Author: Kaie Puur, Estonian Trademark and Design Attorney, Estonian Patent Attorney, Community Trademark and Design Attorney, Lawyer at METIDA
On 21 August 2014 the Board of Appeal of Industrial Property in Estonia made a decision which changes the present practice of the Estonian Patent Office on calculating the terms of supplementary protection of medicinal and plant protection products.
The decision was made in the appeal case filed by Takeda Pharmaceutical Company Limited who contested the decision of the Patent Office on granting supplementary protection on the medical product Ipreziv – azilsartan medoxomil. The corresponding SPC application had been filed in Estonia on 22.03.2012. The basic patent will be valid up to 25.02.2025. The Patent Office made a decision to grant supplementary protection but the validity of SPC was calculated on the basis of the date of the decision of the marketing authorisation that is 07.12.2011. As it is possible to grant supplementary protection up to 15 years from the date of the first marketing authorisation of the medicinal product, the SPC was granted up to 07.12.2026.
Takeda Pharmaceutical Company Limited did not agree with the Patent Office that the date of making decision on the marketing authorisation had been taken as basis for SPC and on 08.08.2012 they filed an appeal to the Board of Appeal of Industrial Property. They found that the date of notification of the first marketing authorisation, i.e. 09.12.2011, should have been taken as basis to the calculation of SPC validity.
The Board agreed with the Appellant that the date of notification of the marketing authorisation has to be handled as the date prescribed in Article 13 (1) of Regulation (EC) No 469/2009. The date of notification is the date when the applicant for the marketing authorisation is notified of the decision by the European Commission to grant the marketing authorisation and this is the date from which the granted authorisation takes effect. The date of notification is a few days later than the date of grant of the marketing authorisation and thus the duration of SPC is a bit longer.