The Interface Between Patents and Regulatory Exclusivities and the View on the New EU Proposals Concerning Patent Compulsory Licensing and Regulatory Exclusivities

Abstract Exclusivity rights such as patents have gained special attention in the post-pandemic period. Patents are intended to be a tool to prevent potential market failure in intangible goods and encourage investment in innovation. At the same time, recently they have been accused of blocking access to COVID-19 vaccines and have even fuelled public debate on the introduction of various measures to limit the exclusivity rights arising from the grant of a patent. However, patents are not the only exclusivity available to (bio)pharmaceuticals. Regulatory exclusivities, though less well-known to broader society, are no less important than patents and no less relied on by the pharmaceutical industry. A fortiori, de lege lata regulatory exclusivities have no exceptions, which means they are more robust than patents and can potentially provide even stronger protection than that afforded by patents. This contribution provides a comparative view on patents and the less explored ‘8+2+1’ regulatory exclusivities, outlining common and distinctive features and the interaction between the two regimes. Some preliminary reflections are made on potential legislative adjustments, without which the much-debated compulsory licensing may prove to be of little use. Finally, insights are provided into the European Commission’s proposals of spring 2023 for general pharmaceutical legislation and compulsory licensing. Some preliminary insights into the proposed changes to the regulatory exclusivity system are also provided. Special attention is paid to the proposal aimed to reach compatibility between regulatory exclusivities and compulsory licensing.