T he Slovenian Intellectual Property Office (hereinafter: the Office) conducts procedures to grant supplementary protection certificates (SPC) pursuant to Regulation (EC) No. 469/2009 of the European Parliament and of the Council of 6 May 2009 on supplementary protection certificate for medicines (codified version)(hereinafter: Regulation 469/2009) and pursuant to Regulation of the European Parliament and of the Council (EC) No. 1610/96 of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (Official Gazette of the Republic of Slovenia, No. 56/06). A Supplementary Protection Certificate (hereinafter: SPC) shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorization to place the product on the market in the Community, reduced by a period of five years (Article 13 of Regulation 1610/96 and Article 13 of Regulation 469/2009).


Up until the judgement No. 846/2012-8 of the Administrative Court of the Republic of Slovenia of 4 June 2013 the Office had a uniform manner of determining duration of an SPC, namely the date of issuance of a marketing authorisation in the Community was considered as the date of the first marketing authorisation. This is also common practice of a number of patent offices in other member states.

In an administrative dispute initiated against the Office in relation to a decision to grant an SPC, the Administrative Court of the Republic of Slovenia passed the judgement No. 846/2012-8 that the Office incorrectly applied the substantive law in the case when the date of issuance of a marketing authorisation was considered as the relevant date of the first authorisation in terms of a provision of Article 13 of Regulation (EC) No. 469/2009. According to the Court, the date when the marketing authorisation in the Community came into effect shall be considered as the date of the first authorisation to place a product on the market in the Community, i. e. with the notification date, with which the European Commission notified the addressee of an issued authorisation. The judgement is based on an explanation that an authorisation to place the product on the market which was obtained by the centralised procedure in compliance with Regulation (EC) No. 716/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter: Regulation 726/2004) is an implementing order of the European Commission, i. e. an act of an EU institution which, in compliance with Article 297, subsection 2, paragraph 3 of the Treaty of the Functioning of the European Union, shall take effect on the date when those to whom they are addressed were notified thereof, in this concrete case the owner of the concrete authorisation to place the product on the market. The authorisation became effective with the notification date and not with the date, on which the authorisation was issued; therefore the notification date should be taken into account for the proper calculation of the duration of validity of a certificate and not the date, on which the authorisation to place the product on the market was issued.

Consequently, the Office adapted its practice regarding the relevant date for the calculation of duration of SPCs. In cases when the first authorisation to place the product on the market in the Community is an authorisation obtained by the centralised procedure pursuant to Regulation (EC) No. 726/2004 the notification date is considered to be the date of the first authorisation as stated in the Official Journal of the European Union relating to marketing authorisations.
Additionally, based on the changed practice of the Office it is not possible to request corrections of the already finally binding decisions to grant an SPC.


Back

logo



Contact

Patentna pisarna d.o.o.
ńĆopova 14 
p.p. 1725
1001 Ljubljana, SLOVENIA


Cookies
© Copyright 2016 Patentna Pisarna