Decision of the UK-IPO: BL O/418/13, 22.10.2013, Genzyme Corporation

Background

According to Article 13 of the SPC-regulation (EC) No. 469/2009 the duration of an SPC is calculated by the time between the filing date of the basic patent and the day of grant of the first market authorization for the product in the community. In the past, most national patent offices used the day of issuing of the market authorization as the relevant day.

The Decision

According to the decision BL O/418/13 of the UK-IPO the date of market authorization is the date of notification of the decision by applicant. This decision only concerns European market authorizations, since the European Commission in its reasoning defined that the period of validity of the authorization issued shall be five years from the date of notification of this decision. Thus, the UK-IPO concluded that since the marketing authorization only is valid from that day, also the duration of the SPC has to be calculated starting from that day.

In its decision the UK-IPO emphasized that in case of national market authorization in the UK furthermore the date of issuing of the market authorization is the relevant date.

Consequences for the Future

These diverging national decisions (or interpretations) have the consequence that the durations of SPC for the same product in different member states of the European Community differ: in the UK they are longer than in the most other member states. This may trigger a decision of the European court of justice to harmonize the interpretation. However, at the moment no ECJ decision is available and, therefore, one has to check in each member state individually on how the term “the date of the first authorization to place the product on the market” is interpreted at the national level.

To be on the safe side one might think of entering the market in all EU member states after the SPC has been lapsed according to the “longest” duration term at national level (which would correspond to the UK interpretation on European market authorizations). This, however, would mean a loss of some days in other EU member states that (at the current status) would allow an earlier market access.

This decision also is of great importance, since it emphasizes that the definition of the day of grant of a marketing authorization by no means is clear. Thus, the definition of the filing period, which according to Article 7 of the SPC-regulation (EC) No. 469/2009 is triggered by the grant of the marketing authorization, also will have to be defined once again by the European Court of Justice.