A recent appeal decision from the Danish High Court (Eastern Division) concerns the issue of whether an application for an interlocutory injunction should be granted on an ex parte basis.

The case concerned (one of several) cases in Denmark regarding the Danish company H. Lundbeck A/S enforcing a process patent for its block buster API, escitalopram, this time against the Danish affiliate of ratiopharm.

Lundbeck argued before the Bailiff’s Court that as one injunction was already in place against the largest Danish wholesaler, Nomeco A/S, selling the ratiopharm escitalopram API there should be no need for a hearing de novo as the product, the facts, the evidence (and even counsel for the defendant) would be the same.

While the Bailiff’s Court did in fact grant the simulataneous application for seizure of evidence, the court turned down the application for an interlocutory injunction.

On appeal, the High Court upheld the decision not to grant an interlocutory injunction on the requested ex parte basis with reference to, inter alia, that the defendant should not be cut off from filing and arguing the its case (not least, added the High Court) since the patentee had invoked a reversed burden of proof (based on the process patent leading to a new pharmaceutical product) and the fact that – despite the earlier decision by another bailiff’s court to grant an interlocutory injunction on the same product from the same manufacturer – it could be not taken for granted that the allegedly infringing product did in fact infringe upon the patent-in-suit.

It is anticipated that the decision will be appealed by the patentee even though the decision is very clear.

Bearing in mind that the Danish bailiff’s courts are not specialty courts (either in terms of patent law or pharmaceutical chemistry), it would seem very unfortunate if the High Court had in fact sanctioned the patentee’s approach – especially under these circumstances where the patentee chose to rely on a reversed burden of proof.

It would be interesting to know about the experiences from other jurisdictions, i.e. whether applications for ex parte injunctions based on pharmaceutical patents are likely to be (or have been) granted?


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3 comments

  1. Interesting. For what it’s worth, I have been wondering if requests for ex-parte “pharmaceutical injunctions” have been treated with unusual caution by the The Hague Dictrict Court (DC), which is widely seen as exclusively competent for ex parte relief in patent cases in The Netherlands.

    First of all, reported cases are scarce, even taking in consideration that such injunctions have only been available since May 2007 (implementation of Directive EC/2004/48). This may be telling, since the majority of *refusals* go unreported.

    Secondly, the only reported cases (I hazard that are only two) suggest a particularly high barrier:

    In DC of The Hague, 24/7/09, GSK/ Pharmachemie, (valaciclovirum – SPC – EP0308065) an injunction was refused because no cease and desist letter had been sent prior to filing a request for injunction.

    In DC of The Hague, 5/10/09, Mundipharma/Mediq Farma (oxycodon formulation – EP 1258246) an injunction *was* granted. However, in that case a cease and desist letter had indeed been sent five days before the request was filed (granted the same day). Moreover the injunction followed an earlier judgment on the merits confirming validity and finding infringement.

    In other cases, not sending a prior cease and desist letter first is rarely, if ever, a reason for refusal.

    In short, although there is little to go on, the evidence suggests that ex parte injunctive relief is extra hard to come by in the form of a Dutch “pharmaceutical ex-parte injunction”. This nicely fits in with Danish High court decision above.

  2. So, upon receipt of a cease and desist letter in a Dutch pharmaceutical case: rush to file a “pre-emptive” defense letter to ward off possible ex-parte requests, as is allowed at the Hague DC. 🙂

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