An Exception to SPC Protection For Medicines


Support to generic pharmaceutical producers provided by the EU

The European Union is adopting new rules that introduce an exception to Supplementary Protection Certificate (SPC) protection for medicines, allowing EU-based manufacturers of generic and biosimilar pharmaceuticals to manufacture for export to non-EU countries during the term of the Supplementary Protection Certificate.

Under existing EU rules, a medicine protected by an SPC has intellectual property rights that effectively extend patent protection beyond the normal 20-year term of the patent, up to an additional five years.

The proposed exceptions will allow under certain circumstances, the export to non-EU countries of generics or biosimilars during the last six months of an SPC, but only when those generics or biosimilars are produced exclusively for export to countries where there is no protection of the originator’s drug.  The new exceptions will also include an exception for stockpiling purposes during the last six months of the SPC validity before the SPC expires.

This important development follows a long debate between the innovative pharmaceutical industry and generic/biosimilar manufacturers on the impact of intellectual property on access, medicines prices and jobs in the EU.

These new EU Rules have to be submitted for formal adoption to the European Parliament and the Council.

The EU is considering that the regulation will affect only SPCs that are applied for on or after the date of entry into force of the regulation, or applied for but only come into force after a set future date.

You may find more information by clicking here ►►►

If you have questions or concerns relating to SPC’s or the new EU exemptions, please contact Marina Mauro, SPC Team Member of Murgitroyd:

Marina Mauro

T: +39 02 8739 8550