The European Parliament Legal Affairs Committee has now approved its position on the proposals for a unitary SPC and the recast SPC regulations for medicinal products. The proposals aim to produce a simplified and centralised application procedure for SPCs (currently done nationally in each state) and an SPC for the unitary patent (also to be centrally administered). See European Parliament Press release, 24 January 2024.
In the words of the Legal Affairs Committee's rapporteur, the new measures will "remove the fragmentation that currently exists between member states when it comes to the implementation of the regulatory framework. This will provide predictability for both the innovative and generic industry.”
The European Parliament will debate these measures on 26 February 2024. If the Parliament adopts a position on these proposals, it will be ready to start talks with EU countries on the final shape of the legislation. This involves a back-and-forth process with the EU Council until a "common position" is adopted.
These proposals were initially covered in our blog posts here and here.
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