Supplementary Protection Certificate - Determination of Term

Determination of Term

The term of an SPC depends on the date of issuance of the first MA within the EEA and can be determined by the equation:

Under normal circumstances, this means the following.

• No SPC term is available if less than 5 years have elapsed between the date of filing of the corresponding patent and the date of issuance of the first MA in the EEA.
• If the first MA is issued more than five years but less than ten years after the filing date of the corresponding patent, an SPC is granted for a term corresponding to the period elapsed between the five-year point and the MA issuance date.
• If the first MA is issued more than ten years after the filing date of the corresponding patent, an SPC is granted for a five-year term.

There have been very few cases where there was any controversy over the precise date of the 1st MA in the EEA. The Hässle AB case (ECJ case C-127/00) was one of that small number. In that case, the ECJ ruled that the decisive date for SPC purposes is the date of an authorisation from a regulatory body tasked with assessing safety and efficacy, and not the date of a subsequent authorisation that may be required under national pricing or reimbursement provisions.

So-called "centralised" (European Medicines Agency / European Commission) MAs were introduced by Regulation 2309/93 and became available in January 1995 (i.e. some 2 years after the introduction of the original SPC legislation for medicinal products). The introduction of these authorisations added a new layer of complexity to the issue of determination of the date of a MA. This is because there are two dates associated with "centralised" authorisations, namely: (1) the date of the European Commission's decision to issue an authorisation; and (2) the date of notification of that decision to the MA applicant. Date (2) is usually a few days (e.g. 2 to 4 days) later than date (1). Although the standard practice of many national patent offices seems to be to calculate SPC term based upon date (1), an October 2011 article in Scrip Regulatory Affairs by Mike Snodin argues that this standard practice is incorrect and that date (2) should be used instead (with the result that some products may be entitled to a slightly longer SPC term than previously thought). Paramount amongst the reasons for preferring date (2) to date (1) is that a "centralised" authorisation does not become effective until it is notified to the MA applicant.

It is still too early to tell whether these arguments will prompt any of the above-mentioned national patent offices to change their standard practice. However, inspection of Belgian SPC certificates for products authorised via the "centralised" procedure reveals that at least the patent office in Belgium already appears to base calculations of SPC term upon date (2). For this reason, it seems that there are divergent practices across different territories within Europe with regard to the selection of a date for a "centralised" MA. If the issue were ever to be debated in a national court, this fact that there are divergent practices across different territories could provide basis for such a court to seek an authoratitive ruling from the ECJ in relation to which of dates (1) and (2) should be used for SPCs. This is because, as European Commission legislation, the Regulations governing SPCs should be interpreted consistently across all member states of the EU.

A MA in Switzerland was also considered as being a first MA for the calculation of the SPC duration, even though Switzerland is not part of the European Economic Area (EEA). This is because such a MA was automatically effective in Liechtenstein, which is a member of the EEA (since May 1, 1995). This was decided by the European Court of Justice (ECJ) in joined cases Novartis et al. v. Comptroller-General and Ministère de l'Economie v. Millennium Pharmaceuticals. However, as answer to the decision of the ECJ the contract between Switzerland and Liechtenstein was amended. Since July 1, 2005 the automatic effect of a Swiss MA in Liechtenstein is abolished. The recognition is now delayed by a time period, which is normally 12 months.