Takeda Pharmaceutical Company Ltd. filed the application for the SPC on 26/03/2012, having EP 1718641 as the base patent and based on the MA for azilsartan medoxomil -- Edarbi. The marketing authorization (MA) for Edarbi was granted by Decision C(2011)9280 of 07/12/2011, with publication in the Official Journal of European Union dated 24/02/2012, where the date of notification to the owner is identified has being 09/12/2011, two days after the date of the Decision.
During prosecution, Takeda filed a note with the PTMO with their arguments in favour of using the Notification date (09/12/2011) instead of the Decision date (07/12/2011) for the calculation of the SPC expiry dates. This SPC was granted on 25/09/2012 with the duration being calculated using the Decision date. The Patent Office argument was the following:
“The purpose of the present Official Communication is to inform that after analyzing the arguments filed on 06/06/2012 related to Supplementary Protection Certificate (SPC) 474, the date of the Marketing Authorization (MA) that is used to calculate the expiry date is, according to Article 13(1) of Regulation 469/2009 of the European Parliament and of the Council of 6 May 2009, the date written in the MA, in this particular case 07/12/2011.”With this, the expected validity end was 07/12/2026 instead of 09/12/2026.
After publication of the Decision from the PTMO, Takeda appealed from said Decision to the Portuguese Intellectual Property Court requiring that the date to be used in the calculation should be the date of the Notification.
The Court decision was based on the following most relevant reasons:
“…the relevant date to determine the validity period of the certificate consists of the starting date of the marketing authorisation associated therewith. It is from that date that the medicament can start to be commercialized. This does not occur with the pronunciation of the marketing authorisation decision but with the effective validity of that authorisation”.It further clarifies:
“It is provided in Article 297 of the Treaty on the Functioning of the European Union, which replaces the Treaty Establishing the European Community, that decisions that are not a legislative act and mentioning a addressee are notified to him/her and producing effects upon that notification.Thus, this decision confirmed that the date to be considered in the calculation of the duration of a SPC is the date of notification of the decision. Briefly, the Court decided that:
From this it results that the decision to grant a marketing authorisation only has effect from the notification date, for which reason the common practice is to make reference to it by publication in the Official Journal of the mention of the date of the decision and of the date of notification to its addressee.
It would not be understandable how an administrative act granting the authorisation for the practice of a fact could produce effects before its notification to the addressee and how the addressee could know that he/she may legitimately practise that fact without being aware of that decision”
* the decision of grant of a Marketing Authorisation has effect as from its date of Notification, not from the Decision date;
Earlier news from was posted by João on The SPC Blog here this April.* the administrative act which grants an authorisation could not have effect before its applicant had been notified.This decision is in agreement with the previous decision BL O/418/13 of the UKIPO [on which see Mike Snodin's earlier contribution on this blog here].
It is still to be seen what will be the understanding of the PTMO of this decision and if it will apply it (to future cases or, even, to previous cases) or if the PTMO will maintain its practice waiting for a referral to the CJEU on this matter.
