The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentives in Patent Law and Politics to end the COVID-19 Pandemic

Abstract

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.

The COVID-19 vaccine patent: a right without rationale

“…Furthermore, public access to patent applications is justifiably delayed. Moreover, overlapping patent applications with only slight variance tend to create patent thickets that preclude competitors from further research and development, which could otherwise benefit society ( Thambisetty et al 2021 ).…”

“…Supporters of the patent waiver proposal also contend that vaccine producers have tried to profit unfairly from the freedom of pricing ( Thambisetty et al 2021 ). According to them, TRIPS paves the way for patent holders to determine prices for their products, which can be kept high and beyond the reach of patients who need them more.…”

“… Cross et al (2021) reported, for example, that over 97% of the funds employed in the research and development process leading to the invention of the AstraZeneca vaccines was public. It is estimated that public funds amounting to over US$100 billion were spent on the development of vaccines ( Thambisetty et al 2021 ).…”

“…Lastly, many other countries in need of treatment, but without production capacity, will not benefit from compulsory licensing as production must be reserved exclusively for the applicant’s domestic market ( Ranjan 2021 ). Thus, the compulsory licensing flexibility is a time-consuming and complex process ( Thambisetty et al 2021 ).…”

COVID-19 Exposes Warped Global Health Power: The System Needs a Course Correction

“…24 The proposal would cut through the morass of laws and restrictions governing intellectual property that impede widespread manufacturing and exports. 25 By that time, rich governments were aggressively signing bilateral deals with pharmaceutical companies to pre-book future COVID-19 vaccines for their own populations. 26 Many of these same governments, facing intense and aggressive lobbying from the pharmaceutical industry, 27 have blocked the TRIPS waiver proposal from moving forward despite support from more than 100 governments, 28 the WHO Director General, 29 Nobel laureates and former world leaders, 30 lawmakers, 31 labour unions, 32 the People's Vaccine Alliance, 33 and countless civil society organizations.…”