The Interaction Between Exclusivity Rights Systems: A Comparative View on Patents and Regulatory Exclusivities

In the post-pandemic period, exclusivity rights such as patents have gained special attention. Patents are intended as a tool to prevent potential market failure in intangible goods and entice 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 introducing various measures to limit exclusivity rights (compulsory licence, IP waiver) (See: Hilty et al. (Covid-19 and the role of intellectual property position statement of the Max Planck Institute for Innovation and Competition of 7 May 2021, 1–11, 2021), Médecins sans Frontières (Médecins sans Frontières, Lack of a real IP waiver on COVID-19 tools is a disappointing failure for people, 17 June 2022, available at: https://www.msf.org/lack-real-ip-waiver-covid-19-tools-disappointing-failure-people . Accessed 27 Feb 2023, 2022), Davies (Legal Stud: 1–18, 2022)., Sven Bostyn, Why a COVID IP waiver is not a good strategy, Position Paper, 10 May 2021, 1 -17.) which has even resulted in a Proposal for a new Regulation on compulsory licensing for crisis management (Proposal of 27 April 2023 for a Regulation on the European Parliament and of the Council on compulsory licensing for crisis management and amending Regulation (EC) 816/2006, Brussels, 27.4.2023 COM(2023) 224 final 2023/0129 (COD) (Further - Proposal for a Regulation on compulsory licensing).). However, patents are not the only exclusivity rights available to (bio)pharmaceuticals. Regulatory exclusivities, although less known to broader society, are no less important than patents and no less relied on by the pharmaceutical industry. The (bio)pharmaceutical industry receives incentives in the form of different exclusivity rights that vary in scope, length and availability (There are nine different exclusivity rights in Europe available to the pharma industry while other fields of technology only have patents available.). Regulatory exclusivities due to their flexibility are attractive as an innovation policy tool while potentially undermining interests which the patent system intends to take into account. This contribution provides a comparative view on patents and the less explored “8+2+1” regulatory exclusivities. And finally, the contribution concludes with some preliminary considerations on potential legislative adjustments, without which much-discussed compulsory licensing may potentially turn out to make little sense (The contribution was submitted on 1 June 2023 considering also the EU proposals concerning regulatory exclusivities. See Proposal of 26 April 2023 for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC, Brussels, 26.4.2023 COM(2023) 192 final 2023/0132 (COD) (Further – Proposal for a Directive of the Union code).).