Addressing Exclusivity Issues During the COVID-19 Pandemic and Beyond

Abstract

Almost every aspect of the COVID-19 response, from vaccines, diagnostics, and therapeutics to medical equipment, tracking systems, software, and other innovations, are or will become subject to some form of exclusive rights. Many of these involve intellectual property rights (IPRs). By offering innovators the exclusive right to exploit their innovations while recouping the costs of research, development, and other expenditures, IPRs may incentivize the development of new technologies. But IPRs may also preclude others from important research, manufacturing, and distribution. In the same vein, these exclusionary rights allow right holders to set prices in the absence of competition. Since this may limit access to innovations that are crucial for tackling pandemics, IPRs are a key factor in pandemic response and preparedness. Consequently, they have generated much controversy around the globe.

Many of these debates have concentrated on traditional IPRs, particularly patent rights. Numerous existing patent claims cover new chemical or molecular entities. Patents are also filed for repurposed drugs and vaccine platforms (e.g., COVID-19 mRNA platforms), with separate patent protection for the vaccine and its elements, including viral particles, adjuvants, and vaccine boosters. Even in situations where no patent protection is available, many COVID-19 therapeutics and vaccines will also obtain regulatory, data, and market exclusivities. Consequently, the specific design and new areas of application for regulatory exclusivities have become an increasingly important issue in general innovation policy debates.

This chapter addresses exclusivity issues, with a particular emphasis on regulatory exclusivities for vaccines and therapeutics. We begin with a basic overview of the current regulatory exclusivity landscape in Europe and the US, followed by a discussion of current developments in COVID-19 vaccines and therapeutics. Next, we describe the influence of these technological developments on debates surrounding regulatory exclusivities while describing their relationship to other forms of exclusivities. From these assessments, we draw some lessons for market exclusivity, innovation, and access during the COVID-19 pandemic and beyond.

Note: Funding: This work was supported by the Collaborative Research Program for Biomedical Innovation Law, which is a scientifically independent collaborative research program supported by the Novo Nordisk Foundation (grant NNF17SA0027784).

Declaration of Interests: Michael S. Sinha has no competing interests to declare. Sven J.R. Bostyn has no competing interests to declare. Timo Minssen reports that he is an IP Advisory Board Member of Chr. Hansen A/S, though the company is not involved in the vaccine business and Prof. Minssen does not receive research support from the company.

Keywords: COVID-19, innovation policy, vaccines, FDA