A patent can be defined as a limited monopoly, legally acknowledged and attributed by a competent authority, granted to an inventor (or its legal successor) in order to commercially exploit an invention in return for the disclosure of the technical information forming the basis of such invention.

As set forth in the definition above, this monopoly is limited in various ways:

First of all, patent protection is limited in time: in principle, a patent is granted for a twenty year period; this term is calculated as from the filing date of the patent application. Nevertheless, certain countries provide for a protection more limited in time, for instance in case the patent applicant opts not to fulfil all required administrative formalities.

On the other hand, so-called “Supplementary Protection Certificates” may be granted for medicinal products protected by patent: since marketing authorizations are required for such products – which procedure may be lengthy in time – an “extension” of the term of the patent to twenty-five years can be allowed in case certain conditions are met.

The system of Supplementary Protection Certificates is designed to extend the time protection given to a patented medicinal product. Nevertheless, it is in a certain way limited than the original patent, as the certificate only protects

    (i)the product covered by the authorization to place the corresponding medicinal product on the market, and

    (ii)any use of the product as a medicinal product that has been authorized before the expiry of the certificate.

In order to benefit from the effects of a Supplementary Protection Certificate (SPC), an application should be filed in a EU Member State within six months of the date of which the Member State authorizes the product to be put on the market as a medicinal product.

Furthermore, in Europe, a similar supplementary protection regime has been foreseen for plant protection products.

Both Regulations are directly applicable in all EU Member States; however, Supplementary Protection Certificates have effect only in the Member State in which they are granted.