In March 2012 H Lundbeck A/S, Lundbeck Espana SA and Almirall SA filed an action on the merits and a preliminary injunction motion for alleged infringement of Supplementary Protection Certificate (SPC) 200300019 concerning escitalopram against 21 generic manufacturers.

Lundbeck is the holder of European Patent EP0347066-B1 (EP'066), which was granted on March 1995 with three different sets of claims - one of them a special set of claims for Spain which contains two process claims. The Spanish translation of the patent was published on May 1995, with the number ES2068891-T3.

In 2004 Lundbeck obtained an SPC (SPC 200300019), which entered into force when the patent expired on June 1 2009. Its expiry date was June 1 2014.

In August 2006 Lundbeck filed with the Spanish Patent and Trademark Office (SPTO) a revised translation of its EP'066 patent, which included the set of product claims that had been granted for other countries, such as Germany, France and the United Kingdom, but not Spain.

Initially, the SPTO refused to publish the revised translation, but Lundbeck appealed the decision - first before the SPTO and then before the contentious-administrative courts. In a September 16 2011 decision the Contentious Administrative Chamber of the Supreme Court upheld Lundbeck's appeal and annulled the SPTO's decision. Thus, the revised translation was published on February 2012 as ES2068891-T4.

After publication of the revised translation of the patent containing product claims, and asserting SPC 200300019, Lundbeck sued all of the companies that were marketing generic escitalopram medicaments in Spain, as well as those in a position to launch theirs.

Prior to this new litigation, Lundbeck had already sued some of those companies for infringement of SPC 200300019, to which Lundbeck attributed the scope of protection of the original translation of the patent (process claims). Barcelona Commercial Court 4, which also handled that case, lifted the preliminary injunctions that it had initially granted ex parte. Consequently, the first escitalopram generics were marketed in May 2010.

In that first litigation Barcelona Commercial Court 4 also dismissed the main infringement action on the merits in a judgment of August 1 2011. The case is currently pending before the Barcelona Court of Appeal.

Lundbeck nonetheless filed a new action and preliminary injunction motion for infringement of SPC 200300019, to which it attributed the scope of the revised translation of the patent (product claims).

On May 7 2012 Barcelona Commercial Court 4 dismissed Lundbeck's petition for a preliminary injunction. As stated in the decision itself, and due to the significance and complexity of the case, the judges of Commercial Courts 1, 4 and 5, which specialise in patent matters, met to deliberate and agreed unanimously as follows:

  • The EP'066 patent was granted with three different sets of claims for the different designated states. One of these was a set of process claims for Spain.
  • The revised translation ES2068891-T4 would broaden the scope of protection conferred by the patent as granted for Spain in the original language of the proceedings (English). Thus, the original text of the patent in English, with process claims, prevailed over the revised translation, with product claims (Article 70 of the EPC and Article 11 RD 2424/1986).
  • Only the European Patent Office, and not the SPTO, was competent to amend the claims of the European patent for Spain.

Based on these grounds, the court concluded that the patent and SPC conferred a process protection only, and not a product protection, regardless of publication of the revised translation.

Lundbeck has appealed this decision before the Barcelona Court of Appeal.

For further information on this topic please contact Sara Pelaz at Grau & Angulo by telephone (+34 93 202 34 56), fax (+34 93 240 53 83) or email ([email protected]).