 Comm’r Dec., p. 127). And so was born the ‘product of nature doctrine’. An 1895 ruling echoed that of Ex parte Latimer. In the case of Hoyt et al. v. J.T. Lovett Co. two nurserymen (James Hoyt and Edwin Hoyt) sued the J.T. Lovett Nursery for selling a grape that had been found in the Green Mountains of Vermont. The Hoyts thought they had purchased the exclusive rights to the grape and had trademarked it as the ‘Green Mountain Grape’. Ultimately, the court ruled against the Hoyts, arguing: The Hoyts did not make the Green Mountain vine, nor, strictly speaking, did they produce it. It grew out of the earth, was fashioned by nature, and endowed with powers and qualities which no human ingenuity or skill could create or imitate. If such protection as that now claimed by the complainants was allowed, a breeder of cattle could with equal propriety and reason demand like protection for the natural increase of his herd. In every aspect such claims would seem to be impracticable and inequitable. (Hoyt et al. v. J.T. Lovett Co., Circuit Court of Appeals, Third Circuit, 71 F.173, 3 Dec. 1895)

One last example of case law evoking the product of nature doctrine is Funk Brothers Seed Co. vs. Kalo Inoculant Co. (1948). This case involves the alleged infringement of a mixed culture of Rhizobia capable of inoculating the seeds of plants belonging to several cross-inoculation groups. In the end, the Supreme Court invalidated the patent then held on the seed inoculating bacteria. In the words of Justice Douglas: [P]atents cannot be issued for the discovery of the phenomena of nature. The qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of the laws of nature, free to all men and reserved exclusively to none. (Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 US 127, 130 [1948])

It is interesting to note that there is no statutory foundation for the product of nature doctrine; nothing, that is, has been expressed by Congress about the patentability of products of nature, nor has Congress stepped in to define just what ‘nature’ is. Consequently, in the words of Gipstein (2002: 2): ‘the precise foundation for the general unpatentability of a product of nature remains somewhat ambiguous’. It is helpful to think of this doctrine as outlining a specific ontological requirement for patentability that deals with issues other than whether something is an artifact of nature. Less concerned about whether something really is natural – recognizing that such an identity is but a social construction – the product of nature doctrine can thus be understood as laying out a negative ontological requirement. That is, what really matters is what the claimed invention is not. And what it cannot be is an unwieldy, unpurified (in the Latourian sense), interdependent hybrid-object. Downloaded from http://tcs.sagepub.com at COLORADO STATE UNIV LIBRARIES on March 5, 2010



The product of nature doctrine was as much an artifact of the scientific knowledge of the time as it was a product of legal reasoning. As mentioned, a property right is only valuable if it can be enforced. The first step towards enforcement is the ability to specify the identity of the property. While easy to accomplish with a tract of land, specifying the identity of a living organism was long considered problematic, given the lack of knowledge about biological identity (e.g. blood types, DNA, etc.) (Kevles, 2007). The identity-specifying analytic tools born out of the so-called genetic revolution were not yet available to 19th and early 20th century scientists/inventors/judges. This therefore left patent law ill-equipped to see ontologically independent ‘objects’ when it looked at biological artifacts, even those altered by human hands. Over time, however, these discrete, stable objects slowly came into view. Widely regarded as a pivotal moment in patent law (Conley and Makowski, 2003), an opinion penned by famed Judge Learned Hand in Parke-Davis & Co. v. H.K. Mulford & Co. (1911) lays the foundation for the so-called ‘purification exception’. Parke-Davis centered on a pure form of adrenaline that was patented in 1900. Specifically, the patentee (Takamine) took the salt form of adrenaline, which is the form naturally found in the suprarenal gland, and chemically converted it into a base. Takamine created, in other words, a purified form of adrenaline. Learned Hand upheld the patent, noting: [T]he base was an original production of Takamine’s. That was a distinction not in degree, but in kind. But, even if it were merely an extracted product without change, there is no rule that such products are not patentable. Takamine was the first to make it available for any use by removing it from the other gland-tissue in which it was found, and, while it is of course possible logically to call this a purification of the principle, it became for every practical purpose a new thing commercially and therapeutically. (ParkeDavis, 189 F. at 103)

Note Hand’s assertion that Takamine’s invention deals with a substance that is different ‘not in degree, but in kind’. To call something different in kind is to give it an alternative ontological identity from its natural counterpart. The natural counterpart: a product of nature. The patented artifact in question: a product of Takamine’s own creative genius. The former: sees only (unwieldy) natural connections – what is. The latter: sees only the purifying act performed by Takamine – what is not. And so was made available a powerful analytic mechanism to create isolated ‘things’ in patent law, even among those artifacts initially believed to be unspecifiable. Evidence of the continued use of the purification doctrine to give otherwise unwieldy artifacts a more object-ive identity is easy to find. Another early opinion that relies upon the analytic device of purification is a 1948 ruling by the Court of Customs and Patent Appeals (CCPA). In In re Williams, the CCPA reversed a decision by the Patent Office to reject an Downloaded from http://tcs.sagepub.com at COLORADO STATE UNIV LIBRARIES on March 5, 2010


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application for a patent on the chemical lactone. Here, the CCPA concluded that the purification of a substance offered sufficient grounds for overstepping the product of nature doctrine: ‘A pure compound may, under certain conditions, be patentable over the same compound in an impure form’ (80 USPQ 150 [CCPA 1948], p. 151). Or take the 1958 case of Merck and Co. v. Olin Mathieson Chemical Corp. This case centered on the alleged patent infringement on a vitamin B-12 compound. To develop this compound, Merck isolated a crystalline substance from several species of microorganisms found in the livers of cattle. The district court agreed with the defendant by finding the patent invalid under the product of nature doctrine, citing how the compound in question was identical to that which already exists naturally in cattle livers (Conley and Makowski, 2003). The Fourth Circuit, however, upheld the patent, finding the product in question to be ‘far from the premise of the [product of nature] principle’ (16 USPQ 484 [4th Cir. 1958], p. 489). In its ruling, the court noted that before Merck had invented this composition ‘there were no such B12 active compositions. No one had produced even a comparable product. The active substance was unidentified and unknown’ (16 USPQ 484 [4th Cir. 1958], p. 488). Evoking language similar to that expressed approximately 50 years earlier by Learned Hand, the court further reasoned that this new substance was not different ‘merely in degree’ from that found in nature, which represents ‘complete uselessness’ (16 USPQ 484 [4th Cir. 1958], p. 490). Rather, the court argued that the vitamin B-12 compound in question was different ‘in kind’ (16 USPQ 484 [4th Cir. 1958], p. 490). Yet the most important opinion on the subject was not offered until 1980 in the in/famous US Supreme Court ruling of Diamond v. Chakrabarty. In 1972, Ananda Chakrabarty, a biochemist for General Electric Company, filed a patent for a bacterium that had been genetically altered to consume oil slicks. Initially, Chakrabarty’s patent application was denied for reasons relating to the product of nature doctrine. Later, patent rejection centered on the point that the bacteria in question were alive. Another important case was also making its way through the courts at this time. The Bergy case deserves mention for the precedent it set on the subject of the patentability of living organisms; a precedent that eventually came to play a role in the Chakrabarty case. Malcolm Bergy was a scientist at Upjohn Company who had developed a process for purifying a strain of a newly discovered fungus whose metabolic chemistry generated an antibiotic (Kevles, 2002). Eventually, Bergy’s patent application on this fungus was heard by the Court of Customs and Patent Appeals in 1977. The issue ultimately to be decided in this case was whether or not living organisms qualified for patent protection. In the end, the court – in a three to two ruling – sided with Bergy. In the majority opinion, it was argued that the biological material in question ‘was more akin to inanimate chemical compositions such as reactants, regents, and catalysts than they are to horses and honeybees or Downloaded from http://tcs.sagepub.com at COLORADO STATE UNIV LIBRARIES on March 5, 2010



raspberries and roses’ (In re Bergy, 563 F.2d 1031, 195 USPQ [BNA] 344 [CCPA 1977], p. 1037). Indeed, the court found the question as to whether or not material is ‘alive is a distinction without legal significance’, noting that such ethical questions are outside the bounds of patent law and thus represent issues ‘not before us’ (563 F.2d 1031, 195 USPQ [BNA] 344 [CCPA 1977], p. 1038). The life/nature-is-nothing-more-than-chemistry argument was apparently convincing, for in 1979 the Court of Customs and Patent Appeals made a similar argument when it ruled in favor of Chakrabarty. Specifically, the court argued that it could find ‘no legally significant difference between active chemicals which are classified as “dead” and organisms used for their chemical reactions which take place because they are “alive”’ (Kevles, 2002: 28). This likewise became a popular argument among the numerous amici that were eventually filed in support of Chakrabarty in preparation for the US Supreme Court. The University of California, for example, explained in its amicus brief that the distinction between living and dead matter is ‘well-nigh imperceptible’, which therefore makes it impossible to draw ‘a bright line between life and its absence’ (Kevles, 2002: 26–7). In the end, the Supreme Court granted Chakrabarty his patent claims in a five to four vote. The court ruled that the bacterium was human-made, that it was a new composition of matter, and, finally, that whether an invention is alive is not a legitimate legal question. In supporting its ruling, the Court wrote the now famous passage that explains the virtually limitless subject matter potentially eligible for patent protection (provided such criteria as novelty, non-obviousness, etc. are met): The Patent Act of 1793, originally authored by Thomas Jefferson, defined statutory subject matter as ‘any new and useful art, machine, manufacture, or composition of matter, or any new or useful improvement.’ [. . .] In 1952, when the patent laws were recodified, Congress replaced the word ‘art’ with ‘process,’ but otherwise left Jefferson’s language intact. The Committee Reports accompanying the 1952 Act inform us that Congress intended the statutory subject to include anything under the sun that is made by man. (447 US 303 [1980], pp. 308–9; my emphasis)

By the latter decades of the 20th century, the analytic tools were in place to cut the biological world up into little pieces. As indicated above, by the 1970s patent law had effectively reduced biological artifacts to chemical processes (and chemical processes have long been considered patentable subject matter). While no molecular biologist actually believes biology is just chemistry – an argument Richard Lewontin (2000) famously makes in his book The Triple Helix – it is this very view of reality that underlies biotechnology patents. In patent law, the fundamental unwieldiness of these artifacts is denied, leaving only discrete, isolated bits of reality to claim ownership over (e.g. chemicals, DNA, etc.). And if one can establish that these bits of reality were made at the hands of man/women – a Downloaded from http://tcs.sagepub.com at COLORADO STATE UNIV LIBRARIES on March 5, 2010


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threshold easily overcome if ‘purification’ is documented – then ‘anything under the sun’ is eligible for patent protection.1 Judicial Gerrymandering The mutability of invented ‘objects’ is nothing new. An exemplary piece of research illustrating this comes from De Laet and Mol (2000), where they speak to the fluidity of the Zimbabwe Bush Pump. In their article, the authors discuss how the boundaries of this technology – in terms of what a ‘working’ Zimbabwe Bush Pump is – change over time and space. In their own words: The Zimbabwe Bush Pump is solid and mechanical and yet, or so we will argue, its boundaries are vague and moving, rather than being clear or fixed. Likewise, the question as to whether or not the Bush Pump actually works, as technologies are supposed to, can only rarely be answered with a clearcut ‘yes’ or ‘no’. Instead, there are many grades and shades of ‘working’; there are adaptations and variants. (De Laet and Mol, 2000: 225)

While the pump may have a core of stability (e.g. in all uses water is pumped), the point of the authors is to highlight its fundamental fluidity. Less an object of immutability, the water pump is best understood as a mutable mobile – something that fundamentally is in continual flux. And others have reached similar conclusions about the ‘things’ of this world. Annemarie Mol (2002) describes the mutability of lower limb atherosclerosis, where the ontological identity of this particular form of heart disease is in part an effect of the actors and actants involved in the relation. Law and Singleton (2005) arrive at a similar finding about alcoholic liver disease. Rather than pointing to differing perspectives of the same object, these cases highlight the enactment of different objects that emerge out of differing relational contexts. So what does this have to do with patents? One goal of the previous section was to illustrate the long road taken by biological patents. As detailed, the ‘it-ness’ of biological patents did not occur overnight. The creation of these ontologically independent, stable objects required the making of important cuts that only became available to legal scholars and scientists in the 20th century. These analytic divisions presented themselves with advances in knowledge about biological identity, such as blood types, DNA and Mendel’s insights concerning genetic transmission. Yet the cuts made were not decisive. While biological patents are still believed to deal only with ‘things’, a closer inspection reveals a multiplicity that threatens to undermine today’s biotechnology regime. Patents as Materiality and Information At the time of the in/famous Diamond v. Chakrabarty ruling, biotechnology was largely directed at cloning genes or engineering novel entities. While these practices are still occurring, increasing amounts of capital are now Downloaded from http://tcs.sagepub.com at COLORADO STATE UNIV LIBRARIES on March 5, 2010



being directed at, for example, large-scale high-throughput sequences of entire genomes and express sequence tags (EST). While Chakrabarty’s bacterium appeared unproblematically ‘thing-like’ in character, the identity of many of today’s biotechnological artifacts is far less clear. Are patents for EST, for example, pointing to a material object or are they directed at the protection of information? The growing interest in bioinformatics, which represents the merging of biology, computer science and information technology, suggests the growing role that information is playing in many of today’s patents. Yet this severely undercuts the argument within patent law, as discussed previously, that DNA-based technology is chemistry by another means. As Thacker (2005) describes in detail, the computer, networks, databases and gene-finding algorithms are the new tools of genomics. And the information uncovered when these techniques and technologies are used to peer into DNA has tremendous social utility. Yet this poses problems for patent law. Patentable subject matter is statutorily defined as ‘any new and useful process, machine, manufacture or composition of matter’ (35 USC § 101). Nowhere in the statute is ‘information’ mentioned as patentable subject matter. In fact, prior judicial decisions have set information outside the bounds of what the patent system can protect. For example, in Diamond v. Chakrabarty, the Court concluded the following: The laws of nature, physical phenomena, and abstract ideas have been held not patentable. [. . .] Einstein could not patent his celebrated law that E = mc2; nor could Newton have patented the law of gravity. Such discoveries are ‘manifestations of [. . .] nature, free to all men [sic] and reserved exclusively to none.’ (447 US 303 [1980], p. 309)

This legal reasoning was repeated in Dickey-John Corp. v. International Tapetronics Corp.: Yet patent law has never been the domain of the abstract – one cannot patent the very discoveries which make the greatest contributions to human knowledge, such as Einstein’s discovery of the photoelectric effect. [. . .] Patent law’s domain has always been the application of the great discoveries of the human intellect to the mundane problems of everyday existence. (710 F.2d 329 [7th Cir. 1983])

Patent law is thus quite clear that laws of nature are fundamentally unpatentable phenomena. Yet this begs an important question: is genetic information the same as a law of nature? Philosophers of science and sociologists of scientific knowledge have long documented how so-called ‘laws’ of nature are in fact contingent upon a host of social variables (Collins and Pinch, 1993; Kuhn, 1970 [1962]; Mulkay, 1976). Indeed, the very idea of a law of nature is an example of what is known as ‘boundary work’ (Gieryn, 1983; Jasanoff, 1987). Usually, boundary work speaks to how discourse is used to uphold distinctions between, say, science and policy or types of Downloaded from http://tcs.sagepub.com at COLORADO STATE UNIV LIBRARIES on March 5, 2010


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knowledge (e.g. sound science and junk science). In the case of patent law, too, the courts appear to be engaging in a type of boundary work. Yet in this case the desired effect is to create a boundary between the seemingly placeless and timeless information of E = mc2 and the contextual information held within sequences of As, Ts, Cs and Gs.2 A further case of boundary work lies in the fact that the courts have yet to speak to why a silicon-based medium (e.g. data bank) and a molecular medium (e.g. DNA) should be viewed as fundamentally different phenomena (Eisenberg, 2000). In this case, the boundary work lies not in actively creating a distinction between the two, as in the case of laws of nature, where the courts have given examples to draw a line in the legal sand regarding what these phenomena ought to look like. Rather, not speaking to why these media differ suggests that the courts believe the distinction to be self-evident and thus unworthy of any articulation – a particularly powerful form of boundary work because it does not even provide discursive space for a challenge. The courts have already established that DNA sequence information stored in an electronic medium cannot be patented (Eisenberg, 2002). So what makes information stored in DNA any different? Indeed, the recent rise of DNA chips, DNA detection systems and in silico screening methods make the distinction between computer technology and DNA technology a particularly difficult one to justify (perhaps this is why the courts to date have evaded the question entirely). It is not my intent to argue that today’s biotechnology patents deal exclusively with either matter or information. Indeed, a convincing argument can be made that their identity is inextricably both (see e.g. Thacker, 2005; Zweiger, 2001). Biotechnologies can at one moment refer to a material object or objects and at another speak to information, which, again, speaks to an aspect of their fundamental mutability. When the relational context of a biological patent includes the courts, patent officials and attorneys, the ‘it’ looks largely material (given the requirements of patent law). In other contexts, however, the ‘it’ appears decidedly more informational. In 2001, for example, Myriad Genetics was granted a European patent related to the BRCA1 breast cancer gene. The patent covers all methods for diagnosing breast cancer by comparing a patient’s BRCA1 gene with the BRCA1 gene sequence patented by Myriad. As a diagnostic tool, then, the test works by comparing these two banks of information, by evaluating the information held in the patient’s BRCA1 gene in relation to the information within the patented BRCA1 gene (Andrews, 2002; Benowitz, 2002). Nor do I suggest that the ‘thing’ changes only as we move across social worlds, from, say, the courtroom to the boardroom. Even within the same social world of patent law we find the identity of biological patents to be fluid. While patent law works to maintain the fiction of an autonomous invention (Purdham, 2007), the purification process of biotechnological artifacts is incomplete. The hybridity of these artifacts, for example, Downloaded from http://tcs.sagepub.com at COLORADO STATE UNIV LIBRARIES on March 5, 2010



continues to come through in discussions over whether certain biotechnologies are fundamentally material or informational in character (Doll, 1998; Eisenberg, 2006). Yet issues of mutability go beyond the matter versus information debate. I now briefly discuss the highly publicized case of Monsanto Canada, Inc. v. Percy Schmeiser (2004), which provides yet another example where the patented ‘thing’ appears to shift from one context to the next. The Courts: Allowing Some Ontological Give (But Not Too Much) This case deals specifically with Monsanto and their ‘Roundup Ready’ technology (which refers to plants that have been engineered to be resistant to the herbicide glyphosate [better known as Roundup]). The case in question centers on Percy Schmeiser, a farmer from Saskatchewan, Canada. Schmeiser discovered Roundup Ready plants in his field and in an adjoining ditch after finding that some canola plants survived repeated spraying of this herbicide. Following an anonymous tip (which turned out to be from an individual in dispute with Schmeiser’s son who would not rent land to this individual [Muller, 2006]), Monsanto brought a suit of patent infringement against Schmeiser. The case was eventually heard by the Supreme Court of Canada. In a five to four decision in favor of Monsanto, the Court affirmed a lower court’s ruling finding that infringement did take place. A key legal question hinged on establishing the ‘thing’ protected by Monsanto’s patent on Roundup Ready canola. The patent itself appears centrally focused on genes. The following are some representative sentences from the patent: A chimeric gene which is expressed in plant cells comprising a promoter from a cauliflower mosaic virus, said promoter selected from the group consisting of a CaMV (35S) promoter isolated from CaMV protein-encoding DNA sequences and a CaMV (19S) promoter isolated from CaMV protein-encoding DNA sequences, and a structural sequence which is heterologous with respect to the promoter.

And: A plant cell which comprises a chimeric gene that contains a promoter from cauliflower mosaic virus, said promoter selected from the group consisting of a CaMV (35S) promoter and a CaMV (19S) promoter, wherein said promoter is isolated from CaMV protein-encoding DNA sequences, and a structural sequence which is heterologous with respect to the promoter.

It is also important to note that organisms do not qualify as patentable subject matter under the Canadian Patent Act. This restriction was the result of a 2002 decision, when the Supreme Court of Canada ruled by a five to four decision to deny Harvard College a patent over its oncomouse (a mouse that had been genetically engineered to develop cancer). One might think, therefore, that Monsanto’s patent on Roundup Ready canola could only be for the specific genes described in the patent application. Downloaded from http://tcs.sagepub.com at COLORADO STATE UNIV LIBRARIES on March 5, 2010


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Statutorily speaking, the patent could not be directed at anything else. The Court, however, came to a different conclusion concerning the ‘thing’ being protected by the patent. In its opinion, the majority came to an interesting conclusion: they likened plant cells to Lego blocks. This, in turn, allowed them to redefine the patent to include exactly what was excluded as patentable subject matter in the Harvard College v. Canada case: an organism – specifically, the GM canola plant. For the Court, if a patent applies to cells or genes then those protections must be granted to the whole organism within which said property resides. Note specifically how the Court maintains a reductionist stance – the cut-up view of reality so important to patent law – to justify the granting of property rights to an entire organism: [B]y analogy, then, the law holds that a defendant infringes upon a patent when the defendant manufactures, seeks to use, or uses a patented part that is contained within something that is not patented. [. . .] [T]he patented genes are not merely a ‘part’ of the plant; rather, the patented genes are present throughout the genetically modified plant. [. . .] In that sense, the cells are somewhat analogous to Lego blocks: if an infringing use were alleged in building a structure with patented Lego block, it would be no bar to a finding of infringement that only the blocks were patented and not the entire structure. (Monsanto Canada, Inc. v. Percy Schmeiser [2004] SCC 34, Per MacLachlin CJ and Major, Binnie, Deschamps and Fish JJ, para. 42)

We therefore have a patent that makes claims to one ‘thing’ (genes) and a court ruling that stakes out property rights around another ‘thing’ (canola plant). This brings me back to a point made early in the article: that the courts cannot ‘fix’ the identity of biological patents without undermining their very existence. The purification exclusion, disclosure requirement, specificity – all work to create discrete, stable and therefore commodifiable objects. Yet commodification presupposes hybridity. In other words, when an invention is commodified it immediately becomes part of a very messy network. There are no purified sequences of DNA in the world of genetic testing; no isolated protein-encoding DNA sequences in a field of engineered canola plants. For instance, had the Court in the Schmeiser case given protection only to that disclosed in Monsanto’s patent, given that Schmeiser possessed nothing that looked like that described in the patent application, it could not have ruled in favor of Monsanto. To ‘fix’ the identity of these objects would therefore greatly reduce the protection offered through – and thus the incentive to seek out – biological patents. It might therefore be useful to think of biological patents as fluid objects, in that their ontological identity ‘flows and gently changes shape, bit by bit’ (Law and Singleton, 2005: 338). As detailed, self-replicating intellectual property, at least under the current patent regime, demands a degree of interpretive flexibility. Without this mutability, biotechnology patents would likely not continue to exist. Yet, conversely, too much flexibility would also threaten the patent regime. If the courts provided too much ‘give’ to Downloaded from http://tcs.sagepub.com at COLORADO STATE UNIV LIBRARIES on March 5, 2010



these artifacts they risk becoming clearly no longer ‘the same’ to a majority of the public (which could ultimately undermine the entire legal system). In this vein, it is interesting just how far these patented objects can change and still remain ‘the same’. A patented bundle of protein-encoding DNA sequences, a seed sold by Monsanto, a canola plant grown by Percy Schmeiser, the seeds of a canola plant grown by Percy Schmeiser – all rendered by patent law as ‘the same’.3 Do Artifacts Have Law? This article has sought to illustrate (1) how patent law creates discrete, immutable biological ‘things’ to patent and (2) the fundamental mutability of those ‘things’. Questions pertaining to the ontological identity of biological patents are important. I have already discussed how the ontological fluidity (but not too much) of biotech patents is necessary for the existence of today’s biotechnology regime. Not yet discussed, however, is how this mutability is playing into the perpetuation of certain inequalities, particularly between holders of various property forms. The mutability of biotechnology serves the interests of patentees, for it allows their patent to be many different ‘things’. Not all property forms, however, have the ability to shift ontological identities as readily in the eyes of property law. Indeed, compared to the fluidity allowed in patent law, classic property law demands far more immutability from its forms (just imagine, for instance, what would happen if the ontological boundaries of land changed from surveyor to surveyor). Consequently, maintaining the fluidity of biotech patents often means that those aforementioned cuts made by the courts are cutting into someone else’s property relation. The case of Monsanto Canada, Inc. v. Percy Schmeiser (see also Hoffman v. Monsanto [2005]), for example, established a tacit hierarchy between property types: namely, between self-reproducing intellectual property (GM canola) and classic property (Percy Schmeiser’s crop and land). British common law had for centuries ruled that a landowner can claim ownership over anything that came onto their land, including the offspring of a stray bull that manages to impregnate a farmer’s cow, what is referred to as stray bull cases or the law of stray animals. Yet, when dealing within GM drift – which, on the face of it, seems little different from the genetic drift that occurs when a stray bull comes onto another’s land and impregnates their cow – the intellectual property relation is given greater significance than the classic property relation. Robert Nozick, in Anarchy, State and Utopia (1974), asks if, when he dumps a can of tomato soup in the Pacific Ocean, he acquires ownership over the ocean (having mixed his tomato soup with it) or merely loses the soup. One need not attend law school to know the answer: the soup is lost and no property claim can be made over the entire ocean. Yet when similar mixing occurs in, say, a field between non-GM and GM varieties of canola – resulting in a crop that contains a significant portion of the latter – the courts have arrived at a different conclusion. Specifically, the ocean of Downloaded from http://tcs.sagepub.com at COLORADO STATE UNIV LIBRARIES on March 5, 2010


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canola held in that field becomes the property of Monsanto, to which the farmer must pay a licensing fee. This is one of the social costs to courts’ ontological gerrymandering when it comes to interpreting ‘the’ subject of GM patents: in allowing this flexibility they are cutting into other property forms, thereby making them part of ‘the’ patent. I therefore predict that legal conflicts over biotechnology will only increase in the years to come. As biotech patents continue to speak in material terms (to satisfy patentability requirements; see e.g. 35 USC § 101), only to create, in practice, a property relation over information, the courts will further struggle in their boundary efforts to maintain this fictitious dichotomy. Similarly, as the courts maintain their tacit embrace of a hierarchy of property forms, all in an attempt to make a fundamentally unwieldy artifact appear ‘the same’ from one context to the next, rulings on infringement cases will likely only grow in their absurdity (e.g. the aforementioned Lego block analogy could quite easily be extended to grant Monsanto ownership over, say, so-called ‘super’ weeds and pests in cases where drift had occurred). The argument that ‘artifacts have politics’ (see e.g. Latour, 1992; Law and Mol, 2008; Winner, 1980, 1986) is a familiar one (though it is not without its critics; see e.g. Joerges, 1999; Woolgar and Cooper, 1999). One link that is frequently downplayed within this literature, however, is how artifacts also have law. And perhaps nowhere is this more evident than in biotechnology once we recognize that it is the adventurous nature of genetically engineered object/s – such as seed and pollen – that allows for the aforementioned ‘cutting into’ another’s property. Again: the courts still have to point to some-thing when ruling on cases of infringement (though the thing often varies from ruling to ruling, which further varies from the thing described on the patent application). In an article titled ‘Do Artifacts Have Politics?’, Winner (1980: 122–7) tells a story of the famous early 20th-century political entrepreneur Robert Moses and the low-hanging overpasses leading into the beaches of Long Island. According to Winner, Moses had these overpasses built to a specific height, under which only automobiles could pass. Buses stood too high and could not pass through these overpasses and therefore could not service the beaches. This was done intentionally, Winner claims, because the typical bus-user at the time was African American. In doing this, these overpasses served political ends: they helped keep the beaches of Long Inland a space for the wealthy automobile-owning (read: white) residents of the area. In discussing this example, Winner’s point is this: material artifacts affect and are in effect a type of politics. In his own words: [T]he devices, techniques, and systems we adopt shed their tool-like qualities to become part of our very humanity. [. . .] In a trivial sense it is true, for example, that ‘You can always turn off your television set.’ But given how central television has become to the content of everyday life, how it has become the accustomed topic of conversation in workplaces, schools, and



Carolan – The Mutability of Biotechnology Patents 125 other social gatherings, it is apparent that television is a phenomenon that, in the larger sense, cannot be ‘turned off’ at all’. (Winner, 1986: 12)

‘Things’ can thus take on a law-like quality, which gives them as much force – and perhaps more in some cases – as law itself. For example, Moses’ overpasses worked like a de facto ‘whites only’ segregationist policy on Long Island beaches, when cars were overwhelmingly driven by those of European descent. But what does this have to do with the mutability of biotechnology and biotechnology patents? When one looks at technology as actively shaping the social landscape – rather than as something dead, inert and politically inconsequential – the ‘age-old political questions about membership, power, authority, order, freedom, and justice’ repeatedly appear and beg to be addressed (Winner, 1986: 47). When talking about today’s complex technologies – such as biotechnology – membership in the decision- (and design-)making processes is anything but ‘democratic’ (Wynne, 2005). If we can accept the premise that material artifacts do/can have politics and law, then we have a responsibility to address the following point: who should be involved in decisions that pertain to the design of these artifacts which have the force of quasi legislators and judges? As Winner (1986) explains, disappearing are definitions of membership in this decision-making process that hinge on broad understandings of ‘citizenship’. Instead, ‘participation’ is increasingly decided by one’s level of technological expertise (Jasanoff, 2003; Wynne, 2005). Recognizing that artifacts have politics and law thus forces us to rethink the research into and design of today’s technologies, particularly in regard to who is involved in this process. Winner (1986: 17) notes that technology must be understood not simply as ‘tools we use’ but as ‘forms of life’: it not only functionally injects itself into almost all aspects of life but also plays a considerable role in shaping who we are and how we live (Tatum, 1995: 22). As this article details, a genetically engineered artifact, as a consequence of its fundamental unwieldiness – recognizing that we are still talking about biotechnology – is never just one ‘thing’. Its ability to transgress borders – from fence rows to property lines and species boundaries – is part of its ontological identity. In doing this, biotechnology can be immensely consequential to who we are and how we live. Thus, rather than attempt to erase or mask this mutability – since the former is impossible and the latter will only lead to even more perverse (and inequitable) legal rulings – we would do well to rethink the design and development of today’s biotechnological artifacts. For expanding who takes part in the decision-making processes of agricultural artifacts – and I am talking here about both biotech and more conventional technological forms – will radically alter what is ultimately produced and the social and environmental impacts encountered. In conclusion, this article seeks to add another layer of sociological understanding to the subject of biotechnology. While a popular topic among social scientists (e.g. Buttel, 2005; Kloppenburg, 1988; Schurman, 2004), Downloaded from http://tcs.sagepub.com at COLORADO STATE UNIV LIBRARIES on March 5, 2010


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most scholars have avoided turning their sociological gaze to the specifics of patent law for added insight. While far from the final word on the subject, I have attempted to show how patent law itself makes the current biotechnology regime possible. Without the aforementioned mutability, which allows ‘the’ biotech patent to take on a fluid ontological identity, biotechnology, at least as we currently know it, would not exist. And within this mutability lies an important source of conflict, inequality and injustice. Notes 1. An example indicating the relevancy of the purification exception today is the Jewish Hospital of St Louis v. IDEXX Lab (951 F. Supp. 2 [D. Maine 1996], p. 5), where a patent application was amended to include the phrase ‘essentially purified and isolated’ to satisfy a US Patent and Trademark Office examiner’s objections. 2. Interestingly, the courts repeatedly draw from physics when citing examples of laws of nature (although geometry has been noted on occasion [see e.g. In re Bergy, 596 F. 2d 952, 965 (CCPA 1979)]). Yet, if the courts are of the belief that laws of nature imply immutability they would be mistaken. For example, Newton’s inverse square law of gravity has been shown to have varied since the beginning of the universe (Davies, 1995). Similarly, the so-called ‘fine structure constant’ – or ‘alpha’ (those supposedly unchanging physical properties, like the speed of light and an electron’s charge, which explain how the universe holds together) – has recently been noted as having changed during the past 10 billion years: ‘light may be slowing down, the electron’s charge growing, and atomic nuclei losing mass’ (Choi, 2002: 7). Even the ironclad ‘thermodynamic arrow of time’ is not immune to this dynamism. It has been described – most convincingly by prominent North American physicist Lawrence Schulman (1997, 1999) – as having the potential to slow down, speed up and even, as unbelievable as it may seem, run backwards. 3. More recent still (and within the US court system), the ruling in Monsanto Co. v. David (Fed. Cir. 2008) arrived at similar ontological conclusions. Mr David was found liable for infringing upon Monsanto’s Roundup Ready soybean patent. On appeal, Mr David argued that his actions were not infringing because the patent in question was not directed towards a plant or seed but to a gene. In finding in favor of Monsanto, the Court gave an ontologically fluid reading of this patent. References Andrews, L. (2002) ‘Genes and Patent Policy: Rethinking Intellectual Property Rights’, Nature 3: 803–8. Bakker, K. (2007) ‘The “Commons” Versus the “Commodity”: Alter-globalization, Anti-privatization and the Human Right to Water in the Global South’, Geoforum 39(3): 430–55. Benowitz, S. (2002) ‘French Challenge to BRCA1 Patent Underlies European Discontent’, Journal of National Cancer Institute 94: 80–81. Berg, M. and A. Mol (eds) (1998) Differences in Medicine: Unraveling Practices, Techniques and Bodies. Durham, NC: Duke University Press. Biagioli, M. (2006) ‘Patent Republic: Representing Inventions, Constructing Rights and Authors’, Social Research 73(4): 1129–72. Buttel, F. (2005) ‘The Environmental and Post-environmental Politics of Genetically Modified Crops and Foods’, Environmental Politics 14: 309–23.



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Carolan – The Mutability of Biotechnology Patents 129 Zweiger, G. (2001) Transducing the Genome: Information, Anarchy, and Revolution in the Biomedical Sciences. New York: McGraw-Hill.

Michael S. Carolan is an Associate Professor of Sociology at Colorado State University (CSU). He is currently engaged in three streams of research. One stream, employing conceptual and analytic terms from the sociology of technology literature, examines past, present and future trajectories of biofuels. Another stream, which is reflected in this article, focuses on patent law. Utilizing concepts from the field of Science and Technology Studies, this line of research highlights the work that goes into giving biotechnological artifacts their ‘objective’ qualities (this object-ivity is a requirement for patentability). He is also interested in the relationship between innovation, patents and development. His third stream of research, grounded in the theoretical framework known as embodied realism, details how changing relationships to food and agriculture have changed our understanding of these phenomena. Along these lines, he looks at how spaces like community-supported agriculture and backyard gardens instill within people certain knowledges and understandings that have been lost with the industrialization of the food system. [email: [email protected]]
