Calculation of Duration of SPC

On 6 October 2015, the Court of Justice of the European Union issued Judgement C-471/14 in the case of Seattle Genetics Inc. deciding that the date of the first authorisation to place a product on the market within the European Union is to be the date of communication of the decision on the marketing authorisation to its addressee.

Pursuant to that judgement, the State Intellectual Property Office (hereinafter: the Office) changed the method of calculating the duration of the SPC by considering relevant the date of notifying the party of the decision on approval, which was applied to the requests for the issuance of the SPC according to which the Office did not issue a decision at the time of application of the judgement.

Following the judgement cited above, on 20 December 2017 the Court of Justice of the European Union delivered judgement C-492/16 in the Incyte case, which enabled the retroactive application of the decision in case C-471/14, which shows that holders of SPCs issued before 6 October 2015 may request a recalculation of the duration of the SPC until its expiration.

Holders of already issued SPCs that require a new calculation of duration are obliged to submit to the Office proof of the date of receipt of the decision on the approval for placing the product on the market, namely:

• a copy of the notice publishing the authorisation in the Official Journal of the European Union, if the authorisation was obtained in accordance with the centralized procedure prescribed by the Regulation (EC) No. 726/2004 of the EUROPEAN PARLIAMENT and of the COUNCIL 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

• appropriate evidence from which the date of receipt of the approval decision can be unambiguously established, if the approval has been obtained from the competent national institution.