Brevet de base

The basic patent is the patent designated by its holder for the purpose of obtaining a supplementary protection certificate. Regulation (EC) No 469/2009 defines it as a patent which protects a product as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for the grant of a certificate. The notion belongs to SPC law alone. It does not refer to a pioneer patent as opposed to improvement patents.

The role of the basic patent in obtaining the SPC

The certificate is granted only if, in the member state where the application is filed and at the date of that application, the product is protected by such a patent in force. The basic patent also determines the duration of the certificate: it corresponds to the period elapsed between the filing of the basic patent application and the first marketing authorisation in the Union, reduced by five years, and may not exceed five years. A six month paediatric extension may be added. The certificate takes effect at the legal expiry of the basic patent.

When is the product protected by the basic patent?

The Court of Justice requires that the product necessarily falls, in the light of the description and the drawings, within the invention covered by the patent, and that it be specifically identifiable by the person skilled in the art in the light of the state of the art at the filing or priority date. For a combination of active ingredients, each of them must satisfy that test. The certificate cannot protect more than the technical features of the claimed invention.

Invalidity of the basic patent and the fate of the certificate

The certificate is invalid where the basic patent lapsed before the expiry of its legal term, or where it is revoked or limited in such a way that the product is no longer protected. A nullity action against the basic patent is therefore often the first lever against an SPC, notably for a manufacturer of generic medicinal products preparing its market entry, relying where appropriate on the manufacturing waiver. On these questions, see our page on pharmaceutical patent and SPC litigation.