Europe: CJEU rules on SPC term

November 21, 2016

In Estonia a patent was granted on April 15 1998 followed by a marketing authorisation on June 8 2001 for a pharmaceutical composition comprising the active agent capecitabine. Based thereon a supplementary protection certificate (SPC) was requested and granted. According to Estonian national SPC regulations the SPC provided a protection term of 15 years from the date of grant of the marketing authorization, that is until June 8 2016.

On December 15 2014, however, a generic competitor wanted to bring a generic composition comprising capecitabine onto the Estonian market since, according to the competitor´s calculation, the SPC protection term ended on June 10 2013. The patentee filed an infringement suit against the competitor and the court of second instance, the Tallinn Court of Appeal, transferred the case to the CJEU for clarification of the termination date of the SPC in Estonia.

How did the discrepancy in the calculation of the termination dates arise?

On May 1 2004 Estonia became a member of the EU and according to European SPC regulations the protection term of an SPC is calculated based on the first marketing authorisation in the EU which, in the present case, was granted for capecitabine in Switzerland on June 10 1998. The CJEU hinted that Article 21(2) of SPC Regulation 469/2009 states that the regulation applies to SPCs granted according to national regulations in Estonia prior to the date of Estonia´s accession to the EU.

Further, Article 13 of this regulation in conjunction with recital 9 thereof indicates that the holder of both the patent and the SPC should not be able to enjoy more than 15 years of exclusivity from the time of the first marketing authorisation granted in the EU which, according to Article 13, has to be interpreted as the European Economic Area (EEA). Accordingly, the protection term of an SPC is calculated based on the first marketing authorisation in the EEA, even if a national SPC was granted based on a national marketing authorisation before accession of the country in question to the EU.