By means of an order dated 3 April 2019, the Spanish Supreme Court rejected the extraordinary appeals filed by Pfizer against a judgement issued by the Barcelona Court of Appeal confirming the dismissal of a patent infringement action against sildenafil generics competitors in Spain.

This order represents the end of a long battle sustained in Spain regarding the interpretation of Articles 27 and 70 of the TRIPs Agreement with respect to the prohibition to patent chemical and pharmaceutical products as such, which was in force in Spain until 7 October 1992.


Pfizer was the holder of European patent EP0463756 ("EP'756"), which was filed in June 1991 and granted in April 1995 with three different sets of claims, one of them specific for Spain with process claims only. The Spanish translation of the patent was published in July 1995.

In 2002 Pfizer obtained an SPC, which entered into force when the patent expired in June 2011 and lasted until June 2013.

In March 2006 Pfizer filed a "revised translation" of the EP'756 patent with the Spanish Patent Office (ESPTO), which included product claims. The ESPTO refused to publish the revised translation and Pfizer brought the case to the contentious-administrative courts. Finally, in November 2010 the Contentious Administrative Chamber of the Supreme Court annulled the ESPTO's decision and ordered the publication of the revised translation of the patent, which was made in August 2011, i.e. after the patent had expired and the SPC had entered into force.

In October 2011 Pfizer sued all the companies that were marketing sildenafil generics in Spain alleging infringement of the patent and of the SPC based on the product claims of the revised translation. Some of these generics had been on the market since late 2009 and early 2010.

By judgment of 28 October 2014, the Commercial Court No. 7 of Barcelona dismissed the infringement action following a decision issued by the Barcelona Court of Appeal just some days earlier in a very similar case (escitalopram). In that decision, the Barcelona Court of Appeal, based on case law from the CJEU of July 2013 (levofloxacin) and January 2014 (atorvastatin) on the correct interpretation of Article 70 of TRIPs, had ruled that the scope of patents granted with process claims only for Spain could not be subsequently broadened by adding product claims to the same through revised translations.

By means of a judgment dated 20 July 2016, the Barcelona Court of Appeal confirmed the previous decision of Commercial Court No. 7 in the sildenafil case.

The Supreme Court decision

By virtue of its Order of 3 April 2019, the Spanish Supreme Court directly refused to even admit Pfizer's extraordinary appeals, thus rejecting them without further prosecution and without the need to assess the substantive grounds of the same. Also, it dismissed Pfizer's request for a referral to be addressed to the CJEU.

In this regard, the Supreme Court considers that the case law from the CJEU is clear and that the previous judgment of the Barcelona Court of Appeal is consistent with the same.

In this way, the Supreme Court has confirmed and reaffirmed its previous decisions in analogous cases of 21 December 2015 (quetiapine) and 20 October 2017 (escitalopram), in which it had already acknowledged that the CJEU judgments regarding Article 70 TRIPs, of 2013-2014, contradicted and superseded the previous case law from the Spanish Supreme Court itself of 2010-2012, which had interpreted this provision too broadly and, based on the same, it had acknowledged the efficacy of pharmaceutical product patents despite being initially affected by the former prohibition to patent chemicals and pharmaceuticals as such.

This is the first time that the Spanish Supreme Court has directly refused to even admit an extraordinary appeal in this type of cases, thus rendering the issue definitively solved for good.

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.