The structure of global intellectual property law as incorporated in the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is implicated in the current lack of COVID-19 vaccines, medical equipment, medicines and diagnostics needed to combat the pandemic. In this paper, we elucidate the legal issues surrounding the 'TRIPS waiver' proposal initially put forward by India and South Africa in October 2020, which, as of June 2021, is supported by more than 60 states. We analyse the different intellectual property rights relevant to the proposal -focusing primarily on patent rights and trade secrets -which are most relevant to the present COVID-19 vaccine context. We explain why the existing TRIPS flexibilities around compulsory licensing are incapable of addressing the present pandemic context adequately, in terms of both procedure and legal substance. Given the ongoing absence of sufficient engagement by the pharmaceutical industry with proposed global mechanisms to share intellectual property rights, data and know-how to address the pandemic, we argue that both incentives and mandatory mechanisms are needed.We make two arguments to this effect: first, the TRIPS waiver is a necessary and proportionate legal measure for clearing intellectual property (IP) barriers in a direct, consistent and efficient fashion, enabling the freedom to operate for more companies to produce COVID-19 vaccines and other health technologies without the fear of infringing another party's IP rights and the attendant threat of litigation; and second, the TRIPS waiver acts as an important political, moral and economic lever towards encouraging solutions aimed at global equitable access to vaccines, which is in the wider interest of the global public. The TRIPS waiver is an essential legal instrument in this context for enabling a radical increase in manufacturing capacity, and hence supply, of COVID-19 vaccines, creating a pathway to achieve global equitable production and access.
ArgumentRecent studies of patents have argued that the very materiality and techniques of legal media, such as the written patent document, are vital for the legal construction of a patentable invention. Developing the centrality placed on patent documents further, it becomes important to understand how these documents are ordered and mobilized. Patent classification answers the necessity of making the virtual nature of textual claims practicable by linking written inscription to bureaucracy. Here, the epistemological organization of documents overlaps with the grid of patent administration. How are scientific inventions represented in such a process? If we examine the process of creating a new patent category within the International Patent Classification (IPC), it becomes clear that disagreements about the substance of the novel inventive subject matter have been resolved by computer simulations of patent documents in draft classifications. The practical needs of patent examiners were the most important concerns in the making of a new category. Such a lack of epistemological mediation between the scientific and legal identities of an invention depicts a legal understanding that science is already inside patent law. From an internal legal perspective, the self-referential introduction of the new patent category may make practical sense; however it becomes problematic from a technological and scientific standpoint as the remit of the patent classification also affects other social contexts and practices.
This chapter presents legal materiality as a distinct approach within law and humanities scholarship. Legal materiality is concerned with the conditions of possibility in and through which law arises, rather than taking law’s materiality to be self-evident, as when it is regarded as a form of material culture or when objects are taken as symbols of law. It distinguishes between matters and materials: if matters are problematizations or “matters of concern” to law, materials are the attributes or properties that are enlisted in acts of interpretation. Rather than addressing materials as inert physical elements that are acted upon by law, legal materiality is concerned with how materials come to matter by being engaged in the production of legal meaning through interpretive and representational practices. Section 2.2 situates this approach in relation to a broader inheritance of materialism and materiality in the Western tradition. It considers different understandings of “materialism,” such as “new materialisms” and historical materialism, that inform but also diverge from legal materiality. Section 2.3 engages with different uses of “materiality” in recent legal scholarship, followed by a detailed discussion of its meaning in two works of legal theory that have sought to articulate a conception of legal materiality. The concluding section discusses the potentials of this approach for law and humanities scholarship to understand how materials are directly implicated in the making of legal difference rather than serving solely as law’s objects.
This article examines global vaccine inequity during the COVID-19 pandemic. We critique intellectual property (IP) law under the 1994 WTO TRIPS Agreement, and specifically, the role that IP has played in enabling the inequities of production, distribution and pricing in the COVID-19 vaccine context. Given the failure of international response mechanisms, including COVAX and C-TAP, to address vaccine inequity, we argue the TRIPS waiver proposal should be viewed as offering a necessary and proportionate legal measure for clearing IP barriers that cannot be achieved by existing TRIPS flexibilities. Finally, we reflect on the waiver debate in the wider context of TRIPS and the need to boost global pandemic preparedness.
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