Category : Unitary Patent

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.

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