SPC rules revised

01 June 2010

In the field of pharmaceuticals, a supplementary protection certificate (SPC) can be obtained for a maximum of five years after the duration of the patent. Originally, this SPC was granted to compensate for the investment pharmaceutical companies needed to make to obtain a marketing approval (MA) to put a new drug on the market.

On January 26 2007, Regulation EC 1901/2006 came into force granting an additional six-month protection to an SPC, so-called paediatric extensions, to reward companies that clinically develop drugs for children. The core of this regulation is that, when applying for a MA for a new product, a plan – which is called the paediatric investigation plan (PIP) – should be defined with the relevant authority – the paediatric committee of the European Medicine Agency (EMEA); further, the clinical trial results carried out with children should be included in the application for a MA. If the product is not a new product, an updated MA can be obtained containing a declaration indicating compliance with an agreed PIP.

The SPC regulation EC 1768/92 has been recently updated to include the requirements for obtaining the paediatric extension from EC 1901/2006 under a new regulation EC 469/2006 on May 6 2009.

The application for a paediatric extension should comprise a copy of the statement indicating compliance with an agreed completed PIP, together with the proof of possession of the authorisations to place the product on the market of all member states – since the product must be authorised in all of the EU member states.

The additional six-month protection given by EC 1901/2006 is not linked to the results of the clinical trials but to the fact that the trials, including children data, complied with the PIP.

The Belgian Patent Office has not yet issued guidelines or rules regarding how those cases should be managed but has already informed us that the "proof of possession of the authorisations to place the product on the market of all member states" is a key formal requirement.

If an SPC has been granted for a duration comprised between four-and-a-half and five years, care should be taken to pay the 26th renewal fee in due time.