No interim relief pending appeal against invalidity, rules Dutch court

PatLit thanks Jaap Bremer and Marleen van den Horst (BarentsKrans NV) for the following information concerning a very recent decision by the Provisions Judge of the District Court of the Hague. According to Jaap and Marleen (who represented Mylan in these proceedings),

"Novartis initiated interim injunction proceedings to obtain a preliminary injunction against two generics manufacturers, Mylan and Actavis, based its European Patent 0 948 320 for a sustained release formulation of fluvastatin, a drug for the treatment of hypercholesterolemia.

Novartis' patent had been nullified by the District Court for lack of inventive step by decision of 4 June 2008. Novartis had appealed against the first instance decision; the oral hearing in the appeal proceedings is scheduled for December 2009. Normally, in such a situation, the patent owner would not take infringement action unless and until the Court of Appeal has overturned the decision of the District Court. However, Novartis argued here that the District Court had clearly erred when finding that the patent lacked inventive step. For that reason, and since the recent market introduction of generic fluvastatin SR meant that Novartis was about to incur irreparable damage (or so it said), Novartis argued it had an urgent interest in obtaining an injunction against Mylan and Actavis and could not await the appeal judgment.

This is the first time that, in the Netherlands, a patent owner has attempted to obtain a preliminary injunction based on a patent that had been nullified in proceedings on the merits beforehand. Novartis' action is likely to have been inspired by the recent Olanzapine case in Germany, the facts of which case were similar to those of the Dutch case.

In the instant decision, the Provisions Judge found that there were no grounds for an injunction, since Novartis had not established that the District Court in the proceedings on the merits had made an evident error. Furthermore, the Judge ruled that, contrary to the arguments of Novartis, the decision of the District court to invalidate the patent has immediate effect erga omnes and is not suspended by appeal. This seems to imply that, after an invalidity decision in first instance, generics companies can enter the market pending appeal proceedings without fear of an injunction (of course, should the patent later revive as a result of a later judgment overturning the first instance decision, they could be liable for damages).

A translation of the decision is not yet available".

Thanks, Jaap and Marleen, for this information. PatLit's readers look forward to finding out what happens next.