"Novel Circumstances" Found In Pharmaceutical Patent Case

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The recent case of Servier v Apotex generated what the Judge referred to as "novel circumstances" which resulted in a speedy consideration by the Court of Appeal of the court’s refusal to maintain an interim injunction against Apotex whilst Servier appealed the order of the High Court to revoke its patent.
UK Intellectual Property
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The recent case of Servier v Apotex generated what the Judge referred to as "novel circumstances" which resulted in a speedy consideration by the Court of Appeal of the court’s refusal to maintain an interim injunction against Apotex whilst Servier appealed the order of the High Court to revoke its patent.

Background

In August 2006, Servier commenced an action in the UK High Court against Apotex for infringement of its patent for the α crystalline form of its ACE inhibitor drug perindopril, sold under the brand name COVERSYL™. Shortly afterwards Servier obtained an interim injunction against Apotex prohibiting Apotex from placing its product on the UK market until judgment in the action was handed down. The trial took place in March 2007 and the judgment was handed down on 10 July. The Judge found the patent invalid on the grounds of lack of novelty and obviousness.

"Novel circumstances"

Before the Judgment was made public, the Court considered an application by Servier to appeal the Court’s finding of invalidity. The Court granted Servier permission to appeal on the basis of the recent decision of the Court of Appeal in Pozzoli SPA v BDMO. In Pozzoli the Court of Appeal directed that when looking at whether to grant a party permission to appeal in patent cases:

"…unless the case is very clear on the facts and can be understood sufficiently readily in an hour or so, the better course of action is normally for the trial judge to give permission."

Given the complexity of the issues raised in Servier v Apotex, the court granted Servier permission to appeal but made it clear that were it not for Pozzoli no permission would have been given, as the court considered there to be no reasonable prospect of success on appeal.

The court was then asked to consider an application by Servier to maintain the current injunction against Apotex pending appeal. In considering this application, the court found itself in the difficult position of having granted permission to appeal where it believed there was no real prospect of success whilst at the same time recognising the irretrievable damage that the subsequent generic entry would cause to Servier’s branded monopoly if the injunction was lifted. In refusing the injunction the court recognised that the "novel circumstances" in which it found itself, having granted permission to appeal where it believed there were no prospects of success were "wholly out of the ordinary".

On the basis of the novel circumstances of the case the court agreed to maintain the injunction over the weekend to allow Servier to ask the Court of Appeal for permission to appeal the court’s refusal to maintain the injunction pending appeal. Servier subsequently lodged an application for permission to appeal, which was refused by the Court of Appeal.

Conclusion

In considering the application for permission to appeal, the Court of Appeal expressed surprise that the court had felt bound by its decision in Pozzoli and conceded that it had not envisaged that the judgment in Pozzoli would result in permission to appeal being granted in cases where the court had considered that there were no real prospects of success on appeal.

What is clear from the unusual circumstances in Servier v Apotex, is that pharmaceutical companies who have obtained an interim injunction against a generic company pending trial, cannot assume that the injunction will be maintained beyond a first instance decision, even where permission to appeal a finding of invalidity has been granted.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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