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Quick reference quide to pharmaceutical innovation inventions in the EU
Article 3 Oct 2019

How does the EU encourage pharmaceutical innovation?

Ben Brigou and Jaap Mannaerts examine the different incentives the EU offers in order to encourage pharmaceutical innovation, including SPCs, regulatory measures and the Bolar exemption.

The protection of pharmaceutical products within the European Union is the result of a complex interplay of different mechanisms which all have one thing in common – they are aimed at encouraging pharmaceutical innovation. While not purporting to be exhaustive or covering every detail, this quick-reference guide explains in a basic manner the different mechanisms which are available in the EU. It should be noted that this is a rapidly evolving field, and that the different in-depth studies which were recently published are likely to give rise to further amendments and fine-tuning to the relevant legislation.

The Bolar exemption allows companies to research generic products before the original patent (and potential SPC) has expired, without infringing the patent.

The member states of the European Union are all contracting states to the European Patent Convention (EPC). Under the EPC, where a substance or composition is already known to have been used in a “first medical use”, it may still be patentable for any second or further use, provided that said use is novel and inventive. A new application of a known compound in the form of a defined, real treatment of a pathological condition is thus considered as an invention eligible for patent protection. This principle extends to many further developments of a known compound or therapy, such as new indications, new dosage forms, new treatment regimens, new patient subgroups for known indications, new combination therapies etc.


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