On 6 October 2015, the EU Court of Justice (“CJEU”) held that the date a centralised marketing authorization (“MA”) holder receives notification that the MA was granted is the relevant date for calculating the term of a supplementary protection certificate (“SPC”).
The CJEU judgment was issued in the Seattle Genetics case (C 471/14) and provides much needed clarity on when MAs are deemed to start and the duration of the corresponding SPC. Until now, it was unclear whether this was the day the MA was granted or the day the MA holder received notification. EU legislation provides that SPCs are calculated on the basis of “the date of first authorisation to place the product on the market in the Community”. However, existing SPC regulation is ambiguous on this point and EU member states have adopted divergent practices. The lack of unification on this point is problematic as there is often a delay between the grant of an MA and its notification to the applicant.
The Seattle Genetics ruling is in line with Advocate General Jääskinen's Opinion, and confirms the approach to the calculation of an SPC's term previously followed by the UK-Intellectual Property Office and several other national patent offices.
The agrochemical and pharmaceutical industries welcome the Seattle Genetics ruling for two reasons. Firstly, the ruling ends the uncertainty regarding the duration of effective patent protection afforded to medicinal and plant protection products as well as the current disparity in the duration of protection conferred by SPCs in different EU member states. Secondly, in certain cases the ruling will give SPC holders a longer period of exclusivity in countries which had previously calculated the SPC's term from the date of the MA decision. For blockbuster drugs, the additional protection – even though it may be a matter of a few days – will likely be of financial significance given the high revenues for these drugs and the significant time and efforts in the development of these innovative products.
What's more, there may be room for discussion for even longer SPC terms. This CJEU decision addresses MAs granted under the centralised procedure which is effective upon notification of the addressee. However, in certain national procedures an MA may become effective upon publication in an official gazette, which typically is even later than the notification to the MA holder. As the CJEU emphasizes, the SPC regulations aim at an "effective" system; procedural steps which are not under the control of the SPC holder, should not reduce the period of validity of an SPC. As such, it may open up an argument in favour of an even longer SPC duration with the date of effect of the MA being decisive.
Recalculation of SPC terms
As a result of this ruling, a number of SPCs will likely need to have their duration recalculated. In this respect, the judgment delivered by the Dutch Council of State – the highest general administrative court in the Netherlands – on 18 February 2015 will be of particular relevance. In that case, the Council of State endorsed a broad interpretation of Article 17 (2) of Regulation 1610/96 and held that SPC owners can request extension of the duration of a SPC at anytime. (Click here and here to see our previous articles on this case).
SPCs are available for certain products operating in the heavily regulated industries of agrochemicals and pharmaceuticals because Community legislators have determined that such companies should have (at most) fifteen years of market exclusivity for their products. The SPC compensates a patent holder for the erosion of patent protection suffered due to the lengthy regulatory process leading to the grant of an MA.
Click here to read the full text of the decision.
For more information on the impact of the Seattle Genetics ruling, please contact Rogier de Vrey.