Introduction

On February 16 2016 Madrid Commercial Court Number 8 dismissed a preliminary injunction motion by Actelion against Accord, Sandoz and Kern in a patent case regarding the drug bosentan (licensed under the tradename Tracleer).

Swiss company Roche was the holder of European patent EP0526708, relating to the active pharmaceutical ingredient bosentan. This patent – filed in June 1992 – was granted in October 2000 with a special set of process claims for Spain.

EP0526708 is the basic patent of a supplementary protection certificate (SPC) granted in Spain in 2004, which – following a paediatric extension – will be in force until August 28 2017. Actelion is the licensee of this SPC.

In July 2010 Roche filed a revised Spanish translation of EP0526708 with product and use claims, which was published by the Patent and Trademark Office in October 2011.

Background

In July 2015 Actelion applied for a preliminary injunction against Accord before the Barcelona Commercial Court for alleged infringement of the SPC, asserting the revised translation of EP0526708. More specifically, Actelion asserted Claim 18, a use claim in the revised translation.

Barcelona Commercial Court Number 1 granted an ex parte preliminary injunction, thus prohibiting the sale of Accord's bosentan medicaments. However, following Accord's opposition and the corresponding hearing, the court issued a decision on September 14 2015 revoking the preliminary injunction, as it concluded that the asserted claim would lack any legal effect.

The court based its decision on European Court of Justice (ECJ) case law – specifically, its July 18 2013 judgment and January 30 2014 orders – regarding the interpretation of Articles 27 and 70 of the Agreement on Trade-Related Aspects of Intellectual Property Rights, which had already been followed and applied by the Barcelona Court of Appeal in its October 22 2014 judgment in the escitalopram case.

Actelion did not appeal the court's decision, which became final.

Facts

In November 2015 Actelion filed another ex parte preliminary injunction motion, this time before the Madrid Commercial Court, and asserted the product and use claims of the EP0526708 revised translation.

Actelion requested a preliminary injunction not only against Accord, but also against Kern and Sandoz (which had acquired one of Accord's marketing authorisations for bosentan – the object of the previous litigation).

The court refused to grant an ex parte preliminary injunction and decided to schedule a hearing, which took place on February 9 2016.

Accord and Sandoz argued that as there had been no change in circumstances, Actelion could not make another request for a preliminary injunction which had already been dismissed by Barcelona Commercial Court Number 1 (Article 736(2) of the Civil Procedure Act).

Kern argued the lack of urgency as, if no preliminary injunction could be ordered to prevent the sale of Accord's and Sandoz's bosentan medicaments, the sale of Kern's product would harm at most Accord and Sandoz and not Actelion.

The defendants also alleged the prima facie weakness of Actelion's case, which was based on the inefficacy (and invalidity) of the product and use claims in the revised translation of EP0526708.

Decision

Madrid Commercial Court Number 8 upheld the defendants' arguments and dismissed the preliminary injunction motion in its February 16 2016 decision.

The court concluded that Actelion could not make another request for a preliminary injunction that had already been dismissed by Barcelona Commercial Court Number 1, as there had been no relevant change in circumstances and the principles of res iudicata (ie, matters already decided) and preclusion must be applied.

The court acknowledged that the prima facie inefficacy of the asserted claims seemed clear, considering recent decisions by Spanish courts based on ECJ case law (ie, the December 21 2015 Supreme Court judgment in the quetiapine case and the October 22 2014 Barcelona Court of Appeal judgment in the escitalopram case), and stated that this was a legal issue to be assessed in depth in the course of the main proceedings on the merits.

Actelion's deadline to appeal the decision was March 21 2016.

For further information on this topic please contact Ignacio Pontijas at Grau & Angulo by telephone (+34 91 353 36 77) or email (i.pontijas@gba-ip.com). The Grau & Angulo website can be accessed at www.gba-ip.com.

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