A guide to supplementary protection

01 February 2010

Because pharmaceutical companies perform time-consuming clinical trials before receiving a marketing authorisation (MA) to put a product on the market, the protection offered by pharmaceutical product patents is often reduced by five to 10 years. This reduces the benefits from an IP monopoly.

Therefore, the European Union has decided to grant supplementary measures to protect drugs, such as a supplementary protection certificate (SPC) for a period of up to five years (EU Rule 469/2009). An SPC can be obtained in Belgium provided that the drug:

is protected by a patent in force in Belgium;
has not already been the subject matter of a previous certificate; and
has obtained a valid MA in Belgium

In Belgium, SPCs are granted after formal examination only. The patent office verifies whether the certificate is filed within six months of the Belgian MA, whether the name of the product is exactly the same as on the MA and other formal requirements. Hence, it is of the utmost importance to carefully choose the name that will appear on the MA.

Since many drugs used to treat children have not been subjected to specific clinical trials, the EU has recently decided to award companies performing such trials under specific circumstances a supplementary six-month protection called paediatric extension. The EU hopes this will promote development of treatments adapted to children's needs.

Generic drugs can only be put on the market after expiration of the protection by the basic patent, the SPC and the paediatric extension.

However, to promote generics, the EU has issued Directive 2004/27CE which provides that tests and studies required to obtain an MA do not constitute IP right infringement. Generic manufacturers are thus allowed to perform all required tests during the protection period of the original drug and to be ready to put the generic on the market as soon as the protection has expired.

Further, generic manufacturers are authorised to refer to the original drug MA data for obtaining their own MA (without performing costly clinical trials). For protecting substantial investments from pharmaceutical companies, the EU has also granted data protection periods of 10 years from the MA granting date. This disposition is really useful for non-patented products or products for which the MA has been granted late.