On January 10 2013 Barcelona Commercial Court No 4 issued a judgment dismissing an action filed by H Lundbeck A/S, Lundbeck España SA and Almirall SA against companies that commercialise escitalopram generics in Spain, for alleged infringement of the supplementary protection certificate (SPC) derived from the basic escitalopram patent.
Lundbeck holds European patent EP0347066-B1 (EP'066), which was filed in June 1989 and granted in March 1995, with three different sets of claims – one of which is a special set of claims for Spain which contains two process claims. The Spanish translation of the patent was published in May 1995, with the number ES2068891-T3.
In 2004 Lundbeck obtained SPC 200300019, which entered into force when the patent expired on June 1 2009. Its expiry date is June 1 2014.
In August 2006 Lundbeck filed a revised translation of the EP'066 patent with the Spanish Patent and Trademark Office (SPTO), which included the set of product claims that had been granted for other countries (eg, Germany, France, the United Kingdom), but not for Spain. Initially, the SPTO refused to publish the revised translation, but Lundbeck appealed the decision – first before the SPTO and subsequently before the contentious administrative courts. On September 16 2011 the Contentious Administrative Chamber of the Supreme Court upheld Lundbeck's appeal and annulled the SPTO's decision. Thus, the revised translation was published in February 2012 as ES2068891-T4 – more than two-and-a-half years after the patent had expired and the SPC had entered into force.
In March 2012, after publication of the revised translation of the patent containing product claims, and asserting the SPC, Lundbeck sued all of the companies that were marketing generic escitalopram medicaments in Spain, as well as those which were due to launch theirs.
During 2009 and 2010 Lundbeck had previously sued some of these companies for infringement of SPC 200300019, to which Lundbeck attributed the scope of protection of the original translation of the patent (process claims).
On August 1 2011 Barcelona Commercial Court No 4, which also handled the previous case, dismissed Lundbeck's action (for further details please see "Infringement action against escitalopram generics is dismissed"). This decision was upheld by the Barcelona Court of Appeal on December 19 2012 (for further details please see "Appeal court dismisses Lundbeck's appeal in patent infringement case"). Lundbeck recently appealed this ruling before the Supreme Court.
Despite this background, Lundbeck 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 January 10 2013 Barcelona Commercial Court No 4 dismissed Lundbeck's second infringement action. On May 7 2012 the court had previously dismissed Lundbeck's preliminary injunction motion against the defendants (for further details please see "Preliminary injunction motion dismissed").
In summary, the court found as follows:
- The European patent is not a unitary patent, and it can contain different sets of claims for different designated states. Once granted, the European patent gives rise to a bundle of national protections.
- The EP'066 patent was granted by the European Patent Office (EPO) with three different sets of claims, one of which was a set of process claims for Spain that does not include product claims, which protect escitalopram as such.
- The revised translation published in February 2012 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, must prevail over the revised translation, with product claims (Article 70 of the European Patent Convention and Article 11 of Royal Decree 2424/1986 for the application of the European Patent Convention in Spain).
- Only the EPO, and not the SPTO, is competent to amend the claims of the European patent for Spain.
- The fact that the revised translation does not match the original patent as granted by the EPO for Spain must constitute a limit to the legal doctrine of the Supreme Court on the effects of the ratification by Spain of the Agreement on Trade-Related Aspects of Intellectual Property Rights.
- In any event, the case law of the Civil Chamber of the Supreme Court case law has not addressed the issue of how to resolve the discrepancy between the original text of the patent as granted (process) and the revised translation, which incorporates claims granted for other states (product), and which broadens the extent of protection of the patent as it was granted for Spain (Article 123.3 of the European Patent Convention).
Based on these grounds, the court concluded that Lundbeck's SPC continues to confer a process protection only, and not a product protection, regardless of the publication of the revised translation.
Lundbeck has filed an appeal against this judgment.
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