3. What is the duration of protection granted by a SPC?

Each case is different, and depends on when the product was granted marketing authorization.

The duration of the SPC is calculated on the basis of the time between the date of filing of the patent application and the date of obtaining marketing authorization.

In particular, after the legal term of the patent, the certificate extends the protection conferred for a maximum of 5 years after the expiry of the patent or 15 years after the date on which the MA was obtained, whichever is shorter.

In other words, the period of protection conferred by the SPC is :

• 5 years if marketing authorization is granted more than 10 years after filing of the patent application;

• less than 5 years if marketing authorization is granted sooner than 10 years....