The European Commission is considering consolidating and modernising the intellectual property (IP) rights framework as a way to stimulate research, innovation and growth within the EU.

A recent tender invited an evidence based analysis of the impact of the incentives on innovation, with a view to improving the patent system in Europe, in particular for pharmaceuticals and other industries whose products are subject to regulated market authorisations.  The tender is now closed, but the tender specification can still be accessed here.

Areas of particular interest cited in the tender include:

– supplementary protection certificates;

– “Bolar” patent infringement exemption relating to clinical trials;

– data exclusivity for medicinal products; and

– market protection for orphan medicinal products.

With regard to SPCs, the tender asks whether the SPC framework ‘is fit for purpose’ and hints at potential revisions to this framework, including

-extension of the scope of SPCs to other sectors, such as medical devices

-establishment of a unitary SPC

– changes to the scope of SPCs, in view of the rise of biosimilars

-changes to the term of SPCs

Any new legislation would, no doubt, have a significant impact on many players in this field, including innovators and manufacturers of generics or biosimilars.  Watch this space!

“The contractor shall conduct an economic evaluation of the incentives and rewards for pharmaceutical innovation, in particular an economic evaluation of national SPC systems in Europe”

https://etendering.ted.europa.eu/document/document-file-download.html?docFileId=24958#