Intellectual Property Rights and Vaccines.

ABSTRACT

Over the past 20 years, there has been steady, year-on-year growth in the number of granted vaccine-related patents. It is therefore important that those involved in vaccine research should be aware of both the risks and opportunities that patents create. The aim of this chapter is to offer a brief introduction to how, and when, patent rights might become available to vaccine developers and to explain the potential risk of infringement of third-party patent rights and the potential consequences.This chapter begins with a brief introduction to the patent application process and the international patent systems. The advantages and drawbacks of patent protection are discussed, followed by an overview of patent infringement and the various legal safe-harbors that may be available for certain research activities. Other features of the patent system which may be of particular relevance in the vaccines context are also discussed, such as compulsory licensing, sovereign states' rights to use patented inventions and voluntary technology sharing agreements. The chapter concludes with a discussion of the SARS-CoV-2 (COVID-19) pandemic and recent developments in the field of vaccine patents that have arisen as part of the international response.