On July 20 2016 the Barcelona Court of Appeal issued a judgment confirming the dismissal of a patent infringement action filed by Pfizer against sildenafil generic competitors in Spain. Pursuant to its October 2014 decision in the Escitalopram case,(1) the appeal court has now confirmed its new case law regarding the Agreement on Trade-Related Aspects of IP Rights (TRIPs) and pharmaceutical patents filed before October 8 1992.

Facts

Pfizer was the holder of European patent EP 0 463 756 (EP'756), which was filed in June 1991 and granted in April 1995 with three different sets of claims, one of them particular to Spain with process claims only. The Spanish translation of the patent was published in July 1995.

In 2002 Pfizer obtained a supplementary protection certificate (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 and Trademark Office (SPTO), which included product claims. The SPTO refused to publish the revised translation and Pfizer brought the case to the contentious administrative courts. In November 2010 the Contentious Administrative Chamber of the Supreme Court annulled the SPTO's decision and ordered publication of the revised translation of the patent, which was made in August 2011 (ie, 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, claiming infringement of the patent and 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.

In a October 28 2014 decision Barcelona Commercial Court No 7 dismissed the infringement action following a Barcelona Court of Appeal decision in the Escitalopram case, which – based on European Court of Justice (ECJ) case law from July 2013 and January 2014 on the interpretation of TRIPs (Article 70) – had acknowledged that former Spanish jurisprudence had to be reviewed and corrected.

Pfizer appealed this first-instance judgment.

Decision

In a July 20 2016 decision the Barcelona Court of Appeal dismissed Pfizer's appeal.

The appeal court ratified the doctrine of its October 2014 decision in the Escitalopram case, which was analogous to the Sildenafil case. Thus, after reviewing the Supreme Court's case law and its own previous decisions regarding the interpretation of Articles 27 and 70 of TRIPs in relation to the Spanish prohibition against patenting pharmaceutical products as such before October 8 1992, the appeal court concluded as follows:

  • The ECJ decisions on the interpretation of Articles 27 and 70 of TRIPs are binding and their doctrine is to be applied to all cases, not just to future cases.
  • The ECJ decisions supersede former Spanish case law regarding the interpretation of these TRIPs provisions because, according to the ECJ, they cannot be construed so broadly. Therefore, Articles 27 and 70 of TRIPs do not contradict former Article 167.5 of the European Patent Convention, which continues to apply.
  • This applies to all European patents filed before October 8 1992, regardless of whether they were granted before or after the entry into force of TRIPs in Spain (1995) and regardless of whether they were granted with or without product claims for Spain. Thus, these patents cannot effectively claim pharmaceutical products as such in Spain.

The appeal court also rejected the additional arguments raised by Pfizer regarding the alleged binding nature of the November 2010 decision of the Contentious Administrative Chamber of the Supreme Court, which acknowledged Pfizer's right to publication of the revised translation of the patent.

Comment

The judgment confirms and consolidates the new doctrine of the Barcelona Court of Appeal as initiated with its decision in the Escitalopram case, which is still pending before the Supreme Court.

Pfizer could still file an extraordinary appeal to bring the Sildenafil case before the Supreme Court as well.

For further information on this topic please contact Ana-Laura Morales at Grau & Angulo by telephone (+34 93 202 34 56) or email (l.morales@gba-ip.com). The Grau & Angulo website can be accessed at www.gba-ip.com.

Endnotes

(1) Lundbeck v Generics – for further details please see "Court confirms precedence of ECJ decisions on TRIPs over national case law".

This article was first published by the International Law Office, a premium online legal update service for major companies and law firms worldwide. Register for a free subscription.