AstraZeneca AB v. Sandoz B.V. interim measures judge, District Court The Hague, the Netherlands, 15 August 2013, Case No. C/09/447111 / KG ZA 13-854
In 2012, the District Court of The Hague had denied Sandoz’ claim to invalidate AstraZeneca’s patent EP 0 907 364 for a sustained release formulation of the drug quetiapine/Seroquel® (see here). Pending the appeal against this judgment, Sandoz wanted to enter the market and had registered its generic quetiapine product on the Dutch price list ('G-Standaard'), arguing that the assessment of the District Court of Sandoz’ lack of inventive step arguments contained obvious errors. Sandoz also referred to parallel judgments from the UK Court of Appeal and the German Federal Patent Court, in which the patent had been invalidated for lack of inventive step. Before entering its product on the price list, Sandoz had proposed to AstraZeneca to refrain from introducing its product on the market pending the appeal proceedings, if AstraZeneca would acknowledge that it would be fully liable for all damage incurred by Sandoz, its affiliates and its customers arising from the enforcement of the patent. AstraZeneca had refused and had commenced preliminary injunction (PI) proceedings against Sandoz.
The PI judge granted the injunction against Sandoz. In accordance with standard case law, a PI judge is obliged to adhere to the judgment of the District Court on the validity of the patent, unless this judgment contains obvious errors. Sandoz had argued, inter alia, that the District Court had erred in its assessment of the various positive and negative pointers to the alleged invention in the prior art. Instead of accepting that the positive pointers rendered the claimed invention in principle obvious, and then assessing whether the negative pointers constituted a technical prejudice, the District Court had assessed obviousness based on all positive and negative pointers taken together. The PI Judge decided that, although it was possible that the Court of Appeal would approach the assessment of the various pointers differently, this was by no means certain and therefore it had not been established that the District Court had made an obvious error. Furthermore, AstraZeneca had admitted that parts of the reasoning of the District Court regarding first pass metabolism and pH dependent solubility were incorrect, but it was unclear whether this would have made a difference for the outcome of the District Court’s judgment.
In light of this, the judge held that AstraZeneca was entitled to enforce its patent against Sandoz, notwithstanding the different judgments in the UK and Germany, since the decision of the Dutch District Court is to be considered decisive. The fact that Sandoz had, before the PI proceedings, offered to refrain from introducing its generic product on the market in return for the acknowledgment of liability did not affect AstraZeneca’s urgent interest in obtaining an injunction, nor its entitlement to a full cost award.
Read thed decision (in Dutch) here.
Head note: Jaap Bremer