Abstract
What if a global public health emergency takes place? This question stopped being a hypothetical one or a matter of semantics while interpreting TRIPS or patent law exceptions, to become a reality. As we live in uncertain and trying times, things have become real and it is time to address the elephant in the room: that is, the power of data exclusivity regimes to deter or interfere with the use of TRIPS flexibilities, such as compulsory licenses for public health emergencies. This article’s objective is twofold. First, addresses the challenges in making effective use of a compulsory licence according to art.31 of the TRIPS in the EU, given its incompatibility with the EU data exclusivity regime deriving from the rules governing the regulation of pharmaceutical products in Directive 2001/83. And, second, this article makes a lege deferenda suggestion to include public health exceptions to data exclusivity at the EU level regardless of the chosen route to obtain a marketing authorization. To achieve its objective, the article starts by explaining what data exclusivity is, and its relation to marketing authorisations for patented pharmaceuticals. Subsequently, it shows why a patent compulsory licence will not be sufficient to address a global health crisis in the EU unless the data exclusivity issue is solved. Finally, the article concludes that public health exceptions are not only relevant in the context of patent law, and this why any exclusivity regime complementing the patent system cannot be insulated from those exception affecting patent law.
Original language | English |
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Peer-reviewed scientific journal | European Intellectual Property Review |
Volume | 42 |
Issue number | 9 |
Pages (from-to) | 539-547 |
ISSN | 0142-0461 |
Publication status | Published - 2020 |
MoE publication type | A1 Journal article - refereed |
Keywords
- 513 Law
- Compulsory licensing
- Coronavirus
- Data protection
- EU law
- Medical research
- Ptents
- Pharmaceuticals
- TRIPS
- Vaccines