The Supplementary Protection Certificate and the Unitary Patent
Regulation 469/2009 (the “SPC Regulation”) lays down a system for the provision of Supplementary Protection Certificates (SPCs) in the EU. SPCs were introduced to compensate for the loss of effective patent term caused by the delay in obtaining marketing authorisation for a pharmaceutical product, by extending the protection offered by the basic patent for a further period of up to five years. During this period, where a product in the form referred to in the marketing authorisation is protected by the basic patent, the SPC protects the product, in the form referred to in the marketing authorisation, in any of the forms enjoying the protection of the basic patent (see C-392/97, Farmitalia). The system currently allows for the grant by national industrial patent offices of SPCs based on basic national patents and European Patents designating that country. An SPC is valid from the expiry of the basic patent, until 15 years after the grant of the first marketing authorisation in the EEA, with a maximum of five years (unless a paediatric extension is also granted). This means that if the first marketing authorisation is granted within five years of the application date of the basic patent, patent term extension may be obtained (although negative terms SPCs are possible, see C-125/10).. If the first marketing authorisation is granted between five and 10 years after the application date of the basic patent, the SPC will be valid from the expiry date of the basic patent until 15 years after the grant of the first marketing authorisation. If the first marketing authorisation is granted more than 10 years after the basic patent, the SPC will be valid for five years after the expiry of the basic patent.
SPCs hence play a major role in the protection of pharmaceutical products. However, with the coming into force in early 2015 of the Unified Patent Court Agreement the fate of SPCs and their relationship with the Unitary Patent need to be clarified.
The Unified Patent Court Agreement (UPCA) states in fact at article 3 (b) that the UPCA will apply to SPCs issued for a product protected by a patent and article 2 (g) of the UPCA precise that “patent” means a “European Patent or/and a European Patent with unitary effect”. The Unified Patent Court will thus have exclusive competence in respect of SPCsissued for a product protected by a European patent with or without unitary effect, as it is confirmed by the European Commission.
It thus seems that the UPCA will introduce two elements of change for the SCP.
First when a SPC will be granted on top of a European Patent, the UPC will be the sole court to be competent in case of litigation, after the end of the transitional regime. Of course, as for European patents, in the case of a SPC issued for a product protected by a European patent without unitary effect, it will be possible to request the opt-out from the exclusive jurisdiction of the UPC before the end of the transitional regime.
Second, the language of articles 2(g) and 3(b) may lead to consider that a SPC may be based on a European Patent with unitary effect as any other European Patent. However, SPCs are national titles which are applied for by the patentee in any of the EU states of his choice. It thus remains to be seen if and how, SPCs based on European patents with unitary effect may be achieved.