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IP laws relating to COVID-19 vaccine

Intellectual property is property that includes intangible assets of human intellect. It is categorized under copyrights, patents, trademarks, trade secrets etc.

Coronavirus or COVID-19 has dominated our lives for the last nine months. It is history constantly being rewritten. The first case was reported by WHO on 31st December 2019, originating from Wuhan City, China. The cause of the severe acute respiratory syndrome that came to be known as COVID-19 was a novel coronavirus, SARS-CoV-2.

As of 10th December, 68.5 million cases have been reported of which 44.2 million have recovered and 1.56 people million have died. Out of these, 9.74 million are in India alone which stands as the second-highest number of cases worldwide after the USA (WHO COVID 19 dashboard, 2020).

As of December 2020, 59 vaccine candidates were in clinical research of which 42 are in Phase I-II trials and 17 are in Phase II–III trials. In November 2020, Pfizer Inc and BioNTech, Moderna, the University of Oxford (in collaboration with AstraZeneca), and the Gamaleya Institute announced positive results from the interim analyses of their Phase III vaccine trials (WHO COVID 19 vaccine, 2020). In December 2020, Sinopharm announced positive results from an interim analysis of their Phase III vaccine trials (Cyranoski D, Dec 2020, Nature.com).

On 2 December, provisional regulatory approval was granted for the Pfizer-BioNTech vaccine by the UK medicines regulator MHRA, and this vaccine is also under evaluation for emergency use authorization (EUA) status by the US FDA, and in various other countries (Corum J and Zimmer C, Dec 2020, New York Times).

Intellectual property (IP) constitutes a barrier to access to innovations. Innovation such as vaccines produce effective results. Countries are not able to obtain the innovation on appropriate and affordable terms and hence in such cases, IP acts as a barrier.

Since the inception of TRIPS (The Agreement on Trade-Related Aspects of Intellectual Property Rights) in 1995 by the WTO, international law has struggled to adequately account for human rights and development concerns. This has been noticeable in the compulsory licensing struggles over HIV-AIDS medications and in the impact of patent and plant variety protection measures upon food security in the Global South. Brielfy, there is room for doubt as to whether international intellectual property (IP) laws fairly and suitably serve global communities.

On October 2, India and South Africa sent a proposition to the World Trade Organisation (WTO), asking that it should allow the countries to suspend the protection of certain kinds of intellectual property (IP) related to the avoidance, containment, and treatment of COVID-19. The two countries propose this abdication to last until widespread COVID-19 vaccination is in place globally, and when the world’s population has developed immunity to the virus.

The concern is that the development of and equitable access to the tools – such as vaccines and treatments – required to fight the pandemic could be limited by patents and other IP barriers. The waiver proposal that was discussed in this meeting in the TRIPS Council aimed to remove dependency by lifting the barriers posed by patents and other forms of intellectual property to local production and distribution of biosimilar products.

The innovation ecosystem is extremely complex and includes many different State and market factors and many different policies, programs, and undertakings. The Global Innovation Index, for example, employs over 80 indicators to measure innovation capacity and performance, covering areas such as educational systems and institutions, research and development expenditure, scientific publications, IP applications, access to capital markets, new organisational frameworks, and business and market sophistication (Global Innovation Index, 2020)

Given the drastic impact of the COVID-19 crisis on human health and welfare and on economic production and welfare, the world needs to position all available innovation strategies, incentives and systems in the trail of vaccines, treatments, and cures. It would be a misinterpretation of the complexity of innovation to focus on one single strategy or solution. It is to be noted that nearly 70% of research and development (R&D) is funded by the commercial sector, while around 30% is funded by the State.

Around 70% of R&D is also performed by the commercial sector and 30% by the State. An effective strategy or approach to encouraging innovation must ensure that the right incentives are in place to encourage the major funders and performers of R&D to deliver results. IP is a central part of those incentives.

There are many measures that can be taken up by governments and market actors to enhance innovation performance and, specifically, innovation outcomes that will contribute to the mitigation and, ultimately, the resolution of the COVID-19 crisis. Many persons, institutions and corporations across the world are working with great effort and energy to achieve such outcomes.

Since the world came to know about SARS-Cov-2, there have been more than 360 clinical trials that are underway currently for potential treatments globally. Success will need the application of all available policy measures and business practices, including increased public research funding, scientific collaboration and the sharing of scientific results, public private partnerships and the use of market incentives to attract investment in pertinent innovation.

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