Reforms that have the potential to destabilize IP are commodified by biopolitics—private interests and citizens are disciplined towards desired behaviors anyway

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 151-155. LJS

While MRCs’ IP strategies stay within the economic system, their strategic approach to IP management emphasises control and is more flexible and context dependent, as for example the case of a one-dose oral typhoid vaccine shows: “the Trust has funded a company to further develop a proprietary technology for application to a disease area that was not attractive to commercial investors. The Trust has structured the IP management arrangements to encourage the company to exploit Trust-funded research itself, but retains rights to intervene if the IP is not exploited for the benefit of the developing world.” (Wellcome Trust 2006) But the use of IP also highlights that this remains an adjustment within the existing economic system’s parameters, not the introduction of a radical alternative. Patent pools and PPPs are using similar flexible IP management strategies in the sector of global health, addressing the needs of populations in developing countries in particular. 4.2. Patent Pools and Public Private Partnerships – Prioritising global health? Within the sector of global health, new patent pools seek to address public health for the benefit of patients in developing countries, who are usually excluded from pharmaceutical companies’ considerations. Patent pools bring together available patents regarding one particular disease, making information about existing patents accessible and negotiating voluntary or reduced licenses on existing medicines, thus making research and distribution of knowledge in the pharmaceutical sector more effective and flexible - especially where it comes to patents covering pharmaceuticals that are needed in developing countries. In general terms, patent pools address the “anticommons effect” of “the existence of multiple patents, held by multiple patent owners (a patent thicket)” (Verbeure 2009, 3, emphasis added) – but they do not contest the existence of IP in general. In contrast with the situation regarding software patents, “[a] principal argument for patenting biomedical inventions is the fact that typically, post-invention development costs far exceed pre-invention research expenditures, and firms are unable to make this substantial investment without protection from competition” (Ibid., 15). Patent pools seek solutions to the exclusionary effects of IP within existing international economic structures, especially in situations “when the IP rights necessary to arrive at a commercial end product such as a kit for diagnostic testing are held by patentees too numerous or heterogeneous to agree on licensing terms” (Ibid., 15f.). The recently established international Medicines Patent Pool is an example of a single-issue international patent pool focusing on HIV/AIDS medication. Their aim is to “[make] patents work for public health, while giving pharmaceutical innovators compensation for their work” (Medicines Patent Pool 2011).80 Lobbying on behalf of HIV/AIDS patients in developing countries, this patent pool successfully negotiated a range of voluntary licenses with pharmaceutical companies. This may have been particularly successful due to the international focus on HIV/AIDS (see for example Elbe 2005), increasing the pressure on companies to make their treatments available to patients in developing countries in particular. The combination of this pressure with a relative “failure” of the market in developing countries makes a compelling case for voluntary licences in these cases without a significant loss of profits (see next chapter). The use of voluntary licenses by patent pools shows that this approach can only work in specific contexts, limited geographically to mainly least-developed countries. The executive director of the Drugs for Neglected Diseases initiative (DNDi) criticises WIPO’s patent pool Re:Search (WIPO 2012b) because of its limited geographical reach: “it currently aims to improve access to neglected disease medicines in just the 49 least-developed countries, [whereas] he thinks it should aim to increase access for all developing countries” (quoted after Frantz 2012). But many PPPs also use tailored IPRs strategies within geographically limited exemptions granted by the pharmaceutical industry. PPPs have become significant partners of international organisations in the implementation of framework aims in the field of global health, and have specialised on particular diseases and local contexts in the process (see Rushton and Williams 2011). These targeted projects can be very effective but are more difficult to replicate on a larger scale, as the Medicines Patent Pool had to discover. An idea of the sheer number of emerging PPPs can be gleaned from the Health Partnerships Database, which seeks to “systemically [sic.] collect data about a new breed of PPPs coalesced around the health needs of the poor” (ESRC Innogen Centre 2008).81 In the best case, “[t]his relatively new trend in global health cooperation is demonstrating significant possibilities for tackling problems that formerly seemed intractable, particularly those requiring increased research and development (R&D) on drugs and vaccines for diseases disproportionately affecting the poor” (Buse and Waxman 2001, 748). PPPs and Product Development Partnerships (PDPs) make strategic use of IP by deriving income from the products they developed (Brooke et al. 2007, 1757). The licensing regime employed by PPPs can be flexible and take into account the relative economic positions of the licensees – as in the example of the licensing regime of FIND Diagnostics: “When research has the potential to result in an invention (patentable or not), we negotiate with the partner(s) in advance to ensure that the IP rights generated by the project will be managed in such a way that the benefits are passed on to patients in resource poor settings. Industry partners assign all rights to FIND for royalty-free use of their technology in the public and private non-profit sectors in high endemic countries, while the industry partner retains distribution rights for developed countries and the private sector in developing countries. This enables the partner to recover R&D costs and to create the returns needed to develop new technologies.” (FIND Diagnostics 2015) Just as in the case of patent pools, this strategy counteracts IP’s exclusionary function in a particular geographical and social context. This limitation is intentional, as a group of PDPs points out in a position paper for the EU’s Horizon 2020 Framework: “PDPs were created specifically to address the research gap present in the development of products for diseases that lack viable commercial markets. PDPs use different models of IP management and licensing arrangements in their partnerships with academic institutions and private companies, aiming to de-link the costs of R&D from the cost of final products” (AERAS et al. 2012). Lezaun & Montgomery note that PPPs have begun to share IP, and use it “as a lever to attract others into risky collaborative ventures” (Lezaun and Montgomery 2015, 3; see also Williams 2012). This is contrary to the usual exclusionary function of IP, and gives rise to “a new moral economy of R&D” emphasising collaborations (Lezaun and Montgomery 2015, 5). However, PPPs combine priorities set by public sector organisations such as the WHO with the mechanisms of the private sector. This approach contains both the potential for more targeted and efficient implementation efforts and the unpredictable consequences of introducing the private sector’s economic rationale to the area of ‘public’ health. This has given rise to fears “that new partnerships are leading down a slippery slope towards the partial privatization and commercialization of the UN system” and “that partnership enables nation states to abdicate their responsibilities for the promotion and protection of their citizens’ health”, as for example “it is charged that the independent setting of standards was jeopardized during the elaboration of the guidelines for the management of hypertension because of the influence of a firm that stood to benefit from them” (Buse and Waxman 2001, 750). Despite these concerns, PPPs are increasingly involved in global health policies, and the WHO sees PPPs and PDPs as central to the future financing and facilitation of research and development of medicines (CEWG 2012a, 31). Thus neither patent pools nor PPPs/ PDPs are intending to challenge the notion of IP in general. They rather address the needs of certain patients from within the parameters of the international economic system. In this way they acknowledge the increasing demands of patients while they are at the same time reinforcing the general function of IP – from which they derive income. However, the emerging “moral economy” surrounding the financing of R&D in global health projects combines the use of IP with a politics of health, in which PPPs can be seen to be “governed at a distance” as they implement centrally defined priorities in small-scale private projects. Instead of focusing on IP’s economic function, it is argued in this thesis that PPPs are becoming involved in a version of somatic ethics developing within international organisations operating at the intersection of global health and the economy. The result is an ongoing process of accommodation between biopolitical and economic priorities, on the national and international level. The next chapter explores particular challenges to the IP system arising from this ethics, which even include frank debates on the introduction of alternatives to IP. Examples of human rights challenges and an increasing focus on the argument of ‘market failure’ could have radically unsettling effects on IP’s legitimation.