Intellectual property rights are a system of governmentality designed to uphold the US’s domestic and international strategic interests

Eva, phD candidate at the University of Sussex. “Intellectual Property and the Genetic Dispositif of Life: The Changing Role of Intellectual Property Law in Governing Participation and Knowledge in the Bioeconomy.” Submitted for the Degree of Doctor of Philosophy University of Sussex, May 2015. Pp 34-38. LJS

Roughly at the same time as the rise of the gene, a new form of intellectual property emerged: the gene patent. This form of intellectual property on information derived from human, plant, animal, or micro-organism genetic materials was highly controversial since its inception in the 1980s, beginning with the patenting of an oildissolving micro-organism (Diamond v. Chakrabarty (1980) 447 U.S. 303). Subsequent very broad patent claims such as the OncoMouse™ raised concerns about the exclusionary effects of this practice, claiming in this case an entire “transgenic non-human mammal all of whose germ cells and somatic cells contain a recombinant activated Onco gene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage” (Jaenichen, McDonell, and Haley Jr. 2002, 8). Further notorious examples consisted of patents applications on basmati rice, traditional indigenous herbal remedies, agricultural seed materials, and also human genetic materials, as for example in the case of the surreptitious patenting of John Moore’s genetic material (Moore v. Board of Regents [1990]). In the unfolding debates about the implications of genetic research and the ownership of genetic materials, the pharmaceutical industry, researchers, philosophers, ‘bioethicists’, patients, IP lawyers, politicians, and national governments all contributed to ethical arguments. These debates resulted in slightly different regional approaches to the regulation of the patentability of human genetic materials, in which in theory every country can establish its own particular regime. However, this changed in 1994 with the introduction of international minimum standards of patentability laid down in the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) as part of the World Trade Organization (WTO). In this treaty, a US model of IP law was implemented worldwide, at the behest of influential US industry interests (Sell 2003). IP has since become a highly charged topic in international negotiations, as these legal standards are mostly perceived to be in the interest of industrial countries, and are widely criticised for their detrimental effects on developing countries – especially in the context of pharmaceuticals and health (Hestermeyer 2007). This chapter presents an evaluation of critiques made of IP’s treatment of genetic conceptions of life, and argues that they are overly focused on the role of IPs within the economy, and do not take into account the wider political dimensions of the emergence of the gene (referred to later as “the genetic dispositif”) and the establishment of exclusive ownership over this knowledge. These dimensions will then be explored throughout the thesis, on the level of contestations over the recognized “truth” of life, of demands for participation and openness voiced by “active patients”, and of critical interventions made upon the international level, seeking to challenge the IP system’s exclusivity in the name of health. This section first briefly explains the legal concepts establishing intellectual property rights especially in the form of patents, and then shows how the national and the international intersect in the IP regime guaranteed by TRIPS. After establishing this background, this chapter then turns to an evaluation of several strands of critiques. 1.1. IPRs in human genetic materials – ‘Inventing’ a commodity Intellectual Property Rights comprise a range of different legal mechanisms for establishing ownership over abstract ‘intellectual’ creations – thus making an abstract idea or invention into a tradeable commodity. Without this, the distribution of knowledge would remain “non-rivalrous”, as knowledge does not diminish when it is distributed, unlike more conventional objects (Boyle 2008, 3). Making commodities out of information derived from ‘life’ pushes the boundaries of intellectual property, as the subsequent discussion shows. In this, the focus of this work rests predominantly on patents, which are the most important means of ‘owning’ information derived from human genetic materials. Copyright is involved in this area to a much more limited extent.4 Patents are the tool that assure ownership over an idea, whereas Copyright is the means by which ownership of a particular way of expressing an idea is established, as for example in a novel or a computer programme (see May 2010, 5). Copyright is not in itself a new invention but rather creative usage of pre-existing concepts such a language. Patents confer a “limited monopoly” on the patentee “in return for the disclosure of technical information” (Bently and Sherman 2009, 335). Patents are usually defined as “a monopoly which is granted for an invention after application to, and examination for patentability by, the Patent Office and lasts for a maximum of 20 years. To be patentable, an invention must be new, show an inventive step, be industrially applicable and not fall into one of the excluded categories of invention” (Colston and Galloway 2010, 4). Most important for IPRs in human genetic materials is the notion of the inventive step, which seeks to ensure that patents are granted for inventions, not discoveries. An invention is the creation of a novel product by a scientist/ inventor, whose creative effort warrants reward (see for example Jasanoff 2012, 165f.). Mere discoveries, on the other hand, are fundamental ‘truths’ that cannot be owned, as this would “inhibit competition and deprive the public of a truth that had always existed, only waiting to be uncovered” (Colston and Galloway 2010, 126; they give an example of the discovery of a new chemical element as one such “truth”). This distinction may seem straightforward at first, but becomes most problematic in the context of human genetic materials, where a determination has to be made whether the human genome or individual genetic sequences constitute a discovery or an invention (see discussion in chapter IV). Even IP’s most basic precondition of the ‘inventive step’ is immersed in debates involving different interests and different interpretations of the truth over life. At stake in these debates is nothing less than the question of IP’s legitimacy in this area – and an entire economy of funding for research. This thesis does not seek to normatively decide this debate, but rather to provide an analytical perspective on debates surrounding parameters of IP that foregrounds contestations about truth contained in technical assumptions such as the inventive step, industrial applicability, or ‘novelty’. Rather than focusing predominantly on the economic role of IPRs in human genetic materials and their making of the commodity, this perspective can account for a wider variety of power exercises surrounding the creation of intellectual property over life – especially IP’s role in the normalization of knowledge and in the management of political challenges emerging from the predominance of genetic conceptions of life. This analysis of the different roles of IP does, however, not seek to argue that IPRs do not fulfill the function of providing commodities. It rather argues against a primary focus on this role, which interprets tensions surrounding IPRs with reference to this role alone. This chapter shows that emphasis on the creation of commodities comes at the expense of a more detailed appreciation of the rise of genetic conceptions of life’s wider political implications – and the way in which this account of life presents problems for governing, negotiated especially in this legal field situated at the intersection of genetic accounts of life and the economy. The economy here becomes a project of government, which puts into place the parameters of the ‘free market’ and regimes such as IPRs, which can be used to ensure the appropriate functioning of this market. Thus, rather than arguing that IPRs are “commodifying life” because of demands of the market, this thesis reverses the analysis on IPRs as a constitutive part of laws governing for the market (see next chapter), arguing that they fulfill more functions in this process than the provision of commodities alone. In this, IPRs contribute to the management of problems for the governing of life while simultaneously maintaining objects for circulation in the economy. 1.2. IP: Connecting the national and international context The establishment of an international IP system built on enforceable minimum standards in the early nineties gave soon rise to fierce criticism and controversy, as later negotiation rounds on WTO treaty amendments showed. The next few decades saw this previously relatively obscure technical area of economic law develop into a hotly debated issue, challenging for example its connection to health concerns and the relative imbalance of interests served by IP. Developing countries succeeded in securing a declaration on the relation between IPRs and public health in the Doha Round of WTO negotiations commencing in 2001, but this declaration fell short of actually introducing new options into the already established system (WTO 2001, see also chapter VI for details of changes that were nonetheless enabled by this declaration). In the field of genetic resources and traditional knowledge, indigenous peoples increasingly challenged the use of IPRs on traditional indigenous knowledge and genetic resources gathered by bioprospecting operations across the globe. Separate treaties were drafted to respond to such concerns, for example the Convention on Biological Diversity (CBD) and its Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (2010), but are still not (to date) endorsed by some of the most important industrialised countries such as the US – which are most in favour of high IP standards and strong enforcement measures. The history of TRIPS and the uneven distribution of IP-producing industries world-wide reveal a very strong interconnection between national and international agendas within the field of IP policy – especially where it comes to the influence of some very powerful industrialised countries such as the US. The standardisation in the field of IP law brought about by TRIPS was heavily influenced by these interests, which also continue to push for more stringent (‘TRIPS Plus’) agreements. As Sell points out, the TRIPS agreement was substantially drafted by a private pressure group called Intellectual Property Committee (IPC), consisting of chief executive officers of pharmaceutical, entertainment and software industries in the US, Europe and Japan (Sell 2003, 2; Tyfield 2008). In the TRIPS agreement’s negotiation, these lobbyists set out to strengthen existing protection measures and succeeded in gaining government support for a highly protectionist new agreement based on already existing IP laws of industrialised countries, thus effectively globalising a previously predominantly national system reflecting the interests of industrialised states (Sell 2003, 2). A similar US-led undertaking can currently be witnessed in the negotiations seeking to introduce TRIPS Plus standards in international agreements such as the Anti-Counterfeiting Trade Agreement (ACTA), the Transpacific Partnership (TPP), and to some extent also in the current negotiations between the US and the EU as part of the Transatlantic Trade and Investment Partnership (TTIP) (Sell 2008; Abbott 2009; UNAIDS 2011; Geist 2010). The biotech sector also traverses national boundaries in a variety of other ways. Biotech companies, for instance, are most likely based within countries with a beneficial IP system. One early high-profile example is deCode Genetics, which set up and ran the Icelandic Biobank – a private corporation formed under US law but with its physical location in Iceland. This is a common occurrence in the biotech sector, where “most biotech companies in the world are given a fictitious Delaware location for legal, tax and patent advantages” (Pálsson and Rabinow 1999, 14). A large proportion of biotech companies are thus actively seeking out the US IP system, which is less restrictive than the European approach especially in the area of human genetic materials. For example, since the Bayh-Dole Act (1980), the US system allowed for IPRs being derived from publicly funded research projects, “[facilitating] the transfer of technology between academe and industry in the United States, and thereby [enabling] rapid commercialization of basic research problems” (Rajan 2012, 2). This gave rise to the “entrepreneurial university” such as Stanford, which gave a “huge spur to the overall commercialization of biotechnology, and specifically to the development of Silicon Valley”, and has “a full-fledged technology-licensing office that focused exclusively on marketing university inventions” (Ibid., 3, this notion of the entrepreneurial university is now also being implemented outside of the US). Generous IP provisions such as these gave rise to an extraordinary influence of the US within the international biotech sector. Beyond this particular expansion of private interests, medical research in general has also become internationalized, as drug trials are increasingly recruiting test subjects from countries in which the population is not already exposed to a large number of pharmaceuticals, trials can be conducted more cheaply, and ethical standards are less strictly enforced (Petryna 2006, 37 and 42). Within this complex intersection of national and international private and public interests, IPRs’ economic role has been analysed from a variety of perspectives, as the next section shows.