Ranbaxy (UK) Limited v. Astra Zeneca AB, District Court of The Hague, The Netherlands, 13 June 2012, Case Number: HA ZA 11-2396
Ranbaxy sought a declaration that certain tablets containing magnesium esomeprazole, for which Ranbaxy obtained market authorisation in the Netherlands, do not infringe EP 1020 461 (Magnesium salt of the (-)-enantiomer of omeprazole and its use) and EP 0 984 957, a new type of esomeprazole. According to Ranbaxy, these tablets do not contain magnesium esomeprazole with an optical purity of ≥ 99.8 % e.e., but magnesium esomeprazole with an optical purity of just 98,0 % - 99.2 % e.e. and therefore the product does not fall within the scope of protection of EP ‘461 and EP ‘957.
In the parallel UK proceedings, the English High Court (Mr Justice Kitchin) had granted Ranbaxys claim for a declaration of non-infringement. To substantiate its claim in the Dutch proceedings, Ranbaxy had submitted an expert opinion by Dr Collicot, an expert on the side of Ranbaxy in the parallel UK proceedings, who according to Ranbaxy had declared that the samples of Ranbaxy’s product contained esomeprazole with an optical purity outside the claimed range. However, the District Court considers that Ranbaxy has not presented a clear and complete version of that statement due to the confidentiality restrictions imposed in the UK proceedings. The District Court considers this at Ranbaxy’s own expense and risk. For this reason the expert opinion cannot be evidence for Ranbaxy’s argument that her tablets do not fall within the scope of protection of EP 461. Contrary to what Ranbaxy has argued, the District Court is not obliged to rule in line with the English High Court. The District Court has to form an independent opinion on the case, based on the arguments and statements as presented by parties in the Dutch proceedings and to which both parties are able to respond. The District Court rules that Ranbaxy has not substantiated her claims sufficiently and therefore rejects Ranbaxy’s claims.
Notably, eight days before the court hearing Ranbaxy had submitted a deed containing a change of claim. At the court hearing Ranbaxy explained that the change of claim must be taken to mean that Ranbaxy now claims that the product, as far as it has an optical purity equal to or lower than 99,2% e.e., does not fall within the scope of protection of EP 461 and EP 957. The District Court considers that Ranbaxy no longer seeks a declaration of non-infringement for an actual product, but a hypothetical product and that AstraZeneca was unable to properly investigate and prepare their defence on this matter. Therefore, the District Court rejected Ranbaxy’s change of claim.
Read the judgment (in Dutch) here.
Head note: Jaap Bremer