02 | 11 | 2015

Notification on Amended Method of Calculating the Duration of the Supplementary Protection Certificate

On 6 October 2015, the Court of Justice of the European Union gave the judgement C-471/14 in case Seattle Genetics Inc. providing that Article 13(1) of Regulation (EC) of the European Parliament and of the Council No 469/2009 concerning the supplementary protection certificate (hereinafter: SPC) for medicinal products is to be interpreted in the following way:

• the “date of the first authorisation to place the product on the market in the European Union” is determined by the law of the Union,
• the “date of the first authorisation to place the product on the market in the European Union”, within the meaning of this Regulation, is the date of notification of the decision on the authorisation to place the product on the market given to its addressee.

Pursuant to this judgement, the State Intellectual Property Office (hereinafter: the Office) shall change the method of calculation the duration of the SPC in the way that the date of notification of the decision on authorisation given to the party shall be considered relevant rather than the date of granting the authorisation, which was the former practice of the Office.

In other words, the method of calculating pursuant to the ruling C-471/14 shall apply to all the requests for granting SPCs filed with the Office until 6 October 2015 or later and still pending with the Office.

The applicants for granting the SPC shall submit proof of the date of receiving the decision on the authorisation to place the product on the market, namely:

• a copy of the notifice publishing the authorisation in the Official Journal of the European Union, if the authorisation was granted in line with a centralised procedure provided for by Regulation (EC) No 726/2004 of the EUROPEAN PARLIAMENT AND THE COUNCIL as of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency,

or

• a corresponding evidence to unambiguously establish the date of receiving the decision on the authorisation, if the authorisation was granted by a competent national institution.