10. Is it possible to challenge the validity of a CCP?

The answer is yes! Just as the validity of a patent can be challenged, the validity of a SPC can also be challenged by a third party.

In the field of drugs, it is quite common for generic companies to challenge the validity of a SPC (just as it is for them to challenge the validity of drug patents).

The SPC can be cancelled if it does not meet the criteria for grant as set out above. In this respect, a SPC can be cancelled if it has been granted on the basis of a patent which was no longer in force before the expiry of its 20-year legal term, for example for non-payment of annuities.

It can also be annulled if the basic patent is invalid, if the SPC relates to a product already covered by a patent which has previously been granted an SPC, if the MA is not technically the first to cover the product in question, etc....