The Danish Laboratory Lundbeck A/S had obtained a favorable decision from the Spanish Supreme Court (Contentious Administrative section) in 2011, whereby its right to file a revised translation of its European patent for escitalopram (EP0347066), covering now the product claims, was acknowledged by virtue of the TRIPS. At the validation moment of this EP in March 1995, Lundbeck had filed a translation into Spanish of the patent, but excluding the product claims, due to the temporary reservation made by Spain to the EPC regarding pharma product’s patents.
Although the EP rights had lapsed in 2011, the Supplementary Protection Certificate (No. 200300019) is in force in Spain until 2014. Consequently, on the basis of the revised translation, Lundbeck and its Spanish licensee Almirall S.A. brought a preliminary injunction petition, along with a main infringement action of the SPC rights against a number of companies manufacturing or commercializing generic escitalopram. The Mercantile Court Nr. 4 of Barcelona had rejected the year before a similar litigation action, but regarding the method claims only. That judgment was confirmed last December by the Provincial Court of Barcelona.
The new case has not succeeded either. In May 2012, the same Court dismissed the preliminary injunction petition arguing that, in a provisional approach to the complex question at issue, the enforcement of the new broadened scope of Lundbeck’s rights over escitalopram would violate provisions of EPC, in particular Art. 123 (3). The Court added by the time, that this decision was not necessarily opposed to the validity of the revised translation, as the assessment of effects of a patent right, when enforced against third parties, belongs exclusively to the Civil Courts.
The ruling dated January 10th, 2013 on the main infringement action has confirmed the first approach. In a long and exhaustive decision, the judge dismisses initial arguments of some defendants regarding the potential invalidity of the SPC, and goes in detail to the enforceability question. The European patent is not a single and unique one in Court’s opinion. Indeed, the application was granted with three different set of claims. The one valid for Spain at that time included only the method claims, following EPO President’s recommendation dated May 13th 1992. Thus, it’s not the same patent for all States, but different patents granted by the same Patent Office. Art. 118 EPC and EPO Guidelines (H-III-4), confirms the validity of exceptional situations like this one, despite the general rule is the uniqueness.
More than this, according to the Judge, granting effects to the revised set of claims would also violate article 70 EPC, which prohibits a broader scope of protection to the EP when translated in the language of any State. Lundbeck’s patent was granted in English without product claims for Spain, and therefore this is the version to prevail. Other interpretation – concludes the Judge- would constitute a serious and groundless violation of the legal certainty of third parties.
Final pages content the reasoning of this particular and new interpretation of this question, expressing the justification to divert from other criteria arising from recent decisions of the Spanish Supreme Court. The Mercantile Court considers that despite the non-compulsory nature of EPO President Recommendation, Lundbeck has to assume now the consequences of its own behavior (venire contra factum proprium non valet).