Court of Appeal of The Hague, 27 August 2013, case number 200.115.757/01 (Teva v Sanofi)

On 27 August 2013, the Court of Appeal of The Hague rendered a remarkable judgment in preliminary injunction proceedings between Teva and Sanofi. These proceedings concern two SPCs held by Sanofi that were issued for (i) irbesartan - marketed under the name Aprovel - and (ii) a combination product comprising irbesartan and hydrochlorothiazide ("HCTZ") - marketed under the name Co-Aprovel. Both SPC's are based on the same basic patent. This basic patent for the class of compounds to which irbesartan belongs, also contains a claim relating to irbesartan and “a diuretic”.

Parallel proceedings are taking place in Germany, France and the United Kingdom. In Germany, the Landgericht Düsseldorf assumed the validity of the combination SPC. In France, the Paris Tribunal de Grande Instance on appeal found that HCTZ was sufficiently identified in the wording of claim 20 by the word “diuretic”. In the United Kingdom, Justice Arnold J of the High Court of Justice referred two questions to the Court of Justice of the European Union ("ECJ"). One of the questions relates to the criteria for deciding whether the combination is sufficiently specified in the claims, as the German and French courts held. The other questions relate to whether it is at all possible to get multiple SPC's on the basis of one basic patent. Similar questions had already been referred by the District Court of The Hague (C-484/12, Georgetown University). Nevertheless, the Court of Appeal of The Hague felt confident enough to decide this issue without waiting for the ECJ.

The Court of Appeal refers to the literal wording of the previous ECJ decisions ("only one certificate for each basic patent"). According to the Court of Appeal, a "product" in the sense of the SPC Regulation is the innovative active ingredient or combination of ingredients the patent was granted for, i.e. the invented basic ingredient. In this case, irbesartan would be the "the inventive advance of the patent". The Court of Appeal goes on stating that the only reason that the combination of irbesartan and HCTZ is novel and inventive is because irbesartan is, while the combination product as such in fact was not the result of inventive step. This reasoning, according to the Court of Appeal, is in line with the objective of the SPC Regulation, namely to encourage pharmaceutical research.

The reasoning applied by the Court of Appeal presupposes a kind of inventive step analysis to determine whether something is a product in the sense of the SPC Regulation. There appears to be no basis in the SPC regulation for such an approach. Furthermore, it can be doubted whether it is fair to attach so much weight to the wording "only one certificate for each basic patent" in the Medeva judgment (et.seq.), and whether this is the correct interpretation of the sentence at all, also in view of other ECJ case law. In any event, the decision was rendered in preliminary relief proceedings, and may still be appealed at the Supreme Court.

The divergence in the outcome of these parallel proceedings throughout Europe is striking. Also the national patent offices now apply different policies on this topic: the UK patent offices does grant multiple SPC for one basic patent, whereas the Dutch Patent Offices refuses them. It goes without saying that there is a need for clear and workable criteria from the ECJ. As said, it is highly questionable that the criterion applied by the Court of Appeal is such a clear and workable criterio